(11 days)
The SafeStitch AMID Stapler® has application in general surgery procedures for fixation of mesh, in the repair of hernia defects and in other surgical specialties for the approximation of tissue(s), including skin.
The SafeStitch AMID Stapler™ contains 17 titanium staples. The AMID Stapler™ places a staple each time the instrument's handle is squeezed. The staple legs first penetrate the tissue or mesh and then fully form, thus anchoring or approximating the tissue(s) and/or mesh.
This document describes a 510(k) submission for the SafeStitch AMID Stapler®, which is a medical device. The submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. Therefore, the information provided does not align with the typical requirements for describing acceptance criteria and a study for an AI/ML powered medical device.
Based on the provided text, the device is a manual surgical stapler, not an AI-powered device. As such, many of the requested categories (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, training set size, ground truth for training set) are not applicable.
Here's the relevant information derived from the document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes "Design verification testing" to ensure the subject device meets required acceptance criteria and functions equivalently to the predicate device. The results are reported as "Pass" for both the predicate and subject devices, indicating they met the defined criteria. While the specific numerical acceptance thresholds are not provided in this summary, the criteria are implied by the test methods.
| Test Method | Acceptance Criteria (Implied) | Reported Device Performance (Subject Device) |
|---|---|---|
| Staple Pull Strength | "Pass" (met predefined strength requirements) | Pass |
| Maximum Staple Penetration | "Pass" (met predefined penetration limits) | Pass |
| Formed Staple Height | "Pass" (met predefined height specifications) | Pass |
| Formed Staple Width | "Pass" (met predefined width specifications) | Pass |
| Maximum Deployment Force | "Pass" (met predefined force limits) | Pass |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not specified in the provided text. The document states "Design verification testing was conducted," but does not mention the number of units tested.
- Data Provenance: Not specified. The testing was non-clinical, so country of origin of patient data is not applicable. This was likely internal company testing.
- Retrospective or Prospective: Not applicable as this is non-clinical device testing, not a study involving patient 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):
Not applicable. Ground truth as typically defined for AI/ML devices (e.g., expert consensus on medical images) is not relevant for the non-clinical mechanical testing of a surgical stapler. The "ground truth" for these tests would be the established engineering specifications and performance standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. Adjudication methods are typically used in studies involving subjective assessments or disagreements among human readers/experts, which is not the case for objective mechanical device testing.
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:
Not applicable. An MRMC study is relevant for AI-powered diagnostic or assistive devices involving human interpretation. This document describes a manual surgical stapler.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an algorithm or an AI system. The testing focused on the mechanical performance of a physical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for this device's testing would be engineering specifications and predefined performance criteria for mechanical properties (e.g., specific force required, dimensions of formed staples, pull strength thresholds). The tests were designed to verify the device met these objective, measurable standards.
8. The sample size for the training set:
Not applicable. This is not an AI/ML device, so there is no "training set."
9. How the ground truth for the training set was established:
Not applicable, as there is no training set for this type of device.
§ 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.