The NerivioInfinity is indicated for acute and/or preventive treatment of migraine with or without aura in patients 12 years of age or older. It is a prescription use, self-administered device for use in the home environment at the onset of migraine headache or aura for acute treatment, or every other day for preventive treatment.
Device Story
Wearable, battery-powered remote electrical neuromodulation (REN) device; treats migraine via low-energy electrical pulses delivered to upper arm. System comprises reusable electronic unit, disposable hydrogel electrode pad, and armband. User controls stimulation intensity (0-40mA), start/stop, and monitors status via mobile application (Android/iOS) connected via Bluetooth. Device operates for 45-minute sessions; auto-shuts off. Designed for self-administration at migraine onset or every other day for prevention. Healthcare providers prescribe device; patients manage therapy at home. Output affects clinical decision-making by providing non-pharmacological migraine management. Benefits include reduced migraine frequency and acute symptom relief.
Clinical Evidence
No clinical trials performed. Substantial equivalence supported by bench testing, including software/firmware verification, battery safety, biocompatibility, and human factors/usability validation. Therapeutic parameters (waveform, intensity, duration, location) are identical to the predicate device.
Technological Characteristics
REN device; biphasic rectangular modulated waveform; max output 40mA; 45-minute treatment duration. Materials: plastic enclosure, hydrogel electrodes. Power: rechargeable Li-Ion battery. Connectivity: Bluetooth to mobile app. Software: firmware-controlled with FOTA update capability. Sterilization: non-sterile.
Indications for Use
Indicated for acute and/or preventive treatment of migraine with or without aura in patients 12 years of age or older. Prescription use, self-administered in home environment.
Regulatory Classification
Identification
A trunk and limb electrical stimulator to treat headache is a device intended to treat headache through the application of electrical stimulation anywhere on the body of the patient apart from the patient's head or neck through electrodes placed on the skin. The stimulation may be provided transcutaneously or percutaneously.
Special Controls
In combination with the general controls of the FD&C Act, the trunk and limb electrical stimulator to treat headache is subject to the following special controls: 1) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. This testing must include: a) Characterization of the electrical stimulation, including the following: waveforms; output modes; maximum output voltage and maximum output current (at 500Ω , 2kQ. and 10k≤2 loads); pulse duration; frequency; net charge per pulse; and maximum phase charge, maximum current density, maximum average current, and maximum average power density (at 500Ω); b) Characterization of the impedance monitoring system; and c) Characterization of the electrode performance including the electrical performance, adhesive integrity, shelf-life, reusability, and current distribution of the electrode surface area. 2) The patient-contacting components of the device must be demonstrated to be biocompatible. 3) Performance testing must demonstrate electromagnetic compatibility and electrical, mechanical and thermal safety in the intended use environment. 4) Software verification, validation, and hazard analysis must be performed. 5) Labeling must include the following: a) Instructions for use, including the typical sensations experienced during treatment: b) A detailed summary of the electrical stimulation output, and the device technical parameters, including any wireless specifications; c) A shelf life for the electrodes and reuse information; and d) Instructions on care and cleaning of the device.
*Classification.* Class II (special controls). The special controls for this device are:(1) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. This testing must include:
(i) Characterization of the electrical stimulation, including the following: Waveforms; output modes; maximum output voltage and maximum output current (at 500Ω, 2kΩ, and 10kΩ loads); pulse duration; frequency; net charge per pulse; and maximum phase charge, maximum current density, maximum average current, and maximum average power density (at 500Ω);
(ii) Characterization of the impedance monitoring system; and
(iii) Characterization of the electrode performance including the electrical performance, adhesive integrity, shelf-life, reusability, and current distribution of the electrode surface area.
(2) The patient-contacting components of the device must be demonstrated to be biocompatible.
(3) Performance testing must demonstrate electromagnetic compatibility and electrical, mechanical, and thermal safety in the intended use environment.
(4) Software verification, validation, and hazard analysis must be performed.
(5) Labeling must include the following:
(i) Instructions for use, including the typical sensations experienced during treatment;
(ii) A detailed summary of the electrical stimulation output, and the device technical parameters, including any wireless specifications;
(iii) A shelf life for the electrodes and reuse information; and
(iv) Instructions on care and cleaning of the device.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".
November 8, 2023
Theranica Bioelectronics ltd % Janice Hogan Partner Hogan Lovells US LLP 1735 Market Street, Suite 2300 Philadelphia, Pennsylvania 19103
Re: K232152
Trade/Device Name: NerivioInfinity Regulation Number: 21 CFR 882.5899 Regulation Name: Trunk And Limb Electrical Stimulator To Treat Headache Regulatory Class: Class II Product Code: QGT Dated: July 19, 2023 Received: July 19, 2023
Dear Janice Hogan:
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.
