(74 days)
The Surgical Staple Marker's intended use is to be applied to soft tissue during open or percutaneous procedures and radiographically mark the surgical location.
The devices consist of a non absorbable material compatible with X-ray, i.e., clearly visible on a radiograph; the staple/markers are deployed with manual appliers or surgical instruments.
The provided text is a summary of safety and effectiveness from a 510(k) submission for a Surgical Staple Marker. It focuses on establishing substantial equivalence to predicate devices rather than describing a study that proves the device meets specific acceptance criteria in terms of performance.
Therefore, many of the requested details cannot be extracted from this document, as it does not contain the specifics of a performance study with acceptance criteria.
Here's an attempt to answer based on the available information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria or report specific performance metrics for the device. Instead, it argues for substantial equivalence based on intended use and technological characteristics.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in document | Not specified in document |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. The document does not describe a performance study with a test set.
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. The document does not describe a performance study with ground truth established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. The document does not describe a performance study.
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. The device is a surgical staple marker, not an AI-powered diagnostic tool, and the document does not describe an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a physical surgical staple marker, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The document does not describe a performance study requiring ground truth. The basis of the submission is substantial equivalence to predicate devices.
8. The sample size for the training set
Not applicable. The device is a physical surgical staple marker, not a machine learning model, and the document does not describe a training set.
9. How the ground truth for the training set was established
Not applicable. The device is a physical surgical staple marker, not a machine learning model, and the document does not describe a training set or ground truth establishment for it.
§ 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.