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The O&P Bivalve Cranial Molding Helmet is intended for medical purposes to apply pressure to prominent regions of an infant's cranium in order to improve cranial symmetry and/or shape in infants from 3 to 18 months of age, with moderate to sever nonsynostotic positional plagiocephaly, including infants with plagiocephalic, brachycephalic and scaphocephalic shaped heads.

O&P Bivalve Cranial Molding Helmets are custom made at the direction of a physician's prescription. Helmets are made by hand for each infant by taking a cast of the baby's head. The cast is filled with plaster and a positive mold of the infant's head is created. The flattened areas of the positive mold (corresponding to the flattened areas of the infants head) are then built up and made round creating a void. As the child's head grows, the skull is slowly reshaped and rounded by growing into the open voids created in the helmet for this purpose. The finished helmet has a foam-lined interior and has rigid plastic exterior. The helmet is bivalve with the anterior section overlapping the posterior section. The helmet is secured by means of a rivet on one side and an elasticized Velcro closure on the opposite side.

The provided 510(k) summary for the O&P Bivalve Cranial Molding Helmet (K063395) describes the device's substantial equivalence to a predicate device rather than presenting a de novo study with specific acceptance criteria and performance data for the new device. Therefore, much of the requested information regarding acceptance criteria and a dedicated study proving performance for this specific device is not present in the provided text.

However, I can extract information related to the predicate device and the general evidence used to support the effectiveness of cranial orthoses.

1. Table of Acceptance Criteria and Reported Device Performance

As this submission relies on substantial equivalence and does not establish new acceptance criteria for the O&P Bivalve Cranial Molding Helmet, a direct table of acceptance criteria and performance for this device cannot be generated.

Instead, the submission refers to the performance of its predicate device and the general effectiveness of cranial orthoses. The "performance" in this context refers to clinical outcomes observed with similar devices.

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: Not applicable. There was no specific "test set" for the O&P Bivalve Cranial Molding Helmet, as its performance was not evaluated through a new clinical study.
• Data Provenance: The submission references:
  • Retrospective clinical experience with the predicate device (Precision Prosthetics' Orthotic Molding Helmet), stating "Precision Prosthetics treated over 2,340 children with their orthotic molding helmet" over nine years. No specific country of origin is mentioned for this experience, but given the company's location (Missouri, USA), it's highly likely to be US-based.
  • Published scientific literature on cranial orthoses by Clarren et al. (1979, 1981, 1977), Persing et al. (1986), Kane et al. (1996), and especially Littlefield et al. (1998). These studies describe general findings on the effectiveness of cranial orthoses. The Littlefield et al. study described monitoring "more than 750 infants." Specific country of origin for these studies is not detailed in the summary, but given the journals and authors often published in English, they are likely from Western countries (e.g., USA).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable. No specific test set was created for this device where expert ground truth was established. The effectiveness claims are based on prior clinical experience with a substantially equivalent device and existing scientific literature on the general class of devices.

4. Adjudication Method for the Test Set

Not applicable, as no dedicated test set was used for this 510(k) submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. This submission does not describe an MRMC comparative effectiveness study, as it is centered on substantial equivalence rather than a new clinical trial comparing human readers with and without AI assistance. This device is a physical medical device, not an AI/software device that would involve human readers.

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

Not applicable. This is a physical cranial orthosis, not an algorithm or AI device.

7. The Type of Ground Truth Used

The "ground truth" for the effectiveness claims cited comes from:

• Clinical outcomes data: From the past 9 years of treating over 2,340 children with the predicate device, implying observed improvement in cranial shape.
• Published clinical studies: Which documented "complete or near complete correction of asymmetry" based on measurements or assessments of infants' head shapes over time (e.g., Littlefield et al. 1998 study). This would typically involve clinical assessment and anthropometric measurements by medical professionals.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set. If interpreted as the "experience" pool for the predicate device, it would be "over 2,340 children" and "more than 750 infants" from the cited studies.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set in the context of an AI/ML device. For the clinical experience and studies cited, the "ground truth" (i.e., whether the treatment was effective) was established through clinical observation, anthropometric measurements, and follow-up assessments by medical professionals involved in the treatment of positional plagiocephaly.

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