Jitendra V. Virani -S
CDR Jitendra Virani Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological
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and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known) K232152
Device Name
NerivioInfinity
Indications for Use (Describe)
The Neriviolnfinity is indicated for acute and/or preventive treatment of migraine with or without aura in patients 12 years of age or older. It is a prescription use, self-administered device for use in the onset of migraine headache or aura for acute treatment, or every other day for preventive treatment.
Type of Use (Select one or both, as applicable)
区 Prescription Use (Part 21 CFR 801 Subpart D)
□ Over-The-Counter Use (21 CFR 801 Subpart C)
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### 510(k) SUMMARY
## Theranica Bio-Electronics LTD.'s NerivioInfinity
#### K232152
### Submitter
Theranica Bio-Electronics LTD. 4 Ha-Omanut St. Netanya, ISRAEL, 4250438 +972-72-3909755 Phone: Facsimile: +972-72-3909762 Contact Person: Dagan Harris
Date Prepared: July 19, 2023
Trade/Device Name: NerivioInfinity Common or Usual Name: NerivioInfinity Regulation Number: 21 CFR 882.5899 Regulation Name: Trunk and limb electrical stimulator to treat headache Regulatory Class: Class II Product Code: QGT
Predicate Device:
Device name: Nerivio Manufacturer: Theranica Bio-Electronics LTD. 510(k) Number: K223169
### Device Description:
The Neriviolnfinity is a wearable, battery-powered device that is controlled by a mobile application. The system delivers low energy electrical pulses to the upper arm for 45 minutes per treatment, after which the device turns off automatically.
The device is composed of:
- . A pair of UltraStim® electrodes (K130987) covered with hydrogel and removable protective film, embedded in an electrodes pad set. The electrodes pad is disposable and replaceable.
- . An electronic circuitry that includes microcontroller with firmware and for wireless connection to Android and iOS mobile platforms, LED indicator, a USB-C charging port, a power button for activating the device and a battery contained in a plastic enclosure.
- An armband that is wrapped over the device to secure the NerivioInfinity position on the user's arm is included.
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The device is operated and controlled via mobile application software that is installed and run on the user's personal mobile device, such as a mobile phone or tablet. The device's hardware communicates with the mobile application through Bluetooth protocol. This mobile application software allows the user to control the stimulation intensity from 0 to 100% (representing intensity levels of 0-40mA), to start, pause or stop the stimulation program, and to view device status such as the device's connection state, stimulation duration, battery level, and user notifications.
The user is instructed to adjust the intensity to the strongest stimulation level just below the perceived pain level. Treatments with Neriviolnfinity are intended to be self-administered by the user immediately after the onset of migraine headache or aura or every other day for prevention.
# Intended Use / Indications for Use:
The Neriviolnfinity is indicated for acute and/or preventive treatment of migraine with or without aura in patients 12 years of age or older. It is a prescription use, self-administered device for use in the home environment at the onset of migraine headache or aura for acute treatment, or every other day for preventive treatment.
# Summary of Technological Characteristics:
Both the subject device and the predicate device function as remote electrical neuromodulation (REN) devices that utilize electro-stimulation that relieves migraine headache, and/or reduces the number of migraine days (depends on the treatment regime), using equivalent output parameters. The basic pulse structure is biphasic, with symmetrical interleaving phases and rectangular shape. The amplitude shift signal alternates between a nominal maximum and a nominal minimum of the amplitude signal. The maximal output current is 40mA. The assumed impedance is 1K ohm +/- 500 ohms.
Table 1 provides a comparison between the key functional features of the Neriviolnfinity and predicate device.
