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OsteoMed Hand Plating System is intended for use in trauma, general surgery and reconstructive procedures of the hand, wrist, or other bones appropriate for the size of the device.

The OsteoMed Hand Plating System implants are intended for single use only.

The OsteoMed Hand Plating System is a rigid fixation system consisting of plates and screws in various configurations. Plates are provided in a variety of shapes and sizes, and offer surgeons compression and locking hole designs. The Hand Plating System includes angulated locking, nonlocking, lag, and cannulated screws as well as a buttress pin and K-wire implants. Surgical instrumentation is provided to facilitate modification, insertion, and removal of implants. The implants are made of Titanium (ASTM F-67 or ASTM F-136) or Stainless Steel (ASTM F-138 or ASTM F-139).

The instrumentation is made from various grades of stainless steel, anodized aluminum, and/or medical grade polymers.

The provided 510(k) summary for the OsteoMed Hand Plating System (K090522) does not contain any data from a study demonstrating the device meets specific acceptance criteria.

The submission focuses on establishing substantial equivalence to predicate devices based on similarities in intended use, material, design, and operational principles. It explicitly states: "Due to the similarity of materials and design to both pre-enactment and post-enactment devices we believe that the OsteoMed Hand Plating System does not raise any new safety or effectiveness issues." This indicates that the regulatory pathway chosen was primarily reliant on comparison to existing, cleared devices, rather than new performance studies with pre-defined acceptance criteria.

Therefore, I cannot provide the requested information for the following sections:

1. A table of acceptance criteria and the reported device performance: No such criteria or performance data are presented in this document.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No test set data is provided.
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, as no test set requiring ground truth establishment is 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: This device is a physical hand plating system, not an AI or imaging device. Therefore, an MRMC study with human readers and AI assistance is not relevant or applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This device is a physical hand plating system, not an algorithm. Therefore, standalone algorithm performance is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as no study requiring ground truth is described.
8. The sample size for the training set: Not applicable, as this is not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document is a 510(k) summary that establishes substantial equivalence through comparison to predicate devices, rather than through presenting new performance data from a primary study with acceptance criteria.

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