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The CapSure ™ Permanent Fixation System is indicated for the approximation of soft tissue and fixation of surgical mesh to tissues during open or laparoscopic surgical procedures, such as hernia repair.

The CapSure™ Permanent Fixation System is a sterile single use device that delivers either 15 or 30 permanent fasteners via a straight shaft. The shaft of the CapSure™ Permanent Fixation System is 37 cm in length. The fasteners are designed with a 316L Stainless steel helical coil and polyetheretherketone (PEEK) cap on the proximal end to support mesh or tissue.

The provided document is a 510(k) premarket notification for the CapSure™ Permanent Fixation System. It focuses on demonstrating substantial equivalence to a predicate device (K142808 CapSure™ Permanent Fixation System) rather than presenting a study for initial market approval. Therefore, the information typically requested for a device's initial acceptance criteria and its demonstration through a study (especially regarding algorithm performance, ground truth establishment, sample sizes for training/test sets, and expert involvement for AI/diagnostic devices) is largely not applicable in this context.

This submission is about minor changes to an already cleared device, asserting that no technological characteristics have changed and that updated instructions for use are supported by adequate performance data from the previous 510(k).

However, I can extract the information related to performance data and acceptance criteria as presented for the original clearance (K142808) and affirmed for this submission.

Here's a breakdown based on the document:

1. Table of Acceptance Criteria and Reported Device Performance

The following questions are largely N/A or cannot be answered from this document, as it focuses on demonstrating substantial equivalence for a mechanical/implantable device and not an AI/diagnostic algorithm.

2. Sample size used for the test set and the data provenance:

• Biocompatibility: "All samples tested met the acceptance criteria." Specific sample sizes are not provided in this summary but would have been in the original K142808 submission. Data provenance is implied to be laboratory testing as per ISO 10993 standards.
• Mechanical Testing: "All samples tested met the acceptance criteria." Specific sample sizes are not provided but would have been in the original K142808 submission. Data provenance is laboratory testing.
• Animal Studies: A "Porcine implantation study" was conducted. The sample size (number of pigs, number of fasteners tested) is not specified in this summary. Data provenance is an animal study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• N/A. This information is not relevant for biocompatibility, mechanical, or animal studies of a fixation device. Ground truth, in this context, relates to objective measurements or physiological responses, not expert interpretation.

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

• N/A. Not applicable for the types of tests performed.

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. This is a mechanical fixation device, not an AI/diagnostic device involving human readers.

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

• N/A. Not applicable for this device.

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

• Biocompatibility: Ground truth is defined by objective parameters according to ISO 10993 standards (e.g., cell viability, erythema scores, implant site reactions, toxicological endpoints).
• Mechanical Testing: Ground truth is defined by engineering specifications and objective measurements (e.g., force values, successful deployment rate, MR compatibility measurements, burst pressure).
• Animal Studies: Ground truth is objective pathological and physiological observations (e.g., presence/absence of tissue attachments, statistical significance of differences compared to control).

8. The sample size for the training set:

• N/A. This is not an AI/machine learning device; there is no "training set."

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

• N/A. Not applicable.

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