K233695 · Cyberdyne, Inc. · PHL · May 7, 2024 · Physical Medicine
Device Facts
Record ID
K233695
Device Name
Medical HAL Lower Limb Type (HAL-ML)
Applicant
Cyberdyne, Inc.
Product Code
PHL · Physical Medicine
Decision Date
May 7, 2024
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 890.3480
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
Medical HAL Lower Limb Type orthotically fits to the lower limbs and trunk; HAL is a gait training device intended to temporarily help improve ambulation upon completion of the HAL gait training intervention. HAL must be used with a Body Weight Support system. HAL is not intended for sports or stair climbing. HAL gait training is intended to be used in conjunction with regular physiotherapy. The device is intended for individuals with: - spinal cord injury at levels C4 to L5 (ASIA C, ASIA D) and T11 to L5 (ASIA A with Zones of Partial Preservation, ASIA B); - post stroke paresis - paraplegia due to progressive neuromuscular diseases (spinal muscular atrophy, spinal and bulbar muscular atrophy, amyotrophic lateral sclerosis, Charcot-Marie-Tooth disease, distal muscular dystrophy, inclusion body myositis, congenital myopathy, muscular dystrophy) -cerebral palsy and are 12 years or older -spastic paraplegia caused by either HTLV-1 Associated Myelopathy (HAM) or hereditary spastic paraplegia (HSP) who exhibit sufficient residual motor and movement-related functions of the hip and knee to trigger and control HAL. In preparation for HAL gait training, the controller can be used while the exoskeleton is not donned to provide biofeedback training through the visualization of surface electromyography bioelectrical signals recorded. HAL is intended to be used inside healthcare facilities while under trained medical supervision in accordance with the user assessment and training certification program.
Device Story
Battery-powered, bi-lateral lower extremity exoskeleton; provides assistive torque at hip and knee joints for gait training. Inputs: surface electromyography (sEMG) signals via electrodes; postural cues; sensor shoe measurements. Operation: proprietary signal processing algorithm detects sEMG to control device in Cybernic Voluntary Control (CVC) mode; also features Cybernic Autonomous Control (CAC) and Cybernic Impedance Control (CIC) modes. Used in healthcare facilities under trained medical supervision (e.g., physical therapist). Output: assistive torque for gait; visual biofeedback of sEMG signals. Clinical impact: synchronizes device movement with patient's neural motor intent to improve ambulation through repeated activity. Benefits: facilitates gait training for patients with neurological/muscular impairments; enables smaller patient fit via new size variations.
Clinical Evidence
Clinical evaluation performed across five indication groups: spinal cord injury, cerebrovascular disease, progressive neuromuscular disease, cerebral palsy, and spastic paraplegia. Data for spinal cord injury, cerebrovascular disease, and progressive neuromuscular disease were previously cleared (K201559). New clinical data submitted for cerebral palsy and spastic paraplegia. Results concluded the device is safe and effective for all five groups when used under trained medical supervision.
Technological Characteristics
Battery-powered, bi-lateral lower extremity exoskeleton; ~9.5 kg. Comprised of controller, main unit, and sensor shoes. 30 size variations (waist/leg length). Sensing: up to 18 surface electrodes for sEMG; sensor shoes for postural/force data. Connectivity: proprietary signal processing. Modes: CVC (sEMG-triggered), CAC (postural/sensor-based), CIC (friction compensation).
Indications for Use
Indicated for patients 12+ years with spinal cord injury (C4-L5 ASIA C/D; T11-L5 ASIA A/B), post-stroke paresis, progressive neuromuscular diseases (e.g., ALS, SMA, muscular dystrophy), cerebral palsy, or spastic paraplegia (HAM/HSP). Requires sufficient residual hip/knee motor function to trigger device. Contraindicated for sports/stair climbing; requires Body Weight Support system.
Regulatory Classification
Identification
A powered lower extremity exoskeleton is a prescription device that is composed of an external, powered, motorized orthosis that is placed over a person's paralyzed or weakened limbs for medical purposes.
Special Controls
In combination with the general controls of the FD&C Act, the Powered Exoskeleton is subject to the following special controls:
*Classification.* Class II (special controls). The special controls for this device are:(1) Elements of the device materials that may contact the patient must be demonstrated to be biocompatible.
(2) Appropriate analysis/testing must validate electromagnetic compatibility/interference (EMC/EMI), electrical safety, thermal safety, mechanical safety, battery performance and safety, and wireless performance, if applicable.
(3) Appropriate software verification, validation, and hazard analysis must be performed.
