(63 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, 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 STARband 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 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 modified further 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 consists of a 5/32" outer copolymer shell with an inner liner made of 1/2" pelite polyethylene foam. There is a top opening and a side opening. The strap across the side opening is 1 ½" Dacron and Velcro and is attached to the STARband with a chafe and loop. A 1/2" pelite polyethylene foam gap block fills any gap in the side opening. Since the original clearance, a variation of the STARband has been released. It is identical in design; however, the inner liner is made of 1/2" Aliplast foam (closed cell polyethylene).
The provided text describes a 510(k) submission for the STARband® Cranial Orthosis. It focuses on demonstrating substantial equivalence to predicate devices and detailing minor technical changes to the orthosis itself and the scanning systems used for head shape capture. The document does not contain information about a study that assesses the clinical performance of the device against specific acceptance criteria for improving cranial symmetry or shape. Instead, the performance data presented relates to the accuracy, reproducibility, and repeatability of the scanning devices used to create the orthosis.
Therefore, many of the requested sections (e.g., acceptance criteria for device performance, sample size for test set, ground truth experts, MRMC studies, standalone performance) cannot be fully addressed in the context of the provided text, as those types of studies were not discussed for the STARband itself.
Here's the information that can be extracted from the document regarding the acceptance criteria and study for the scanning devices:
1. Table of Acceptance Criteria and Reported Device Performance (for Scanning Devices):
| Acceptance Criteria Category | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| STARscanner | Predetermined (not specified quantitatively in the text, but implies accuracy, reproducibility, and repeatability within acceptable limits for orthosis fabrication) | "Each device met the predetermined acceptance criteria and was found acceptable." |
| Accuracy | Evaluated by scanning three cylindrical shapes (100mm, 125mm, 150mm diameters) five times at five different positions. | |
| Reproducibility | Evaluated using standard measurement systems statistical process control procedures. | |
| Repeatability | Evaluated using standard measurement systems statistical process control procedures. | |
| OWW Omega Scanner | Predetermined (not specified quantitatively in the text, but implies accuracy, reproducibility, and repeatability within acceptable limits for orthosis fabrication, and safe for use with Class 1 laser) | "Through testing, the OWW Omega Scanner was found to be safe and effective." |
| "Each device met the predetermined acceptance criteria and was found acceptable." | ||
| Accuracy | Evaluated by scanning three cylindrical shapes (100mm, 125mm, 150mm diameters) five times while in random motion. | |
| Reproducibility | Evaluated using standard measurement systems statistical process control procedures. | |
| Repeatability | Evaluated using standard measurement systems statistical process control procedures. | |
| Laser Safety | Class 1 laser device (inherently safe for use without eye protection under normal operating conditions) | Both STARscanner and OWW Omega Scanner are Class 1 laser devices. |
2. Sample size used for the test set and the data provenance:
- Test Set (for scanning devices):
- STARscanner: Three different cylindrical shapes (100mm, 125mm, 150mm diameters) were scanned five times at five different positions within the scan volume. This represents a total of $3 \times 5 \times 5 = 75$ scan instances and measurements.
- OWW Omega Scanner: Three different cylindrical shapes (100mm, 125mm, 150mm diameters) were scanned five times in random motion. These 15 scan files were then converted to .aop files 3 times, creating a total of $15 \times 3 = 45$ scan files for analysis.
- Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. Given the nature of mechanical testing, it's likely institutional testing rather than clinical data from human subjects.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The "ground truth" for the scanning device evaluation was based on known geometries of cylindrical shapes. There were no human experts involved in establishing this ground truth for the mechanical accuracy testing.
4. Adjudication method for the test set:
- Not applicable. This relates to human expert review which was not involved in the scanning device accuracy testing. The evaluation was statistical.
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:
- No. This type of study was not reported. The submission focuses on device safety and substantial equivalence, not the comparative effectiveness of human readers with or without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, for the scanning devices. The accuracy, reproducibility, and repeatability tests for both the STARscanner and the OWW Omega Scanner represent a standalone evaluation of the scanning technology's ability to capture accurate 3D geometry. The performance evaluated was of the algorithm/hardware of the scanner itself, not in conjunction with human interpretation or interaction related to clinical outcome.
7. The type of ground truth used:
- For the scanning device evaluation, the ground truth was known physical dimensions/geometries of cylindrical shapes.
8. The sample size for the training set:
- Not applicable. The document describes a medical device (cranial orthosis) and scanning technologies, not an AI/machine learning algorithm requiring a "training set" in the conventional sense. The "training" for such systems would typically involve calibration procedures or internal engineering data collection, which is not detailed in terms of sample size.
9. How the ground truth for the training set was established:
- Not applicable. As above, there is no explicit mention of a training set or its ground truth establishment in this technical description.
§ 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)).