(214 days)
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.
| Acceptance Criteria (Implicit) | Reported Device Performance (Summary) |
|---|---|
| Fixation Device & Fastener: | |
| Insertion Force | Tested |
| Fatigue Testing | Tested (for durability and integrity of the Fastener) |
| Dynamic Grip Strength | Tested |
| Retraction in response to different tension forces | Tested |
| Rigidity Tests | Tested |
| Cyclic Loading | Tested |
| Anterior Fixation | Tested |
| Pullout Strength | Tested |
| Reliability Tests | Tested |
| Fastener Spread | Tested |
| Ergonomics | Tested |
| Sterility | Tested |
| Extraction Device: | |
| Reliability | Tested |
| Surgical Mesh: | |
| Anterior Fixation | Tested |
| Sterility | Tested |
| Thickness | Tested |
| Weave Characteristics | Tested |
| Pore Size | Tested |
| Mesh Density | Tested |
| Tensile Strength | Tested |
| Pullout Strength | Tested |
| Burst Strength | Tested |
| Tear Resistance | Tested |
| Fatigue | Tested |
| Flexibility | Tested |
| Overall System (Animal Study): | |
| Safety | Established (histological examination) |
| Effectiveness | Established |
| Ease of Introduction | Demonstrated (simple, fast insertion) |
| Effective Anchoring | Demonstrated |
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.
§ 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.