(163 days)
The CAIS Staple is an absorbable implant used in the fixation of periosteal autograft to articular cartilage lesions of the knee.
The CAIS Staple is a PDS implant that attaches a scaffold to articular cartilage lesions in the knee.
The provided text describes a 510(k) summary for the CAIS Staple, a medical device. However, it does not contain any information regarding specific acceptance criteria, performance metrics, or details of a study that proves the device meets such criteria.
The document establishes substantial equivalence to a predicate device (PDS/PGA Staple, K021953) based on indications for use, technological characteristics, and comparison. It states "Results of performance and safety testing have demonstrated that the modified device is substantially equivalent to the predicate devices," but does not provide any specific data, test results, or study methodologies.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and the reported device performance: This information is not present.
- Sample size used for the test set and the data provenance: Not mentioned.
- Number of experts used to establish the ground truth and their qualifications: Not mentioned.
- Adjudication method: Not mentioned.
- MRMC comparative effectiveness study: Not mentioned.
- Standalone performance study: Not mentioned.
- Type of ground truth used: Not mentioned.
- Sample size for the training set: Not mentioned.
- How the ground truth for the training set was established: Not mentioned.
This 510(k) summary is a regulatory document focused on demonstrating substantial equivalence rather than detailing scientific studies with specific performance metrics against pre-defined acceptance criteria.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.