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ALLY™ Bone Screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation, appropriate for the size of the device.

The ALL Y™ Bone Screws are fully threaded cortical screws offered in various diameters and lengths. All screws are manufactured from titanium alloy. The implants are single use only.

The provided text describes the 510(k) submission for the ALLY™ Bone Screws, a Class II medical device. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of its performance in a clinical setting against specific acceptance criteria in the way an AI/ML device would.

Therefore, many of the requested categories are not applicable to this submission. This device is a bone screw, not an AI/ML algorithm or software device.

Here's a breakdown of the available information based on your request:

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

For a traditional medical device like a bone screw, acceptance criteria typically refer to engineering specifications and performance testing results against established industry standards.

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

This information is not provided in the document. For engineering tests of a medical device, the sample size would typically refer to the number of screws tested for each mechanical property. The data provenance would be that the tests were conducted in a lab setting, not from clinical data.

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. For a bone screw, "ground truth" is established through standardized mechanical testing and engineering analysis rather than expert consensus on clinical data.

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

Not applicable. Adjudication methods are relevant for studies involving human interpretation (e.g., image reading) to establish ground truth, not for mechanical testing of a device.

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 screw, not an AI/ML diagnostic tool requiring MRMC studies.

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

Not applicable. This device is a bone screw, not an AI/ML algorithm.

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

The "ground truth" for this device's performance is established by objective mechanical testing against ASTM F543 standards and engineering analysis. It is not based on expert consensus, pathology, or outcomes data in the traditional sense.

8. The sample size for the training set

Not applicable. This device is a bone screw, not an AI/ML algorithm that requires a training set.

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

Not applicable. This device is a bone screw, not an AI/ML algorithm.

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