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The Kozy Comfort product is indicated for healthy infants 0-12 months to aid in the prevention of skull deformities that may arise from consistent back-sleeping postures, namely the condition know as deformational (or positional) plagiocephaly

Kozy Comfort™ Infant Positioner is a polyurethane based infant positioner.

The provided 510(k) summary for the "Kozy Comfort™ Infant Positioner" (K062143) does not contain any information regarding acceptance criteria or a study that proves the device meets such criteria.

The document states: "FDA has not established special controls or performance standards for this device." This indicates that the device was approved based on substantial equivalence to predicate devices, rather than through a performance study against specific acceptance criteria.

Therefore, for each of your requested points, the answer is that the information is not available in the provided text.

Here's a breakdown based on your request, explicitly stating why the information is not present:

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

   • Not available. The document states no special controls or performance standards exist for this Class I device. As such, no defined acceptance criteria are presented, nor is there a study reporting performance against such criteria.

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

   • Not available. No performance study is mentioned or referenced.

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 available. No performance study requiring expert adjudication or ground truth establishment is described.

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

   • Not available. No performance study or test set requiring adjudication 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 available. This device is an infant positioner, not an AI-assisted diagnostic tool. No MRMC study is mentioned.

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

   • Not available. This device is an infant positioner, not an algorithm.

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

   • Not available. No performance study requiring ground truth is described.

8. The sample size for the training set

   • Not available. No training set is applicable or described for this type of device.

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

   • Not available. No training set or ground truth establishment is applicable or described.

In summary, the provided 510(k) summary is for a Class I medical device (infant positioner) that was cleared based on substantial equivalence to existing predicate devices, without the need for performance studies against specific acceptance criteria. Therefore, the information you requested about performance studies, data, and ground truth is not part of this 510(k) submission.

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