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The MicroCutter XCHANGE® 30 is intended for transection in multiple open or minimally invasive urologic, thoracic, and pediatic surgical procedures, as well as application for transection, and/or creation of anastomoses in the small and large intestine, and the transection of the appendix.

The MicroCutter XCHANGE® 30 is a single patient use stapler that delivers two, double staggered rows of 316L stainless steel staples while simultaneously transecting tissue between staple rows. The size of the White Cartridge staple is compatible with tissue that can be easily compressed to 1.0mm. The staple line is approximately 30mm long with a transection length of approximately 27mm.

Here's a breakdown of the acceptance criteria and study information for the Cardica MicroCutter XCHANGE® 30, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state numerical acceptance criteria for specific performance metrics. Instead, for the tissue burst pressure tests, the acceptance is implied by demonstrating "no statistical difference" compared to the predicate device. For the animal studies, the acceptance is based on an "uncomplicated 5-week postoperative course" and "unremarkable" histological evaluation with "no demonstrable difference between the two groups."

Therefore, the table below reflects the reported performance relative to the predicate, rather than explicit numerical acceptance criteria.

2. Sample Size and Data Provenance for Test Set (Bench Testing & Animal Studies)

• Bench Testing:

  • Sample Size: Not explicitly stated in the provided text for the bench testing. The results are described generally as "Tissue Burst pressure testing was conducted."
  • Data Provenance: Porcine carotid artery and porcine jugular vein were used, indicating animal tissue (ex vivo) for these specific tests. The country of origin is not specified, but it's likely a controlled laboratory environment. This is prospective data generation for the purpose of the 510(k).

• Chronic Animal Studies:

  • Sample Size: Not explicitly stated as a number of animals per group, but it involved two studies: "a study in which unilateral nephrectomies were performed and a study in which unilateral lobectomies were performed." "All animals" had an uncomplicated course, implying the sample size was sufficient for the study's conclusions.
  • Data Provenance: The studies were "chronic animal studies," meaning conducted in vivo on live animals. The type of animal (e.g., porcine, canine) is not specified. The country of origin is not specified. This is prospective data generation.

3. Number of Experts and Qualifications for Ground Truth for Test Set

• Not Applicable. The described studies are performance tests (bench and animal), not diagnostic or image-based studies requiring human expert interpretation as ground truth. The "ground truth" (or outcome assessment) was based on direct physiological measurements (burst pressure), macroscopic observation (postoperative course, stump condition), and microscopic histological evaluation. These evaluations would typically be performed by trained technicians, veterinarians, and pathologists, but they are not "experts" in the context of establishing diagnostic ground truth from images or clinical data.

4. Adjudication Method for Test Set

• Not Applicable. As mentioned above, the studies are performance tests and do not involve human interpretation or adjudication in the manner of, for example, multiple readers assessing medical images. Outcomes are based on objective measurements and pathological/histological findings.

5. MRMC Comparative Effectiveness Study

• No. The provided document describes bench testing and chronic animal studies, not a Multi-Reader Multi-Case (MRMC) comparative effectiveness study involving human readers and AI assistance. The device is a surgical stapler, not an AI-powered diagnostic tool.

6. Standalone Performance (Algorithm Only)

• No. The device is a surgical stapler. This concept primarily applies to AI/software as a medical device (SaMD) where an algorithm's performance is evaluated independently of human interaction.

7. Type of Ground Truth Used

• Bench Testing: Direct physical measurements (e.g., burst pressure) under controlled laboratory conditions, and comparison to a legally marketed predicate device.
• Chronic Animal Studies:
  • Macroscopic observation: Postoperative course assessment (complications, bleeding, infection), visual inspection of vascular and ureter stumps.
  • Microscopic evaluation: Histological assessment of tissue.
  • Comparison of these outcomes between the subject device and the predicate device.

8. Sample Size for the Training Set

• Not Applicable. This device is a mechanical surgical stapler. There is no AI or machine learning component that would require a "training set" in the conventional sense. The "development" or "training" of the device involves engineering design, material selection, and iterative physical testing, not data-driven algorithm training.

9. How Ground Truth for Training Set Was Established

• Not Applicable. As there is no AI/ML component, there is no "training set" or ground truth for it. The design and validation relied on established engineering principles, material science, and pre-clinical testing against known performance benchmarks from predicate devices.

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The MicroCutter XCHANGE™30 is intended for use in multiple open or minimally invasive surgical procedures for the transection, resection, and/or creation of anastomoses in small and large intestine as well as the transection of the appendix.

The MicroCutter XCHANGE™ 30 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. The MicroCutter XCHANGE™ 30 Blue Staple Cartridge is available for deployment with the MicroCutter XCHANGE ™ 30 Stapler which delivers a blue staple (3.5mm) compatible with tissue that can be compressed to 1.5mm. The staple line is approximately 30mm long with a transection length of approximately 27mm.

The provided document is a 510(k) Summary for a medical device (MicroCutter XCHANGE™ 30 Blue Staple Cartridge) and describes its non-clinical performance data for demonstrating substantial equivalence to a predicate device. It is not a study proving the device meets clinical acceptance criteria or describing a comparative effectiveness study involving human readers and AI.

Here's an analysis of the provided information based on your request, highlighting what is present and what is missing because this document focuses on non-clinical data for a 510(k) submission:

1. Table of acceptance criteria and the reported device performance

The document provides a comparative table of technological characteristics between the predicate and subject devices and mentions various tests were conducted. However, it does not explicitly define acceptance criteria as a specific numeric or qualitative threshold for each test directly alongside reported performance data in a clear table format. It states that tests "met design specifications" or "passed."

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

The document does not explicitly state the sample sizes for the "test sets" for the listed non-clinical tests. It refers to "design verification testing."

• Sample Size: Not specified for individual tests.
• Data Provenance: Not specified, but implied to be internal testing by Cardica, Inc. (Redwood City, California, USA). The tests are non-clinical bench tests.
• Nature: The testing described is prospective, as it was conducted to verify a design modification.

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

This information is not applicable to this document. The tests described are non-clinical (mechanical, biological, physical) and do not involve human experts establishing ground truth for a diagnostic algorithm.

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

This information is not applicable. No adjudication method is described as the tests are non-clinical engineering and biological assessments.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This document describes non-clinical testing for a surgical stapler, not an AI diagnostic device.

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

This information is not applicable. This document describes the performance of a physical medical device (surgical stapler component), not an algorithm.

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

For the non-clinical tests, the "ground truth" implicitly refers to engineering specifications, regulatory standards (e.g., ISO, ASTM, ANSI/AAMI), and established performance of the predicate device. For instance, 'Bioburden testing passed in accordance with ANSI/AAMI/ISO 11737-1' means the standard itself defines the acceptable reference. 'No statistical difference as compared to Covidien ENDO GIA Universal blue staple cartridge' means the predicate device's performance sets the benchmark.

8. The sample size for the training set

This information is not applicable. This document describes the testing of a physical medical device, not an AI algorithm that requires a training set.

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

This information is not applicable. As no AI algorithm or training set is involved, there is no "ground truth for the training set" to establish.

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