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The Synthes Stainless Steel Modular Hand System consists of plates and screws intended for use in selective trauma, reconstructive procedures, and general surgery of the hand, wrist, and other small bones.

The Synthes Stainless Steel Modular Hand System is a series of plates and screws of varying lengths and thickness, and configurations including straight, T-, Y-, and extended H- plates. These plates are attached to bone via 1.8 mm buttress pins and 1.0, 1.3, 1.5, 2.0, and 2.4 mm self-tapping cortex screws.

This document is a 510(k) premarket notification for a medical device called the "Synthes Stainless Steel Modular Hand System." It establishes the device's substantial equivalence to other legally marketed devices, rather than presenting a study to prove the device meets specific acceptance criteria. Therefore, most of the requested information regarding acceptance criteria and performance studies is not available in the provided text.

Here is the information that can be extracted or deduced from the provided documents:

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

• Acceptance Criteria: Not explicitly stated as this document is a 510(k) submission for substantial equivalence. The primary "acceptance criteria" for a 510(k) are demonstrating substantial equivalence to a legally marketed predicate device.
• Reported Device Performance: Not reported in terms of specific metrics, as this is not a study report. The document indicates that "Documentation is provided which demonstrated the Synthes Stainless Steel Modular Hand System to be substantially equivalent to other legally marketed devices."

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

• Not applicable. This is a 510(k) submission for substantial equivalence, not a clinical or performance study that utilizes a test set in the described manner.

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. Ground truth establishment is not relevant in this 510(k) submission.

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

• Not applicable. Adjudication methods are not relevant in this 510(k) submission.

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 comparative effectiveness study was done, as this is a submission for a mechanical implant system, not an AI-assisted diagnostic or therapeutic device.

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

• Not applicable. This is a mechanical device, not an algorithm.

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

• Not applicable. Ground truth is not relevant in this 510(k) submission. The basis for approval is substantial equivalence to predicate devices, implying similar design, materials, and intended use, rather than performance against a "ground truth" as in diagnostic accuracy studies.

8. The sample size for the training set

• Not applicable. This is a mechanical device, not a machine learning model requiring a training set.

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

• Not applicable.

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