(198 days)
The Talee and the Talee PostOp are the Cranial Remolding Orthoses intended for medical purposes for infants from 3 to 18 months of age with moderate-to-severe cranial deformities.
The Talee is used for infants from 3 to 18 months with moderate-to-severe non-synostotic positional plagiocephaly, including infants with plagiocephalic- and scaphocephalic- shaped heads and combination of these defects.
The Talee PostOp is used for infants from 3 to 18 months of age whose synostosis has been surgically corrected, but who still have cranial deformities including plagiocephalic- and scaphocephalic- shaped heads.
The Talee and the Talee PostOp are Cranial Remolding Orthoses which are individually designed and manufactured medical devices class II. The Cranial Remolding Orthosis (Talee/Talee PostOp) has contact with the prominent regions, and a precisely pre-defined internal space in the areas where flattening occurs. The skull only has the possibility to grow into that pre-defined space, which as a result improves the cranial symmetry and/or physiological shape. The same cranial remolding principle is applied to patients with positional plagiocephaly and to post-operative patients. The Cranial Orthosis is made individually as a patient-specific device according to the type of deformity and disposition of the patient. The Cranial Orthosis is made according to the 3D scan of the infant´s head. The modified shape of the infant's symmetrical head shape is created in CAD software (R4D CADCAM software, Rodin4D, http://rodin4d.com/en/Products/rectification) from the 3D scan. CAD model of the outer shell of the Orthosis is based on modified shape of infant's head. The outer shell of the Orthosis is produced by 3D printing (industrial HP MJF 3D printed shell provides stiffness of the Orthosis and the control of the desired head shape. The Cranial Orthosis is assembled from two-part outer 3D printed shell and the inner soft foam layer. Inner soft foam layer is made from polyethylene foam (Plastazote), which ensures soft contact with the skin of the child's head. The Plastazote is held in place by double sided tape. On the left/right side of the orthosis there is a fastening mechanism, which is used for easy donning/doffing of the Cranial Orthosis.
The device under consideration is "Talee and Talee PostOp", Cranial Remolding Orthoses.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance:
| Tested Area | Acceptance Criteria (Implied from stated results) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Non-cytotoxic, non-irritating, non-sensitizing to intact skin. | Plastazote foam: |
- Cytotoxicity (ISO 10993-5): No reactivity (Grade 0).
- Intracutaneous Irritation (ISO 10993-10): No irritation (Scores 0).
- Guinea Pig Maximization Sensitization (ISO 10993-10): No sensitization response (Grade 0).
Overall: Biocompatibility assessments revealed no adverse effects on patients under intended conditions of wear. Materials are not reported to cause skin irritation or toxic effects. |
| Software (CCA - Cranial Comparison App) | Comparable accuracy to manual and CAD methods; same or greater capabilities than manual or CAD. | CCA software program met all acceptance criteria, providing comparable accuracy to manual and CAD methods, and possessing the same (or greater) capabilities. |
| Product (Talee/Talee PostOp) Mechanical Strength | Equivalent safety and equivalent (or higher) structural strength compared to predicate devices. | Tested devices (Talee and Talee PostOp) showed equivalent safety and equivalent (or higher) structural strength than the predicate devices in impact strength and structural stiffness mechanical tests. |
| Manufacturing Accuracy | Ensured required dimensional accuracy and accurate device fit. | Manufacturing Test – Dimensional Accuracy of Laser Plotter and Accuracy Test – Manufacturing of Cranial Remolding Orthosis showed all acceptance criteria were met, ensuring required dimensional accuracy and accurate device fit. |
2. Sample size used for the test set and the data provenance:
- Biocompatibility:
- Cytotoxicity: Not specified, but generally refers to in-vitro testing.
- Intracutaneous Irritation: Rabbits (number not specified).
- Guinea Pig Maximization Sensitization: Albino guinea pigs (number not specified).
- Data Provenance: The document does not specify the country of origin for these tests; they are reported as per ISO standards. These are typically laboratory-based tests.
- Software (CCA) Accuracy and Capabilities Study: The study is described as having "utilized a representative cranial shape that possesses a predefined shape with known dimensions" and compared CCA to "manual measurements and 3D-CAD software". The sample size (number of "representative cranial shapes") is not explicitly stated. The provenance is not specified.
- Mechanical Tests (Impact strength, Structural stiffness): The document refers to "tested devices Talee and Talee PostOp". The number of devices tested is not specified. The provenance is not specified.
- Manufacturing Test and Accuracy Test: These refer to internal manufacturing processes. The number of instances tested is not specified. The provenance is not specified.
3. 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):
The document does not mention the involvement of external experts to establish ground truth for any of the non-clinical tests. The "ground truth" for the software accuracy study was based on a "predefined shape with known dimensions" and "manual measurements and 3D-CAD software," implying a comparative approach rather than expert consensus on clinical cases.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
No explicit adjudication method is mentioned. The non-clinical tests described follow laboratory or engineering validation methodologies against defined acceptance criteria or comparisons to known standards (manual measurements, CAD software).
5. 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 comparative effectiveness study was conducted or described in the provided text. The device is a cranial orthosis, and its associated software (CCA) is for reporting measurements derived from 3D models, not for diagnostic assistance to human readers. Therefore, there is no discussion of human reader improvement with or without AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
The software (Cranial Comparison App - CCA) underwent an "Accuracy and Capabilities Study" which compared its measurements to "manual measurements and 3D-CAD software." This can be interpreted as a standalone performance evaluation of the algorithm's measurement capabilities. However, it's not described as an "AI algorithm" in the common sense of machine learning for diagnosis or prediction. Its function is to present measurements from a 3D digital model.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Biocompatibility: Ground truth is established by standard ISO test protocols (e.g., observing lack of cellular reactivity, irritation, or sensitization in biological models).
- Software (CCA) Accuracy and Capabilities Study: The ground truth was established by comparing the software's output to a "representative cranial shape that possesses a predefined shape with known dimensions" and measurements obtained through "manual measurements and 3D-CAD software." This is a metrological ground truth rather than a clinical one.
- Mechanical Tests: Ground truth is against engineering standards for impact strength and structural stiffness, comparing to predicate device performance.
- Manufacturing Tests: Ground truth is against manufacturing specifications for dimensional accuracy.
8. The sample size for the training set:
The document does not mention a training set, as the device and its associated software are not described as using machine learning or AI models that require traditional training data in the context of diagnostic or predictive tasks. The software primarily processes geometrical data from existing 3D scans.
9. How the ground truth for the training set was established:
As no training set is mentioned for an AI/machine learning model, this question is not applicable.
§ 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)).