Search Results

The Universal Locking 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" and oblique "T" configurations. Plates accommodate either standard or locking screws via figure-8 shaped holes.

The provided submission K082527 describes a Zimmer Universal Locking System: 3.5mm Locking Plates and Screws. This is a physical orthopedic device and therefore the acceptance criteria and study described will not align with typical AI/ML device evaluations. The summary indicates that non-clinical (laboratory) performance testing was conducted to demonstrate safety and effectiveness. This means no studies involving human subjects or AI/ML evaluations are described in this document.

For the requested information:

1. A table of acceptance criteria and the reported device performance:

   Acceptance Criteria	Reported Device Performance
   Device safety	Demonstrated safe
   Device effectiveness	Demonstrated effective
   Performance characteristics	Similar to predicate devices

2. Sample size used for the test set and the data provenance: Not applicable. The device is a physical orthopedic implant. Performance was evaluated through non-clinical laboratory testing, not a dataset of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical device's performance is typically established through engineering and biomechanical testing specifications, not expert consensus on medical images or diagnoses.

4. Adjudication method for the test set: Not applicable. Adjudication methods like 2+1 or 3+1 are used for expert review of medical cases, not for the performance testing of physical orthopedic implants.

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, an MRMC study was not done. This device is an orthopedic implant, not an AI-powered diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm.

7. The type of ground truth used: For this physical device, the "ground truth" would be established by engineering specifications, material properties, and biomechanical performance standards adhered to during non-clinical laboratory testing.

8. The sample size for the training set: Not applicable. This is not an AI algorithm, so there is no training set in the conventional sense.

9. How the ground truth for the training set was established: Not applicable.

Ask a specific question about this device