K124023 · Orthomerica Products, Inc. · OAN · Jun 10, 2013 · Neurology
Device Facts
Record ID
K124023
Device Name
STARBAND
Applicant
Orthomerica Products, Inc.
Product Code
OAN · Neurology
Decision Date
Jun 10, 2013
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 882.5970
Device Class
Class 2
Attributes
Therapeutic, Pediatric
Indications for Use
The STARband is intended for medical purposes for use on infants from 3 to 18 months of age, with moderate-to-severe non-synostotic positional plagiocephaly, including infants with plagiocephalic-, brachycephalic- and scaphocephalic-shaped heads by applying mild pressure to prominent regions of the infant's cranium in order to improve cranial symmetry and/or shape. The device is also indicated for adjunctive use for infants from 3 to 18 months of age whose synostosis has been surgically corrected, but who still have moderate-to-severe cranial deformities including plagiocephalic-, brachycephalic- and scaphocephalic-shaped heads.
Device Story
STARband is a custom-molded cranial orthosis for infants; redirects head growth to improve symmetry/proportion. Practitioner captures head shape via plaster cast or 3D scanner (e.g., scanGogh-II); positive model created via 5-axis routing. Device consists of outer copolymer shell, inner polyethylene/Aliplast foam liner, and adjustable strap. Worn ~23 hours/day; provides total contact over prominent areas to discourage growth, while allowing expansion in flattened areas. Practitioner modifies interior over time to guide growth. Benefits include improved cranial shape and symmetry. Used in clinical settings by trained practitioners.
Clinical Evidence
Bench testing only. No clinical data. Performance evaluated via repeatability and reproducibility (R&R) analysis using uniform shapes representing pediatric patients (3-18 months). Cranial Shape Capture Accuracy Study compared scanGogh-II to cast and predicate methods across multiple coordinate planes (A-P, M-L, P-D, radius, squareness, flatness). Eye Shield Fit Assessment confirmed safety for infants during scanning.
Technological Characteristics
Custom-molded cranial orthosis. Materials: .156" copolymer outer shell, 1/2" pelite polyethylene or Aliplast foam liner, Dacron/Velcro straps. Principle: Passive mechanical pressure to redirect cranial growth. Manufacturing: 5-axis routing of positive model from 3D scan or plaster cast. Connectivity: scanGogh-II (Polhemus Fastscan) laser/camera scanner for shape capture. Sterilization: N/A (custom device).
Indications for Use
Indicated for infants 3-18 months old with moderate-to-severe non-synostotic positional plagiocephaly (plagiocephalic, brachycephalic, or scaphocephalic shapes) or post-surgical craniosynostosis with residual moderate-to-severe cranial deformities.
Regulatory Classification
Identification
A cranial orthosis is a device that is intended for medical purposes to apply pressure to prominent regions of an infant's cranium in order to improve cranial symmetry and/or shape in infants from 3 to 18 months of age, with moderate to severe nonsynostotic positional plagiocephaly, including infants with plagiocephalic-, brachycephalic-, and scaphocephalic-shaped heads.
Special Controls
*Classification.* Class II (special controls) (prescription use in accordance with § 801.109 of this chapter, biocompatibility testing, and labeling (contraindications, warnings, precautions, adverse events, instructions for physicians and parents)).
In addition to the general controls of the act, the Dynamic Orthotic Cranioplasty - DOC™ Band is subject to the following special controls in order to provide reasonable assurance of the safety and effectiveness: (1) The sale, distribution and use of this device are restricted to prescription use in accordance with 21 CFR 801.109. (2) The labeling must include (a) contraindications for the use of the device on infants with synostosis or with hydrocephalus; (b) warnings indicating the need: (i) to evaluate head circumference measurements and neurological status at intervals appropriate to the infant’s age and rate of head growth, and to describe steps that should be taken in order to reduce the potential for restriction of cranial growth and possible impairment of brain growth and development; (ii) to evaluate the skin at frequent intervals, e.g., every three to four hours, and to describe steps that should be taken if skin irritation or breakdown occurs; (c) precautions indicating the need: (i) to additionally treat torticollis, if the positional plagiocephaly is associated with torticollis; (ii) to evaluate device fit and to describe the steps that should be taken in order to reduce the potential for restriction of cranial growth, possible impairment of brain growth and development and skin irritation and/or breakdown; (iii) to evaluate the structural integrity of the device and to describe the steps that should be taken to reduce the potential for the device to slip out of place and cause asphyxiation or trauma to the eyes or skin; (d) adverse events, i.e., skin irritation and breakdown that have occurred with the use of this device; (e) clinician’s instructions for casting the infant, for fitting the device, and for care and use of the device; and (f) parents’ instructions for care and use of the device. (3) The materials must be assessed for biocompatibility with testing appropriate for long term direct skin contact.
