Plastic Fixation Devices (X5) and a Handle. Each Fixation Device is preloaded with a Spider Fastener. The Spider Fastener is provided with a Retrieval Unit, which together with the Extraction Device (described below), enables facile retrieval of the deployed Fastener when needed.
A plastic Extraction Device, provided for easy removal of the Fastener when needed, under direct vision.
Polypropylene monofilament Surgical Mesh

AI/ML Overview

The provided text describes a 510(k) premarket notification for the EndoFast Reliant™ System, a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting a full clinical study to establish novel performance criteria or a comparative effectiveness study.

Therefore, the specific information requested in the prompt, such as acceptance criteria, reported device performance against those criteria, sample sizes for test/training sets, expert qualifications, and ground truth establishment, is generally not found in these types of FDA premarket notifications for devices demonstrating substantial equivalence through bench testing.

Here's an analysis of the provided text in relation to your questions, noting where the information is not present due to the nature of the submission:

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

Not explicitly provided as a table with specific numerical acceptance criteria and performance values. The submission states that "A series of safety and performance testing, including bench testing were performed to demonstrate that the modified EndoFast Reliant™ System does not raise any new questions of safety and efficacy."
The tests mentioned include:
- "Performance testing, including the reliability and insertion force test of the Fixation Device and Handle and the Fastener, the reliability of the Fastener in expending and holding forces (pullout strength), the Extraction Device with Thread Reliability and force test, and the Cadaver study."
- Biocompatibility testing.
- Sterility and packaging testing.
The results of these tests are summarized by the statement that the device is "substantially equivalent to the cleared EndoFast Reliant™ System without raising new safety and/or effectiveness issues." This implies that the device performed comparably to the predicate or met internal benchmarks for safety and efficacy derived from the predicate's known performance. However, specific numerical acceptance criteria or performance metrics are not detailed in this document.

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

Not specified for bench tests. The submission mentions "Performance testing" and a "Cadaver study," which would be the "test sets." However, the document does not disclose the sample sizes for any of these tests (e.g., how many fixation devices were tested, how many cadavers were used).
Data Provenance: The applicant is EndoGun Medical Systems Ltd. based in Kibbutz Haogen, Israel. It's highly probable the testing was conducted in Israel, but this is not explicitly stated for the data provenance. The studies appear to be prospective, as they were conducted to support the 510(k) submission.

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)

Not applicable/Not provided. For a device based on mechanical function and biocompatibility like this, "ground truth" in the sense of expert review of images or clinical outcomes is not the primary assessment method. The "ground truth" for the bench tests would be the established engineering and materials science standards, and the performance of the predicate device. Experts would likely be engineers, material scientists, and potentially surgeons for the cadaver study, but their number and specific qualifications are not detailed.

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

Not applicable/Not provided. Adjudication methods like 2+1 or 3+1 typically refer to the process of resolving discrepancies in expert interpretations (e.g., reading medical images). This is not relevant to the bench and cadaver testing described for this device.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging AI devices. The EndoFast Reliant™ System is a surgical fastening device, not an AI-powered diagnostic tool. The submission focuses on substantial equivalence through bench and cadaver testing, not on human reader performance.

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

No, a standalone algorithm performance study was not done. This device does not involve an algorithm separate from human-in-the-loop performance. It's a mechanical surgical device.

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

For the performance tests (e.g., pullout strength, insertion force), the "ground truth" would be objective physical measurements against pre-defined engineering specifications or performance metrics derived from the predicate device.
For the cadaver study, the "ground truth" would likely involve direct visual inspection and possibly physical measurements of the mesh fixation in anatomical models, simulating surgical use.
For biocompatibility, the ground truth is established by biocompatibility standards and laboratory testing.
For sterility and packaging, the ground truth is established by validated sterilization and packaging integrity tests.

8. The sample size for the training set

Not applicable/Not provided. This device is not an AI/machine learning device, so there is no concept of a "training set" in this context.

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

Not applicable. As there is no training set for an AI/machine learning device, this question is not relevant.

