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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.

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.

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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.

Periarticular Plating System Calcaneal plates are indicated for complex extra-articular fractures and osteotomies of the calcaneus.

Periarticular 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 (plates and screws) and instrumentation for the management of periarticular bone fractures through interfragmentary compression and bone plating. Bone screws are provided for use with or without bone plates for fractures. This submission covers non-sterile versions of previously cleared sterile Zimmer Periarticular Plating System screws and various sizes of the following sterile plates: Distal Volar Radial Radius, Distal Volar Ulnar Radius, Lateral Calcaneal.

This document is a 510(k) premarket notification for the Zimmer Periarticular Plating System. It describes the device, its intended use, and its substantial equivalence to predicate devices. The information provided is primarily related to regulatory approval and does not contain details about a study designed to prove the device meets specific acceptance criteria in terms of diagnostic performance or clinical outcomes.

Here's a breakdown of why the requested information cannot be fully provided based on this document:

• Type of Device: The Zimmer Periarticular Plating System is a medical implant (plates and screws for bone fixation), not a diagnostic device or an AI-powered system that would typically undergo performance studies with acceptance criteria like sensitivity, specificity, or reader studies.
• Regulatory Pathway: This is a 510(k) submission, indicating a claim of substantial equivalence to already legally marketed predicate devices. This pathway primarily relies on demonstrating that the new device has the same intended use, technological characteristics, and performs as safely and effectively as the predicate, rather than requiring extensive de novo clinical trials to prove efficacy against acceptance criteria.

Therefore, many of the requested points are not applicable or cannot be extracted from this type of regulatory document.

However, I can extract the information that is present and explain why other points are not.

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

This document does not specify "acceptance criteria" in the sense of diagnostic performance metrics (e.g., sensitivity, specificity, AUC) or detailed clinical outcome success rates for a study designed to prove the device meets those criteria. Instead, the "performance" described is about non-clinical aspects related to safety and function for substantial equivalence.

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

This information is not provided. The performance data is based on non-clinical testing (shelf life, biocompatibility, engineering analysis), not human clinical data with a "test set" of patients.

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. There was no clinical test set for which ground truth needed to be established by experts.

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

Not applicable. There was no clinical test set requiring adjudication.

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 is not an AI-powered or diagnostic device. No MRMC study was conducted.

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

Not applicable. This is not an algorithm or AI device.

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

Not applicable to the clinical performance. For the non-clinical performance:

• Shelf Life: Determined by laboratory accelerated aging protocols.
• Biocompatibility: Determined by laboratory testing against ISO 10993-1 and 21 CFR 58 GLP.
• Mechanical Performance: Determined by engineering analysis and comparison to predicate device specifications and performance.

8. The sample size for the training set

Not applicable. This is not a device developed through machine learning.

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

Not applicable.

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