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STARband® Cranial Orthosis
## 510(k) Summary
.
· ·
# JUN 1 0 2013
### I. Applicant Information
| Name: | Orthomerica Products, Inc. |
|------------|------------------------------------------------------|
| Address: | 6333 North Orange Blossom Trail<br>Orlando, FL 32810 |
| Telephone: | (407) 290-6592 |
| Facsimile: | (407) 290-2419 |
## FDA Establishment Registration Number
1058152
:
## Contact Information
| Contact Person: | David Hooper, Manufacturing Engineer |
|-----------------|--------------------------------------|
| Address: | 6333 North Orange Blossom Trail |
| | Orlando, FL 32810 |
| Telephone: | (407) 290-6592 |
| Facsimile: | (407) 290-2419 |
| Email: | dhooper@orthomerica.com |
| Date Prepared: | December 21, 2012 |
## II. Submission Information
| Type: | Special 510(k) Submission |
|----------------------|--------------------------------------------------------|
| Proprietary Name: | STARband® |
| Common Name: | Cranial Orthosis |
| Classification: | Class II (special controls); OAN; MVA; 21 CFR 882.5970 |
| Classification Name: | Cranial Orthosis |
f
### Manufacturer Site III.
.
| Name: | Orthomerica Products, Inc. |
|----------------------------------------|---------------------------------|
| Address: | 6333 North Orange Blossom Trail |
| | Orlando, FL 32810 |
| Telephone: | (407) 290-6592 |
| Facsimile: | (407) 290-2419 |
| FDA Establishment Registration Number: | 1058152 |
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#### IV. Description of Device/Modification
The STARband redirects the head growth to improve proportion and symmetry. The practitioner takes a plaster impression or a scan of the baby's head to acquire the existing shape. The mold is sealed and filled with plaster or the scanned shape is carved from using polyurethane foam blank to create a positive model of the head shape. The positive model is modified to obtain greater symmetry and space in the areas of flattening. The STARband provides total contact over the prominent or bossed areas of the baby's head to discourage growth there. Over the course of treatment, the inside of the band is modified further by the practitioner to provide space for growth to occur in the flat or depressed areas. The shape of the STARband directs growth into the areas of least resistance and creates a precise pathway for the head shape to improve in symmetry and proportion.
The STARband as it was released in K082950 is essentially still the same device. The STARband consists of a 5/32" outer copolymer shell with an inner liner made of 1/2" pelite polyethylene foam or 1/2" Aliplast foam (closed cell polyethylene). There is a top opening and a side opening. The strap across the side opening is 1 ½" Dacron and Velcro and is attached to the STARband with a chafe and loop. A ½" pelite polyethylene foam gap block fills any gap in the side opening. The proposed device modification is the addition of a new shape capture method, specifically the scanGogh-II" by Vorum Research, Inc. This scanner uses one laser and one camera to capture shape data.
### V. Statement of Indications and Intended Use
## Statement of Indications:
The STARband is intended for medical purposes for use on infants from 3 to 18 months of age, with moderate-to-severe non-synostotic positional plagiocephaly, including infants with plagiocephalic-, brachycephalic- and scaphocephalic-shaped heads by applying mild pressure to prominent regions of the infant's cranium in order to improve cranial symmetry and/or shape. The device is also indicated for adjunctive use for infants from 3 to 18 months of age whose synostosis has been surgically corrected, but who still have moderate-to-severe cranial deformities including plagiocephalic-, brachycephalicand scaphocephalic-shaped heads.
## Intended Use:
The STARband is designed to treat infants with abnormal head shapes from age 3 months to 18 months and is available by prescription only. Since growth is the driving factor in head shape correction, the infants wear the STARband for approximately 23 hours per
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day. The most common head deformities are positional plagiocephaly, brachycephaly, and scaphocephaly. The STARband has also been cleared to treat unresolved head deformities in patients who have undergone surgery to correct craniosynostosis. The same principles of cranial remolding apply to positional deformities and post-operative patients.
