(24 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™ bone 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.
The subject devices are design modifications to PERI-LOC™ Periarticular Locked Plating System devices previously cleared under K033669, K051735 and K061352. Like the predicate devices listed below, the subject components include various sizes of contoured, locking bone plates made from stainless steel. PERI-LOC™ locking bone plates incorporate a screw-to-plate locking feature which forms a locked, fixed angle construct to aid in holding fracture reduction.
The provided text is a 510(k) summary for a medical device (PERI-LOC™ Locking Bone Plates). It describes design modifications to an existing device and asserts substantial equivalence to predicate devices. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement for assessing performance.
Therefore, I cannot populate the requested table or answer most of the questions based on the provided input.
Here's a breakdown of what can be inferred:
1. A table of acceptance criteria and the reported device performance
- Not available in the provided text. The document focuses on demonstrating substantial equivalence through design modifications, material composition, and intended use, rather than presenting new performance data against specific acceptance criteria.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not available in the provided text. No performance testing data is presented.
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 available in the provided text. No performance testing data is presented.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not available in the provided text. No performance testing data is presented.
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 / Not available in the provided text. This device is a mechanical bone plate system, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable / Not available in the provided text. This device is a mechanical bone plate system, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not available in the provided text. No performance testing data is presented. The "ground truth" for this type of device would typically involve mechanical testing (e.g., fatigue, static strength) and biocompatibility, but no such details are provided for this specific submission beyond asserting similarity to predicates.
8. The sample size for the training set
- Not applicable / Not available in the provided text. This is not an AI device, so there is no "training set."
9. How the ground truth for the training set was established
- Not applicable / Not available in the provided text. This is not an AI device, so there is no "training set" or its associated ground truth establishment.
Summary of what the document does provide:
The document describes design modifications to existing PERI-LOC™ Periarticular Locked Plating System devices. The submission focuses on demonstrating substantial equivalence to previously cleared predicate devices (K033669, K051735, and K061352) based on:
- Identical indications for use.
- Identical material (stainless steel).
- Very similar technological design characteristics.
The modifications are described as minor (e.g., removal of tunnels, chamfers, tabs, or slots) and do not appear to fundamentally change the intended mechanical function or safety profile in a way that would necessitate new, extensive clinical or performance studies for this 510(k) submission. The FDA clearance letter confirms the substantial equivalence determination.
§ 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.