(13 days)
The Disposable Circular Stapler is intended to be used throughout the alimentary tract for the creation of end-to-end and end-to-side anastomosis.
The Disposable Circular Stapler places a circular, double staggered row of titanium staples and resects the excess tissue, creating a circular anastomosis. The instrument is activated by squeezing the handle firmly as far as it will go. It is applicable to end-to-end and end-to-side anastomosis. The proposed device is provided EO sterilized.
The provided text is a 510(k) Summary for a medical device (Disposable Circular Stapler) and the FDA's response. It does not contain information about acceptance criteria or a study designed to prove the device meets those criteria in the way typically expected for an AI/CADe device. The "Testing Conclusion" section states: "Performance testing was conducted to validate and verify that the proposed device, Disposable Circular Stapler met all design specifications and was substantially equivalent to the predicate device." However, it does not provide details about what those design specifications (acceptance criteria) were, nor does it describe the study that was conducted.
Therefore, most of the requested information cannot be extracted from the provided document.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance:
- Cannot be provided. The document states "Performance testing was conducted to validate and verify that the proposed device... met all design specifications," but it does not list these specific design specifications (acceptance criteria) or the quantitative results of the device's performance against them.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Cannot be provided. The document states "Performance testing was conducted," but it does not specify any test set size, data provenance, or the nature of the data (e.g., in-vitro, ex-vivo, in-vivo animal, or human clinical data).
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):
- Cannot be provided. There is no mention of ground truth establishment by experts for a test set, as this is not a study of diagnostic accuracy or similar performance for which expert consensus would typically be required. The device is a surgical stapler, and its performance evaluation would likely involve mechanical and functional testing, not expert interpretation of outputs.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Cannot be provided. As there's no mention of a test set or expert involvement, adjudication methods are not applicable and not discussed.
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:
- Cannot be provided. This is not an AI/CADe device, and therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device and was not performed or reported.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Cannot be provided. This is a physical surgical device, not an algorithm. Standalone algorithm performance is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Cannot be provided. The concept of "ground truth" as typically applied in AI/CADe studies (e.g., for diagnostic accuracy) does not directly apply to the performance testing of a mechanical surgical stapler. Its "ground truth" would likely be defined by engineering specifications, material properties, and functional tests (e.g., staple formation, burst pressure, tissue compression, leak tests). The document does not detail these.
8. The sample size for the training set:
- Cannot be provided. The device is a physical stapler, not a machine learning model, so there is no training set in the context of AI.
9. How the ground truth for the training set was established:
- Cannot be provided. As above, there is no training set for this type of device.
In summary: The provided document is a 510(k) summary for a physical surgical device. It states that performance testing was conducted to verify that the device met design specifications and was substantially equivalent to a predicate device. However, it does not provide the specific details of these design specifications (acceptance criteria) or the methodology, sample sizes, or results of the performance testing in the manner typically expected for a detailed study report of an AI/CADe device. The questions posed are primarily relevant to AI/CADe device evaluation, which is not what this document addresses.
§ 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.