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The device is intended for fixation of prosthetic material to soft tissies in various minimally invasive and open surgical procedures such as hernia repair.

The ReliaTack™ Articulating Reloadable Fixation Device is a reloadable sterile, single use device for fixation of prosthetic material, such as mesh, to soft tissue. The tack is constructed of an for mxaller synthetic polyester copolymer derived from lactic and glycolic acid and is dyed with D&C Violet No. 2. The device is offered as a stand-alone reloadable handle pre-packaged with:

K140609:

• Three, single use, ReliaTack™ reloads with 10 Standard Purchase (5.1mm) absorbable . (PGLA) tacks
  Or Proposed
• One, single use, ReliaTack™ reload with 5 Deep Purchase (7.0mm) absorbable (PGLA) . tacks & three, single use, ReliaTack™ reloads with 8 Deep Purchase (7.0mm) absorbable (PGLA) tacks
  Single use reloads can be packaged separately in the following configurations:

K140609:

• one ReliaTack™ reload with 5 Standard Purchase (5.1mm) absorbable (PGLA) tacks .
• one ReliaTack™ reload with 10 Standard Purchase (5.1mm) absorbable (PGLA) tacks .
  Or
  Proposed
• one ReliaTack™ reload with 5 Deep Purchase (7.0mm) absorbable (PGLA) tacks .
• one ReliaTack™ reload with 8 Deep Purchase (7.0mm) absorbable (PGLA) tacks .

The provided text describes a 510(k) premarket notification for the "ReliaTack™ Articulating Reloadable Fixation Device with Deep Purchase Absorbable Tacks" (K151659). This device is compared to a predicate device, "ReliaTack™ Articulating Reloadable Fixation Device with Standard Purchase Absorbable Tacks" (K140609). The submission aims to demonstrate substantial equivalence, not to prove clinical effectiveness or specific diagnostic performance with AI. Therefore, many of the requested categories (e.g., expert involvement, MRMC study, training set ground truth) are not applicable or cannot be extracted from this document as it pertains to a medical device for affixing materials, not an AI diagnostic tool.

Acceptance Criteria and Reported Device Performance

The device's acceptance criteria are framed in terms of demonstrating substantial equivalence to the predicate device through various non-clinical tests. The goal is to show that the design differences (primarily tack length and reload length) do not impact safety or performance compared to the predicate.

Study Proving Acceptance Criteria:

The study proving the device meets the acceptance criteria is a design verification activity and nonclinical testing comparison against a legally marketed predicate device (K140609). The document explicitly states: "The design differences were found to have no impact on safety or performance. This was established through applicable design verification activities that showed conformance to applicable technical design specifications and performance requirements, applicable medical device performance standards, and other nonclinical testing."

Detailed Information based on provided text:

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

   • Test Set Sample Size: Not explicitly stated as "sample size" in terms of number of data points for a diagnostic algorithm. For the bench tests, it would refer to the number of devices or components tested. For ex vivo tests, it would refer to the number of tissue samples or test repetitions. These specific numerical sample sizes are not provided in the document.
   • Data Provenance: The tests are described as bench tests using simulated tissue medium and mesh, and ex vivo tests using porcine tissue. There is no mention of country of origin, and these are prospective tests conducted for the purpose of this submission, not retrospective data analysis.

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

   • This question is not applicable as the document describes a physical medical device (a fixation device/stapler) and its mechanical/biocompatibility performance, not an AI diagnostic device requiring expert interpretation for ground truth.

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

   • Not applicable for this type of device and testing. Adjudication methods are typically used in clinical or image-based studies to establish a consensus ground truth, which is not the focus here.

4. 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 submission does not involve AI or human readers for diagnostic purposes. It is a comparison of a physical medical device to a predicate device.

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

   • Not applicable. This is a physical medical device; there is no algorithm in this context. The document explicitly states: "This premarket submission did not rely on the assessment of clinical performance data to demonstrate substantial equivalence."

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

   • The "ground truth" here is compliance with technical design specifications, performance requirements, applicable medical device performance standards (e.g., ISO Standard 10993-1), and the established performance characteristics of the predicate device. The performance is measured directly by mechanical and material properties, not by clinical outcomes or expert interpretation of diagnostic findings.

7. The sample size for the training set:

   • Not applicable. There is no "training set" as this is not an AI/machine learning device.

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

   • Not applicable. There is no "training set" for this device.

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