Summary

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K080836 page 1/3

510(K) SUMMARY

APR 2 1 2008

EndoGun Medical Systems Ltd EndoFast Reliant™ System

6.1.1 Applicant's Name:

EndoGun Medical Systems Ltd. Kibbutz Haogen, Israel, 42880 Tel: +972 (9) 8987033 Fax: +972 (9) 8987119 Email: noga@endogun.com

6.1.2 Contact Person:

Dorit Winitz, Ph. D Biomedical Strategy (2004) Ltd. Moshe Aviv Tower, 34th Floor, 7 Jabotinsky Street Ramat Gan 52520, Israel Tel: +972-3-612-3281 Fax: +972-3-612-3282 dorit@ebms.co.il

6.1.3 Date Prepared:

March, 2008

6.1.4 Trade Name:

EndoFast Reliant™ System

6.1.5 Common Name:

Minimal invasive fastening device with surgical polymenric mesh.

6.1.6 Classification:

21 CFR 876.1500, 21 CFR 878.3300 Class:II KOG and GCI (Endoscope and accessories). FTL (Mesh, Surgical Polymeric)

6.1.7 Predicate Devices

EndoGun EndoFast Reliant™ Susyem, clered under K060329.

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K080636 page 2/3

6.1.8 Device Description:

The EndoFast Reliant™ System is a sterile, single use system, consisting of the following componnents:

1. Plastic Fixation Devices (X5) and a Handle. Each Fixation Device is preloaded with a Spider Fastener.
  The Spider Fastener is provided with a Retrieval Unit, which together with the Extraction Device (described below), enables facile retrieval of the deployed Fastener when needed.
1. A plastic Extraction Device, provided for easy removal of the Fastener when needed, under direct vision.
1. Polypropylene monofilament Surgical Mesh

6.1.9 Intended Use:

The EndoFast Reliant™ System is indicated for fixation of surgical mesh tissues for tissue reinforcement during minimally to invasive procedures.

6.1.10 Performance Data & Substantial Equivalence

The EndoFast Reliant™ System is substantially equivalent in all aspects. e.g., technological characteristics, mode of operation, performance characteristics, intended use, etc., to the commercially available EndoFast Reliant™ System, cleared under K060329.

The principle changes between the devices include:

The materials of the Fixation Device and the Extraction Device were 1. changed from stainless steel to plastic (the material of the stainless steel Fastener were not changed).
The Fixation Device was angulated in its distal end. is
A separate handle was added to the Fixation Device, thus discharge 3. of the Fastener can be accomplished only after the Fixation Device is locked in the Handle.
The Extraction mechanism was changed to include a thread guided 4. mechanism.
The pacakging of the device was changed to blister packaging. 5.
The flat polypropylene monofilament surgical mesh is provided pre-6. cut in two shapes instead of one rectangular shape, to better suit different anatomies. The mesh with the 4 pouches at the corners is not used with the modified device.

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K080836 Page 3/3

A series of safety and performance testing, including bench testing were performed to demonstrate that the modified EndoFast Reliant™ System does not raise any new questions of safety and efficacy. These tests include:

Performance testing, including the reliability and insertion force test of I the Fixation Device and Handle and the Fastener, the reliability of the Fastener in expending and holding forces (pullout strength), the Extraction Device with Thread Reliability and force test, and the Cadaver study.
이 Biocompatibility testing.
8 Sterility and packaging testing.

Based on these tests results, EndoGun Medical Systems Ltd. believes that the modified EndoFast Reliant™ System is substantially equivalent to the cleared EndoFast Reliant™ System without raising new safety and/or effectiveness issues.

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Public Health Service

Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles three overlapping human figures or abstract shapes.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 1 2008

Endogun Medical Systems % Biomedical Strategy Dorit Winitz Jabotinsky St 7 Ramat Gan 52520 Israel

Re: K080836

Trade/Device Name: EndoFast Reliant™ System Regulation Number: 21 CFR 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: FTL Dated: March 19, 2008 Received: March 25, 2008

Dear Dorit Winitz:

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.

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.

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Page 2 - Dorit Winitz

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark M. Millican

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K080836

Device Name: EndoFast Reliant™ System

Indications for Use:

The EndoFast Reliant™ System is indicated for fixation of surgical mesh to tissues for tissue reinforcement during minimally invasive procedures.

Prescription Use _ V (Part 21 C.F.R. 801 Subpart D) AND/OR

Over-The-Counter Use (Part 21 C.F.R. 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil RP Oglan Forman

(Division Division of General, Restorative, and Neurological Devices

510(k) Number K080836

6-10

Regulation Number and Section

§ 878.3300 Surgical mesh.

(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.