(114 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, 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 devices are also indicated for adjunctive use 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 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 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 Side Opening design and STARband Bi-Valve design is made with an outer shell of 5/32" polyethylenepolypropylene 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 (1 ½' 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 three new systems to use for 3dimensional shape capture, specifically, the 3dMDhead™ System, the 3dMDcranial™ System and the 3dMDflex™ System all distributed by 3dMD, Inc. These systems use a non-coherent (i.e. non-laser light) structured light source and triangulated cameras to capture shape data.
The provided 510(k) summary (K140353) concerns the addition of three new 3D imaging systems (3dMDhead™ System, 3dMDcranial™ System, and 3dMDflex™ System) for use with the existing STARband® and STARlight® Cranial Orthosis. The primary goal of the submission is to demonstrate that these new 3D capture systems are substantially equivalent to previously cleared 3D imaging devices for the same cranial orthosis fabrication.
Here's a breakdown of the requested information based on the provided text:
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria for the 3dMD Systems are primarily based on demonstrating repeatability, reproducibility, and accuracy in shape capture, and biocompatibility of the materials used in the orthosis itself. The performance is assessed by substantiating equivalence to predicate devices and established methods.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Shape Capture Repeatability & Reproducibility (for 3dMD Systems) | "The shape capture repeatability and reproducibility was evaluated and determined to be acceptable." |
| Study Method: Utilized uniform shapes with known dimensions representing various sizes of pediatric patients (3-18 months). Compared the proposed device (3dMD Systems) to cast and predicate devices. Parameters included A-P (Anterior-Posterior) and M-L (Medial-Lateral) measurements. | |
| Cranial Shape Capture Accuracy (for 3dMD Systems) | "An additional, Cranial Shape Capture Accuracy Study was performed concluding that the 3dMD Systems yield a safe and effective product that is substantially equivalent to the predicate device." |
| Study Method: Utilized a representative cranial shape with predefined known dimensions. Compared the proposed device (3dMD Systems) to cast and predicate devices. Parameters included A-P, M-L, P-D (Posterior-Distal) and various Radius Parameters, Squareness, Flatness. Concluded substantial equivalence. | |
| Biocompatibility (for STARband and STARlight materials - Surlyn, Copolymer with Pelite Foam, Copolymer with Aliplast Foam) | Demonstrated acceptable biocompatibility: |
- Closed Patch Sensitization: All materials scored 0.00/0.00 (Test/Control) for Incidence and Severity at 24 and 48 hours, concluding "Not a Sensitizer," and "No Erythema or Edema Formation."
- Primary Dermal Irritation: Surlyn scored 0.00, Copolymer with Pelite Foam scored 0.06, Copolymer with Aliplast Foam scored 0.00. All concluded "Negligible Dermal Response."
- Cytotoxicity (Agar Diffusion): Surlyn and Copolymer with Pelite Foam exhibited no reactivity (Grade 0), concluded "Non-cytotoxic." Copolymer with Aliplast Foam exhibited slight reactivity (Grade 1), concluded "Non-cytotoxic." |
| Safety of Scanner Light Source (for 3dMD Systems) | "The scanner uses a quick flash of structured white light which is equivalent to the flash from a consumer grade camera and shown that is safe to use on infants without any extra eye protection." This references that the non-coherent light source is safe, similar to the predicate device K014012. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Repeatability & Reproducibility Analysis: Not explicitly stated as a number of "samples." The study "utilized uniform shapes with known dimensions that represent various sizes of pediatric patients between ages 3 to 18 months of age." This suggests a set of standardized models rather than clinical patient data.
- Sample Size for Cranial Shape Capture Accuracy Study: Not explicitly stated as a number of "samples." The study "utilized a representative cranial shape that possesses a predefined shape with known dimensions." This also suggests a focus on physical models rather than patient data.
- Data Provenance: The studies appear to be laboratory-based validation studies using physical models ("uniform shapes," "representative cranial shape") rather than retrospective or prospective clinical patient data. Therefore, country of origin related to patient data is not applicable.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not mention the involvement of "experts" in establishing the ground truth for the test sets (uniform shapes, representative cranial shape). The ground truth was based on the "known dimensions" and "predefined shape" of these physical models.
4. Adjudication Method for the Test Set
Not applicable. The ground truth was based on the known, predefined dimensions of physical models rather than human interpretation requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not mentioned or performed for this submission. The focus was on the accuracy, repeatability, and reproducibility of the 3D scanning systems themselves.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, the studies conducted for the 3dMD Systems (Repeatability & Reproducibility Analysis, Cranial Shape Capture Accuracy Study) assessed the performance of the scanning technology in isolation, or "standalone," by comparing its measurements to the known dimensions of physical models. This does not involve a "human-in-the-loop" aspect for the performance evaluation of the scanner itself.
7. Type of Ground Truth Used
The ground truth used was based on the known dimensions and predefined shapes of physical models ("uniform shapes with known dimensions," "representative cranial shape that possesses a predefined shape with known dimensions").
8. Sample Size for the Training Set
The document does not mention a "training set" or "training data" in the context of machine learning. The 3dMD Systems are described as using "non-coherent (i.e. non-laser light) structured light source and triangulated cameras to capture shape data," which implies a direct measurement technology rather than a machine learning algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as a training set for a machine learning algorithm is not described in the document.
§ 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)).