K201376 · Vista Lifesciences, Inc. · POM · Mar 25, 2021 · Neurology
Device Facts
Record ID
K201376
Device Name
ANAM Test System
Applicant
Vista Lifesciences, Inc.
Product Code
POM · Neurology
Decision Date
Mar 25, 2021
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 882.1471
Device Class
Class 2
Attributes
Software as a Medical Device
Indications for Use
The ANAM® Test System: Military, Military Expanded, Core, and Sports Batteries are intended for use as computerbased neurocognitive test batteries to aid in the assessment of mild traumatic brain injury. The ANAM Test System: Military, Military Expanded, Core, and Sports Batteries are neurocognitive test batteries that provide healthcare professionals with objective measure of neurocognitive functioning as assessment aids and in the management of mild traumatic brain injury in individuals ages 13-65. The ANAM Test System should only be used as an adjunctive tool for evaluating cognitive function.
Device Story
Software-only neurocognitive test system; provides objective measurements of cognitive performance (reaction time, memory, attention, spatial processing speed) and concussion symptoms. Input: user performance on standardized test modules (e.g., Code Substitution, Go/No-Go, Mathematical Processing) via Windows PC or Android tablet. Operation: clinician-administered or supervised; tests combined into batteries (Core, Sports, Military, Military-Expanded). Output: ANAM Performance Report (APR) containing raw scores, standard scores, and ANAM Composite Score (ACS); Reliable Change Indices (RCI) calculated to compare current performance against baseline or normative data. Healthcare providers use output to monitor cognitive recovery and inform concussion management decisions. Benefits: provides standardized, objective data to assist clinical assessment of brain injury.
Clinical Evidence
Bench testing and concurrent validity studies provided. Studies demonstrate correlations between ANAM and traditional neuropsychological tests in both normal and concussed populations. Results confirm ANAM provides reliable measures of cognitive function for concussion assessment and management.
Technological Characteristics
Software-only device; compatible with Windows 10 PCs (e.g., Dell Inspiron 15 3000) and Android tablets (e.g., Samsung Galaxy Tab A, Android 7.1–8.1). Operates as a series of sequential neurocognitive test modules. No hardware provided. Connectivity: standalone software download.
Indications for Use
Indicated for individuals ages 13-65 to aid in the assessment and management of mild traumatic brain injury (concussion). Used as an adjunctive tool for evaluating neurocognitive functioning.
Regulatory Classification
Identification
The computerized cognitive assessment aid for concussion is a prescription device that uses an individual's score(s) on a battery of cognitive tasks to provide an indication of the current level of cognitive function in response to concussion. The computerized cognitive assessment aid for concussion is used only as an assessment aid in the management of concussion to determine cognitive function for patients after a potential concussive event where other diagnostic tools are available and does not identify the presence or absence of concussion. It is not intended as a stand-alone diagnostic device.
Special Controls
*Classification.* Class II (special controls). The special controls for this device are:(1) Software, including any proprietary algorithm(s) used by the device to arrive at its interpretation of the patient's cognitive function, must be described in detail in the software requirements specification (SRS) and software design specification (SDS). Software verification, validation, and hazard analysis must be performed.
(2) Clinical performance data must be provided that demonstrates how the device functions as an interpretation of the current level of cognitive function in an individual that has recently received an injury that causes concern about a possible concussion. The testing must:
(i) Evaluate device output and clinical interpretation.
(ii) Evaluate device test-retest reliability of the device output.
(iii) Evaluate construct validity of the device cognitive assessments.
(iv) Describe the construction of the normative database, which includes the following:
(A) How the clinical workup was completed to establish a “normal” population, including the establishment of inclusion and exclusion criteria.
(B) Statistical methods and model assumptions used.
(3) The labeling must include:
(i) A summary of any clinical testing conducted to demonstrate how the device functions as an interpretation of the current level of cognitive function in a patient that has recently received an injury that causes concern about a possible concussion. The summary of testing must include the following:
(A) Device output and clinical interpretation.
(B) Device test-retest reliability of the device output.
(C) Construct validity of the device cognitive assessments.
(D) A description of the normative database, which includes the following:
(
*1* ) How the clinical workup was completed to establish a “normal” population, including the establishment of inclusion and exclusion criteria.(
*2* ) How normal values will be reported to the user.(
*3* ) Representative screen shots and reports that will be generated to provide the user results and normative data.(
*4* ) Statistical methods and model assumptions used.(
*5* ) Whether or not the normative database was adjusted due to differences in age and gender.(ii) A warning that the device should only be used by health care professionals who are trained in concussion management.
(iii) A warning that the device does not identify the presence or absence of concussion or other clinical diagnoses.
(iv) A warning that the device is not a stand-alone diagnostic.
(v) Any instructions technicians must convey to patients regarding the administration of the test and collection of cognitive test data.
In combination with the general controls of the FD&C Act, the Computerized Cognitive Assessment Aid for Concussion is subject to the following special controls:
{0}------------------------------------------------
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, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font size below.
