(84 days)
The RHS 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 RHS 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 helmet, three-eighths of an inch thick, that 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.
The provided text is a 510(k) summary for the RHS Helmet, a cranial orthosis. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting extensive performance studies against specific acceptance criteria for a novel device.
Therefore, many of the requested categories for a study proving device meets acceptance criteria are not applicable or not detailed in this document.
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not specify quantitative acceptance criteria or provide a table of performance data against such criteria. The basis for clearance is "biocompatibility of the materials and the safety and effectiveness of helmet therapy," which are qualitative statements rather than specific metrics.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document | Not specified in the document |
2. Sample Size Used for the Test Set and Data Provenance
No specific test set or clinical study data on device performance is provided in this 510(k) summary. The document mentions "Performance Data: Information was provided on the biocompatibility of the materials and the safety and effectiveness of helmet therapy," but does not detail any particular study results or sample sizes.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. As no specific test set or clinical study is detailed, there's no mention of experts establishing ground truth for performance.
4. Adjudication Method for the Test Set
Not applicable. No test set or clinical study is detailed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
Not applicable. This document does not describe an MRMC study. The focus is on demonstrating substantial equivalence to a predicate device, not on comparative effectiveness against humans or other devices.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. The RHS Helmet is an orthotic device, not an algorithm, so a standalone algorithm performance study is irrelevant.
7. The Type of Ground Truth Used
The concept of "ground truth" as typically applied to performance studies (e.g., pathology, outcomes data) is not explicitly discussed in this 510(k) summary. The device's effectiveness relies on the established principles of cranial orthosis therapy for nonsynostotic positional plagiocephaly, which is a recognized medical approach. The "effectiveness" mentioned refers to the general understanding of helmet therapy, not a specific ground truth derived from a novel study for this particular device.
8. The Sample Size for the Training Set
Not applicable. This device is a physical orthotic device, not an algorithm or AI model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. See #8.
In summary, the provided 510(k) documentation for the RHS Helmet primarily relies on the concept of "substantial equivalence" to a legally marketed predicate device (Clarren Helmet -- 510(k) # 003035). This means that the device's safety and effectiveness are supported by its similarity to an already cleared device, rather than through extensive, independent, novel performance studies with specific acceptance criteria as might be required for a completely new technology or a PMA application. The "Performance Data" mentioned likely refers to general information and existing knowledge about cranial helmet therapy and material biocompatibility, rather than data from a new, comprehensive clinical trial for the RHS Helmet itself.
§ 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)).