| Characteristic | Subject Device | Predicate Device | Comparison |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|------------|
| Submission<br>Number | K232152 | K223169 | |
| Device Name | NerivioInfinity | Nerivio | Modified |
| Manufacturer | Theranica Bio-Electronics<br>LTD. | Theranica Bio-Electronics<br>LTD. | Same |
| Indications for Use | NerivioInfinity is indicated for<br>acute and/or preventive<br>treatment of migraine with or<br>without aura in patients 12 | Nerivio is indicated for acute<br>and/or preventive treatment<br>of migraine with or without<br>aura in patients 12 years of | Same |
| Table 1. Comparison between subject and predicate devices | | | |
|-----------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | | |
| Characteristic | Subject Device | Predicate Device | Comparison |
| | years of age or older. It is a prescription use, self-administered device for use in the home environment at the onset of migraine headache or aura for acute treatment, or every other day for preventive treatment. | age or older. It is a prescription use, self-administered device for use in the home environment at the onset of migraine headache or aura for acute treatment, or every other day for preventive treatment. | |
| Prescription or OTC | Prescription | Prescription | Same |
| Electrical waveform | Biphasic rectangular, modulated | Biphasic rectangular, modulated | Same |
| Electrical output | | | |
| Max output voltage | | | Same |
| 500 Ω | 20V (measured) | 20V (measured) | |
| 2 KΩ | 60V (measured) | 60V (measured) | |
| 10 KΩ | 60V (measured) | 60V (measured) | |
| Max output current | | | Same |
| 500 Ω | 40 mA | 40 mA | |
| 2 KΩ | 30 mA | 30 mA | |
| 10 KΩ | 6mA | 6mA | |
| Maximum phase charge (500Ω) | 8μC | 8μC | Same |
| Maximum average current (500Ω) | 1.76mA | 1.76mA | Same |
| Maximum current density (peak) (500Ω) | 1.6mA/cm2 | 1.6mA/cm2 | Same |
| Maximum current density (r.m.s) (500Ω) | 0.34mA/cm | 0.34mA/cm | Same |
| Maximum average current density (abs value) (500Ω) | 0.07mA/cm2 | 0.07mA/cm2 | Same |
| Characteristic | Subject Device | Predicate Device | Comparison |
| Maximum average<br>power density<br>(500Ω)<br>Frequency | 1.41mW/cm2 | 1.41mW/cm2 | Same |
| Primary phase<br>duration [µSec] | 200 | 200 | Same |
| Pulse Duration<br>[µSec] | 400 | 400 | Same |
| Electrode Area | 25 cm² | 25 cm² | Same |
| Treatment location | Upper arm | Upper arm | Same |
| Treatment duration | 45 min. | 45 min. | Same |
| Reusable | Yes | Yes | Same |
| # of treatments per<br>one device | Up to 18 treatments for each<br>disposable electrodes pad. No<br>limitation for device body unit | 18 treatments per one entire<br>device. | Different:<br>The subject<br>device uses<br>disposable<br>electrode<br>pads, and<br>thus the<br>device body<br>unit is<br>reusable<br>beyond 18<br>treatments.<br>The predicate<br>device is<br>limited to 18<br>uses. |
| Power source | Li-lon cell battery -<br>rechargeable | LiMnO2 cell battery - non-<br>rechargeable | Different:<br>Subject<br>device<br>includes a<br>rechargeable<br>battery. |
| On/off button | Power push-button | Power push-button | Same |
| Dimensions | Device - 7.9x3.5x1.7cm | Device (electrodes included)-<br>12.0x7.5x1.5 cm | Similar |
| Characteristic | Subject Device | Predicate Device | Comparison |
| | Electrodes pad -<br>13.7x7.6x5.3cm | Armband - 48.0x10.0x0.3 cm | |
| | Armband - 48.0x10.0x0.3 cm | | |
| Weight | Device – 38 gr<br>Electrode pad set – 15 gr<br>Armband - 33 gr | Device (including an embedded<br>pair of electrodes) - 50 gr<br>Armband - 33 gr | Similar |
| Mobile Application<br>software | Yes | Yes | Similar |
| Biocompatibility | Yes | Yes | Same |
| Sterile | No | No | Same |
| Processor control | Yes | Yes | Same |
| Wireless control | Yes | Yes | Same |
| Automatic<br>overload trip | Yes | Yes | Same |
| Automatic no load<br>trip | Yes | Yes | Same |
| Automatic shut off | Yes | Yes | Same |
| Mobile Application<br>treatment control | Yes | Yes | Same |
| Remote (over-the-<br>air) FW update<br>option | Yes | No | Different |
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### Performance Data:
### Non-Clinical Tests:
The Neriviolnfinity's design concept and performance is similar to that of the predicate device. The subject device presents a few minor upgrades and additions in the software and firmware, including additions of a rechargeable battery, disposable electrodes, and FOTA upgrade capability. Accordingly, a comprehensive non-clinical bench tests addressed verification and validation of the software, firmware, battery, biocompatibility, usability and device performance were performed.
The company conducted internal bench tests and external lab testing to verify and validate the device battery's safety, firmware verification testing, system performance and labeling verification testing, mobile application software testing. In all instances, the NerivioInfinity functioned and expected. Human factor (Usability) tests were performed to validate that all critical tasks related to
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use-errors and knowledge errors were successfully performed by representative intended users and/or mitigated to comply with requirements of usability standards.
### Clinical Tests:
No clinical trials were performed with the subject device, given that the therapeutic elements (electrodes, electrical waveform, location on the body, treatment instructions, treatment duration, etc.) are the same as in the predicate device.
### Conclusions
The Neriviolnfinity has the same intended use and indications for use and substantially similar technological characteristics as its predicate device. The modifications to the device and minor changes to the procedures for use related to the rechargeable battery do not raise different questions of safety or effectiveness. Performance data demonstrate that the NerivioInfinity is as safe and effective as the predicate device. Thus, the NerivioInfinity is substantially equivalent to its 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.
