(21 days)
The GENICON implantable clips are intended for use during procedures for the purpose of approximating soft tissue, closing off vessels and other structures in order to stop bleeding or to connect internal tissues to aid in healing.
The ligation clips are composed exclusively of titanium, and are supplied as sterile products in various sizes (mini-micro, micro, smallmedium, medium, medium-large, large and extra large) with six clips per disposable holder. The titiaum used meets all requirements for A.S.T.M. specifications F-67 95 "Unalloyed Titanium for Surgical Implant Applications", Grade I and ISO 5832-2-93 and 10993 "Implants for Surgery - Metallic Materials - Part 2: Unalloyed Titanium".
The provided text is a 510(k) summary for the GENICON Titanium Ligation Clip. It describes the device, its intended use, and substantial equivalence to a predicate device, but it does not contain information about a study that proves the device meets specific acceptance criteria in the way a diagnostic AI/ML device would.
Instead, the summary focuses on:
- Material Composition: Stating the device is made of titanium meeting specific ASTM and ISO standards.
- Substantial Equivalence: Claiming the device is substantially equivalent in material and function to a predicate device (Ethicon K830503).
- Safety and Efficacy: Asserting that titanium is "well recognized as being safe and effective for long term implantation" and that millions of titanium clips applied yearly "attest to the wide acceptance of this method of hemostatic and ligation control."
- Compliance with Standards: Stating that devices are manufactured according to GMP, AAMI, ASTM, and ISO 13485 requirements.
Therefore, many of the requested items related to an AI/ML device performance study cannot be answered from this document.
Here's an analysis based on the information available in the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Material meets specified biocompatibility/strength standards. | Titanium used meets ASTM F-67 95, Grade I, and ISO 5832-2-93 and 10993. |
| Substantially equivalent to predicate device (Ethicon K830503) | Material composition and disposable holder material are "substantially equivalent." Functionally, clips are "substantially equivalent." |
| Safe and effective for its intended use (ligation, hemostasis). | "Titanium is well recognized as being safe and effective for long term implantation. Millions of titanium clips are applied yearly and since inception in the 1960's attest to the wide acceptance of this method of hemostatic and ligation control." |
| Manufacturing quality | Devices are manufactured according to Good Manufacturing Practices (G.M.P.), Association for Advancement of Medical Instrumentation (A.A.M.I.) and American Society for Testing and Materials (A.S.T.M.) requirements and applicable Harmonized Standards ISO 13485 (This refers to the manufacturing process, not clinical performance data from a specific study). |
2. Sample size used for the test set and the data provenance
Not applicable. This document describes a medical device (titanium ligation clip), not an AI/ML diagnostic or predictive model that would use a "test set" in this context. The "safety and efficacy information" refers to general acceptance of titanium clips over time, not a specific clinical study with a test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is not an AI/ML device's performance study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not an AI/ML device's performance study.
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
Not applicable. This is not an AI/ML device, nor is an MRMC study described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document implicitly relies on:
- Material Standards: ASTM and ISO specifications for titanium.
- Historical Clinical Use/Outcomes: "Millions of titanium clips are applied yearly...attest to the wide acceptance of this method of hemostatic and ligation control."
- Substantial Equivalence: Ground truth for equivalence is based on comparison to a legally marketed predicate device, likely involving material properties, design, and intended use.
8. The sample size for the training set
Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.
§ 878.4300 Implantable clip.
(a)
Identification. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.