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The Craniocephalic Custom Remolding Orthosis (CCRO), is indicated for infants 3 - 18 months old to improve cranial symmetry in moderate to severe nonsynostotic positional plagiocephaly, including plagiocephalic, braciocepahlic, and scaphocephalic heads.

The CCRO is a passive cranial orthosis that allows an infants cranium to improve in symmetry and/or shape during natural infant growth. Appropriate for infants 3 to 18 months, the CCRO consists of a polypropylene (or copolymer, or polyethylene as warranted), outer shell with multiple inner polypropylene foam liners of various thicknesses, and an optional support strap. The foam liners and outer plastic shell, are vacuum formed over a positive mold developed from an impression of the infant's head. The orthosis allows applicable areas for the infant heads fill in during normal infant growth, to achieve appropriate cranial symmetry.

The provided text is a 510(k) summary for the Craniocephalic Custom Remolding Orthosis (CCRO). It focuses on establishing substantial equivalence to predicate devices rather than presenting a performance study with acceptance criteria in the typical sense of a clinical trial for a new drug or a novel AI software.

Therefore, many of the requested categories for acceptance criteria and study details cannot be directly extracted from this document, as the submission relies on demonstrating similarity to existing, legally marketed devices.

Here's an attempt to answer the questions based only on the provided text, noting where information is absent:

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

This document does not present quantitative acceptance criteria or a formal study comparing performance against such criteria. The "performance" claimed is based on the device's design and mechanism of action being similar to predicate devices, with an assertion that it will perform "as-well-as, if not better than" its counterparts.

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

• Sample Size for Test Set: Not applicable. No formal test set or clinical study data is presented in this 510(k) summary for performance validation. The submission relies on comparative claims to predicate devices.
• Data Provenance: Not applicable. No clinical data is presented.

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. There is no mention of a test set with ground truth established by experts.

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

• Not applicable. There is no mention of a test set or an adjudication method.

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 is not an AI/software device. There is no MRMC study or AI assistance involved.

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

• Not applicable. This is a physical medical device (cranial orthosis), not an algorithm.

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

• Not applicable. No ground truth is discussed as no performance study data is presented. The "truth" in this context is the FDA's determination of substantial equivalence based on comparison to predicate devices, materials, and intended use.

8. The sample size for the training set

• Not applicable. This is a physical device, not an AI algorithm requiring a training set.

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

• Not applicable. As above, this is a physical device.

Summary regarding the provided document:

The K070694 submission is a 510(k) notification for a Craniocephalic Custom Remolding Orthosis (CCRO). The document primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices (LLUMC K023572, Ballert K030669, Clarren K003035).

The justification for equivalence is based on:

• Similar materials: All devices are made of similar materials widely used in orthotics.
• Similar fabrication processes: All use vacuum forming, similar casting/impression techniques, and mold creation/modification.
• Similar mechanism of action: All function in the same way to improve cranial symmetry during natural infant growth.
• Similar intended use: All are for improving cranial symmetry in infants 3-18 months with moderate to severe nonsynostotic positional plagiocephaly (including plagiocephalic, brachycephalic, and scaphocephalic heads).

The "acceptance criteria" here are implicit and relate to the FDA's regulatory requirements for 510(k) clearance, primarily showing that the device is as safe and effective as a legally marketed predicate device. There is no mention of a formal clinical performance study with specific quantitative acceptance criteria, sample sizes, expert ground truth, or adjudication methods in this summary. The submission argues that the CCRO is "equivalent if not an enhancement in effectiveness" by design and comparison, rather than through new clinical performance data.

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