(12 days)
The Zimmer Periarticular Locking Plate System is indicated for temporary internal fixation and stabilization of osteotomies and fractures, including:
- Comminuted fractures
- Supracondylar fractures .
- Intra-articular and extra-articular condylar fractures .
- . Fractures in osteopenic bone
- . Nonunions
- Malunions .
The Zimmer Periarticular Locking Plate System is a plate and screw system intended for internal fracture fixation. The low-profile periarticular locking plate is anatomically contoured and has threaded holes which accept locking screws to create a stable, fixed angle construct.
The provided document refers to the Zimmer® Periarticular Locking Plate System, a plate and screw system for internal fracture fixation.
Crucially, no acceptance criteria or a study proving the device meets specific performance criteria are described in the provided text.
Here's an breakdown based on the information available:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| NONE STATED | "The results of non-clinical (laboratory) performance testing and analysis demonstrate that the device is safe and effective." |
Explanation: The document explicitly states that "Clinical data and conclusions were not needed for this device." The basis for clearance is substantial equivalence to a predicate device, supported by non-clinical laboratory performance testing. However, no specific performance metrics or acceptance criteria for this non-clinical testing are provided.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not applicable, as no clinical test set was used. "Non-clinical (laboratory) performance testing and analysis" was performed, but no details on sample size for these tests are provided.
- Data Provenance: Not applicable, as no clinical data was used.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
- Not applicable, as no clinical test set requiring expert ground truth was used.
4. Adjudication Method for the Test Set:
- Not applicable, as no clinical test set requiring adjudication was used.
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:
- No MRMC study was done. This device is a physical medical device (bone plates and screws), not an AI-assisted diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No standalone algorithm performance study was done. This device is a physical medical device, not a software algorithm.
7. The Type of Ground Truth Used:
- Not applicable, as no clinical data or ground truth in the traditional sense was used for this 510(k) submission. The safety and effectiveness were demonstrated through "non-clinical (laboratory) performance testing and analysis" and comparison to a predicate device, rather than clinical outcome-based ground truth.
8. The Sample Size for the Training Set:
- Not applicable, as no training set for a machine learning model was used.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable, as no training set for a machine learning model was used.
Summary of Device Evaluation Approach:
The Zimmer® Periarticular Locking Plate System received 510(k) clearance based on substantial equivalence to a previously cleared predicate device (Zimmer® Periarticular Locking Plates, K042598). The submission documents state:
- "The Zimmer Periarticular Locking Plate System has the same intended use, operates with the same fundamental scientific technology, is manufactured from the same materials using similar processes, and is similar in design to the predicate device."
- "The results of non-clinical (laboratory) performance testing and analysis demonstrate that the device is safe and effective."
- "Clinical data and conclusions were not needed for this device."
Therefore, the "proof" that the device meets safety and effectiveness criteria relies on bench testing (non-clinical laboratory performance testing) and the demonstration of substantial equivalence to an already approved device, rather than specific clinical acceptance criteria met through a detailed 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.