(4) Design characteristics must ensure geometry and materials composition are consistent with intended use.
(5) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Performance testing must include:
(i) Mechanical bench testing (including durability testing) to demonstrate that the device will withstand forces, conditions, and environments encountered during use;
(ii) Simulated use testing (
*i.e.,* cyclic loading testing) to demonstrate performance of device commands and safeguard under worst case conditions and after durability testing;(iii) Verification and validation of manual override controls are necessary, if present;
(iv) The accuracy of device features and safeguards; and
(v) Device functionality in terms of flame retardant materials, liquid/particle ingress prevention, sensor and actuator performance, and motor performance.
(6) Clinical testing must demonstrate a reasonable assurance of safe and effective use and capture any adverse events observed during clinical use when used under the proposed conditions of use, which must include considerations for:
(i) Level of supervision necessary, and
(ii) Environment of use (
*e.g.,* indoors and/or outdoors) including obstacles and terrain representative of the intended use environment.(7) A training program must be included with sufficient educational elements so that upon completion of training program, the clinician, user, and companion can:
(i) Identify the safe environments for device use,
(ii) Use all safety features of device, and
(iii) Operate the device in simulated or actual use environments representative of indicated environments and use.
(8) Labeling for the Physician and User must include the following:
(i) Appropriate instructions, warning, cautions, limitations, and information related to the necessary safeguards of the device, including warning against activities and environments that may put the user at greater risk.
(ii) Specific instructions and the clinical training needed for the safe use of the device, which includes:
(A) Instructions on assembling the device in all available configurations;
(B) Instructions on fitting the patient;
(C) Instructions and explanations of all available programs and how to program the device;
(D) Instructions and explanation of all controls, input, and outputs;
(E) Instructions on all available modes or states of the device;
(F) Instructions on all safety features of the device; and
(G) Instructions for properly maintaining the device.
(iii) Information on the patient population for which the device has been demonstrated to have a reasonable assurance of safety and effectiveness.
(iv) Pertinent non-clinical testing information (
*e.g.,* EMC, battery longevity).(v) A detailed summary of the clinical testing including:
(A) Adverse events encountered under use conditions,
(B) Summary of study outcomes and endpoints, and
(C) Information pertinent to use of the device including the conditions under which the device was studied (
*e.g.,* level of supervision or assistance, and environment of use (*e.g.,* indoors and/or outdoors) including obstacles and terrain).
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of the seal is the FDA logo in blue, with the words "U.S. FOOD & DRUG" on one line and "ADMINISTRATION" on the line below. The logo is simple and professional, and it is easily recognizable.
May 7, 2024
Cyberdyne Inc. Yohei Suzuki Official Correspondent 2-2-1 Gakuen-Minami Tsukuba, Ibaraki 305-0818 Japan
Re: K233695
Trade/Device Name: Medical HAL Lower Limb Type (HAL-ML) Regulation Number: 21 CFR 890.3480 Regulation Name: Powered Lower Extremity Exoskeleton Regulatory Class: Class II Product Code: PHL, HCC Dated: April 9, 2024 Received: April 9, 2024
Dear Yohei Suzuki:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
# Tushar Bansal -S
for Heather Dean, PhD Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Rehabilitation Devices OHT5: Office of Neurological and Physical Medicine Devices
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Office of Product Evaluation and Quality Center for Devices and Radiological Health
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#### Indications for Use
Submission Number (if known)
K233695
Device Name
Medical HAL Lower Limb Type (HAL-ML)
Indications for Use (Describe)
Medical HAL Lower Limb Type orthotically fits to the lower limbs and trunk; HAL is a gait training device intended to temporarily help improve ambulation upon completion of the HAL gait training intervention. HAL must be used with a Body Weight Support system. HAL is not intended for sports or stair climbing. HAL gait training is intended to be used in conjunction with regular physiotherapy.
The device is intended for individuals with:
- spinal cord iniurv at levels C4 to L5 (ASIA C. ASIA D) and T11 to L5 (ASIA A with Zones of Partial Preservation, ASIA B);
- post stroke paresis
- paraplegia due to progressive neuromuscular diseases (spinal muscular atrophy, spinal and bulbar muscular atrophy, amyotrophic lateral sclerosis, Charcot-Marie-Tooth disease, distal muscular dystrophy, inclusion body myositis, congenital myopathy, muscular dystrophy)
-cerebral palsy and are 12 years or older
-spastic paraplegia caused by either HTLV-1 Associated Myelopathy (HAM) or hereditary spastic paraplegia (HSP)
who exhibit sufficient residual motor and movement-related functions of the hip and knee to trigger and control HAL.
