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ZPS One-Third Tubular Plates, T-Plates, Symphyseal Bridge Plates, Reconstruction Plates, and Contourable Dual Compression Plates are indicated for temporary internal fixation and stabilization of osteotomies and fractures, such as:

• comminuted fractures
• · supracondvlar fractures
• extra-articular fractures
• · fractures in osteopenic bone
• nonunions
• · malunions

Smaller-sized ZPS plates are used for small bones and small fragments of the hands and feet.

ZPS Calcaneal plates are indicated for temporary internal fixation of osteotomies and fractures of the calcaneus. ZPS and Forte Screws are temporary internal fixation devices designed to stabilize fractures during the normal healing process

The ZPS System is a non-locking, stainless steel plate and screw system. Plate shapes vary to address varying patient bone sizes and injury fragment sizes. Plates incorporate a spherical sliding slope plate hole design to achieve the compression required to treat bone fractures. The plates are used with a variety of screws for temporary fixation to the bone. The Forte Cancellous Screws are used with the ZPS Plates to form a fixation construct.

Here's an analysis of the provided text regarding the acceptance criteria and study information for the Zimmer Plates and Screws System (ZPS):

Device Name: Non-sterile Zimmer® Plates and Screws System (ZPS) Compression/Reconstruction/Symphyseal Plates and Forte Cancellous Screws

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

• Test Set Sample Size: Not explicitly stated as a number of devices. Descriptions relate to the types of ZPS plates and Forte screws and their corresponding predicate devices that underwent testing.
• Data Provenance: Non-clinical (laboratory testing). No information on country of origin, but it's implied to be internal testing by Zimmer, Inc. The testing was retrospective as it was conducted to support the 510(k) submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

• Not applicable. The "ground truth" for the non-clinical performance evaluation was established through standardized testing methodologies (e.g., ISO 10993-1, mechanical testing protocols). No human experts were involved in establishing "ground truth" for these performance metrics.

4. Adjudication Method for the Test Set:

• Not applicable. The performance data is objective and derived from physical testing, not subjective human assessment.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical data and conclusions were not needed for these devices."

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance:

• Not applicable. This is a medical device (plates and screws), not an algorithm or AI system. Its performance is assessed physically, not through computational means.

7. Type of Ground Truth Used:

• The ground truth for the non-clinical performance data was based on:
  • Standardized testing protocols: For biocompatibility (ISO 10993-1) and mechanical properties (static, fatigue, beam bending).
  • Predicate device performance: The "ground truth" for comparative effectiveness was the established performance of the legally marketed predicate devices. The new device was deemed acceptable if its performance was "similar" to these predicates.

8. Sample Size for the Training Set:

• Not applicable. This is not an AI/ML device, so there is no "training set."

9. How the Ground Truth for the Training Set Was Established:

• Not applicable, as there is no training set.

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