(105 days)
The STARband is intended for medical purposes for use on infants from three to 18 months of age, with moderate to severe non-synostotic positional plagiocephaly, infants with plagiocephalic-, brachycephalic-, and scaphocephalic- shaped heads by applying mild pressure to prominent regions of the infant's cranium in order to improve cranial symmetry and/or shape. The device is also indicated for adjunctive use for infants from three to eighteen months of age whose synostosis has been surgically corrected, but who will have moderate to severe cranial deformities including plagiocephalic-, brachycephalic-, and scaphocephalic- shaped heads.
The STARband® redirects the head growth to improve proportion and symmetry. The practitioner takes a plaster impression or 3-dimensional captured image of the infant's head to acquire the existing shape. The mold is sealed and filled with plaster or the 3dimensional image is carved from a rigid polyurethane foam blank to create a positive model of the head shape. The positive model is modified to obtain greater symmetry and space in the areas of flattening. The STARband® provides total contact over the prominent or bossed areas of the baby's head to discourage growth there. Over the course of treatment, the inside of the band is further modified by the practitioner to provide space for growth to occur in the flat or depressed areas. The shape of the STARband® directs growth into the areas of least resistance and creates a precise pathway for the head shape to improve in symmetry and proportion.
The STARband® Side Opening design and STARband® Bi-Valve design are made with an outer shell of 5/32" polyethylene-polypropylene copolymer plastic with an inner liner made of 1/2" pelite polyethylene foam or 1/2" Aliplast foam (closed cell polyethylene). The STARband® Side Opening design has a top opening and a side opening. The band is held in place by a Velcro® strap (1½" for STARband® Side Opening) across the side opening. The STARband® Bi-Valve design consists of two plastic shells that overlap with a superior sliding mechanism. The right and left overlap tabs are connected via a Velcro strap with chafe and loop.
The STARband® Plus cranial orthosis device proposed in this submission has identical indications for use to the predicate submission K082950. The difference with this proposed device is a structural change to a dual side opening design with a living hinge at the top. The indications for use, the intended use, and the underlying principles of operation of the STARband® cranial orthosis remain exactly the same.
The provided document describes materials testing and durability testing for the STARband® Plus cranial orthosis. It does not contain information about a study that assesses the device's performance in improving cranial symmetry or shape in infants, which would typically involve clinical outcomes or efficacy data related to the device's intended use. The provided information focuses on the physical properties and structural integrity of the device itself.
Based on the provided text, here's what can be extracted regarding acceptance criteria and studies:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (for Durability) | Reported Device Performance |
|---|---|
| Living hinge to achieve or exceed 1440 cycles without experiencing failure (fatigue/fracture/yield) when donned and doffed roughly 4 times a day for 6 months. | All STARband Plus configurations (1/2" Aliplast, (4) 1/8" Aliplast, and ½" Pelite) successfully completed 1440 cycles without fatigue/failure impacting the living hinge. |
2. Sample size used for the test set and the data provenance
The document states that the "sample population included both deformational and post-operative patients" for the STARband Plus durability test, but it does not specify the exact number of devices (sample size) or the provenance of the data (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable as the described study is a non-clinical, mechanical durability test and does not involve human expert assessment for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as the described study is a non-clinical, mechanical durability test and does not involve adjudication by multiple reviewers. The assessment involved visual inspection for wear or failure.
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
This information is not applicable. The device is a cranial orthosis, not an AI-assisted diagnostic or imaging device, so an MRMC study is not relevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical medical device (cranial orthosis), not an algorithm or software. The testing described is for the physical durability of the device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the durability test, the "ground truth" was the physical integrity of the device's living hinge after repeated cycling, assessed by visual inspection for signs of wear or failure.
8. The sample size for the training set
This information is not applicable. There is no "training set" mentioned or implied as this is a non-clinical, mechanical durability test of a physical device, not an algorithm that requires training.
9. How the ground truth for the training set was established
This information is not applicable as there is no training set involved.
§ 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)).