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The Periarticular Locking Plate System is indicated for temporary internal fixation and stabilization of osteotomies and fractures, including:

• Comminuted fractures. .
• . Supracondylar fractures,
• . Intra-articular and extra-articular condylar fractures,
• . Fractures in osteopenic bone,
• . Nonunions, and
• . Malunions

The Zimmer Periarticular Locking Plate System is a plate and screw system. The low-profile periarticular plates are anatomically contoured with threaded holes to engage and "lock" the screws at a fixed angle relative to the plate.

The provided text does not contain information about the acceptance criteria or a study proving that a device (specifically, an AI/analytic model) meets those criteria. The document is a 510(k) summary for the Zimmer Periarticular Locking Plate System, which is a physical medical device (a plate and screw system for bone fixation).

The document discusses:

• Device Description: A plate and screw system for bone fixation.
• Intended Use: Temporary internal fixation and stabilization of osteotomies and fractures.
• Comparison to Predicate Device: The submission is to add a sterile version of existing non-sterile devices.
• Performance Data (Nonclinical):
  • Sterilization Validation (terminal sterilization to SAL greater than or equal to 10-6 at 20kGy gamma dose).
  • Shelf Life (10 years, based on accelerated aging).
  • Sterile Packaging (to withstand normal distribution and storage and maintain sterile barrier).
• Clinical Data: Stated that "Clinical data and conclusions were not needed for this device."

Therefore, I cannot provide the requested information regarding acceptance criteria and study details for an AI/analytic model, as the document is about a hardware device and does not involve AI or analytical performance testing with ground truth, expert review, or statistical measures like sample size, effect size, etc.

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The Periarticular Locking Plate System is indicated for temporary internal fixation and stabilization of osteotomies and fractures, including:

• · Comminuted fractures
• · Supracondylar fractures
• · Intra-articular and extra-articular condylar fractures
• · Fractures in osteopenic bone
• Nonunions
• · Malunions

The Zimmer Periarticular Locking Plate System is a plate and screw system intended for internal fracture fixation. The low-profile periarticular locking plate is anatomically contoured and has threaded holes which accept locking screws to create a stable, fixed angle construct.

This is a 510(k) premarket notification for the Zimmer Periarticular Locking Plate System, which is a medical device for internal fracture fixation. The provided document is a regulatory submission, not a study report detailing acceptance criteria for an AI/CADe device. Therefore, most of the requested information about acceptance criteria, study design, and performance metrics related to AI algorithm evaluation cannot be found here.

However, I can extract the information that is present:

1. Table of Acceptance Criteria and Reported Device Performance:

This document does not specify "acceptance criteria" in the way it would for an AI algorithm's performance (e.g., sensitivity, specificity thresholds). Instead, for a traditional medical device like a bone plate system, acceptance is based on demonstrating substantial equivalence to a predicate device and showing the device is safe and effective through non-clinical performance data.

2. Sample size used for the test set and the data provenance:

• Not Applicable. This submission is for a traditional medical device (bone plate system) and refers to non-clinical testing (likely mechanical and material property tests), not a clinical or AI algorithm performance study with a "test set" in the context of diagnostic or prognostic accuracy.
• The document implies laboratory-based non-clinical testing rather than human data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not Applicable. No ground truth establishment by human experts for a "test set" is described, as this is not an AI/CADe or diagnostic study.

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

• Not Applicable. No adjudication method for a 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 is not an AI-assisted diagnostic device; therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed or described.

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

• Not Applicable. This is not an algorithmic device.

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

• Not Applicable (in the context of AI/diagnostic ground truth). The "ground truth" for this device would be established through engineering specifications, material standards, and biomechanical testing results, not through expert consensus, pathology, or outcomes data in the way an AI algorithm's performance is validated.

8. The sample size for the training set:

• Not Applicable. This device does not involve a "training set" for an AI algorithm.

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

• Not Applicable. This device does not involve a "training set" or corresponding ground truth establishment.

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The Zimmer Periarticular Locking Plate System is indicated for temporary internal fixation and stabilization of osteotomies and fractures, including:

• Comminuted fractures
• Supracondylar fractures .
• Intra-articular and extra-articular condylar fractures .
• . Fractures in osteopenic bone
• . Nonunions
• Malunions .

The Zimmer Periarticular Locking Plate System is a plate and screw system intended for internal fracture fixation. The low-profile periarticular locking plate is anatomically contoured and has threaded holes which accept locking screws to create a stable, fixed angle construct.

The provided document refers to the Zimmer® Periarticular Locking Plate System, a plate and screw system for internal fracture fixation.

Crucially, no acceptance criteria or a study proving the device meets specific performance criteria are described in the provided text.

Here's an breakdown based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance:

Explanation: The document explicitly states that "Clinical data and conclusions were not needed for this device." The basis for clearance is substantial equivalence to a predicate device, supported by non-clinical laboratory performance testing. However, no specific performance metrics or acceptance criteria for this non-clinical testing are provided.

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

• Sample Size: Not applicable, as no clinical test set was used. "Non-clinical (laboratory) performance testing and analysis" was performed, but no details on sample size for these tests are provided.
• Data Provenance: Not applicable, as no clinical data was used.

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

• Not applicable, as no clinical test set requiring expert ground truth was used.

4. Adjudication Method for the Test Set:

• Not applicable, as no clinical test set requiring adjudication was used.

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 MRMC study was done. This device is a physical medical device (bone plates and screws), not an AI-assisted diagnostic tool.

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

• No standalone algorithm performance study was done. This device is a physical medical device, not a software algorithm.

7. The Type of Ground Truth Used:

• Not applicable, as no clinical data or ground truth in the traditional sense was used for this 510(k) submission. The safety and effectiveness were demonstrated through "non-clinical (laboratory) performance testing and analysis" and comparison to a predicate device, rather than clinical outcome-based ground truth.

8. The Sample Size for the Training Set:

• Not applicable, as no training set for a machine learning model was used.

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

• Not applicable, as no training set for a machine learning model was used.

Summary of Device Evaluation Approach:

The Zimmer® Periarticular Locking Plate System received 510(k) clearance based on substantial equivalence to a previously cleared predicate device (Zimmer® Periarticular Locking Plates, K042598). The submission documents state:

• "The Zimmer Periarticular Locking Plate System has the same intended use, operates with the same fundamental scientific technology, is manufactured from the same materials using similar processes, and is similar in design to the predicate device."
• "The results of non-clinical (laboratory) performance testing and analysis demonstrate that the device is safe and effective."
• "Clinical data and conclusions were not needed for this device."

Therefore, the "proof" that the device meets safety and effectiveness criteria relies on bench testing (non-clinical laboratory performance testing) and the demonstration of substantial equivalence to an already approved device, rather than specific clinical acceptance criteria met through a detailed study.

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