(113 days)
The Reusable PPH Circular Stapler, Disposable Reload & Accessory Set has application throughout the anal canal to perform surgical treatment of hemorrhoidal disease.
The Reusable PPH Circular Stapler, Disposable Reload & Accessory Set consists of a reusable circular stapler handle, a disposable reload (containing the anvil, knife, washer, and staples), and accessory set (consisting of the circular anal dilator, pursestring anoscope, anal introducer, and suture threader).
The provided 510(k) summary for the "Reusable PPH Circular Stapler, Disposable Reload & Accessory Set" describes performance data from bench testing and animal tissue testing. However, it does not contain the level of detail requested for a comprehensive description of acceptance criteria and a study proving a medical AI device meets those criteria. The provided document is for a traditionally mechanical surgical stapler, not an AI device.
Therefore, many of the requested points, such as sample size for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, and how ground truth for training data was established, are not applicable or not provided in the context of this document.
However, I can extract the available information and state where details are missing or not relevant to the provided document.
Acceptance Criteria and Device Performance (Based on available information)
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Bench Testing | "bench testing acceptance criteria were met." (Specific criteria not detailed.) |
| Animal (Tissue) Testing (Leak Pressure) | "leak pressure acceptance criteria." (Specific criteria not detailed, applied to anastomotic stoma created in porcine colon.) |
Study Details (Based on available information)
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Sample size used for the test set and the data provenance: Not specified for bench testing or animal testing. Data provenance is "porcine colon" for animal testing.
- Retrospective/Prospective: Not specified.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not specified, as this is a mechanical device, and ground truth in this context would likely be physical measurements and observations, not expert interpretations of data like in AI.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable/not specified.
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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, as this is not an AI device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For bench testing: Implied to be engineering specifications and measurement outcomes (e.g., staple formation, material integrity, handle function).
- For animal tissue testing: Measured leak pressure of anastomotic stoma.
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The sample size for the training set: Not applicable, as this is not an AI device. (The concept of a "training set" is not relevant to the described testing of a mechanical device).
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How the ground truth for the training set was established: Not applicable, as this is not an AI device.
Summary of Device Performance Studies:
The document states that:
- Bench testing was conducted to demonstrate and verify the performance of the disposable reload and the reusable handle after 200 simulated uses. The results indicated that the acceptance criteria were met.
- Animal (tissue) testing was conducted using porcine colon to evaluate the pressure tolerance of an anastomotic stoma. The results showed that the staple lines created by the device met the "leak pressure acceptance criteria."
Key Missing Information:
The document provides high-level statements but lacks specific details on:
- The exact numerical or qualitative "acceptance criteria" for both bench and animal testing.
- The specific methods and full results of these tests.
- The number of samples/tests performed in each study.
§ 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.