March 25, 2021
Vista LifeSciences, Inc. Margaret Molloy President and CEO 7375 S. Peoria St. Suite 210 Englewood, Colorado 80112
Re: K201376
Trade/Device Name: ANAM Test System Regulation Number: 21 CFR 882.1471 Regulation Name: Computerized Cognitive Assessment Aid for Concussion Regulatory Class: Class II Product Code: POM Dated: February 11, 2021 Received: February 19, 2021
Dear Margaret Molloy:
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 (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 located 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.
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
{1}------------------------------------------------
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 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 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 medical devices and radiation-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,
Jay Gupta Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
# Indications for Use
510(k) Number (if known) K201376
Device Name ANAM Test System
#### Indications for Use (Describe)
The ANAM® Test System: Military, Military Expanded, Core, and Sports Batteries are intended for use as computerbased neurocognitive test batteries to aid in the assessment of mild traumatic brain injury. The ANAM Test System: Military, Military Expanded, Core, and Sports Batteries are neurocognitive test batteries that provide healthcare professionals with objective measure of neurocognitive functioning as assessment aids and in the management of mild traumatic brain injury in individuals ages 13-65.
The ANAM Test System should only be used as an adjunctive tool for evaluating cognitive function.
| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------|---------------------------------------------------------------------------------|
| <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |
#### CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
#### 5. 510(K) SUMMARY
In accordance with 21 CFR 807.87(h) and (21 CFR 807.92) the 510(k) Summary for the ANAM Test System is provided below.
| Device Common Name: | Computerized Cognitive Test |
|----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Proprietary Name: | ANAM Test System |
| Applicant: | Vista LifeSciences, Inc.<br>PO Box 4670<br>Parker CO 80134<br>Phone: 888.733.8804 Ext. 1<br>www.vistalifesciences.com |
| Contact: | Margaret E. Molloy<br>CEO and President<br>Vista LifeSciences, Inc.<br>PO Box 4670<br>Parker CO 80134<br>Phone: 888.733.8804 Ext. 4<br>Email: memolloy@vistapartners.com |
| Prepared by: | Lori White<br>Quality Systems Program Manager<br>Vista LifeSciences, Inc.<br>PO Box 4670<br>Parker CO 80134<br>Phone: 888.733.8804 Ext. 1<br>Email: lori.white@vistalifesciences.com |
| Date Prepared: | March 22, 2021 |
| Classification Regulation: | 882.1471 Computerized Cognitive Assessment Aid for<br>Concussion |
| Panel: | Neurology |
| Product Code: | POM |
| Predicate Device: | DEN150037, ImPACT |
{4}------------------------------------------------
## Indication for Use:
The ANAM® Test System: Military, Military Expanded, Core, and Sports Batteries are intended for use as computer-based neurocognitive test batteries to aid in the assessment and management of mild traumatic brain injury. The ANAM Test System: Military Expanded, Core, and Sports Batteries are neurocognitive test batteries that provide healthcare professionals with objective measure of neurocognitive functioning as assessment aids and in the management of mild traumatic brain injury in individuals ages 13-65.
The ANAM Test System should only be used as an adjunctive tool for evaluating cognitive function.
## Device Description:
The ANAM Test System is a software only device that provides clinicians with objective measurements of cognitive performance in populations, to aid in the assessment and management of concussion. ANAM measures various aspects of neurocognitive functioning including reaction time, memory, attention, and spatial processing speed. It also records symptoms of concussion in the test taker.
The software is downloaded from the Vista LifeSciences website and is for use on Dell Inspiron 15 3000 Series or similar Windows PC model or Android Samsung Galaxy tablet or similar Android device. The hardware is not provided as part of the device but is purchased separately by the user. Each ANAM battery consists of a collection of pre-selected modules that are administered in a sequential manner.
Specific modules included in the ANAM Test System:
- 1. Questionnaires
- 1. Demographics
- 2. Mood Scale
- 3. Neurobehavioral Symptom Inventory (NSI)
- 4. PTSD Checklist (PCL)
- 5. Sleepiness Scale
- 6. Symptoms Checklist
- 7. TBI Questionnaire
#### Performance Tests
- 8. Code Substitution Learning
- 9. Code Substitution Delayed
- 10. Go/No-Go"
- 11. Matching to Sample*
- 12. Mathematical Processing
- 13. Memory Search
- 14. Procedural Reaction Time
- 15. Simple Reaction Time*
- 16. Spatial Processing*
- *Available for tablet platform.
{5}------------------------------------------------
The tests and questionnaires can be combined into custom batteries or users can choose from pre-configured standardized batteries. The standardized batteries include ANAM Core, ANAM Sports. ANAM Military, and ANAM Military-Expanded. These standardized batteries have fixed test settings and parameters to ensure standardized presentation and enable comparison to normative data.
This 510(k) submission provides evidence demonstrating that the ANAM Test System is substantially equivalent to a POM predicate device and is therefore safe and effective to use following concussion. The ANAM Core, Sports, Military, and Military-Expanded batteries as well as the individual tests comprising these batteries have demonstrated sensitivity to the cognitive effects of concussion and, thus, will serve as the focus of the materials provided herein. In some cases descriptions and features of the entire ANAM Test System have been provided to better facilitate the understanding of the complete system and its many features as a computerized cognitive assessment aid.
