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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 and 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.

This document is a 510(k) premarket notification for a medical device called the "Zimmer Universal Locking System." It is a traditional 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than proving specific performance against acceptance criteria in a detailed clinical study.

Therefore, much of the requested information (acceptance criteria table, sample sizes, expert qualifications, adjudication, MRMC studies, standalone performance, ground truth details, training set size) is not present in this type of regulatory submission because it is not required for a 510(k) clearance process.

Here's what can be extracted and what cannot:

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

• Not provided. A 510(k) submission generally does not include specific quantitative acceptance criteria tables and detailed performance data against them in the same way a PMA would. Instead, it refers to equivalence to predicate devices.
• The document states: "The results of non-clinical (laboratory) performance testing demonstrate that the device is safe and effective." However, it does not provide the specific results or the acceptance criteria used for this testing.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not provided. This document only mentions "non-clinical (laboratory) performance testing," which implies mechanical or bench testing. It does not refer to a "test set" in the context of clinical data or human subjects.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable/Not provided. No clinical "test set" with expert-established ground truth is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable/Not provided. No clinical "test set" is described.

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

• Not applicable. This device is a mechanical bone fixation system, not an AI-driven diagnostic or assistive tool for human readers. No MRMC study would be relevant or expected for this type of device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This device is a mechanical bone fixation system, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not applicable/Not provided in the traditional sense. For a mechanical device, "ground truth" typically relates to engineering specifications, material properties, and biomechanical performance rather than clinical diagnoses. The document mentions "non-clinical (laboratory) performance testing," which would assess parameters like strength, fatigue life, etc., often against established industry standards for predicate devices.

8. The sample size for the training set

• Not applicable/Not provided. This device does not involve machine learning or AI, so there is no training set.

9. How the ground truth for the training set was established

• Not applicable/Not provided. As above, no training set for AI is involved.

Summary of what is available:

• Device: Zimmer Universal Locking System (plate and screw system for internal fracture fixation).
• Study described: "Non-clinical (laboratory) performance testing."
• Purpose of testing: To demonstrate that the device is "safe and effective" and comparable to predicate devices. The document explicitly states: "The Zimmer Universal Locking System plates have the same intended use, similar performance characteristics, are manufactured from similar materials and are similar in design to the predicate devices."
• Predicate Devices: Zimmer® ECT® Internal Fracture Fixation system and Synthes Small Fragment Dynamic Compression Locking (DCL) System (K000684).

In the context of a 510(k) for a conventional medical device like this, the "study that proves the device meets the acceptance criteria" is the non-clinical (laboratory) performance testing that shows substantial equivalence to the predicate devices in terms of performance characteristics. The acceptance criteria would generally be that the device performs at least as well as or similarly to the predicate devices in relevant biomechanical and material tests. However, the specific details of those tests and their numerical acceptance criteria are not included in this high-level summary.

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