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

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.
2. A plastic Extraction Device, provided for easy removal of the Fastener when needed, under direct vision.
3. Polypropylene monofilament Surgical Mesh

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.

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

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

stainless steel Fixation . A Device preloaded with the Spider Fastener. The Fixation Device is provided with a safety pin that prevents inadvertent deployment of the Spider Fastener.

. Surgical Mesh; Polypropylene monofilament Mesh

· A stainless steel Extraction Device; provided for easy removal of the Spider Fastener when needed under direct vision.

Endogun's EndoFast Reliant System is used to attach or reinforce tissues by fastening them with Spider Fasteners. These Fasteners will attach a suitably designed mesh onto the tissue to ensure fixation between two tissues.

The devices are preloaded for single use.

The EndoFast Reliant System is supplied sterilized and ready for use upon removal from its packaging.

The Fixation Device is provided with a safety pin that prevents inadvertent deployment of the Spider Fastener.

Here's an analysis of the provided text regarding the acceptance criteria and study for the EndoFast Reliant System:

This document describes a 510(k) submission, which primarily focuses on demonstrating substantial equivalence to a predicate device, rather than establishing acceptance criteria and proving performance against them in the same way a PMA (Premarket Approval) might. Therefore, the "acceptance criteria" here are implicitly linked to demonstrating equivalence through a battery of tests.

Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated with quantitative targets. Instead, the performance tests were designed to demonstrate that the EndoFast Reliant System is substantially equivalent to the predicate devices. The "acceptance" is implied by the successful completion of these tests.

Conclusion from document: "Results of this testing indicate that the EndoFast Reliant System is substantially equivalent to the predicate devices."

Study Information:

The provided text describes a combination of in-vitro/bench testing and an animal study. It does not describe a clinical study involving human subjects or a multi-reader multi-case (MRMC) comparative effectiveness study.

2. Sample Size Used for the Test Set and Data Provenance:

• Bench Testing (Fixation Device, Fastener, Extraction Device, Mesh): Specific sample sizes for each test are not provided. The document states that the components "were tested" for various parameters.
• Animal Study:
  • Sample Size: "Altogether five different experiments were conducted using 4 sheep (2 before sacrifice) and a pig as an animal model."
  • Data Provenance: Retrospective, conducted prior to the 510(k) submission. Country of origin not explicitly stated, but the applicant and contact person are associated with Israel.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

• Bench Testing: Not applicable. These are physical/mechanical tests, not requiring expert ground truth in the same way clinical data would.
• Animal Study: "Following animal sacrifice, the pathological effects on tissues were assessed by histological examination." This implies expert assessment (e.g., veterinary pathologists). The number of experts and their specific qualifications are not provided.

4. Adjudication Method for the Test Set:

• Bench Testing: Not applicable as it's objective measurement against established test methods.
• Animal Study: Not explicitly stated. The histological examination suggests expert assessment, but no details on adjudication (e.g., consensus, single reader) are given.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No, an MRMC comparative effectiveness study was not done. This document describes a 510(k) submission for a surgical device, not an imaging AI algorithm.

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

• Not applicable. This device is a physical surgical fastening system and mesh, not an AI algorithm. Therefore, "standalone" in this context refers to the device's physical performance, which was evaluated through bench and animal testing.

7. The Type of Ground Truth Used:

• Bench Testing: Objective physical and mechanical measurements according to established test methodologies (e.g., tensile strength, pullout strength, rigidity, sterility).
• Animal Study: Pathological effects on tissues assessed by histological examination. This could be considered a form of "pathology" ground truth, evaluated by experts.

8. The Sample Size for the Training Set:

• Not applicable. This document describes a physical medical device. There is no AI component requiring a "training set."

9. How the Ground Truth for the Training Set was Established:

• Not applicable. As there is no AI component, there is no "training set" or ground truth for it.

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