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The MEMOMETAL ANCHORAGE® Bone Plate Systems are indicated for stabilization and fixation of fresh fractures, revision procedures, joint fusion, and reconstruction of small bones of the hand, feet, wrist and ankles, fingers and toes. The system may be used in both adults and pediatric patients.

MEMOMETAL ANCHORAGE® Bone Plate Systems are single use bone fixation appliances intended to be permanently implanted. They are designed with different shape plates made of biocompatible titanium. The Bone Plate Systems use either 3mm or 3,5mm screws. The drill holes of the plates are aligned to assure the screws do not touch. The plates vary essentially through different curvatures, lengths, number of plate holes and shape.

The provided document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. Instead, it is a 510(k) Premarket Notification for the ANCHORAGE® Bone Plate System, primarily focused on establishing substantial equivalence to a predicate device.

Here's why the requested information cannot be extracted from this document:

• Performance Data: The document explicitly states under "Performance data": "No clinical or non clinical tests were used in the claim of substantial equivalence." This means no studies were conducted by the manufacturer to demonstrate the device's performance against specific criteria, as they were relying on the equivalence to an already approved device.
• Substantial Equivalence: The basis of this 510(k) submission is that the ANCHORAGE® Bone Plate System is "substantially equivalent" to the predicate device (K061808 DARCO locking bone plate system) in terms of intended use, indications for use, material, design, and function. This pathway allows a device to come to market without new clinical studies if it can be shown to be as safe and effective as a legally marketed predecessor.

Therefore, for each of your requested points, the answer based on this document is as follows:

1. Table of acceptance criteria and the reported device performance: Not applicable. No acceptance criteria or performance data are reported in this submission as no new tests were performed to support substantial equivalence.
2. Sample size used for the test set and the data provenance: Not applicable. No test set was used as no new studies were conducted.
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 was conducted as no new studies were performed.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. No test set or adjudication was performed.
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 bone plate system, not an AI-assisted diagnostic tool, and no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This device is a bone plate system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. No ground truth was established as no new studies were performed.
8. The sample size for the training set: Not applicable. This device is a physical medical device, not a machine learning model, and therefore had no "training set."
9. How the ground truth for the training set was established: Not applicable. Same reason as above.

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