(29 days)
The STARlight is intended for medical purposes for use on infants from three to 18 months of age, with moderate to severe non-synostotic positional plagiocephaly, including 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 still have moderate to severe cranial deformities including plagiocephalic-, brachycephalic-, and scaphocephalic-shaped heads.
The STARlight redirects the head growth to improve proportion and symmetry. The practitioner takes a plaster impression or scan of the baby's head to acquire the existing shape. The mold is sealed and filled with plaster or the scanned shape 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 STARlight 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 modified further by the practitioner to provide space for growth to occur in the flat or depressed areas. The shape of the STARlight directs growth into the areas of least resistance and creates a precise pathway for the head shape to improve in symmetry and proportion.
The STARlight Side Opening design, STARlight Bi-Valve design and the STARlight Cap design are all made of a plastic shell of 5/32" - 1/4" clear Surlyn or 1/8" - 7/32" Clear Co-Polyester. The STARband Bi-Valve design is made with an outer shell of 5/32" polyethylene-polypropylene copolymer plastic and an inner liner of 1/2" pelite polyethylene foam. Optional Aliplast (closed cell polyethylene) padding is available for the clear plastic bands.
The STARlight Cap design is made of the above plastic and contains no straps. The STARlight Side Opening design has a top opening and a side opening. The band is held in place by a Velcro strap across the side opening. The STARlight Bivalve design and the STARband Bi-Valve design consist 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 proposed device modification is the addition of a new shape capture method, specifically the Ohio Willow Wood (OWW) Omega Scanner. Like the STARscanner Laser Data Acquisition system cleared with the STARlight (K021207 and K081994), the OWW Omega Scanner is a class 1 laser device. The OWW Omega Scanner is a handheld scanner consisting of two cameras, one laser, and eight LED lights.
The provided text describes a 510(k) submission for a modification to the STARlight Cranial Orthosis, specifically the addition of the Ohio Willow Wood (OWW) Omega Scanner as a new shape capture method. The study focuses on demonstrating the safety and efficacy of this new scanner.
Here's an analysis of the acceptance criteria and study as per your request:
Acceptance Criteria and Reported Device Performance
The core of this submission is the evaluation of the OWW Omega Scanner. The acceptance criteria and reported performance relate to its accuracy, reproducibility, and repeatability.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety: Meet Class 1 laser device standards | OWW Omega Scanner is a Class 1 laser device; inherently safe. |
| Efficacy: Accuracy | Met predetermined acceptance criteria for accuracy. |
| Efficacy: Reproducibility | Met predetermined acceptance criteria for reproducibility. |
| Efficacy: Repeatability | Met predetermined acceptance criteria for repeatability. |
The document states, "The OWW Omega Scanner met the predetermined acceptance criteria and was found safe and effective for use with Cranial Orthoses." However, specific numerical thresholds for these criteria (e.g., a specific accuracy percentage, standard deviation for reproducibility) are not detailed in the provided text.
Study Details
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not specified in the provided text.
- Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective or prospective).
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified. The study appears to be a technical validation of the scanner's performance (accuracy, reproducibility, repeatability) rather than a clinical study requiring expert ground truth for diagnosis or outcome measurement. The "ground truth" for scanner performance would likely involve physical measurements from a reference object or repeated scans, not expert consensus on patient data.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable as the study appears to be a technical validation of a measurement device, not a diagnostic or treatment outcome study requiring adjudication of expert interpretations.
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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:
- No MRMC comparative effectiveness study was done. This submission is for a physical measurement device (scanner) used to create an orthosis, not an AI-assisted diagnostic or interpretative tool.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- The OWW Omega Scanner's performance (accuracy, reproducibility, repeatability) was evaluated in a standalone manner, meaning the scanner itself was tested for its ability to capture shape accurately and consistently. The results relate to the scanner's intrinsic technical performance.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this type of technical validation would typically involve a precisely known reference object or repeated measurements against a highly accurate standard. The document does not specify the exact nature of the ground truth, but it would not be expert consensus, pathology, or outcomes data in this context. It would be a physical reference standard or highly precise measurement method to compare the OWW Omega Scanner's output against.
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The sample size for the training set:
- Not applicable. The OWW Omega Scanner is a commercial device being integrated into a workflow, not a machine learning algorithm that requires a training set in the conventional sense.
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How the ground truth for the training set was established:
- Not applicable, as there is no training set for this device in the context of this submission.
§ 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)).