(34 days)
Periarticular Plating System plates are indicated for temporary internal fixation and stabilization of osteotomies and fractures, including: comminuted fractures, supracondylar fractures, intra-articular condylar fractures, fractures in osteopenic bone, nonunions, and malunions.
Periarticular Plating System Small Distal Volar Radial Radius and Small Distal Volar Ulnar Radius plates are indicated for temporary internal fixation and stabilization of fractures and osteotomies of the distal radius, including associated carpal fusions.
Periaticular Plating System Calcaneal plates are indicated for complex extra-articular fractures and osteotomies of the calcaneus.
Periatioular Plating System screws are temporary internal fixation devices designed to stabilize fractures during the normal healing process.
The Zimmer Periarticular Plating System consists of temporary implants for the management of periarticular bone fractures through interfragmentary compression and bone plating. This submission covers various sizes of femoral, tibial, fibular, femoral, humeral, ulnar, and radial plates.
The provided text describes a 510(k) premarket notification for the Zimmer® Periarticular Plating System. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving device performance against specific acceptance criteria through a clinical study. Therefore, most of the requested information regarding acceptance criteria, study design, and ground truth establishment is not available in this document.
Here's a breakdown of what can be gleaned:
1. A table of Acceptance Criteria and the Reported Device Performance:
- Acceptance Criteria: Not explicitly stated as pass/fail thresholds for clinical performance. The "acceptance criteria" implicit in a 510(k) for this type of device are substantial equivalence to predicate devices in terms of intended use, function, fundamental scientific technology, and not raising new issues of safety or effectiveness.
- Reported Device Performance:
- Shelf Life: Successfully demonstrated a 10-year shelf life through accelerated aging testing.
- Biocompatibility: Passed testing according to ISO 10993-1 and Good Laboratory Practices (21 CFR 58).
- Performance Testing (Engineering Analysis): Demonstrated that the devices are safe and effective and substantially equivalent to the predicate devices. This likely involved mechanical testing, but specific metrics and acceptance thresholds are not provided.
| Criterion | Reported Performance |
|---|---|
| Shelf Life | 10 years (based on accelerated aging testing) |
| Biocompatibility | Passed (per ISO 10993-1 and 21 CFR 58) |
| Performance (Safety & Effectiveness) | Demonstrated (via Engineering Analysis, substantially equivalent to predicate devices) |
2. Sample Size Used for the Test Set and Data Provenance:
- Not applicable for clinical studies seeking to prove performance. The evaluation relied on non-clinical performance data and a comparison to predicate devices, not a clinical test set with human subjects.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- Not applicable. No clinical test set with ground truth established by experts was used or described.
4. Adjudication Method:
- Not applicable. No clinical test set requiring expert adjudication was used or described.
5. Multi-reader Multi-case (MRMC) Comparative Effectiveness Study:
- No. This type of study (comparing human readers with and without AI assistance) is not mentioned and is not relevant for the Zimmer Periarticular Plating System, which is a physical medical device (implants for bone fixation), not an AI diagnostic tool.
6. Standalone (Algorithm Only) Performance Study:
- No. This is not relevant. The device is not an algorithm.
7. Type of Ground Truth Used:
- Not applicable for clinical studies. For the non-clinical performance data, the "ground truth" was established by standardized engineering tests and biocompatibility assays (e.g., meeting specific mechanical properties, not eliciting adverse biological responses).
8. Sample Size for the Training Set:
- Not applicable. There is no mention of a training set as this is not an AI/machine learning device.
9. How the Ground Truth for the Training Set was Established:
- Not applicable.
In summary: The Zimmer Periarticular Plating System K150121 submission is a 510(k) premaket notification that demonstrates substantial equivalence to predicate devices primarily through non-clinical testing (shelf-life, biocompatibility, engineering analysis). It does not involve clinical studies with human subjects, expert-derived ground truth, or AI algorithms, and therefore, most of the detailed questions regarding study design are not applicable to the information 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.