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The Suture Clinch fastens sterile non-absorbable sutures in sizes 0 to 4-0 USP by crimping the suture ends during soft tissue approximation.

The Suture Clinch fastens sterile non-absorbable sutures in sizes 0 to 4-0 USP by crimping the suture ends during soft tissue approximation. The Suture Clinch is manufactured from poly acetyl plastic. Its unique shape provides an optimum means of capturing and securing the suture. The unique shape of the Suture Clinch also allows the applicator (clip applier) to close the Suture Clinch completely around the suture. The single use Suture Clinch Cartridge is supplied sterile, packaged individually in a Tyvek® pouch. The method of sterilization is EO with a Sal of 10°.

Here's an analysis of the provided text regarding the Suture Clinch device's acceptance criteria and studies:

Based on the provided information, the Suture Clinch (K033024) is a predicate device, meaning its 510(k) submission primarily focuses on demonstrating substantial equivalence to a previously cleared device (K992852), rather than extensive de novo clinical trials. Therefore, the details regarding clinical study design, sample sizes, expert involvement, and ground truth are very limited or non-existent in this typical 510(k) summary for a predicate device.

Here's a breakdown of the requested information:

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

"The Technological characteristics are the same as or equivalent to the predicated device." |
| Biocompatibility (material in clinch) | "The polyacetal material used in the clinch is shown to be biocompatible according to ISO 10993-1 requirements." |
| Design control, risk analysis, design verification in accordance with 21 CFR § 820.30, EN 1441, ISO 9001/13485, AAMI/ISO TIR 14971. | "Design control, risk analysis and design verification activities...have been conducted in accordance with all applicable internal Applied Medical Procedures."

"validation and verification activities addressed the profile." |
| Performance requirements specified by internal procedures (presumably related to crimping sutures and soft tissue approximation) | Not explicitly detailed in terms of quantitative performance metrics, but implicitly met by substantial equivalence and bench testing. |
| Sterility (SAL of 10⁻⁶) | "The single use Suture Clinch Cartridge is supplied sterile... The method of sterilization is EO with a Sal of 10⁻⁶." |

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

• Sample Size for Test Set: Not explicitly stated. The submission mentions "bench top testing was conducted and comparisons were made to the predicated device." This typically refers to laboratory testing, not human subject testing. The sample size for such bench testing (e.g., number of sutures crimped, force tests) is not provided.
• Data Provenance: The nature of "bench top testing" suggests it was conducted internally by the manufacturer. The country of origin and whether it was retrospective or prospective is not specified but likely internal lab data.

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 specified. Given this is a 510(k) for a predicate device based on bench testing (not a clinical study involving diagnosis or interpretation), there's no mention of experts establishing a "ground truth" in the sense of clinical annotations or disease labels. The "ground truth" for non-clinical testing would be defined by engineering specifications and predicate device performance.

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

• Not applicable / None specified. Adjudication methods are typically used in clinical studies when multiple human readers evaluate data (e.g., images) to resolve discrepancies. This device's submission revolves around bench testing, not clinical evaluation by multiple human assessors.

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 study was not conducted. This device is a physical surgical clip, not an AI-powered diagnostic or assistive tool. Therefore, there's no concept of human readers improving with or without AI assistance.

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

• Not applicable. This device is a physical, mechanical medical device. It does not involve an algorithm or AI that would have a "standalone" performance.

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

• For the bench testing, the "ground truth" would be the engineering specifications and performance characteristics of the predicate device (K992852). For biocompatibility, the ground truth is established by the ISO 10993-1 requirements. No clinical data (pathology, outcomes data, expert consensus on clinical cases) is mentioned as being used for ground truth.

8. The sample size for the training set

• Not applicable / Not specified. This device does not involve machine learning or AI, so there is no concept of a "training set" in the conventional sense.

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

• Not applicable. As there is no training set for an AI/ML algorithm for this physical device, there's no ground truth established for it.

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