(195 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 and STARlight redirects the head growth to improve proportion and symmetry. The practitioner takes a plaster impression or 3-dimensional captured inage 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 last cleared in K180109 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 St. Louis Band (formally known as the O&P Bivalve Molding Helmet in K063395) was last cleared in K180109 by Orthomerica Products Inc. 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 Cranial Comparison Utility (CCU) is a software component for a previously cleared shape capture method, the STARscanner Data Acquisition System, distributed by Orthomerica Products, Inc. The CCU is a separate software program that is designed to present specific measurements derived from a three-dimensional (3D) digital model and can be used to compare three-dimensional (3D) digital models during the patient treatment period for the purpose of tracking progress. These presented measurements can be incorporated into the patient assessment.
The proposed addition is a new software component for a previously cleared shape capture method, the NetVirta SmartSoc Data Acquisition System, distributed by Orthomerica Products, Inc. The new software component is the Measurement Comparison Utility (MCU). The MCU is a separate software program, not used in manufacturing, which is designed to present specific measurements derived from a threedimensional (3D) digital model and can be used to compare three-dimensional (3D) digital models during the patient treatment period for the purpose of tracking progress. These presented measurements can be incorporated into the patient assessment.
The provided document describes a 510(k) premarket notification for Orthomerica Products Inc.'s cranial orthoses (STARband, STARlight, and St. Louis Band) with the addition of a new software component, the Measurement Comparison Utility (MCU). The acceptance criteria and supporting study details are primarily focused on the MCU Accuracy and Capabilities Study.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria in a table format. However, it indicates that the MCU's performance was evaluated against the predicate Cranial Comparison Utility (CCU) and manual/3D-CAD software measurements. The reported device performance is that the MCU was determined to be substantially equivalent to the predicate CCU.
| Feature | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Measurement Accuracy & Capabilities | To be comparable to manual measurements and 3D-CAD software, and substantially equivalent to the predicate CCU in terms of model alignment, differential maps, calculations, and reporting. | MCU was determined to be substantially equivalent to the predicate CCU regarding accuracy of measurements and capabilities of model alignment, differential maps, calculations, and reporting. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document states that the MCU Accuracy and Capabilities Study "Utilized representative cranial shapes that reflect symmetrical and asymmetrical cranial shapes." However, it does not specify the exact number (sample size) of these cranial shapes used in the test set.
- Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective. It refers to "representative cranial shapes," which could be phantom models or de-identified patient data.
3. Number of Experts Used to Establish Ground Truth and Qualifications
The document states that the MCU was "Compared... to manual measurements and 3D-CAD software." This implies that the ground truth for some measurements was established through manual methods and potentially by experts using 3D-CAD software. However, the document does not specify the number of experts used or their qualifications.
4. Adjudication Method
The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for establishing the ground truth of the test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted in this submission. The focus was on the performance of the software (MCU) in comparison to established methods (manual measurements, 3D-CAD, and predicate software).
6. Standalone (Algorithm Only) Performance
A standalone performance study was performed. The "MCU Accuracy and Capabilities Study" evaluates the MCU software program itself, without human intervention in its measurement calculations or reporting. It compares the MCU's outputs to manual measurements and 3D-CAD software.
7. Type of Ground Truth Used
The ground truth used for the MCU Accuracy and Capabilities Study was:
- Manual measurements
- 3D-CAD software measurements
This combination provided a reference for assessing the accuracy of the MCU's measurements and capabilities.
8. Sample Size for the Training Set
The document does not mention a training set sample size. The MCU is described as a software component designed to present specific measurements from 3D digital models. It seems to function as a measurement and comparison tool rather than a machine learning algorithm that requires a traditional training set for model development in this context. The study focuses on its accuracy for processing existing 3D models.
9. How the Ground Truth for the Training Set Was Established
Since a training set is not explicitly mentioned as relevant for this type of software (a measurement utility rather than a predictive model), the document does not describe how ground truth for a training set was established.
§ 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)).