(182 days)
The STARband 3D is intended for medical purposes for use on infants from three 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.
The STARband® redirects the head growth to improve proportion and symmetry. The practitioner takes a 3-dimensional captured image of the infant's head to acquire the existing shape. The 3-dimensional 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 further modified 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® 3D™ cranial orthosis device proposed in this submission has identical indications for use to the predicate submission K211376. The difference with this proposed device is a structural change with a bilateral side opening design and two latch closure mechanisms at each opening. The indications for use, the intended use, and the underlying principles of operation of the STARband® cranial orthosis remain the same.
The provided text is a 510(k) summary for the STARband 3D cranial orthosis, which is a medical device for treating infants with abnormal head shapes. This document does not include information about a study that proves the device meets acceptance criteria related to AI/algorithm performance or human reader improvement, as it is not an AI-powered device.
The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this document refer to the non-clinical performance testing conducted for the STARband 3D. The device is a physical cranial orthosis, and its evaluation revolves around its physical characteristics, manufacturing process, and safety, not AI diagnostic performance.
Therefore, many of the requested points regarding AI/algorithm performance, multi-reader multi-case studies, ground truth establishment for AI, and sample sizes for training sets of AI models are not applicable to this device and the provided document.
However, I can extract information related to the physical device's performance testing and "acceptance criteria" from the document.
Here's the relevant information from the provided text, adapted to the closest interpretations of your questions for a non-AI device:
Acceptance Criteria and Device Performance (for a physical medical device)
The device is a cranial orthosis (a helmet) designed to improve cranial symmetry and/or shape in infants. The "acceptance criteria" for a physical device like this are met through demonstrating that its design, manufacturing process, and materials are safe and perform as intended, comparable to a predicate device.
Here's a table summarizing the non-clinical performance and acceptance criteria for the STARband 3D, as reported in the 510(k) summary:
| Test Type | Test Name | Acceptance Criteria (Implicit from Test Results) | Reported Device Performance |
|---|---|---|---|
| Dimensional Analysis | Dimensional Analysis | Acceptable part consistency and reproducibility across build cycles for both controlled and random sample populations. The dimensional differences between 3D printed parts and computer design files must be within acceptable limits (implied by "acceptable part consistency and reproducibility"). | "Dimensional analysis of the additively manufactured Starband® 3D orthoses resulted in acceptable part consistency and reproducibility across build cycles for both controlled and random sample population." |
| Fit Analysis | Fit Assessment | Proper fit, form, and function when 3/16" pads are installed and the device is fit to an unmodified patient-matched mold. All helmets must align and secure properly, and total contact (appropriate hold) must be achieved at the prominent or bossed areas of the unmodified patient model. | "The fit assessment of the additively manufactured Starband® 3D orthoses was successful for all parts evaluated. All helmets aligned and secured properly and total contact (appropriate hold) was achieved at the prominent or bossed areas of the unmodified patient model." |
| Pressure Test | Pressure Test | Pressure distribution for the Starband 3D design, when fit on patient (or model), must be equivalent to or better than the predicate device. | "The Starband® 3D orthoses design successfully showed that the pressure force is comparable to the predicate device." |
| Mechanical Analysis | Latch Closure Cyclic Test | The latch closure must successfully exceed the established don & doff cycles without fatigue or failure impacting function during normal utilization. The design must maintain operational criteria of latching and successfully securing the anterior and posterior shells on the patient model throughout the duration of the cyclic fatigue testing. | "The latch closure design successfully exceeded the established don & doff cycles without fatigue or failure impacting function during normal utilization. The design maintained operational criteria of latching and successfully securing the anterior and posterior shells on the patient model throughout the duration of the cyclic fatigue testing." |
| Mechanical Analysis | Latch Closure Destructive Testing | The maximum force required to fail the latch must exceed a maximum average pull strength of 9.18 lbf for an adult using defined pinch grips (Razza et al., 2022). This demonstrates it can withstand and surpass the pull forces of Don & Doff throughout the entire treatment. | "Destructive testing successfully proved that the STARband 3D latch closure design exceeds the average pull strength of an adult when using various pinch grips in application. It was concluded that the latch closure mechanism can withstand and surpass the pull forces of Don & Doff throughout the entire treatment." |
| Biocompatibility Analysis | Material Biocompatibility Test | All biocompatibility testing must successfully meet the acceptance criteria of ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Sensitization, Irritation). | "Biocompatibility test reports demonstrate that all biocompatibility testing successfully met the acceptance criteria." |
Here are the answers to your specific questions, indicating where the information is not applicable (N/A) for this type of device submission:
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A table of acceptance criteria and the reported device performance
- See the table above.
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Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size: The document refers to "test samples" for Dimensional Analysis, Fit Assessment, and Mechanical Testing, and "test samples" or "finished, fully assembled additively manufactured device" for Biocompatibility. However, specific numerical sample sizes for these tests are not provided in this 510(k) summary.
- Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. Given that these are non-clinical (bench/lab) tests for a physical device, the concepts of retrospective/prospective clinical data are not directly applicable. These appear to be laboratory-based validation studies.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- N/A. This device does not involve "ground truth" derived from expert interpretation of medical images or patient data in the typical sense of AI/diagnostic device evaluation. The "ground truth" for these tests comes from engineering specifications, known dimensions, mechanical properties of materials, and successful operation based on design intent. For example, the "unmodified patient matched mold" serves as a reference for the fit assessment.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set
- N/A. Adjudication methods are typically relevant for clinical studies or studies where multiple human readers interpret data to establish a consensus "ground truth." This is a non-clinical, bench testing report for a physical device.
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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
- N/A. This is not an AI-powered diagnostic device, and therefore, no MRMC study or assessment of human reader improvement with AI assistance was conducted or would be applicable.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A. This is a physical cranial orthosis, not a software algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- N/A in the typical AI sense. For this physical device, "ground truth" is established by:
- Engineering Specifications/Design Files: For Dimensional Analysis (comparison of 3D printed part to original design file).
- Physical Models/Molds: For Fit Assessment (fitting to an "unmodified patient matched mold").
- Predicate Device Performance: For Pressure Test (comparing pressure force to the predicate device).
- Defined Mechanical Criteria: For Latch Closure tests (e.g., specific cycle counts, exceeding a defined pull strength threshold).
- International Standards: For Biocompatibility (conformance to ISO 10993-5 and ISO 10993-10).
- N/A in the typical AI sense. For this physical device, "ground truth" is established by:
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The sample size for the training set
- N/A. This device does not involve machine learning or a "training set."
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How the ground truth for the training set was established
- N/A. This device does not involve machine learning or a "training set."
§ 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)).