(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 include PERI-LOC* Periarticular Locking Bone Plates, Locking and Non-locking Bone Screws, which are line additions to and modifications to the PERI-LOC* Periarticular Locked Plating System devices previously cleared under K051735. Like the predicate devices listed below, the subject components include various sizes of contoured, locking bone plates, locking and 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.
This document is a 510(k) Summary of Safety and Effectiveness for the PERI-LOC® Locking Bone Plates and Locking and Non-locking Bone Screws for the Upper Extremity. It describes a medical device and its intended use, and states that it is substantially equivalent to previously cleared predicate devices.
Based on the provided text, there is no information about acceptance criteria, device performance, or any studies conducted to prove the device meets specific criteria. The document is a regulatory submission focused on demonstrating substantial equivalence to predicate devices, not on presenting novel performance data.
Therefore, I cannot provide the requested information in the format requested. The document does not contain:
- A table of acceptance criteria and the reported device performance: This information is absent.
- Sample size used for the test set and the data provenance: This information is absent.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is absent.
- Adjudication method for the test set: This information is absent.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: This information is absent.
- If a standalone performance (i.e., algorithm only without human-in-the-loop performance) was done: This information is absent.
- The type of ground truth used: This information is absent.
- The sample size for the training set: This information is absent.
- How the ground truth for the training set was established: This information is absent.
The document primarily focuses on:
- Device Description: The PERI-LOC® Periarticular Locking Bone Plates, Locking and Non-locking Bone Screws for the Upper Extremity are line additions and modifications to a previously cleared system. They are made from stainless steel and incorporate a screw-to-plate locking feature.
- Intended Use: Fixation of pelvic, small, and long bone fractures in adult and pediatric patients, including those with osteopenic bone, across various anatomical sites.
- Technological Characteristics: Similar to legally marketed devices, with identical indications for use (compared to K051735), identical material, and very similar technological characteristics.
- Substantial Equivalence: Based on similarities with regard to overall indications for use, material composition, and technological design characteristics to predicate devices: Smith & Nephew Locked Plating System (K033669) and PERI-LOC Periarticular Locked Plating System for the Upper Extremity (K051735).
The letter from the FDA confirms that the device is substantially equivalent to legally marketed predicate devices, allowing it to be marketed, subject to general controls provisions. This process for Class II medical devices like bone fixation appliances often relies on demonstrating equivalence to existing devices rather than requiring new clinical performance studies or specific acceptance criteria for novel performance metrics.
§ 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.