(152 days)
The AOI Cranial 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 age 3 to 18 months of age, with moderate to severe nonsynotic positional plagiocephaly, including infants with plagiocephalic- and brachycephalic- shaped heads.
The AOI Cranial Helmet is a cranial orthosis which is made through a custom fabrication process to apply mild pressure to prominent regions of a young child's cranium to slow further growth in that area while allowing flattened portions of the cranium to grow into voids built into the helmet in order to improve overall cranial symmetry. The helmet itself, once finished and delivered, covers the majority of the head and is trimmed as follows. The anterior inferior edge is trimmed just above the eyebrows, and the sides are trimmed above the ears. The posterior inferior is trimmed low to capture the occiput. A Velcro strap is attached to one side of the helmet to keep it securely in place. The finished AOI Cranial Helmet is composed of a hard outer shell, made of thermoform-able plastic (Copolymer 5/32 inch) and an inner layer of polyethylene foam ( 1/2 inch).
The provided document is a 510(k) summary for the AOI Cranial Helmet, a custom-fabricated cranial orthosis. The document aims to demonstrate substantial equivalence to a predicate device, the OPIBand by Orthomerica (K001167), rather than conducting independent clinical trials or establishing new acceptance criteria.
Therefore, the sections of your request related to specific performance metrics, sample sizes for test and training sets, expert qualifications, and ground truth establishment are not directly applicable or available in the provided text. The submission focuses on comparing the new device's design, materials, and intended use to a previously cleared predicate device.
Here's an analysis of the provided information, addressing what is present and noting what is absent:
1. Table of Acceptance Criteria and Reported Device Performance
No specific acceptance criteria with quantifiable metrics are provided in the document for the AOI Cranial Helmet's performance. The basis for acceptance is demonstrating "substantial equivalence" to the predicate device.
| Comparison Criteria | Predicate Device (OPIBand K001167) | AOI Cranial Helmet (Subject Device) |
|---|---|---|
| Product Code | MVA | MVA |
| Prescription Device | YES | YES |
| Materials | 1. Outer shell of 5/32 inch copolymer plastic. |
- An inner liner of 1/2 inch pelite polyethylene foam or Aliplast foam.
- 1 1/2 in. Dacron Strap
- Gap block 1/2 inch firm pelite polyethylene foam.
- Nylon Washer | 1. Outer rigid shell made of 5/32 inch copolymer plastic.
- Inner liner of 1/2 inch polyethylene foam.
- 1 1/2 inch Dacron Strap.
- 1 1/2 inch Chafe with roller loop.
- Nylon Washer
- Gap Block 1/2 inch firm pelite polyethylene foam. |
| Product Design | Custom made cranial orthosis, approx 6 oz. | Custom made cranial orthosis, approx. 6 oz. |
| Indications for Use | "The OPIBand 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- and brachycephalic- shaped heads." | The AOI Cranial 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 age 3 to 18 months of age, with moderate to severe nonsynotic positional plagiocephaly, including infants with plagiocephalic- and brachycephalic- shaped heads. |
| Contraindications | "This device is not for use on infants with pre-surgical craniosynostosis or hydrocephalus." | The AOI Cranial Helmet is not for use on infants with craniosynostosis or hydrocephalus. |
The reported performance is based on the claim that "The proposed AOI Cranial Helmet does not differ substantially from the predicate device. The predicate is made of the same materials and in the same fashion as the AOI proposed device." Thus, its "performance" is inferred to be equivalent to the predicate.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. No new clinical trials or test sets were conducted for the AOI Cranial Helmet as part of this 510(k) submission. The submission relies on demonstrating substantial equivalence to a previously cleared device. The safety and effectiveness are inferred from the predicate device's history and the biocompatibility assessments of the materials used, which have a "demonstrable history of use."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. No new test set requiring expert ground truth establishment was used for this submission. The effectiveness is largely based on the established safety and efficacy of the predicate device and the common materials used.
4. Adjudication Method for the Test Set
Not applicable. As no new test set was conducted that required expert review or adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This device is a physical cranial orthosis, not an imaging analysis or diagnostic AI tool that would typically involve an MRMC study to assess human reader improvement with or without AI assistance. The submission focuses on device design and material equivalence.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. The AOI Cranial Helmet is a physical medical device, not an algorithm or software. Its application always involves human-in-the-loop (Certified Orthotist, treating physicians, caregivers).
7. Type of Ground Truth Used
The "ground truth" for the device's acceptability in this submission is the demonstrated safety and effectiveness of the legally marketed predicate device (OPIBand K001167) and the established biocompatibility and safe use history of the materials used in its construction. The submission explicitly states: "The safety of cranial helmets has also been shown through past biocompatibility assessments," and "no testing is needed if the material has a demonstrable history of use in a specified role that is equivalent to that of the device under design." Reference is made to a publication for the "Treatment of Craniofacial Asymmetry with Dynamic Orthotic Cranioplasty" (Littlefield et al., 1988), which presumably supports the general effectiveness of such devices.
8. Sample Size for the Training Set
Not applicable. As this is not an AI/algorithm-based device, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no concept of a "training set" for this physical device.
§ 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)).