(97 days)
The ValuTrus™ Reusable Circular Stapler and Disposable Reloads have application throughout the alimentary tract for end-to-end, end-to-side, and side-to-side anastomoses.
The ValuTrus™ Reusable Circular Stapler and Disposable Reloads consists of a reusable circular stapler handle and disposable reloads (containing the anvil, knife, washer, and staples) in three sizes (25.5, 28.5, and 32.5 mm).
The provided text describes performance testing for a medical device called the "ValuTrus™ Reusable Circular Stapler and Disposable Reloads." However, it does not contain the detailed quantitative acceptance criteria and device performance results that would typically be presented in a table for an AI/CADe system. The information is more general, stating that criteria were "met" for bench and animal testing.
Therefore, I cannot fully complete a table with specific numerical acceptance criteria and reported device performance. I will extract and organize the available information as best as possible, and highlight what is missing.
Here's the breakdown based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Bench Testing | Not specified quantitatively. Implies performance of disposable reload and reusable handle after 200 simulated uses. | "Test results demonstrated the bench testing acceptance criteria were met." |
| Animal (Tissue) Testing | Leak pressure for an anastomotic stoma created in porcine colon. | "Testing results demonstrated that staple lines created by the circular stapler device met the leak pressure acceptance criteria." |
Missing Information: The specific numerical thresholds or qualitative attributes for "bench testing acceptance criteria" and "leak pressure acceptance criteria" are not provided in the document.
Study Details for Device Performance
The provided text focuses on the performance of a mechanical surgical stapler, not an AI/CADe system for image analysis. Therefore, many of the requested points related to AI/CADe studies (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable to this document.
However, I will address the relevant points based on the information provided for this mechanical device:
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Bench Testing: The sample size for bench testing is not explicitly stated. The testing was conducted to demonstrate performance after "200 simulated uses."
- Animal (Tissue) Testing: The sample size (number of animals or anastomoses) for animal testing is not specified. The data provenance is "porcine colon" (animal testing). It is implicitly prospective in nature as it's part of a device clearance application.
- Country of Origin: 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 (e.g. radiologist with 10 years of experience):
- Not applicable. This relates to human interpretation of data, which is not described for this mechanical device's performance studies. Ground truth here refers to physical measurements and observations.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This relates to discrepancies among human evaluators, which is not described for this mechanical device's performance studies.
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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. This type of study applies to image-based diagnostic systems with human interpretation, not a surgical stapler.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. There is no algorithm described for this device. Its "performance" is based on mechanical function and physical outcomes (e.g., staple line integrity).
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Bench Testing: The ground truth would be direct physical measurements and observations of the device's mechanical function (e.g., staple formation, cutting ability, durability after simulated uses), as defined by engineering specifications.
- Animal (Tissue) Testing: The ground truth was "leak pressure" of the anastomotic stoma, which is an objective physiological measurement.
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The sample size for the training set:
- Not applicable. This device is a mechanical stapler, not an AI/machine learning system that requires a "training set."
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How the ground truth for the training set was established:
- Not applicable. As above, no training set for an AI model is involved.
§ 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.