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The Cranial Symmetry System is intended for medical purposes to provide contact to prominent areas of the cranium while allowing space for growth in the flattened areas in order to improve cranial symmetry in infants' three to eighteen months of age, with moderate to severe non-synostotic positional plagiocephaly, including infants' with plagiocephalic and brachycephalic shaped heads.

The Cranial Symmetry System is intended for medical purposes to provide contact to prominent areas of the cranium while allowing space for growth in the flattened areas in order to improve cranial symmetry in infants' 3 to 18 months of age, with plagiocephalic and brachycephalic shaped heads.

The sale and distribution of the device is restricted to prescription use in accordance with 21CFR801.109

The Cranial Symmetry System provides passive pressure to the prominent areas of the infants' skull while allowing for growth into the flattened areas. There are no exceeding pressures that could put restrictions on brain growth. The cranial orthosis helmet is custom fabricated with lightweight materials. The outer shell consists of a sheet of three-sixteenths inch thick polypropylene. The padded inner liner consists of three-sixteenths Aliplast. These materials are vacuumed formed over the modified plaster cast mold of the infants' skull. There is a Velcro chinstrap that is used as a method of suspension. The chinstrap is fastened securely through the Dacron loops at the cut out section for the infants' ears. The chinstrap holds the helmet in place eliminating the risk of slippage. There are air holes drilled into the helmet for ventilation.

The provided text describes a 510(k) submission for the Cranial Symmetry System helmet. However, it does not include detailed acceptance criteria or a dedicated study section with specific performance data to prove the device meets such criteria. Instead, it relies on substantial equivalence to a predicate device and references two existing medical journal articles as "Performance Data."

Therefore, based on the provided text, I cannot complete a table of acceptance criteria and reported device performance or provide specific details for points 2 through 9 as they are not present in the document.

Here's a breakdown of what is available and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated or quantified in terms of specific performance metrics (e.g., percentage improvement in cranial symmetry, time to achieve symmetry).
• Reported Device Performance: The document does not report performance metrics for the Cranial Symmetry System itself. It references two articles by Clarren et al. (1979 and 1981) for the general concept of helmet treatment for plagiocephaly and torticollis, implying that the methodology and technique are "gleaned" from this work. However, no specific data from these studies are presented to establish performance criteria or compare with the Cranial Symmetry System's performance.

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

• Sample Size: Not provided for the Cranial Symmetry System.
• Data Provenance: Not provided for the Cranial Symmetry System. The referenced studies by Clarren et al. would contain this information for their studies, but not for the specific device under review.

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

• Not provided anywhere in the document.

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

• Not provided anywhere in the document.

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 a medical device (helmet), not an AI diagnostic or image analysis tool for human readers.

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

• Not applicable. This is a medical device (helmet), not an algorithm.

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

• Not explicitly stated for the Cranial Symmetry System. The referenced studies would likely use clinical assessments or anthropometric measurements.

8. The sample size for the training set:

• Not applicable/Not provided. There is no mention of a "training set" as this is not an AI/machine learning device.

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

• Not applicable/Not provided.

Summary of the document's approach to "Performance Data":

The manufacturer, Beverly Hills Prosthetics Orthotics, Inc., largely bases its submission on substantial equivalence to the predicate device, the Clarren Helmet (K003035).

Under the "Performance Data" section, instead of presenting new study data for the Cranial Symmetry System, it references two articles:

• Clarren, Sterling, M.D., "Plagiocephaly and torticollis: Etiology, natural history, and helmet treatment, "Journal of Pediatrics, 98:1 (92-95)(Jan. 1981)
• Clarren, et al., "Helmet treatment for plagiocephaly and congenital muscular torticollis," Journal of Pediatrics, 94:1 (43-46)(Jan. 1979)

The text states that "Helmet therapy was introduced to Beverly Hills Prosthetics Orthotics, Inc. by Sterling Clarren M.D. and therefore the methodology and technique for measurements and casting gleaned is still used in practice today." This suggests that the company adopted the principles and techniques from Dr. Clarren's work, rather than conducting a new performance study on their specific device and providing its data within this 510(k) submission. The conclusion explicitly states: "Based on the foregoing and all information included in this 510(k) application, Beverly Hills Prosthetics Orthotics, Inc. believes that the performance data provides reasonable assurance of the safety and effectiveness of the Cranial Symmetry System for its proposed indications for use. Further, the Cranial Symmetry System is substantially equivalent to its claimed predicate device under the conditions of intended use."

In essence, the "study that proves the device meets the acceptance criteria" in this 510(k) is the assertion of substantial equivalence to a legally marketed predicate device, supported by the general scientific literature on the efficacy of helmet therapy for plagiocephaly using methods derived from the referenced works. Specific, quantifiable performance data for the Cranial Symmetry System itself is not provided in this document.

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