(48 days)
PERI-LOC™ Periarticular Locked Plating System Proximal Femur Bone Plates, Bone Screws and Cable Accessories can be used for adult patients as well as patients with osteopenic bone. PERI-LOC™ Proximal Femur Locking Bone Plates, Bone Screws and Cable Accessories are indicated for fractures of the trochanteric region including simple intertrochanteric, reverse oblique trochanteric, transverse trochanteric, complex multi-fragmentary, and fractures with medial cortex instability; proximal femur fractures combined with ipsilateral shaft fractures; pathological fractures of the proximal femur including metastatic fractures; proximal femur osteotomies; fixation of fractures in osteopenic bone; fixation of nonunions and malunions; basi/transcervical femoral neck fractures; subcapital femoral neck fractures; and subtrochanteric femur fractures.
PERI-LOC™ Periarticular Locked Plating System -- Proximal Femur Locking Bone Plates, Bone Screws and Cable Accessories 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 lengths of contoured locking bone plates and locking/non-locking bone screws made from stainless steel and titanium. PERI-LOC™ Proximal Femur 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 510(k) summary (K072818) describes the PERI-LOC™ Periarticular Locked Plating System – Proximal Femur Locking Bone Plates, Bone Screws and Cable Accessories, a medical device used for fracture fixation. The submission declares substantial equivalence to previously cleared devices.
Based on the provided text, there is no acceptance criteria or dedicated study described that proves the device meets specific performance acceptance criteria in the typical format of a clinical or performance study report.
Instead, the submission relies on the concept of substantial equivalence to legally marketed predicate devices. This means that the new device is deemed safe and effective because it is similar in design, materials, technological characteristics, and intended use to devices already on the market.
Therefore, many of the requested fields related to a performance study will be "Not Applicable" or "Not Provided" in this context.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (e.g., Sensitivity, Specificity, Accuracy, Mechanical Strength) | Reported Device Performance (Value/Outcome) |
|---|---|
| Substantial Equivalence to Predicate Devices | Device is substantially equivalent to legally marketed predicate devices in design features, overall indications for use, and material composition. |
| Material Composition | Similar to predicate devices (Stainless Steel and Titanium). |
| Technological Characteristics | Similar to predicate devices (e.g., screw-to-plate locking feature forms a locked, fixed angle construct). |
| Indications for Use | Similar to predicate devices (e.g., fractures of the trochanteric region, proximal femur fractures, pathological fractures, osteotomies, nonunions, malunions, femoral neck fractures, subtrochanteric femur fractures). |
Explanation: The "acceptance criteria" here is primarily the demonstration of substantial equivalence. The "device performance" is implicitly met by virtue of being equivalent to devices already proven safe and effective. No specific numerical performance metrics are provided for the new device as a standalone entity in this submission.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable / Not provided. This submission relies on substantial equivalence rather than a new performance study with a specific test set of data.
- Data Provenance: Not applicable / Not provided. The evaluation is based on a comparison to existing predicate devices, not on new data collected for this specific device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not applicable / Not provided. No specific "ground truth" for a test set was established by experts for this 510(k) as part of a performance study.
- Qualifications of Experts: Not applicable / Not provided.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable / Not provided.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study Done: No. This is a submission for a bone plating system, not an imaging or diagnostic device requiring human reader interpretation in an MRMC study.
- Effect Size of Human Readers with vs. without AI: Not applicable.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Standalone Study Done: No. This is a mechanical device, not an algorithm.
7. Type of Ground Truth Used
- Type of Ground Truth: Not applicable / Not provided in the context of a dedicated performance study for this device. The "ground truth" for the substantial equivalence claim rests on the established safety and effectiveness of the predicate devices in clinical use.
8. Sample Size for the Training Set
- Sample Size for Training Set: Not applicable / Not provided. This is a mechanical device, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth Was Established: Not applicable / Not provided.
§ 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.