(89 days)
The St. Louis Band is 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. This device is 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 St. Louis Band 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 3dimensional 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 St. Louis Band provides total contact over the prominent or bossed areas of the baby's head to discourage growth there. Over the course of treatment, 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 St. Louis Band 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 (formally known as the O&P Bivalve Molding Helmet) was released in K063395. 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 modifications include:
(1) A clarification to the indications for use for the St. Louis Band. This change would have the device 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.
(2) The addition of two new 3-dimensional shape capture methods, specifically, the STARscanner™ Data Acquisition System and the SmartSocTM System. The STARscanner is a stationary system that uses Class I Lasers and cameras to record surface data for shape capture. The SmartSoc System is a hand held system that uses a flexible fabric sock with a customized non-repetitive printed pattern and a consumer grade digital camera with it's a built-in flash light source. The built-in flash feature is a non-coherent (i.e. non-laser light) light source. Both of these shape capture systems are cleared with the STARband predicate device (K151979).
The provided text describes the acceptance criteria and study proving the device meets them for the Orthomerica Products, Inc. "St. Louis Band" cranial orthosis (K161138), primarily focusing on the addition of new 3D shape capture methods (STARscanner and SmartSoc System) rather than the orthosis itself.
Here's an analysis of the requested information, based on the provided document:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Test | Reported Device Performance |
|---|---|
| Repeatability and Reproducibility (R&R) Analysis | The shape capture devices (STARscanner and SmartSoc System) passed the acceptance criteria. The relevancy of the tests determined substantial equivalence of the proposed shape capture devices to the casting process. |
| Cranial Shape Capture Accuracy Study | The shape capture devices (STARscanner and SmartSoc System) passed the acceptance criteria for all parameters (A-P, M-L, P-D, various radius parameters, squareness, and flatness). The relevancy of the test determined substantial equivalence of the proposed shape capture device to the casting process. |
| Material Biocompatibility Testing (Copolymer with Aliplast Foam) | Closed Patch Sensitization: A score of 0.00/0.00 (Test/Control) was given for both Incidence and Severity in the 24-hour and 48-hour scoring interval, concluding "Not a Sensitizer" and "No Erythema or Edema Formation." Primary Dermal Irritation: Primary Irritation Index: 0.00, concluding "Negligible Dermal Response." Cytotoxicity – Agar Diffusion: Cell culture treated with test sample exhibited slight reactivity (Grade 1), concluding "Non-cytotoxic." |
Study Details for Shape Capture Devices
This document primarily focuses on the validation of the new 3D shape capture methods (STARscanner and SmartSoc System) for manufacturing the St. Louis Band, not clinical efficacy of the band itself with these new methods.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Repeatability and Reproducibility (R&R) Analysis: "Utilized uniform shapes with known dimensions that represent various sizes of pediatric patients between ages 3 to 18 months of age." The specific number of shapes or scans is not provided.
- Cranial Shape Capture Accuracy Study: "Utilized a representative cranial shape that possesses a predefined shape with known dimensions." The specific number of shapes or scans is not provided.
- Data Provenance: Not specified, but given the manufacturing context, it's likely internal testing by the manufacturer. It is not specified if it was retrospective or prospective, but the nature of the tests suggests bespoke testing/data collection.
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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)
- For both R&R and Accuracy studies, the ground truth was established by "uniform shapes with known dimensions" and a "representative cranial shape that possesses a predefined shape with known dimensions." This implies engineered or measured physical models, not human expert assessment of clinical cases. Therefore, no clinical experts were used for ground truth for these specific tests on the shape capture devices.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable as the ground truth was based on physical models with known dimensions. There was no clinical adjudication process described for these engineering validation tests.
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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
- No MRMC or comparative effectiveness study involving human readers or AI assistance in a clinical diagnostic context was described. The testing focused on the accuracy and precision of the shape capture devices for manufacturing, comparing them to a traditional casting method.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The "standalone" performance here refers to the device's ability to accurately capture shape data compared to a physical reference ("casting process" or "known dimensions"). This was evaluated. The results indicate that the STARscanner and SmartSoc System "passed the acceptance criteria" and were "substantially equivalent" to the casting method in terms of accuracy and repeatability/reproducibility.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the R&R and Accuracy studies of the shape capture devices, the ground truth was based on known dimensions of uniform/representative physical shapes/models, not clinical data from patients or expert consensus.
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The sample size for the training set
- The document does not describe a "training set" in the context of an AI/machine learning algorithm. The tests are for the accuracy and precision of a measurement device, not a classification or diagnostic algorithm.
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How the ground truth for the training set was established
- Not applicable as no AI/ML training set is mentioned or implied. The ground truth for the validation tests was established by physical models with precisely known dimensions.
§ 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)).