(90 days)
The Molded Cranial Helmet is used to treat children 3-18 months of age for moderate to severe non-synostotic 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 device is for use by or on the order of a physician.
The Molded Cranial Helmet is a cranial orthosis used to treat children 3-18 months of age for moderate to severe non-synostotic positional plagiocephaly, including infants with plagiocephalic-, brachycephalic-, and scaphocephalic-shaped heads.
The Molded Cranial Helmet consists of a 1/8" light-weight, semi-rigid polypropylene outer shell and a ¼'' medium-density closed cell plastazote foam inner lining. The anterior inferior edge is trimmed just above the eyebrows, and the sides are trimmed above and around the ears. The posterior inferior is trimmed low to capture the occiput. A Velcro strap is attached on one side of the Helmet to keep it securely in place. The device allows for growth of the flattened areas of the infant's skull into the voids of the shell/foam lining, thus correcting the plagiocephaly and giving the infant's skull a more symmetrical shape.
The Molded Cranial Helmet is custom designed and custom-fit for each patient from a plaster mold of the infant's head. The mold is prepared by an orthotist using precise measurements of the infant's skull and plaster modification techniques. The orthosis is fabricated from the mold by lab technicians, with the trimming and final modifications performed by the orthotist. Precise fit and alignment are monitored by the orthotist during treatment.
The provided text describes a 510(k) summary for the "Molded Cranial Helmet," a cranial orthosis. It includes information about the device, its intended use, comparison to a predicate device, and performance data. However, it does not contain the specific details required to fully address your request in the format of a clinical study acceptance criteria and results.
Here's a breakdown of what can be extracted and where the information is missing:
The document does not detail specific, quantified acceptance criteria in the format of a table, nor does it present device performance data against such criteria in a systematic way that would typically be found in a clinical study report. Instead, it refers to general efficacy and safety.
Given the information provided in the 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Efficacy: Correction of moderate to severe non-synostotic positional plagiocephaly, including plagiocephalic-, brachycephalic-, and scaphocephalic-shaped heads in infants 3-18 months of age. | "Researchers studying the effects of treatment with cranial orthoses on infants with plagiocephaly, including Fairview orthotists, have concluded that the devices are effective in correcting plagiocephaly without evidence of relapse after treatment." "A comprehensive assessment of cranial orthoses monitored the treatment of more than 750 infants over nearly ten years. Results recorded at the end of the treatment period and at 12, 18, and 24 month follow-ups documented complete or near complete correction of asymmetry." |
| Safety: No adverse events, no skin irritation or abrasion, no improper slippage or excessive pressure on the infant's cranium. Biocompatibility with skin. | "Fairview orthotists have experienced similar results, having treated infants for positional plagiocephaly and observing significant improvement in head shape with no adverse events." "Plastazote is not reported to cause skin irritation or abrasion and is widely accepted in the industry as a safe material for skin contact." "the device is custom-designed and custom-fit for each patient, thus avoiding improper slippage or excessive pressure on the infant's cranium." |
Missing Information/Not Applicable (based on the provided text):
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- The document mentions "a comprehensive assessment of cranial orthoses monitored the treatment of more than 750 infants over nearly ten years." This appears to be a retrospective analysis of treatment outcomes.
- Data provenance (country of origin) is not explicitly stated, but Fairview Orthopedic Laboratory is located in Minneapolis, MN, USA.
The text does not specify the sample size used for a test set in the context of a controlled study designed to prove the device meets specific acceptance criteria. The 750+ infant assessment seems to be a broader observational study or review of clinical practice.
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 specified. The assessment mentions "Fairview orthotists" who concluded effectiveness and observed results, but the number and specific qualifications for establishing ground truth are not detailed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not specified.
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 medical device (cranial orthosis), not an AI-assisted diagnostic tool for human "readers."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical device, not an algorithm. Performance is inherently "standalone" in this context but not in the way an AI algorithm's standalone performance is evaluated.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The ground truth for efficacy appears to be "correction of asymmetry" as documented by healthcare professionals (orthotists) based on clinical observation and measurements taken at various follow-up periods. Safety ground truth is based on observation of adverse events and material biocompatibility. This broadly falls under "outcomes data" and "expert assessment."
8. The sample size for the training set
- Not applicable. This refers to an AI/machine learning context, which is not relevant for this physical medical device.
9. How the ground truth for the training set was established
- Not applicable (see above).
In summary, the provided 510(k) focuses on demonstrating substantial equivalence to a predicate device and relies on existing literature and clinical experience (including an assessment of over 750 infants) to support the safety and efficacy of cranial orthoses in general, and by extension, this specific device. It does not present a de novo clinical study with pre-defined acceptance criteria and a structured evaluation of performance against those criteria in the manner expected for a novel AI or diagnostic 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)).