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The OsteoMed Cranial Distraction System is intended for use in the treatment of cranial conditions such as syndromic craniosynostosis and congenital deficiencies in which osteotomies and gradual bone distraction are indicated. This device is intended to provide temporary stabilization and gradual lengthening of the cranial bones. This device is intended to be removed after consolidation. The OsteoMed Cranial Distraction System implants are intended for single use only.

The OsteoMed Cranial Distraction System is comprised of distractors, spacers, screws and instrumentation. The distractor is an internal distraction device for bone elongation of cranial bones. The distractor is anchored between the osteotomy with 1.2mm standard or 1.2mm AutoDrive screws previously cleared under K924138 and K023260, respectively. The distractor is activated using a distractor tool via the distraction rod. The distraction rod is preassembled within the distractor device. The non-threaded portion of the distractor rod can be removed during the consolidation period. The distractors, spacers, and screws are removed after consolidation. The instruments include distractor tool, drills, plate bending forceps, plate cutters and screwdrivers to facilitate the placement of screws and modification of the distractor assembly plates. A distractor rod removal tool is also available to partially remove the distractor rod leaving the distracted device in place. The distractor assembly is made from Titanium (ASTM F-67) and Titanium Allov (ASTM F-136), and the spacer is made from Titanium (ASTM F-67). The screws are made from Titanium Alloy (ASTM F-136). The instrumentation is made from various grades of surgical grade stainless steel, anodized aluminum, and/or medical grade plastic.

The provided text describes the OsteoMed Cranial Distraction System and its clearance via a 510(k) submission. However, the document does not contain a study that proves the device meets specific acceptance criteria in terms of performance metrics like sensitivity, specificity, accuracy, or any similar quantitative measures that would be found in a study about a software algorithm or diagnostic device.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device (KLS-Martin, K003883) based on inherent characteristics and verification testing.

Therefore, many of the requested categories for a study are not applicable or cannot be extracted from this document, as it's not a performance study of a device against specific diagnostic or algorithmic metrics.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Regarding the "study that proves the device meets the acceptance criteria," the document states:

• "Verification testing consisted of mechanical testing and comparisons against the KLS predicate device."
• "Clinical Testing is not required to support substantial equivalence."

This indicates that the "study" was a non-clinical verification testing phase, primarily mechanical in nature, comparing the OsteoMed device to the KLS predicate device to ensure similar performance characteristics.

Here's a breakdown of the other requested information, highlighting what is not applicable (N/A) or not provided in the document for the reasons explained above:

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

• Sample Size: Not specified for the mechanical verification testing. It would likely refer to the number of device units tested.
• Data Provenance: N/A as it's mechanical testing, not patient data.

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

• N/A. This does not apply to mechanical verification testing of a distraction system. Ground truth, in the context of diagnostic performance, is not relevant here.

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

• N/A. This is for assessment of diagnostic findings, not mechanical device performance.

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:

• N/A. This device is a mechanical cranial distraction system, not an AI-powered diagnostic tool. No MRMC study was conducted or is relevant.

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

• N/A. This device is a mechanical system, not an algorithm.

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

• N/A. For mechanical testing, the "ground truth" would be established engineering specifications derived from the predicate device's performance, as well as general engineering principles and material standards (e.g., ASTM standards cited for materials).

8. The sample size for the training set:

• N/A. This is for machine learning models; this document describes a mechanical device.

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

• N/A. This is for machine learning models; this document describes a mechanical device.

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