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The DePuy Small Locking Plate System is intended for stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion and reconstructions of small bones of the hand, foot, wrist, ankle, humerus, scapula, finger, toe, pelvis and craniomaxillofacial skeleton, particularly in osteopenic bone.

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The provided text is a 510(k) summary for the DePuy Small Locking Plate System. It describes the device's intended use and claims substantial equivalence to predicate devices based on technological characteristics and pre-clinical data. However, the document does not contain information regarding detailed acceptance criteria, a specific study proving device performance against those criteria, or any of the detailed aspects requested in the prompt (e.g., sample sizes, expert qualifications, ground truth methods, MRMC studies, or standalone performance data).

The 510(k) summary states: "The Small Locking Plate System is substantially equivalent to currently marketed devices as demonstrated with pre-clinical data. No new issues of safety or efficacy have been raised." This indicates that the regulatory approval was based on demonstrating equivalence, not necessarily on a de novo study against defined acceptance criteria, or an AI-driven system.

Therefore, most of the requested information cannot be extracted from the provided text.

Here is a summary of what can be inferred or directly stated:

Information from the Provided Text:

• Device Name: Small Locking Plate System
• Intended Use: Stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion and reconstructions of small bones of the hand, foot, wrist, ankle, humerus, scapula, finger, toe, pelvis and craniomaxillofacial skeleton, particularly in osteopenic bone.
• Basis for Approval: Substantial equivalence to predicate devices based on pre-clinical data.

Missing Information:

The following information, as requested in the prompt, is not present in the provided 510(k) summary:

1. A table of acceptance criteria and the reported device performance: Not provided. The approval is based on substantial equivalence, not explicit performance metrics against acceptance criteria.
2. Sample sizes used for the test set and the data provenance: Not provided. No specific "test set" for performance evaluation is mentioned in the context of this 510(k) summary, as it relies on pre-clinical data demonstrating equivalence.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no such "test set" and ground truth establishment process for performance evaluation are described.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
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 physical medical implant (a bone fixation plate), not an AI-driven diagnostic or assistive system for human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as no such ground truth establishment for performance evaluation is described. The approval is based on "pre-clinical data" for substantial equivalence.
8. The sample size for the training set: Not applicable, as this is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established: Not applicable.

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