(61 days)
The Profyle® System is intended for use in internal fixation of the bones of hand and wrist. Examples of these procedures may include but are not limited to replantation, lag screw techniques, joint fusions, corrective osteotomies, and the treatment of fractures.
This submission is a line extension to the Profyle® Hand and Small Fragment System to add alternate styles of plates and screws. Also, locking plates and locking screws are being added to the system.
This 510(k) summary (K062498) describes the Profyle® System, which consists of bone plates and screws. This is a traditional device submission and not one for AI/ML software. Therefore, the requested information, which pertains to AI/ML device performance studies, is not applicable or available in the provided text.
Here's a breakdown of why this information isn't present in this type of submission:
- Acceptance Criteria/Device Performance: For a traditional device like bone plates and screws, "acceptance criteria" and "reported device performance" are typically related to mechanical testing (e.g., tensile strength, fatigue life, biocompatibility) and clinical data if applicable (though often not required for 510(k) if substantial equivalence can be shown). The provided document only details the device description, indications for use, and a comparison to predicate devices, which is typical for a 510(k) summary demonstrating substantial equivalence. Mechanical testing results are usually in a separate part of the 510(k) submission, not the summary.
- Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth, Training Set: These terms are specific to the evaluation of AI/ML algorithms, particularly in medical imaging or diagnostic contexts. They refer to the methodologies used to train, validate, and test AI models against a human-established ground truth. Since the Profyle® System is a physical medical device (bone plates and screws) and not an AI/ML algorithm, these concepts do not apply.
Conclusion:
The provided document (K062498) is a 510(k) summary for a physical medical device (bone plates and screws). The questions posed are designed for the evaluation of AI/ML-driven medical devices. Therefore, none of the specific information requested in the prompt can be extracted from this document, as it is not relevant to the type of device or regulatory submission described.
§ 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.