(149 days)
The indications for use would include infants from three to eighteen months of age to be treated for Plagiocephalic, Brachycephalic, or scaphocephalic shaped heads by a medical physician. The purpose of the P.A.P. Orthosis is to apply pressure to prominent regions of an infant's cranium to improve cranial symmetry and/or shape. This device is to be prescribed by a physician in writing indicating the need for cranial positional molding due to the above diagnoses. The device is indicated to treat moderate to severe nonsynostotic positional plagiocephaly.
It is a proprietary transparent ionomer based thermoplastic molded orthosis extended for medial purposes to apply pressure to the prominent regions of an infants cranium to improve cranial symmetry and to shape. This orthosis is used to treat infants from three to eighteen months of age with a diagnosis of moderate to severe non-synastolic positional Plagiocephaly.
This 510(k) summary (K012804) for the Plagiocephalic Applied Pressure (P.A.P.) Orthosis does not provide the detailed information requested regarding acceptance criteria, study design, or performance metrics in the way that would be expected for a device proving performance against specific acceptance criteria. This type of submission focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets predefined performance benchmarks through a clinical study.
Therefore, many of the requested sections cannot be filled from the provided text.
Here's a breakdown of what can and cannot be extracted:
1. Table of acceptance criteria and the reported device performance:
This information is not provided in the document. The submission focuses on substantial equivalence based on function, purpose, and intended use to existing predicate devices (D.O.C. band K964992 and STARband K001167). There are no specific performance criteria or benchmarks listed for the P.A.P. Orthosis itself.
2. Sample sized used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
This information is not provided. As this is a substantial equivalence submission, it does not detail a clinical study with a test set.
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):
This information is not provided. There is no mention of a test set or ground truth establishment by experts for performance evaluation.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not provided. No test set 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:
This information is not provided. The device is an orthosis, not an AI-assisted diagnostic tool, so an MRMC study would not be applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not provided. The device is an orthosis, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
This information is not applicable as there is no described study with a ground truth. The "ground truth" in a substantial equivalence submission is essentially the proven safety and efficacy of the predicate devices.
8. The sample size for the training set:
This information is not provided. There is no mention of a training set as would be found in an algorithm-based device.
9. How the ground truth for the training set was established:
This information is not provided. No training set is described.
Summary based on the provided text:
The submission for the P.A.P. Orthosis (K012804) is a 510(k) premarket notification demonstrating substantial equivalence to two legally marketed predicate devices: the D.O.C. band (K964992) and the STARband (K001167).
- Acceptance Criteria & Performance: The document does not specify quantitative acceptance criteria or detailed performance data for the P.A.P. Orthosis itself. Instead, it argues that the device is "similar in function and purpose" and has the "same intended use" as the predicate devices, implying that their established safety and effectiveness are the basis for acceptance. The performance is indirectly "reported" by stating it "more completely encompasses the cranium with clear copolymer plastic" compared to the predicate, while serving the same purpose.
- Study Data: No specific study data, sample sizes, or ground truth establishment methods are detailed because this type of submission relies on demonstrating similarity to existing, approved devices rather than presenting novel clinical study results.
- Ground Truth (Implicit): The "ground truth" for the P.A.P. Orthosis's suitability is the regulatory history and proven safety/efficacy of the predicate devices (D.O.C. band and STARband) for treating moderate to severe nonsynostotic positional plagiocephaly, brachycephaly, or scaphocephaly in infants aged three to eighteen months.
In essence, the "study" proving the device meets "acceptance criteria" here is the comparison made by the applicant to existing predicate devices, and the FDA's subsequent determination that this comparison is valid for substantial equivalence.
§ 882.5970 Cranial orthosis.
(a)
Identification. A cranial orthosis is a device that 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 severe nonsynostotic positional plagiocephaly, including infants with plagiocephalic-, brachycephalic-, and scaphocephalic-shaped heads.(b)
Classification. Class II (special controls) (prescription use in accordance with § 801.109 of this chapter, biocompatibility testing, and labeling (contraindications, warnings, precautions, adverse events, instructions for physicians and parents)).