(157 days)
The ADHOC® CLAW is an implant used for rotator cuff repair in shoulder surgery.
The ADHOC® CLAW is an implant used for rotator cuff repair in shoulder surgery. The ADHOC® CLAW is made of 316L stainless steel.
The provided text is a 510(k) summary for the ADHOC® CLAW soft tissue fixator. It does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria.
The document primarily focuses on establishing substantial equivalence to predicate devices (MITEK GII and ACUFEX MICROSURGICAL) based on similar intended use and design, rather than on performance metrics or clinical study results demonstrating new acceptance criteria.
Therefore, I cannot provide the requested information. The sections below indicate why each point cannot be addressed from the given text:
1. A table of acceptance criteria and the reported device performance
- Not applicable. The document does not define any specific acceptance criteria for performance (e.g., tensile strength, fixation force, biocompatibility thresholds) nor does it report device performance against such criteria. The basis for clearance is substantial equivalence to legally marketed predicate devices, not meeting novel performance benchmarks.
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. No test set or study data are mentioned explicitly in the provided summary.
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. No ground truth establishment or expert involvement in a test set is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No test set or adjudication method is mentioned.
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. This device is a medical implant (soft tissue fixator), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to AI assistance is irrelevant and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. As stated above, this is an implant, not an algorithm, so standalone performance in that context is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. No ground truth for performance evaluation is mentioned. The "ground truth" for clearance in this context is the safety and effectiveness of the predicate devices.
8. The sample size for the training set
- Not applicable. No training set is mentioned as this is not an AI/ML device.
9. How the ground truth for the training set was established
- Not applicable. No training set or ground truth for it is mentioned.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.