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The intended use is for the gradual bone distraction of the facial bones that are deformed due to birth defects, disease, or trauma.
The indications for use are an uni-directional, intro-oral device for the distraction of facial bones.

Distractor similar to the KLS distractor approved as K973275

I apologize, but the provided text from the K991875 510(k) submission does not contain the detailed information necessary to fully answer your request regarding acceptance criteria and a study proving device performance.

Specifically, this document primarily constitutes the 510(k) summary and the FDA's clearance letter. It establishes the device's substantial equivalence to a predicate device (KLS Intraoral Distractor, K973275) based on its description and intended use.

Here's what I can extract from the provided text and what information is missing:

Information Present:

• Device Name: K-L-W Intraoral Distractor
• Intended Use: For the gradual bone distraction of the facial bones that are deformed due to birth defects, disease, or trauma. The Indications For Use document clarifies this as "an uni-directional, intro-oral device for the distraction of facial bones."
• Predicate Device: KLS Intraoral Distractor (K973275)

Information Not Present in the Provided Text:

• A table of acceptance criteria and the reported device performance: The document mentions the device is "similar" to the predicate, but it does not provide specific performance metrics, acceptance criteria, or a table detailing them.
• Sample size used for the test set and the data provenance: No information about a test set, sample size, or data origin is provided.
• Number of experts used to establish the ground truth for the test set and their qualifications: Ground truth establishment and expert details are not discussed.
• Adjudication method for the test set: No information is available regarding adjudication.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: No mention of such a study.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This device is a physical intraoral distractor, not a software algorithm, so this question is not applicable in its literal sense.
• The type of ground truth used: As no study is detailed, no ground truth is described.
• The sample size for the training set: Not applicable for this type of device, as it's not an AI/ML algorithm.
• How the ground truth for the training set was established: Not applicable.

Why this information is missing:

For a 510(k) submission like K991875, particularly for a well-understood mechanical device like an intraoral distractor, the primary focus for clearance is demonstrating substantial equivalence to a previously cleared predicate device. This often relies on:

1. Comparison of technological characteristics: Showing the new device has the same fundamental scientific technology and principles of operation as the predicate.
2. Comparison of materials: Demonstrating similar or equivalent materials.
3. Comparison of design and performance: Showing that any differences in design or materials do not raise new questions of safety and effectiveness, or if they do, that these differences are addressed through appropriate testing (e.g., mechanical strength, biocompatibility).

The provided text simply states the device is "similar to the KLS distractor approved as K973275" and does not detail the specific tests, performance data, or acceptance criteria that would have been submitted to demonstrate this similarity or the device's own standalone efficacy. These details would typically be found in the actual 510(k) submission document, which is much more extensive than the summary provided here.

Therefore, I cannot fulfill your request for a table of acceptance criteria, study details, or AI-specific performance metrics based solely on the provided K991875 summary and clearance letter.

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