(135 days)
The Auto Suture* Site Marker** staple is intended for use in soft tissue during an open or percutaneous biopsy procedure to radiographically mark the location.
The Auto Suture* Site Marker** staple, is a single use disposable staple, which consists of a non-absorbable material that is clearly visible on a radiograph. The staple is deployed into soft tissue during open or percutaneous procedures to mark a surgical location for radiograph by a manual stapler.
The provided text does not contain information about acceptance criteria or a study proving the device meets them. The document is a 510(k) summary for the "Auto Suture* Site Marker** staple," detailing its description, intended use, materials, and its substantial equivalence to a predicate device (MicroMark™ clip). It includes the FDA's clearance letter.
Therefore, I cannot provide the requested information, as there is no mention of:
- A table of acceptance criteria and reported device performance.
- Sample size or data provenance for a test set.
- Number or qualifications of experts used for ground truth.
- Adjudication method.
- A multi-reader multi-case (MRMC) comparative effectiveness study.
- Standalone performance testing.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.) beyond the general statement that it's "clearly visible on a radiograph."
- Sample size for the training set.
- How ground truth for the training set was established.
The 510(k) summary focuses on demonstrating equivalence to an already marketed device, rather than providing detailed performance study results against specific acceptance criteria.
§ 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.