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Normed Distal Radius Reconstruction System intended for use in internal fixation of small bones - primary the distal radius in the forearm such as, compression fractures, intra-articular fractures, displaced fractures and surgical reductions.

Normed Distal Radius Reconstruction System consists of a series of titanium plates in various shape and length in left and right curved configurations, which are attached to the bone using 2,7 mm diameter titanium bone screws. The plates are available in 8, 11, and 13 holes with 2.0 mm plate thickness and can be contoured as needed to fit the specific anatomy. The self-tapping 2.7 mm screw diameters will be available in hex-lock screw head designs, in sixteen length 8 through 38 mm long in 2mm intervals. A hand fixation table system is also available for the surgeon to rest the injured hand during the surgery.

It appears there might be a misunderstanding of the provided text. The document is a 510(k) summary for the Normed Distal Radius Reconstruction System, which is a metallic bone fixation appliance.

This type of device is a physical medical implant, not a software algorithm or an AI-powered diagnostic tool. Therefore, the concepts of "acceptance criteria" and "study that proves the device meets the acceptance criteria" as they would apply to the performance of an AI or diagnostic algorithm do not directly apply in the same way.

The 510(k) process for a device like this focuses on demonstrating substantial equivalence to a legally marketed predicate device, primarily through:

• Design comparison: Showing the new device has similar materials, design, and intended use as a predicate.
• Mechanical testing: Demonstrating that the device meets established engineering standards for strength, fatigue, material biocompatibility, etc.
• Clinical use (if necessary, but often not for 510(k)s): Sometimes, if there are significant differences or new indications, clinical data might be required, but it's not the primary route for most 510(k)s.

The provided document does not contain information about:

• Acceptance criteria for an algorithm's performance (e.g., sensitivity, specificity, AUC).
• A "study" in the sense of an effectiveness trial for an AI model.
• Sample sizes for test or training sets for an algorithm.
• Expert involvement in establishing ground truth for an algorithm.
• MRMC studies, standalone algorithm performance, or different ground truth types for an AI.

To answer your request based on the provided document, I can only state what is present and what is absent:

The document describes a medical device (bone plate and screws) and its intended use, along with the FDA's clearance (510(k)) based on substantial equivalence. It does not pertain to an AI or diagnostic algorithm.

Therefore, most of the fields you requested cannot be filled from the provided text.

Here's an attempt to address your points by clarifying their applicability or lack thereof:

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

   • Applicability: Not applicable in the context of an AI/diagnostic algorithm performance.
   • What's in the document: The document states the device is "substantially equivalent" to predicate devices, implying it meets criteria for safety and effectiveness for its intended use, typically through design and material comparisons, and potentially mechanical testing, though those specific results are not detailed here.

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

   • Applicability: Not applicable. There is no "test set" for an algorithm performance evaluation described.
   • What's in the document: N/A.

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):

   • Applicability: Not applicable. There is no "ground truth" for an algorithm described.
   • What's in the document: N/A.

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

   • Applicability: Not applicable. No test set or adjudication method is described.
   • What's in the document: N/A.

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:

   • Applicability: Not applicable. This is a physical implant, not an AI assistance tool for human readers.
   • What's in the document: N/A.

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

   • Applicability: Not applicable. This is a physical implant, not an algorithm.
   • What's in the document: N/A.

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

   • Applicability: Not applicable. No ground truth is described in this context. Substantial equivalence for this device would rely on established engineering standards and predicate device characteristics rather than "ground truth" in an AI sense.
   • What's in the document: N/A.

8. The sample size for the training set:

   • Applicability: Not applicable. No training set for an algorithm is described.
   • What's in the document: N/A.

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

   • Applicability: Not applicable. No training set or ground truth for it is described.
   • What's in the document: N/A.

In summary, the provided text is about the regulatory clearance (510(k)) of a conventional surgical implant, not an AI or diagnostic algorithm, and thus the specific questions about algorithm performance, test sets, training sets, and expert evaluations are not relevant to this document.

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