(21 days)
The Universal Locking Plate System is indicated for temporary internal fixation and stabilization of osteotomies and fractures, including;
- Comminuted fractures .
- Supracondylar fractures .
- Extra-articular fractures .
- Fractures in osteopenic bone .
- Nonunions .
- Malunions .
The Zimmer Universal Locking System is a plate and screw system intended for internal fracture fixation. The plate selection consists of dual compression, reconstruction, tubular, straight "T", straight "L" and oblique "L" configurations. Plates accommodate either standard or locking screws via figure-8 shaped holes.
Here's an analysis of the provided text regarding the Zimmer Universal Locking System, focusing on acceptance criteria and study details.
Important Note: The provided document is a 510(k) summary for a medical device (bone plates and screws). For this type of device, "acceptance criteria" and "device performance" are typically related to mechanical properties (e.g., strength, fatigue life) rather than diagnostic accuracy as one might find for an AI-powered diagnostic tool. Similarly, "ground truth" and "expert consensus" are not applicable in the same way. The document explicitly states that clinical data and conclusions were not needed for this device. This means there was no study involving human patients to assess its clinical performance in terms of diagnostic effectiveness. The evaluation was primarily based on non-clinical (laboratory) performance testing and demonstrating substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Mechanical performance equivalent to predicate device for internal fracture fixation. | Test results "demonstrate that the device is safe and effective." (Specific quantitative criteria and results are not provided in this summary.) |
| Biocompatibility equivalent to predicate device. | Manufactured from the "same materials" as the predicate device. (Implying equivalent biocompatibility). |
| Similar design characteristics to predicate device. | "Similar in design to the predicate device." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated as this was a non-clinical (laboratory) performance study, not a clinical trial with patient data. The "test set" would consist of manufactured devices subjected to various mechanical tests.
- Data Provenance: Non-clinical (laboratory) testing. Not applicable for country of origin or retrospective/prospective as it doesn't involve patient data.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
- Not Applicable. This device is a bone plating system, not a diagnostic tool requiring expert interpretation of results. "Ground truth" in this context would be defined by engineering specifications and material science standards.
4. Adjudication Method for the Test Set
- Not Applicable. As there was no expert review of patient data, no adjudication method like 2+1 or 3+1 was used. The evaluation would have been based on engineering measurements and comparisons to design specifications.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. This was not an AI-powered diagnostic device, so a MRMC study comparing human readers with and without AI assistance is not relevant.
6. Standalone (Algorithm Only) Performance Study
- No. This device does not involve an algorithm. The assessment was of the physical device itself.
7. Type of Ground Truth Used
- Engineering Specifications and Material Science Standards. For a medical implant like this, "ground truth" would be defined by established mechanical and material properties required for safe and effective internal fixation, typically based on industry standards, validated testing methods, and comparison to the predicate device's known performance.
8. Sample Size for the Training Set
- Not Applicable. There is no "training set" in the context of this device's evaluation. This is a physical product, not a machine learning model.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there is no training set, this question is not relevant.
§ 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.