## Performance Data:
The 510(k) includes the results of numerous studies that have examined the concurrent validity of ANAM as a clinical tool by documenting correlations with traditional neuropsychological tests with both normal and concussed populations. The results of these studies demonstrate that ANAM provides a reliable measure of cognitive function for use as an assessment aid and in the management of concussion and is therefore substantially equivalent to the predicate device.
#### Substantial Equivalence:
Both the predicate device and ANAM "provide healthcare professionals with objective measure of neurocognitive functioning as an assessment aid and in the management of concussion". The predicate device does this by measuring verbal and visual memory, visual motor speed, impulse control, and reaction time. ANAM also measures fundamental neurocognitive functions including response speed, attention/concentration, immediate and delayed memory, spatial processing, inhibition, and decision processing speed and efficiency.
The intended use of ANAM is the same as that of the predicate device, namely for use as a computer-based neurocognitive test battery to aid in the assessment and management of concussion.
| | Proposed Device | Predicate Device |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | TBD | DEN 150037 |
| Device Name | ANAM Test System | ImPACT |
| Submitter | Vista LifeSciences, Inc. | ImPACT Applications, Inc. |
| Classification Regulation | Class II | Class II |
| Product Code | POM | POM |
| | Proposed Device | Predicate Device |
| Indication | The ANAM® Test System:<br>Military, Military Expanded,<br>Core, and Sports Batteries are<br>intended for use as computer-<br>based neurocognitive test<br>batteries to aid in the assessment<br>and management of mild<br>traumatic brain injury. The<br>ANAM Test System: Military,<br>Military Expanded, Core, and<br>Sports Batteries are<br>neurocognitive test batteries that<br>provide healthcare professionals<br>with objective measure of<br>neurocognitive functioning as<br>assessment aids and in the<br>management of mild traumatic<br>brain injury in individuals ages<br>13-65.<br>The ANAM Test System should<br>only be used as an adjunctive<br>tool for evaluating cognitive<br>function. | ImPACT is intended for use as a<br>computer-based neurocognitive<br>test battery to aid in the<br>assessment and management of<br>concussion.<br>ImPACT is a neurocognitive test<br>battery that provides healthcare<br>professionals with objective<br>measure of neurocognitive<br>functioning as an assessment aid<br>and in the management of<br>concussion in individuals ages<br>12-59. |
| Platform | PC: Dell Inspiron 15 3000 Series<br>or similar Windows laptop<br>computer, Windows 10 operating<br>system.<br>Tablet: Samsung Galaxy Tab A<br>tablet or similar Android device,<br>Android 7.1 – 8.1 operating<br>systems. | Internet browser. |
| Use Cases | Measures change over time<br>and/or compares performance<br>with normative data. | Measures change over time<br>and/or compares performance<br>with normative data. |
| Patient Population | Individuals | Individuals |
| Age of Users | 13-65 years | 12-59 |
| How Provided | Software only, downloaded | Internet browser |
| | Proposed Device | Predicate Device |
| Reporting features | ANAM Performance Report<br>(APR) provides raw scores and<br>standard scores (calculated with<br>the normative database) for each<br>test within the battery. APR also<br>yields the ANAM Composite<br>Score (ACS) summarizing<br>performance across the test<br>battery. The ACS is a summed T-<br>score that is computed relative to<br>the summed T-score of a<br>normative control group. The<br>ACS is reported in standard<br>deviation units. Reliable Change<br>Indices (RCI) are calculated and<br>displayed for each individual test<br>to capture change in performance<br>between a specified test session<br>and a previous test session (e.g.<br>baseline). | ImPACT Clinical Report<br>provides composite scores for<br>tests in the battery including<br>Verbal Memory Composite,<br>Visual Memory Composite,<br>Visual Motor Speed Composite,<br>Reaction Time Composite,<br>Impulse Control Composite,<br>Total Symptom Score, and<br>Cognitive Efficiency Index<br>(CEI). Reliable Change Indices<br>(RCI) are calculated and<br>displayed to capture change in<br>performance between a specified<br>test session and a previous test<br>session (e.g. baseline). |
| Results Interpretation | Clinical interpretation of the<br>results includes comparison with<br>the normative database and/or<br>previous test sessions. ANAM<br>provides raw scores, standard<br>scores, and reliable change<br>indices for each test.<br>Performance on sub-tests are<br>evaluated individually as well as<br>within the context of the entire<br>test battery. | Clinical interpretation of the<br>results includes comparison with<br>the normative database and/or<br>previous test sessions. ImPACT<br>provides raw scores and<br>percentile scores. Performance<br>on sub-tests are evaluated<br>individually and presented as<br>composite scores. |
A technological comparison is provided in the table below.
{6}------------------------------------------------
{7}------------------------------------------------
## Summary / Conclusion of Substantial Equivalence Rationale
Although there are some differences in the modules between ANAM and the predicate device, the performance testing demonstrates that ANAM provides a reliable measure of neurocognitive functioning to aid in the assessment and management of concussion and is therefore substantially equivalent to the predicate device.
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.
