(40 days)
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."
| Feature/Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Reliability Testing | Meets design specification | Demonstrated device performance and strength meets design specification, post gamma sterilization, transit conditioning, environmental conditioning, and accelerated aging. |
| Bioburden Testing | Passed per ANSI/AAMI/ISO 11737-1 | Passed in accordance with ANSI/AAMI/ISO 11737-1. |
| Shelf Life Testing | Passed per ASTM F 1980 | Completed and passed in accordance with ASTM F 1980. |
| Biocompatibility Testing | Passed per ISO 10993-1 | Completed and passed in accordance with ISO 10993-1 requirements. |
| Tissue Leak Pressure (Bench) | No statistical difference vs. predicate (p>0.05) | No statistical difference as compared to Covidien ENDO GIA Universal blue staple cartridge: p>0.05. |
| Other technological characteristics (e.g., staple material, size, deployment) | "No Change" compared to predicate | Subject device characteristics were "No Change" from predicate, implying they meet the predicate's established performance. |
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.
§ 878.4750 Implantable staple.
(a)
Identification. An implantable staple is a staple-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.