In preparation for HAL gait training, the controller can be used while the exoskeleton is not donned to provide biofeedback training through the visualization of surface electromyography bioelectrical signals recorded.
HAL is intended to be used inside healthcare facilities while under trained medical supervision in accordance with the user assessment and training certification program.
Type of Use (Select one or both, as applicable)
> Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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| 510(k) #: K233695 | 510(k) Summary | Prepared on: 2024-04-29 |
|-------------------|----------------|-------------------------|
|-------------------|----------------|-------------------------|
Contact Details
| Applicant Name | CYBERDYNE Inc. |
|-----------------------------|----------------------------------------------------|
| Applicant Address | 2-2-1 Gakuen-minami Tsukuba Ibaraki 305-0818 Japan |
| Applicant Contact Telephone | +81298698453 |
| Applicant Contact | Mr. Yohei Suzuki |
| Applicant Contact Email | suzuki_yohei@cyberdyne.jp |
Device Name
| Device Trade Name | Medical HAL Lower Limb Type (HAL-ML) |
|---------------------|--------------------------------------|
| Common Name | Powered lower extremity exoskeleton |
| Classification Name | Powered Exoskeleton |
| Regulation Number | 890.3480 |
| Product Code | PHL |
Legally Marketed Predicate Devices
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
|-------------|----------------------------------------------------------|--------------|
| K201559 | HAL for Medical Use (Lower Limb Type) | PHL |
Device Description Summary
| 21 CFR 807.92(a)(1) |
|---------------------|
|---------------------|
| 21 CFR 807.92(a)(2) |
|---------------------|
|---------------------|
| 21 CFR 807.92(a)(3) |
|---------------------|
|---------------------|
| 21 CFR 807.92(a)(4) |
|---------------------|
|---------------------|
Medical HAL Lower Limb Type is a battery powered bi-lateral ower extremity exoskeleton that provides assistive torque at the knee and hip joints for gait training. HAL is comprised of a controller, a main unit, and sensor shoes in 30 size variations (variation same as predicate: 3 different leg lengths, 2 different leg lengths, 2 different waist widths >> total 24. New size variation: 3 different leg configurations, 1 leg lengths, 2 different waist widths >> total 6) and weighs ~9.5 kg (21 lbs). The main difference between the Model ML05 and ML07 is the leglengths. ML05 has S.M, L, XL sizes, while ML07 has 2S sizes. The device uses legally marketed electrodes (up to 18 electrodes) to record surface electromyography bioelectrical signals that are processed using a propriety signal processing algorithm. The propriety processing algorithm allows the detect surface electromyography bioelectrical signals to control the HAL device in CVC mode and provide visualization of the surface electromyography bioelectrical signals during biofeedback training. The assistive torque can be adjusted using three parameters: sensitivity level, torque tuner, and balance tuner. The device can also provide two additional modes: Cybernic Autonomous Control (CAC) mode and Cybernic Impedance Control (ClC) mode. CAC mode provides assistive torque leg trajectories based on postural cues and sensor shoe measurements. CC mode provides torque to compensate for frictional resistance of the motor based on joint motion. CIC mode does not provide torque assistance for dictating joint trajectories. A trained medical professional (i.e., physical therapist, etc.) can configure, operate, and monitor the device during gait training to make adjustments as needed.
Patients must exhibit sufficient residual motor and movement-related functions of the hip and knee to trigger and control HAL. The patient must be supported by a Body Weight Support (BWS) system before and during device use. The BWS must not be detached from the patient before doffing this device. HAL is not intended to provide sit-stand or stand-sit movements. HAL is capable of gait speeds up to approximately 2 km/hour on level ground. HAL is not intended for sports or stairclimbing.
In preparation to using HAL, the controller can be used while the exoskeleton is not donned to provide biofeedback training through the visualization of surface electromyography bioelectrical signals recorded. HAL is intended to be used in conjunction with regular physiotherapy. HAL is intended to be used inside a medical facility under the
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supervision of trained medical professionals who have successfully completed the HAL training program.
It is thought that one of the causes of the brain, nerves, and muscles lies in an abnormality of the signal transmission loop of the brain/nervous system between the brain and the peripherals that normally allows the body to function appropriately.
All Medical Cybernic Systems, including HAL, are designed to detect and adjust the patient's neurological information in a way that allows the device to assist with the appropriate function of the body. Through repeated activity that is synchronized with the brain's neural signal of motor intent, the patient's physical function gradually improves.
