(44 days)
The Clarren Helmet is a cranial orthosis that applies passive 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.
The Clarren Helmet is a cranial orthosis that applies passive 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. It consists of a polypropylene sheet, three-eights of an inch thick, which is vacuum formed over a plaster model of a baby's head to produce a helmet. A liner for the helmet is made of Plastizote, one-fourth of an inch in thickness. Small holes are bored in the helmet for ventilation and large holes for the child's ears A Velero chinstrap is attached to help keep the helmet in place on the baby's head. It is manufactured from a positive model, obtained via traditional manual casting methods or a three-dimensional scan of the infant's head.
The submission describes the Clarren Helmet (Orthomerica) and its use in conjunction with the STARscanner.
Here's an analysis of the provided information regarding acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state specific quantifiable acceptance criteria for the Clarren Helmet or the STARscanner. Instead, it relies on substantial equivalence to previously cleared devices.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated as quantifiable metrics. The submission relies on substantial equivalence. | The Clarren Helmet (Orthomerica) is stated to be "safe and effective and identical to the Clarren Helmet (Children's Hospital)." The STARscanner's performance data "demonstrates that the proposed automation of measuring for and carving a positive mold of the patient's head yields more accurate results than the manual process used for the predicate device." |
2. Sample Size Used for the Test Set and Data Provenance
- Clarren Helmet (Orthomerica): No specific test set or sample size is mentioned for the Orthomerica version of the Clarren Helmet. The claim is based on its identity to the Clarren Helmet (Children's Hospital), which presumably had supporting data in its original clearance.
- STARscanner: No specific test set or sample size is mentioned for the STARscanner in this submission. It refers to its previous FDA clearance (K011350) and states that data "demonstrates more accurate results than the manual process." This implies a comparison, but details about the comparison's sample size or provenance (country of origin, retrospective/prospective) are not provided in this excerpt.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Clarren Helmet (Orthomerica): Not applicable, as no dedicated test set for this specific device is described. The original Clarren Helmet's studies (if they involved expert ground truth) are referenced, but details are not here.
- STARscanner: Not applicable. The submission mentions "more accurate results" but does not detail the method of establishing ground truth or expert involvement for the STARscanner's performance evaluation.
4. Adjudication Method for the Test Set
- Clarren Helmet (Orthomerica) / STARscanner: Not applicable, as no specific test set requiring adjudication is described in this excerpt.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Clarren Helmet (Orthomerica) / STARscanner: No MRMC comparative effectiveness study is mentioned in this document. The focus for the Clarren Helmet is on substantial equivalence to a predicate, and for the STARscanner, on automation accuracy compared to manual processes.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)
- Clarren Helmet (Orthomerica): Not applicable. The Clarren Helmet is a physical cranial orthosis, not an algorithm.
- STARscanner: The description of the STARscanner states it "yields more accurate results than the manual process," implying a standalone assessment of its automated measurement and carving capability. However, the details of how this accuracy was measured and whether it was without human intervention in the loop of the measurement phase are not provided. The previous FDA clearance (K011350) for the STARscanner likely contains these details.
7. Type of Ground Truth Used
- Clarren Helmet (Orthomerica): The references provided for the Clarren Helmet (Children's Hospital) are medical journal articles from 1979 and 1981, suggesting that the ground truth for its efficacy might have been based on clinical outcomes data (e.g., improvement in cranial symmetry/shape, as assessed by clinicians or objective measurements over time) observed in those studies.
- STARscanner: For the STARscanner, the claim of "more accurate results than the manual process" suggests the ground truth would be based on highly precise physical measurements of the infant's head model or actual head, against which both the STARscanner's output and the manual process's output are compared. The exact nature of this "ground truth" (e.g., gold standard precision measurement tools) is not specified.
8. Sample Size for the Training Set
- Clarren Helmet (Orthomerica) / STARscanner: The submission does not mention any training sets, as it is focused on demonstrating substantial equivalence and the performance of a physical device/scanner, not on a machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Clarren Helmet (Orthomerica) / STARscanner: Not applicable, as no training set is mentioned.
Summary of the Study and Its Limitations (based on provided text):
The submission does not present a new, comprehensive study with explicit acceptance criteria for the Clarren Helmet (Orthomerica). Instead, it relies on two primary arguments:
- Substantial Equivalence to a Predicate Device: The Clarren Helmet (Orthomerica) is deemed "safe and effective and identical" to the predicate, the Clarren Helmet (Children's Hospital), which had prior FDA clearance based on published studies (Clarren, 1979, 1981). This implies the acceptance criteria and proof of effectiveness for the Orthomerica version are derived from the prior clearance of the Children's Hospital version.
- Previous Clearance and Demonstrated Performance of the STARscanner: The STARscanner had already received FDA clearance (K011350) when used with another cranial orthosis (STARband). The submission asserts that the STARscanner's "performance data demonstrates that the proposed automation of measuring for and carving a positive mold of the patient's head yields more accurate results than the manual process used for the predicate device."
Key Missing Information: The document lacks specific details regarding quantitative acceptance criteria, new clinical study data for the Orthomerica Clarren Helmet, or detailed technical study data for the STARscanner's accuracy (including sample sizes, ground truth establishment, or expert involvement) within this specific submission. It heavily leverages previous clearances and external publications for its justification.
§ 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)).