(217 days)
The CAMLab Cranial Orthosis Helmet is intended for use on infants from 3 to 18 months of age with moderate to severe nonsynostotic positional plagiocephaly, including infants with plagiocephalic-, brachycephalic-, and scaphocephalic-shaped heads. The device 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.
The CAMLab Cranial Orthosis Helmet is intended for use on infants from 3 to 18 months of age with moderate to severe nonsynostotic positional plagiocephaly, including infants with plagiocephalic-, brachycephalic-, and scaphocephalic-shaped heads. The device 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. This orthosis is only available if prescribed by a physician.
The initial geometry of the patient is acquired from either laser scanned measurements using the BioScanner (a.k.a. Polhemus Fastscan handheld laser scanner) or via traditional casting methods. If a cast is taken, the cast will be scanned with the BioScanner as well.
The resulting three dimensional model along with a digital order form and any other pertinent information is then sent to BioSculptor Corporation via email or secured internet application. Utilizing this information, the BioSculptor CAD/CAM system will then create a positive mold representative of the patient scan. This positive model will then be used to create the orthosis.
Each orthosis consist of a plastic outer shell, a foam inner shell, a strap and fastener to secure the orthosis. The practitioner modifies the orthosis to achieve an accurate fit and monitors the progress to ensure that no adverse effects occur.
The provided text is a 510(k) Summary for the CAMLab Cranial Orthosis Helmet. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with specific acceptance criteria and performance metrics for the new device.
Therefore, the information you've requested about acceptance criteria, detailed study design, sample sizes for test and training sets, expert qualifications, and ground truth establishment is not available in the provided text. The 510(k) summary explicitly states that the safety and effectiveness summary has been prepared pursuant to the requirement for 510(k) summaries, which primarily aims to show equivalence.
However, I can extract the comparison table that highlights the equivalence between the CAMLab Cranial Orthosis Helmet and its predicate device, the STARband Orthomerica. This table implicitly represents the "acceptance criteria" not as novel, quantifiable performance metrics achieved by a new study, but as alignment with the established characteristics and performance of the legally marketed predicate device.
Here's a breakdown of what can be extracted and what is not present:
Acceptance Criteria and Performance (Based on Substantial Equivalence to Predicate)
| Feature / Criteria | Predicate Device (Orthomerica STARband Cranial Orthosis K011350) | CAMLab Cranial Orthosis Helmet (This submission) |
|---|---|---|
| Indications for Use | Treatment of abnormal infant head shape (positional/deformational plagiocephaly) | Treatment of abnormal infant head shape (positional/deformational plagiocephaly) |
| Clinical Population | Infants age 3-18 months | Infants age 3-18 months |
| Materials | Copolymer plastic/closed cell polyethylene foam/Velcro strap | Copolymer plastic/closed cell polyethylene foam/Velcro strap |
| Daily Wear Time | 23 hrs./day | 23 hrs./day |
| Average Time to Effectiveness (patients age 3-7 months) | 2-4 months | 2-4 months |
| Contradictions for Use | Craniosynostosis/Hydrocephalus | Craniosynostosis/Hydrocephalus |
| Method of Manufacture | Custom from mold using a laser scanner, CAD/CAM system and 5-axis router machine | Custom from mold using a laser scanner, CAD/CAM system and 5-axis router machine |
Explanation of "Acceptance Criteria" in this context: The "acceptance criteria" here are implicitly met by demonstrating that the new device shares the same indications for use, clinical population, materials, wear time, average time to effectiveness, contraindications, and manufacturing method as the legally marketed predicate device. The FDA's issuance of the 510(k) clearance signifies that the CAMLab Cranial Orthosis Helmet is "substantially equivalent" to the predicate, meaning it is as safe and effective.
Information Not Available in the Provided Document:
- Sample sizes used for the test set and the data provenance: Not applicable or not detailed for a novel performance study. The submission relies on equivalence to a predicate.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there's no independent performance study described with a test set requiring expert ground truth.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not applicable. The document does not describe such a study.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical cranial orthosis, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable, as there's no independent performance study described.
- The sample size for the training set: Not applicable, as this is a physical device, not an AI/ML algorithm requiring a training set in the conventional sense. The "training" in the context of manufacturing refers to the CAD/CAM system's design capabilities, based on established practices, rather than a data-driven model.
- How the ground truth for the training set was established: Not applicable for the reasons stated above.
In summary: The provided 510(k) summary is a regulatory document focused on demonstrating substantial equivalence. It does not contain independent performance study data, acceptance criteria, or details regarding ground truth establishment that would be present in a submission for a novel device or an AI/ML product. The "study" proving the device meets the acceptance criteria is the comparison presented in the "Substantial Equivalence Comparison Table," which shows alignment with the predicate device's established characteristics and performance.
§ 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)).