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The MicroCutter 5/80 Stapler and MicroCutter 30 White, Blue, and Curved Tip White and Blue Reloads are intended for transection and resection in multiple open or minimally invasive urologic, thoracic, and pediatric surgical procedures, as well as application for transection, resection, and/or creation of anastomoses in the small and large intestine, and the transection of the appendix.

The MicroCutter 5/80 Stapler and MicroCutter 30 White and Curved Tip White Reloads may additionally be used in conjunction with open solid organ parenchymal dissection techniques on veins 4-5 mm in diameter and arteries 3-7 mm in diameter.

Each MicroCutter 30 Reload contains two double rows of 316L stainless steel staples. The size of the MicroCutter 30 Blue Reload and MicroCutter 30 Curved Tip Blue Reload staple is compatible with tissue that can be easily compressed to 1.5mm. The size of the MicroCutter30 White Reload and MicroCutter 30 Curved Tip White Reload staple is compatible with tissue that can be easily compressed to 1.0mm. If tissue cannot comfortably compress to the Maximum Tissue Thickness listed for each reload, or easily compresses to less than the Maximum Tissue Thickness listed for each reload, the tissue is contraindicated as it may be too thick or too thin for the selected staple size. The cut length of the staple line is 28.0mm (1.10in) and the staple line length is 30mm long. The MicroCutter 30 Reloads are deployed using the Dextera MicroCutter 5/80TM Stapler. The MicroCutter 5/80 Stapler is a single patient use stapler that delivers two, double staggered rows of 316L stainless steel staples while simultaneously transecting tissue between staple rows.

This document is a 510(k) Premarket Notification from the FDA regarding the Dextera MicroCutter 30 Reloads, which are implantable staples. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing a standalone study with detailed acceptance criteria and performance against those criteria.

However, based on the provided text, we can extract information regarding a performance comparison study.

Here's an analysis of the acceptance criteria and study information available:

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

The document does not explicitly state quantitative acceptance criteria in a table format. Instead, it describes a "functional performance testing" where the "results demonstrated the subject devices to be substantially equivalent to the predicate devices." This implies that the performance of the Dextera MicroCutter 30 Reloads (subject device) was at least as good as or not statistically worse than the Ethicon ENDOPATH® ETS-Flex45 Endoscopic Articulating Linear Cutters and their Reloads (predicate device).

The performance metric mentioned is "Tissue Burst Pressure." The acceptance criterion, though not explicitly quantified, is that the subject devices perform equivalently to the predicate devices in this test.

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 the test set: Not explicitly stated in the provided text for the Tissue Burst Pressure testing. It mentions "porcine veins" without specifying the number of samples or trials.
• Data provenance:
  • Country of origin: Not specified.
  • Retrospective or prospective: This appears to be a prospective non-clinical performance study.

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)

This information is not applicable and not provided in the document. The study described is a non-clinical, in-vitro/ex-vivo functional performance test (Tissue Burst Pressure) on animal tissue, not a human reader study requiring expert interpretation of results.

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

Not applicable nor provided. This refers to human reader studies, which is not what is described here.

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 document describes non-clinical functional performance testing of a surgical stapler, not an AI-assisted diagnostic device. Therefore, an MRMC comparative effectiveness study involving human readers and AI is not relevant.

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

No. This is a medical device (surgical stapler) that is used by a human surgeon; it is not an algorithm or AI.

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

For the "Tissue Burst Pressure" testing, the ground truth is the directly measured burst pressure of the stapled tissue, which is a quantitative physical property. There isn't an "expert consensus" or "pathology" in the typical sense for this type of mechanical performance testing.

8. The sample size for the training set

Not applicable. The described study is a non-clinical performance comparison, not an AI/algorithm training process.

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

Not applicable, as there is no training set for an AI/algorithm described in this document.

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