The EndoHelix endarterectomy device is a tubular device with an expanding helical element at the distal tip. The expandable helical element is controlled by the user with a sliding tab on the handle. The device is designed to be used with or without a guidewire. The device is packaged in an industry standard Tyvek/Mylar pouch and is provided sterile. The EndoHelix device is a single use product and is not intended to be resterilized or reused.

AI/ML Overview

This document, a 510(k) summary for the EndoHelix™ Endarterectomy Device, does not contain the detailed information required to describe the acceptance criteria and the study proving the device meets those criteria.

A 510(k) submission generally focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive clinical efficacy studies with predefined acceptance criteria. The level of detail you are requesting, commonly found in clinical trial reports or pre-market approval (PMA) applications, is not typically present in a 510(k) summary like this one.

Here's a breakdown of why each specific piece of information from your request is largely absent or unaddressed by the provided text:

1. A table of acceptance criteria and the reported device performance

Absence: The document states, "Testing was performed to assess product compliance with the product specification. Testing included device operation, wire actuation, and bond pull strengths. All product met specification."
Explanation: This is a very high-level statement. It indicates some testing was done and that the device passed its own specifications, but it does not define what those specifications (acceptance criteria) were, nor does it provide any quantitative performance data. For example, it doesn't give a specific "bond pull strength" target (e.g., 5 N) and the achieved result (e.g., 5.2 N).

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Absence: No information provided regarding sample sizes for any tests. The document only mentions "Testing was performed..."
Explanation: This document focuses on demonstrating substantial equivalence, not on providing results from a controlled clinical study with human subjects. The "testing" mentioned likely refers to bench testing (e.g., mechanical tests, material compatibility) rather than clinical performance testing with a specific "test set" of patients.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Absence: Not applicable. There is no mention of a "test set" that would require expert-established ground truth.
Explanation: This type of information is relevant for studies involving diagnostic accuracy or clinical outcomes where a "ground truth" needs to be established (e.g., by expert consenso, biopsy). The EndoHelix device is an interventional device, and the provided document does not include such clinical study details.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Absence: Not applicable. No clinical test set requiring adjudication is described.
Explanation: Similar to point 3, adjudication methods are used in clinical studies when multiple observers interpret data and discrepancies need to be resolved to establish ground truth. This is not touched upon in this 510(k) summary.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Absence: Not applicable.
Explanation: This document describes a mechanical endarterectomy device, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study and discussions of "human readers improve with AI" are entirely irrelevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Absence: Not applicable.
Explanation: This question refers to the performance of an algorithm (typically AI or software). The EndoHelix is a physical medical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Absence: Not applicable.
Explanation: As discussed, no clinical performance testing with a "ground truth" is detailed in this 510(k) summary.

8. The sample size for the training set

Absence: Not applicable.
Explanation: There is no "training set" as this is a physical medical device, not an algorithm that requires training data.

9. How the ground truth for the training set was established

Absence: Not applicable.
Explanation: Similar to point 8, there is no training set mentioned or implied.

In summary, the provided 510(k) document focuses on demonstrating substantial equivalence based on device description, materials, and a general statement about meeting internal product specifications. It does not contain the detailed clinical or performance study information you are asking for, which would be typical for a dataset used to validate specific acceptance criteria in a clinical context.

Summary

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OCT 3 0 2003

510(k) Summary

General Information

Classification	Class II
Trade Name	EndoHelix™ Endarterectomy Device
Submitter	ENDARx Inc.3270 Alpine RoadPortola Valley, CA 94028650-926-9335

Contact

Scott Adams President

Intended Use

The EndoHelix Endarterectomy Device is intended to remove plaque deposits from arteries.

Predicate Devices

Transluminal Endarterectomy Device K904944 from Baxter Healthcare Corporation
Periscope Device from Vascular Architects K003719

Device Description

The device is packaged in an industry standard Tyvek/Mylar pouch and is provided sterile. The EndoHelix device is a single use product and is not intended to be resterilized or reused.

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Materials

All materials used in the manufacture of the EndoHelix Endarterectomy Device are suitable for this use and have been used in numerous previously cleared products.

Testing

Testing was performed to assess product compliance with the product specification. Testing included device operation, wire actuation, and bond pull strengths.

All product met specification.

Summary of Substantial Equivalence

The EndoHelix Endarterectomy Device is equivalent to the predicate devices. The indications for use, basic overall function, methods of manufacturing, and materials used are substantially equivalent. ENDARx Inc. believes the EndoHelix Endarterectomy Device is substantially equivalent to existing legally marketed devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus.

OCT 3 0 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

EndarX, Inc. c/o Mr. J. Scott Adams 3270 Alpine Road Portola Valley, CA 94028

Re: K032105

EndoHelix™ Endarterectomy Device Regulation Number: 21 CFR 870.4875 Regulation Name: Intraluminal Artery Stripper Regulatory Class: Class II (two) Product Code: DWX Dated: October 20, 2003 Received: October 22, 2003

Dear Mr. Adams:

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. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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Page 2 - Mr. J. Scott Adams

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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.qov/cdrh/dsma/dsmamain.html

Sincerely vours,

Ashley B. Evans

$\int_{0}^{1}$

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):	This application
Device Name:	EndoHelixTM Endarterectomy Device
Indications for Use:	The EndoHelix Endarterectomy Device isintended to remove plaque deposits fromarteries.

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use / OR Over-The-Counter Use _
(Per 21 CFR 801.109) (Optional Format 1-2-96)

(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number /C032105

Regulation Number and Section

§ 870.4875 Intraluminal artery stripper.

(a)
Identification. An intraluminal artery stripper is a device used to perform an endarterectomy (removal of plaque deposits from arterisclerotic arteries.)(b)
Classification. Class II (performance standards).