(89 days)
The Lerman & Son Cranial Orthosis Helmet is intended to be used by or under the direction of a physician for treatment of abnormal head shape in infants from 3-18 months of age (positional/ deformational plagiocephaly).
The Lerman & Son Cranial Orthosis Helmet is a custom made orthosis used to treat children between the ages of three and eighteen months for abnormal head shapes. Through the concavity formed during the design of this helmet, the skull is encouraged to grow in a more normal manner.
This is a premarket notification (510(k)) for a cranial orthosis helmet, not a study evaluating a device's performance against acceptance criteria using advanced AI or imaging technology. Therefore, the requested information elements related to AI, statistical studies, expert ground truth, and training/test sets are not applicable to this document.
The document establishes substantial equivalence to a predicate device, Orthomerica STARband (K001167), primarily by comparing design, materials, intended use, and other key specifications.
Here's a breakdown of the relevant information from the provided document:
1. A table of acceptance criteria and the reported device performance
The document does not present "acceptance criteria" in the typical sense of numerical thresholds for performance metrics. Instead, it demonstrates "substantial equivalence" to a predicate device. The "reported device performance" is essentially that it matches the predicate device in key characteristics.
| Feature / Criteria (as compared to predicate) | Predicate Device (Orthomerica STARband K001167) | Lerman & Son 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) |
| Materials | Copolymer plastic/Closed Cell Polyethylene Foam/Velcro strap | Copolymer plastic/Closed Cell Polyethylene Foam/Velcro strap |
| Clinical Population | Infants age 3-18 months | Infants age 3-18 months |
| Daily Wear Time | 23 hrs./day | 23 hrs./day |
| Avg. Time to Effectiveness (patients age 3-7 mos.) | 2 - 4 months | 2 - 4 months |
| Contraindications for Use | Craniosynostosis/ Hydrocephalus | Craniosynostosis/ Hydrocephalus |
| Method of Manufacture | Custom from mold | Custom from mold by Certified Orthotist |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is a 510(k) submission focusing on substantial equivalence, not a clinical trial with a "test set" to evaluate performance. There is no mention of a specific test set or data provenance in this document beyond the predicate device's existing clearance.
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)
Not applicable. No "ground truth" was established for a test set in the context of this 510(k) submission. Substantial equivalence relies on comparing the device to an already legally marketed predicate, not on new clinical data requiring expert review for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There was no "test set" or adjudication method described in this 510(k) submission.
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 device is a physical cranial orthosis helmet and does not involve AI or human readers for diagnostic interpretation. Therefore, an MRMC study is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a physical medical device, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The concept of "ground truth" as used in testing AI or diagnostic devices is not relevant here. The "truth" for this submission is based on the established safety and effectiveness of the predicate device (Orthomerica STARband K001167).
8. The sample size for the training set
Not applicable. This is a physical device, and the submission does not involve machine learning or a "training set."
9. How the ground truth for the training set was established
Not applicable. As there is no training set mentioned, there is no ground truth established for it.
§ 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)).