(45 days)
PERI-LOC Periarticular Locked Plating System B-Plates and Screws can be used for adult and pediatric patients, as well as patients with osteopenic bone. PERI-LOC contoured B-Plates and Screws are indicated for partial articular fractures of the distal fibula, distal tibia, and proximal tibia. PERI-LOC Locking Tubular Plates are indicated for fracture fixation of the tibia, fibula, femur, metacarpals, humerus, ulna, radius, calcaneus, and clavicle.
Components in the PERI-LOC® Periarticular Locked Plating System are for single use only.
PERI-LOC* Periarticular Locked Plating System - B-Plates are line additions to the PERI-LOC* Periarticular Locked Plating System cleared under K033669. Like the predicate devices listed below, the subject components include various sizes of contoured and straight, locking bone plates and locking/non-locking bone screws made from stainless steel. PERI-LOC B-Plate locking bone plates and locking/non-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 - B-Plate Locking Bone Plates and Locking/Non-locking Bone Screws. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study or standalone algorithm performance.
Therefore, the following information about acceptance criteria and studies is not available in the provided text:
- A table of acceptance criteria and the reported device performance: The document does not define specific performance metrics or acceptance criteria for the device itself. The focus is on demonstrating equivalence to existing devices.
- Sample size used for the test set and the data provenance: No test set is described, as the evaluation is based on comparison to predicate devices, not on a new performance study.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method for the test set: Not applicable.
- 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: This is a medical device for bone plating, not an AI or imaging diagnostic device. MRMC studies are not relevant here.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as no new performance study generating "ground truth" data is described.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
What the document does state about the device's "study" and "criteria":
The "study" in this context is the 510(k) substantial equivalence submission process. The "acceptance criteria" are implicitly met by demonstrating that the new device is "substantially equivalent" to legally marketed predicate devices.
The document explicitly states:
- Substantial Equivalence Information: "When compared to the predicate devices listed below, substantial equivalence is based on similarities in design features, overall indications for use, and material composition."
- Predicate Devices:
Essentially, the device "meets acceptance criteria" by being sufficiently similar in its technological characteristics, intended use, and materials to devices already cleared by the FDA, without requiring new clinical performance data.
§ 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.