(44 days)
The STARband, STARlight, and St. Louis Band 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. 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®, STARlight®, and St. Louis Band are custom made cranial orthoses. The STARband® and STARlight® redirect head growth to improve proportion and symmetry in infants with moderate-to-severe non-synostotic positional plagiocephaly. The practitioner takes a plaster impression or 3-dimensional captured image the 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 St. Louis Band is a Bi-Valve design made with an outer shell of 1/4" polyethylene-polypropylene copolymer plastic with an inner liner made of 1/4" Aliplast foam (closed cell polyethylene). The Bi-Valve design consists of two plastic shells that overlap and are held together with rivet fasteners. The St. Louis Band utilizes a Velcro® strap with chafe and loop for a secure fit. The proposed device modification is the addition of the CurveCapture application for iOS enabled device for a previously cleared shape capture method, the Net Virta SmartSoc™ System distributed by Orthomerica Products, Inc, used with the STARband, STARlight, and St. Louis Band devices. The system uses a flexible fabric sock with a customized non-repetitive printed pattern and a consumer grade mobile phone device with a camera and a built-in flash light source. The built-in flash feature is a non-coherent (i.e. non-laser light) light source. The CurveCapture™ application uses the camera on the device to take video footage of the patient wearing the SmartSoc. Specific images are then selected and sent to the cloud to be processed into a detailed 3D digital model of the patient's cranium.
The provided text describes a 510(k) submission for a medical device (cranial orthoses STARband, STARlight, and St. Louis Band) with a modification related to the associated 3D imaging system called SmartSoc. The modification involves the addition of an iOS-compatible application (CurveCapture) for the SmartSoc system. The document focuses on demonstrating substantial equivalence to predicate devices, primarily through technological characteristics and non-clinical performance data, particularly an accuracy study.
Here's a breakdown of the information requested based on the provided text:
Acceptance Criteria and Device Performance:
The document broadly states that the "Cranial Shape Capture Accuracy Verification was performed concluding that the SmartSoc™ System for iOS enabled device yields a safe and effective product that is substantially equivalent to the predicate device." It also mentions that the study compared the proposed device to a cast and the predicate device, considering "Associated Coordinate Planes (A-P; M-L; P-D and various Radius Parameters; Squareness; Flatness)."
However, specific numerical acceptance criteria (e.g., "accuracy must be within X mm") and the reported device performance values against those criteria are not explicitly stated in a quantitative table format within this summary. The text only indicates that the device met the criteria for substantial equivalence.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Metric (if available) | Acceptance Threshold (if available) | Reported Device Performance (if available) |
|---|---|---|---|
| Cranial Shape Capture Accuracy | Accuracy in various coordinate planes (A-P; M-L; P-D), Radius Parameters, Squareness, Flatness | Not explicitly stated numerically | Device yields "a safe and effective product that is substantially equivalent to the predicate device" in cranial shape capture accuracy. |
| Biocompatibility | Cytotoxicity (Agar Diffusion) | Grade 0 (Non-cytotoxic) or Grade 1 for slight reactivity (Non-cytotoxic) | All materials tested (Surlyn, Copolymer with Pelite Foam, Copolymer with Aliplast Foam) showed "Non-cytotoxic" results (Grade 0 or Grade 1 as noted in table 3). |
| Closed Patch Sensitization | Not a Sensitizer, No Erythema or Edema Formation | All materials showed "Not a Sensitizer" and "No Erythema or Edema Formation". | |
| Primary Dermal Irritation | Negligible Dermal Response (e.g., Primary Irritation Index: 0.00 or 0.06 as noted in table 3). | All materials showed "Negligible Dermal Response". | |
| Safety | Eye Protection Requirement | Safe to use on infants without any eye protection. | "The system uses a consumer grade camera and is safe to use on infants without any eye protection." |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions "Cranial Shape Capture Accuracy Study" but does not specify the sample size for the test set (i.e., how many cranial shapes or subjects were included in this accuracy study). It also does not specify the geographic origin (country of origin) of the data or whether the study was retrospective or prospective. It only states that the study "Utilized a representative cranial shape that possesses a predefined shape with known dimensions" and "Compared proposed device to cast and predicate device."
3. Number of Experts and Qualifications for Ground Truth:
The document does not mention the involvement of experts in establishing the ground truth for the test set. The ground truth seems to be based on a "representative cranial shape that possesses a predefined shape with known dimensions" and comparison to a physical "cast," implying an objective measurement rather than expert consensus on images.
4. Adjudication Method:
Given that expert involvement is not mentioned, an adjudication method (like 2+1 or 3+1) for the test set is not applicable and not described in the document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
A multi-reader multi-case (MRMC) comparative effectiveness study was not performed or described. This study focuses on the accuracy of the imaging system itself in capturing shape, not on the improvement of human readers' performance with or without AI assistance. The device is a shape capture system for orthotic fabrication, not a diagnostic imaging interpretation tool for humans.
6. Standalone (Algorithm Only) Performance:
The "Cranial Shape Capture Accuracy Study" described is essentially a standalone (algorithm only) performance study as it evaluates the ability of the SmartSoc System for iOS to accurately capture the "predefined shape with known dimensions" and compare it to a cast and the predicate device. It assesses the algorithm's output (3D digital model) directly.
7. Type of Ground Truth Used:
The ground truth used for the accuracy verification was:
- An objective, known "predefined shape with known dimensions" (likely a phantom or a precisely manufactured model).
- Comparison to a physical "cast" of a cranial shape.
This is not expert consensus, pathology, or outcomes data, but rather a direct measurement against a known physical standard.
8. Sample Size for the Training Set:
The document does not specify any training set size for the CurveCapture application or the SmartSoc system. This suggests that the development of the CurveCapture application might have relied on existing algorithms from the Android version, or that the training data details are not considered part of this simplified FDA summary for a Special 510(k). For a Special 510(k), significant changes to the algorithm often require more detailed information on training, but here the focus is on the "firmware expansion" and consistent technological characteristics.
9. How Ground Truth for Training Set was Established:
Since a training set is not explicitly mentioned or detailed, the method for establishing its ground truth is not provided.
§ 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)).