(62 days)
The STARband and STARlight are intended for medical purposes for use on infants from 3 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. These devices are also indicated for infants from 3 to 18 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 and STARlight 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 3-dimensional 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 and STARlight provide 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 and 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 STARband and STARlight product families as it was released in K141842 are essentially still the same devices. The STARband Side Opening design and STARband Bi-Valve design is 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 STARlight Side Opening design and the STARlight Bi-Valve design are made of a plastic shell of 5/32" - 1/4" clear Surlyn or 1/8" - 7/32" Clear Co-Polyester. The STARlight PRO (Post-operative Remolding Orthosis) design is made of 1/4" to 3/8" clear Surlyn. Optional Aliplast (closed cell polyethylene) padding is available for the clear plastic bands and in addition, optional Reston (polyurethane - 3M Medical Product) foam is available for the STARlight PRO design.
The STARband Side Opening design and the STARlight 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 and 1" for STARlight Side Opening) across the side opening. The STARlight PRO has two side openings, no top opening, and is held in place by a Velcro strap across each side opening. The STARlight Bi-Valve 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 3-dimensional shape capture method, specifically, the Rodin4D M4DScan System and the BodyScan System. The BodyScan System is the same as the M4DScan System (Hardware and Software included) except it is distributed in the United States by TechMed 3D, Inc. on behalf of Rodin4D. This system uses a structured white light projector and a single camera to detect the shape of the surface captured. This system utilizes LED white light which is a non-coherent (i.e. non-laser) light source. Because this system utilizes a non-coherent light source, it is safe to use on infant patients under all circumstances.
This document describes the 510(k) premarket notification for the STARband and STARlight Cranial Orthosis, specifically focusing on the addition of the Rodin4D M4DScan System and the BodyScan System as new 3-dimensional shape capture methods.
Here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Repeatability and Reproducibility (R&R) Analysis | The new shape capture device (M4DScan/BodyScan) should demonstrate comparable repeatability and reproducibility to the casting process and the predicate device. | "The shape capture device passed the acceptance criteria. The relevancy of the test determined substantial equivalence of the proposed shape capture device." (Page 9) |
| Cranial Shape Capture Accuracy Study | The new shape capture device (M4DScan/BodyScan) should demonstrate comparable accuracy to the casting process and the predicate device for predefined cranial shapes and dimensions (A-P, M-L, P-D, radius parameters, squareness, flatness). | "The shape capture device passed the acceptance criteria for all parameters. The relevancy of the test determined substantial equivalence of the proposed shape capture device." (Page 9) |
| Material Biocompatibility Testing (Surlyn, Copolymer with Pelite Foam, Copolymer with Aliplast Foam) | Materials used in the orthosis should be non-sensitizing, cause negligible dermal response, and be non-cytotoxic. | Surlyn: Not a Sensitizer, No Erythema or Edema Formation (Closed Patch Sensitization); Negligible Dermal Response (Primary Dermal Irritation); Non-cytotoxic (Cytotoxicity – Agar Diffusion). |
| Copolymer with Pelite Foam: Not a Sensitizer, No Erythema or Edema Formation; Negligible Dermal Response; Non-cytotoxic. | ||
| Copolymer with Aliplast Foam: Not a Sensitizer, No Erythema or Edema Formation; Negligible Dermal Response; Non-cytotoxic (Note: exhibited slight reactivity (Grade 1) in Cytotoxicity, but conclusion states Non-cytotoxic, implying it met the criteria). (Page 10) |
Note on Acceptance Criteria: The document primarily states that the devices "passed the acceptance criteria" and demonstrated "substantial equivalence" rather than explicitly delineating numerical thresholds for acceptance. The acceptance criteria are inferred from the stated purpose of the tests (comparing to predicate/casting process and finding substantial equivalence).
2. Sample Size Used for the Test Set and Data Provenance
- R&R Analysis & Cranial Shape Capture Accuracy Study:
- Sample Size: The document states the tests "Utilized uniform shapes with known dimensions that represent various sizes of pediatric patients between ages 3 to 18 months of age" and "Utilized a representative cranial shape that possesses a predefined shape with known dimensions" (Page 9). However, specific numerical sample sizes for the test set (number of uniform shapes, number of measurements, etc.) are not provided.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). The study appears to be a laboratory/benchtop study using uniform or representative cranial shapes, not patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- R&R Analysis & Cranial Shape Capture Accuracy Study: The ground truth was established by "predefined shape with known dimensions" of uniform or representative cranial shapes (Page 9). This implies that the ground truth was based on engineered or calibrated measurements of these physical models, not expert human assessment. Therefore, no experts were used to establish the ground truth for these specific tests.
4. Adjudication Method for the Test Set
- Since the ground truth was based on precisely measured physical models or known dimensions, and not human interpretation, no adjudication method (like 2+1, 3+1) was necessary or performed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC comparative effectiveness study was mentioned or performed. The clearance is for a medical device (cranial orthosis) and a new shape capture method, not an AI diagnostic algorithm that assists human readers.
6. Standalone (Algorithm only without human-in-the-loop performance) Study
- Yes, a standalone study was performed for the shape capture devices. The R&R Analysis and Cranial Shape Capture Accuracy Study directly evaluated the performance of the M4DScan/BodyScan System itself in accurately capturing known shapes, comparing its measurements to predefined dimensions (ground truth) and to other existing shape capture methods (casting process and predicate devices). This is essentially a standalone performance evaluation of the new technology.
7. The Type of Ground Truth Used
- For the R&R Analysis and Cranial Shape Capture Accuracy Study: The ground truth used was based on "uniform shapes with known dimensions" and "a representative cranial shape that possesses a predefined shape with known dimensions." This is akin to engineered ground truth or physical model measurements, where the true dimensions are precisely known.
- For Biocompatibility Testing: The ground truth was established by recognized biological assay standards and methodologies (e.g., scoring systems for sensitization, irritation, and cytotoxicity) as per ISO 10993 standards (implied, though not explicitly cited in detail).
8. The Sample Size for the Training Set
- This document is for a medical device and a shape capture method, not an AI model that requires a "training set" in the machine learning sense. The device is a physical orthosis and the M4DScan/BodyScan system is a 3D scanner.
- Therefore, the concept of a "training set" as traditionally understood for machine learning models is not applicable here, and no specific training set sample size is mentioned.
9. How the Ground Truth for the Training Set Was Established
- As the concept of a "training set" is not applicable, the establishment of ground truth for a training set is also not relevant to 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)).