(61 days)
The PERI-LOC Periarticular Locked Plating System can be used for adult and pediatric patients, as well as patients with osteopenic bone. PERI-LOC bones plates and screws are indicated for fixation of pelvic, small and long bone fractures, including those of the tibia, fibula, femur, pelvis, acetabulum, metacarpals, metatarsals, humerus, ulna, radius, calcaneus, and clavicle.
Components in the PERI-LOC™ Periarticular Locked Plating System are for single use only.
Volar Distal Radius Locking Plates for the Upper Extremity manufactured from ASTM F139 material are line additions to the PERI-LOC™ Periarticular Locked Plating System cleared under K051735 and K061352. Like the predicate devices listed below, the subject components include various sizes of contoured locking bone plates and locking/non-locking bone screws made from stainless steel. PERI-LOC™ locking bone plates and locking bone screws incorporate a screw-to-plate locking feature which forms a locked, fixed angle construct to aid in holding fracture reduction.
The provided text describes a 510(k) summary for the PERI-LOC™ Periarticular Locked Plating System – Volar Distal Radius Locking Plate for the Upper Extremity – ASTM F139 Material Change. This is a medical device submission, and the content focuses on establishing substantial equivalence to previously cleared devices rather than presenting a study demonstrating performance against specific acceptance criteria for a new AI or diagnostic algorithm.
Therefore, many of the requested categories for AI/diagnostic studies, such as acceptance criteria, reported device performance, sample size for test sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details, are not applicable to this type of submission.
The document primarily addresses the following aspects:
- Device Description: It describes the Volar Distal Radius Locking Plates as line additions to an existing system, made from ASTM F139 material, and incorporating a screw-to-plate locking feature.
- Intended Use: Specifies that the system is for adult patients with osteopenic bone and is indicated for fixation of various bone fractures.
- Technological Characteristics: States that the device is similar to legally marketed devices in terms of indications, materials, and technological characteristics.
- Substantial Equivalence Information: Compares the device to several predicate devices based on design features, indications, and material composition.
Key points from the document regarding the device's assessment:
- No specific acceptance criteria for a new performance metric are listed. The approval is based on demonstrating "substantial equivalence" to existing, legally marketed predicate devices. This means the new device is considered as safe and effective as the predicate devices, without needing to prove new performance thresholds.
- No explicit study proving specific performance metrics is included. The 510(k) summary relies on comparison to predicate devices, implying that the established performance and safety of the predicates serve as the benchmark.
- No sample sizes for test sets, data provenance, expert numbers, adjudication, MRMC studies, or standalone performance are mentioned. These are typically associated with studies evaluating diagnostic or AI-driven devices, which this orthopedic implant is not.
- The "ground truth" for this type of device is implicitly the clinical performance and history of the predicate devices. Its substantial equivalence implies it should perform similarly in a clinical setting.
- No training set or ground truth establishment for a training set is relevant as this is not an AI/machine learning device.
In summary, based on the provided text, the device approval is based on substantial equivalence, not on meeting specific quantitative acceptance criteria through a performance study. The document does not contain the information required to populate the requested table or answer the specific questions about an AI/diagnostic study.
§ 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.