More specifically, in order to allow the body to appropriately function even if the signal detected at the periphery is too faint to elicit actual muscle movement, an MD can intervene by tuning the parameters embedical Cybernic System. This intervention enables the Medical Cybernic System to realize the movement in place of the patient's muscles. Even if the muscles barely function, repetition of neurologically-controlled voluntary movement and walking treatment has been shown to improve ambulation.
## Intended Use/Indications for Use
#### 21 CFR 807.92(a)(5)
Medical HAL Lower Limb Type orthotically fits to the lower limbs and trunk;
HAL is a gait training device intended to temporarily help improve ambulation of the HAL gait training intervention. HAL must be used with a Body Weight Support system. HAL is not intended for sports or stair climbing. HAL gait training is intended to be used in conjunction with regular physiotherapy.
The device is intended for individuals with:
- spinal cord injury at levels C4 to L5 (ASIA C, ASIA D) and T11 to L5 (ASIA A with Zones of Partial Preservation, ASIA B);
- post stroke paresis
- paraplegia due to progressive neuromuscular diseases (spinal and bulbar muscular atrophy, amyotrophic lateral sclerosis, Charcot-Marie-Tooth disease, distal muscular dody myositis, congenital myopathy, muscular dystrophy)
-cerebral palsy and are 12 years or older
-spastic paraplegia caused by either HTLV-1 Associated Myelopathy (HAM) or hereditary spastic paraplegia (HSP) who exhibit sufficient residual motor and movement-related functions of the hip and knee to trigger and control HAL.
In preparation for HAL gait training, the controller can be used while the exoskeleton is not donned to provide biofeedback training through the visualization of surface electromyography bioelectrical signals recorded.
HAL is intended to be used inside healthies while under trained medical supervision in accordance with the user assessment and training certification program.
# Indications for Use Comparison
### 21 CFR 807.92(a)(5)
21 CFR 807.92(a)(6)
The device has additional diseases as target populations and consequently has different indications for use in comparison to the predicate device.
The additional diseases are "cerebral paraplegia caused by either HTLV-1 Associated Myelopathy (HAM) or hereditary spastic paraplegia (HSP).
The applicant has submitted clinical data to support the safety and efficacy of the treatment with these diseases. The level of evidence is equivalent to the other diseases aready reviewed in K201559. Therefore the difference does not raise new questions regarding the safety and effectiveness of the device and do not constitute a new intended use.
# Technological Comparison
The subject device expands the indication for use (target disease) and expands the height range of intended patients enabling smaller patients to use the device. The comparison of target diseases and patient physique are listed below:
<Target diseases>
- Spinal cord injury: Intended for both the subject and predicate devices
- Post stroke paresis: Intended for both the subject and predicate devices
- Progressive neuromuscular diseases: Intended for both the subject and predicate devices
- Cerebral palsy: Newly intended for the subject device (Not intended for the predicate device)
- Spastic paraplegia caused by either HTLV-1 Associated Myelopathy or hereditary spastic paraplegia: Newly intended for the subject device (Not intended for the predicate device)
<Patient physique>
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- Weight: 15kg-100kg for the subject device, and 40kg-100kg for the predicate device. - Height(approx.): 100cm-190cm for the subject device, and 150cm-190cm for the predicate device.
The subject device adds a smaller variation to enable use by patients who were too small (short) to fit the predicate device. The additional variation is based on the same concept and is assembled using different parts that reflect the difference in device size.
Performance testing on electrical safety and EMC were newly conducted for the additional variation where different questions about safety may arise. The selection of the device size variation depends completely on the patient, and does not depend on the disease.
#### Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
The following nonclinical test were newly submitted for the additional size variation device. FDA quidance documents and recognized consensus standards were not used/referenced.
-Maximum angle velocity
-Torque output
-Angle measurement performance
-Trunk absolute angle measurement performance
-Plantar force measurement performance
-BES input impedance
-BES measurement performance (CMRR)
-BES measurement performance (Frequency characteristics)
The safety and effectiveness of the subject device is demonstrated through the following clinical evaluation procedure for each of the 5 indication groups (A: spinal cord injury (K171909 cleared, and included in K201559), B: cerebrovascular disease (K201559 cleared), C: progressive neuromuscular disease (K201559 cleared), D: cerebral palsy (new) and E: spastic paraplegia (new)). After evaluating the results for the 5 groups, we conclude that:
A. The device is sufficiently safe when used under general and special controls described in this submission; and
B. The evaluation results are sufficient to support the claims identified in the Indications for Use for this submission.
The nonclinical and clinical tests submitted demonstrate that the device is as safe and as effective, and performs as well as the legally marketed device cleared as K201559.
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