#### VI. Predicate Devices
- 트 STARband, Cranial Orthosis, K082950
- Boston Band Cranial Remolding Orthosis, K072862
- CAMLab Cranial Orthosis Helmet, K081787
- I Boston Band, K111609
#### VI. Summary of Technological Characteristics
The modification proposed is the use of an additional tool which can be used to capture the infants head shape; the technological characteristics and the underlying principles of operation of the STARband Cranial Orthosis will remain exactly the same. This table illustrates that the device will in fact remain the same.
| Feature | From K082950 | Proposed Device | | Proximal<br>Radius | Proximal<br>Anterior<br>Radius | Anterior<br>Radius | Anterior<br>Posterior<br>Length | M-L<br>Width<br>Anterior | M-L<br>Width<br>Posterior | Posterior<br>Panel<br>Flatness | Lateral<br>Panel<br>Flatness | L-P<br>Panels<br>Square | Medial<br>Panels<br>Flatness | M-P<br>Panels<br>Squares |
|-------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------|--------------------|--------------------------------|--------------------|---------------------------------|--------------------------|---------------------------|--------------------------------|------------------------------|-------------------------|------------------------------|--------------------------|
| Intended<br>Use | Maintains total contact over areas of<br>bossing or protrusion and creates voids<br>over areas of depression or flattening to<br>redirect cranial growth toward greater<br>symmetry. | Maintains total contact over areas of<br>bossing or protrusion and creates voids<br>over areas of depression or flattening to<br>redirect cranial growth toward greater<br>symmetry. | scanGogh-ll<br>vs. Cast<br>Cranial Head<br>Shape | Pass | Pass | Pass | Pass | Pass | Pass | Pass | Pass | Pass | Pass | Pass |
| Materials | Outer shell of .156 copoly plastic<br>-<br>An inner liner of ½" pelite<br>-<br>polyethylene foam or ½" Aliplast<br>foam<br>- A strap of 1 ½" Dacron<br>- A 1 ½" chafe buckle<br>- Large Flange, Blind Rivet<br>- A Gap Block made from ½" firm<br>- pelite polyethylene foam<br>- A nylon washer | Outer shell of .156 copoly plastic<br>-<br>An inner liner of ½" pelite<br>-<br>polyethylene foam or ½" Aliplast<br>foam<br>- A strap of 1 ½" Dacron<br>- A 1 ½" chafe buckle<br>- Large Flange, Blind Rivet<br>- A Gap Block made from ½" firm<br>- pelite polyethylene foam<br>- A nylon washer | | | | | | | | | | | | |
| Product<br>Design | Custom made cranial orthosis, approx 6oz.<br>in weight | Custom made cranial orthosis, approx 6oz.<br>in weight | | | | | | | | | | | | |
| Production | - Form orthosis from a positive mold of infant's head<br>- Positive mold is formed based upon measurements of the infant's head taken by the STARscanner, or the OWW Omega Scanner from which a 3-dimensional image is made or from a traditional plaster cast<br>- The 3-dimensional image is used to produce a positive mold using a 5-axis routing machine | - Form orthosis from a positive mold of infant's head<br>- Positive mold is formed based upon measurements of the infant's head taken by the STARscanner, the OWW Omega Scanner, or the scanGogh-II from which a 3-dimensional image is made or from a traditional plaster cast<br>- The 3-dimensional image is used to produce a positive mold using a 5-axis routing machine | | | | | | | | | | | | |
| Testing | Repeatability and Reproducibility (R&R) Analysis<br>- Utilized uniform shapes with known dimensions that represent various sizes of pediatric patients between ages 3 to 18 months of age<br>- Compared proposed device to cast and predicate device<br>- Associated parameters includes A-P and M-L<br>- Proposed device is substantially equivalent to predicate device | Repeatability and Reproducibility (R&R) Analysis<br>- Utilized uniform shapes with known dimensions that represent various sizes of pediatric patients between ages 3 to 18 months of age<br>- Compared proposed device (scanGogh-II) to cast and predicate device<br>- Associated parameters includes A-P and M-L<br>- Proposed device is substantially equivalent to predicate device<br>- Cranial Shape Capture Accuracy Study<br>-- Utilized a representative cranial shape that possesses a predefined shape with known dimensions<br>- Compared proposed device (scanGogh-II) to cast and predicate device<br>- Associated Coordinate Planes (A-P; M-L; P-D and various Radius Parameters; Squareness; Flatness)<br>- Proposed device is substantially equivalent to predicate device.<br>- Eye Shield Fit Assessment<br>-- A specific eye shield would properly fit infants<br>- Assess coverage, fit and effectiveness<br>- Proposed eye shields pass the assessment and provide safe and effective protection | | | | | | | | | | | | |
Table 1 - Comparison of Predicate Device cleared in K082950 to the proposed device
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STARband® Cranial Orthosis
The inclusion of the scanGogh-II is the focus of this submission. Additional testing was performed on the scanGogh-II to ensure substantial equivalence, that change is indicated in Table 1 under the testing section. Table 2 shows the additional accuracy testing
Orthomerica Products, Inc.
