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The Merete 3.0 mm and 3.5 mm Locking Screws are intended to be used in combination with Merete Locking plates for adult and pediatric patients as indicated for small bone fracture fixation. Indications for use include fixation of fractures, osteotomies, non unions of the clavicle, scapula, olecranon, radius, ulner, fibula, metacarpals, metatarsals, Hallux Valgus osteotomy corrections, middle hand and middle foot bones, particular in osteopenic bone.

The screws are fully threaded and self-tapping with a threaded head to lock into Merete Locking plates. Locking screws/plates incorporate a screw-to-plate locking feature which creates a locked, fixed angle construction to hold fracture or osteotomy reduction. The screws are made of titanium (ASTM F-136) and are available in the lengths from 12 mm to 32 mm in 2 mm increments.

The provided text is a 510(k) summary for the Merete 3.0 mm and 3.5 mm Locking Screws. This type of regulatory submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving device performance against specific acceptance criteria through clinical studies in the same way a PMA (Premarket Approval) would.

Therefore, the document does not contain the information requested regarding acceptance criteria or a study proving the device meets those criteria, as it relates to performance metrics typical for AI/medical device studies (e.g., sensitivity, specificity, accuracy).

However, I can extract information relevant to the substantial equivalence determination and the nature of the device:

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

• The document does not provide a table of acceptance criteria and reported device performance in terms of typical performance metrics like sensitivity, specificity, or accuracy.
• Instead, the "performance" demonstrated for a 510(k) is primarily based on substantial equivalence to predicate devices. The "technological characteristics" are the basis for this equivalence.
• Technological Characteristics (from the document): The Merete 3.0 mm and 3.5 mm Locking Screws are similar to the screws of the legally marketed predicate devices listed above in that they share similar indications for use, are similar and incorporate similar technological manufactured from characteristics.

2. Sample size used for the test set and the data provenance:

• Not applicable. This document describes a 510(k) submission for metallic bone fixation fasteners. It does not involve a "test set" of data or patient cases in the context of an AI/diagnostic device study. The evaluation focuses on engineering parameters, material properties, and comparison to existing devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. Ground truth for a test set is not established for this type of device submission.

4. Adjudication method for the test set:

• Not applicable. No test set or human adjudication method is described.

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 mechanical bone fixation fastener, not an AI-assisted diagnostic or imaging interpretation tool. Therefore, MRMC studies are not relevant.

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

• Not applicable. This device does not involve an algorithm.

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

• Not applicable. Ground truth in the context of diagnostic or AI device performance is not relevant here. The "ground truth" for a 510(k) submission largely revolves around demonstrating that the new device is as safe and effective as existing legally marketed predicate devices, often through engineering analysis, material testing, and comparison of design and intended use.

8. The sample size for the training set:

• Not applicable. There is no "training set" as this is not an AI/machine learning device.

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

• Not applicable. There is no training set or associated ground truth establishment process for this type of device.

In summary: The provided document is a 510(k) summary for a medical device (locking screws) and focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and indications for use. It does not involve performance studies in the context of AI or diagnostic devices, and therefore, most of the requested information is not present.

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