.
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performed and the comparison results of the scanGogh-11. The term Pass within Table 2 indicates the scanGogh-II accuracy performed superior to the Cast method.
Table 2 - scanGogh-II Accuracy Comparison Summary
The actual scanner wand hardware (camera and laser included) of the scanGogh-II is also known as the Fastscan Handheld Laser Scanner by Polhemus, Inc. The Fastscan Scanner has already received FDA clearance as part of other Cranial Remolding Orthosis 510(k) submissions, by Boston Band Cranial Remolding Orthosis (K072862 and K111609) and the CAMLab Cranial Orthosis Helmet (K081787). These submissions used the STARband (K011350 and K082950) as their predicate device and given that the technological characteristics are the same as the proposed device, these devices are all substantially equivalent.
#### VII. Summary and Conclusions of Non-Clinical Performance Data
The STARband Cranial Orthosis has been successfully used in clinical practice since its original clearance in 2001. The scanGogh-II is the only proposed change. The scanGogh-II was evaluated through accuracy, reproducibility and repeatability testing. The shape capture repeatability and reproducibility was evaluated and determined to be acceptable. An additional, Cranial Shape Capture Accuracy Study was performed concluding that the scanGogh-II yields a safe and effective product that is substantially equivalent to the predicate device. An Eye Shield Fit Assessment showed the eye shields were an acceptable fit for infants, providing safe and effective protection of the infant's eye during scanning. With sufficient accuracy and proper laser safety procedures, the scanGogh-II was determined safe and effective for scanning infants for STARband Cranial Orthosis.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of an eagle.
June 10, 2013
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
Orthomerica Products, Inc. c/o Mr. David L. Hooper Manufacturing Engineer 6333 North Orange Blossom Trail Orlando, FL 32810
Re: K124023
Trade/Device Name: STARband® Cranial Orthosis Regulation Number: 21 CFR 882.5970 Regulation Name: Laser Scan Cranial Orthosis Regulatory Class: Class II Product Code: OAN Dated: April 22, 2013 Received: April 23, 2013
Dear Mr. Hooper:
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":"Act":"equire":"approval":"a"premarket":"pproval":application":(PMA): You may, therefore, market the device, subject to the general controls provisions of the Act. 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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
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Page 2 - Mr. David L. Hooper
forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
# Joyce M. Whang -S
for Victor Krauthamer, Ph.D. Acting Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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## Indications for Use
510(k) Number (if known): K124023
Device Name: STARband® Cranial Orthosis
Indications For Use:
The STARband is intended for medical purposes for use on infants from 3 to 18 months of age, with moderate-to-severe non-synostotic positional plagiocephaly, including infants with plagiocephalic-, brachycephalic- and scaphocephalic-shaped heads by applying mild pressure to prominent regions of the infant's cranium in order to improve cranial symmetry and/or shape. The device is also indicated for adjunctive use for infants from 3 to 18 months of age whose synostosis has been surgically corrected, but who still have moderate-to-severe cranial deformities including plagiocephalic-, brachycephalic- and scaphocephalic-shaped heads.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
Concurrence of CDRH, Office of Device Evaluation (ODE)
# Jovce Mi
(Division Sian Off) Division of Neurological and Physical Medicine Devices (DNPMD)
510(k) Number K124023
Page 1 of 1
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.
