(121 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 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 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. The Cranial Orthosis is assembled from two-part outer 3D printed shell and the inner soft foam layer.
The provided text does not contain the detailed information required to fill out a table of acceptance criteria and reported device performance for a medical device that relies on AI or an algorithm. The submission is for a Cranial Orthosis (Talee, Talee PostOp), which is a physical device, not an AI-driven diagnostic or assistive tool.
Therefore, many of the requested points, such as "effect size of how much human readers improve with AI vs without AI assistance," "standalone (i.e. algorithm only without human-in-the-loop performance)," "number of experts used to establish ground truth," and "sample size for training set," are not applicable to this specific device submission as an AI/algorithm is not the primary component of the device being evaluated for clinical effectiveness.
The document focuses on non-clinical performance testing of the physical cranial orthosis and its manufacturing process, along with demonstrating substantial equivalence to a predicate device.
However, I can extract information related to the device's physical and material properties, and the testing conducted on those aspects, to address the spirit of the request as much as possible given the provided text.
Here's an attempt to categorize the relevant information from the document, acknowledging that it's a physical device and not an AI/algorithm:
Acceptance Criteria and Device Performance (for a Physical Cranial Orthosis)
Given that this is a 510(k) submission for a physical cranial orthosis (Talee, Talee PostOp) and not an AI/algorithm-driven device, the "acceptance criteria" and "device performance" are primarily related to its mechanical properties, manufacturing accuracy, and biocompatibility, rather than diagnostic or assistive performance metrics for an AI. The document indicates that all predetermined acceptance criteria for these tests were met.
Table of Acceptance Criteria and Reported Device Performance (Physical Device Focus)
| Acceptance Criteria Category | Specific Test/Evaluation | Reported Device Performance / Conclusion |
|---|---|---|
| Biocompatibility | ISO Cytotoxicity MEM Elution (ISO 10993-5) | Results: Cell culture treated with test sample exhibited no reactivity (Grade 0). Conclusion: Non-cytotoxic. |
| ISO Intracutaneous Irritation (ISO 10993-10) | Results: Rabbits treated with test samples exhibited no irritation (Scores 0). Conclusion: Non-irritating. | |
| ISO Guinea Pig Maximization Sensitization (ISO 10993-10) | Results: Albino guinea pigs treated with test sample did not elicit a sensitization response (Grade 0). Conclusion: Non-sensitizer. | |
| Mechanical Strength | Impact Strength mechanical test | The tested devices Talee and Talee PostOp have comparable safety and comparable (or higher) structural strength than the predicate/reference devices. Predetermined acceptance criteria were met. |
| Structural Stiffness mechanical test | The tested devices Talee and Talee PostOp have comparable safety and comparable (or higher) structural strength than the predicate/reference devices. Predetermined acceptance criteria were met. | |
| Manufacturing Accuracy | Accuracy Test – Manufacturing of Cranial Remolding Orthosis | All of the acceptance criteria were met, ensuring required dimensional accuracy and that the devices fit accurately. Based on the Accuracy and Capabilities study, the CCA software program met all the acceptance criteria and provides comparable accuracy to manual and CAD method. |
| Manufacturing Test - Dimensional Accuracy of Laser Plotter | All of the acceptance criteria were met, ensuring required dimensional accuracy and that the devices fit accurately. | |
| Software Functionality | Accuracy and Capabilities Study (for Cranial Comparison App - CCA) | The CCA software program met all the acceptance criteria and provides comparable accuracy to manual and CAD method. The CCA also has the same (or greater) capabilities as the manual or CAD method. |
Study Details (Focusing on non-clinical performance and substantial equivalence)
Given that this is a physical medical device (Cranial Orthosis), not an AI/algorithm, many of the requested AI-specific points are not relevant. However, I will address what is present in the document.
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Sample size used for the test set and the data provenance:
- The document mentions "tested devices Talee and Talee PostOp" for mechanical tests, but does not specify numerical sample sizes for these non-clinical performance tests (e.g., how many orthoses were impact tested).
- For biocompatibility, the tests describe standard animal models (rabbits, guinea pigs for irritation/sensitization) and cell cultures for cytotoxicity. No specific numerical sample sizes for these tests are provided within the document itself, but these are standard ISO methods.
- Data Provenance: The tests were conducted to support a submission to the U.S. FDA. The data provenance for the non-clinical tests would be the testing laboratories that performed them. The document refers to "non-clinical performance testing (Software, Product, Manufacturing method)." It does not discuss patient data for algorithms (as there is no AI algorithm being cleared).
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in the context of AI/algorithm ground truth. The "ground truth" for this device relates to established physical/material standards (e.g., ISO for biocompatibility, mechanical engineering standards for strength/stiffness). The specialists involved would be testing technicians and engineers, not clinical experts establishing a ground truth for a diagnostic AI.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable as there is no human reader "adjudication" in the context of an AI/algorithm performance study. The evaluation of non-clinical tests would follow standard laboratory quality control and reporting procedures.
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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 study was done, and it is not applicable. This device is a physical cranial orthosis, not an AI diagnostic or assistance tool. Therefore, there are no "human readers" whose performance is being augmented by AI.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. The device itself is a physical product. While it uses digital scanning and CAD software in its manufacturing process, the submission does not describe an AI or algorithm as a "standalone" medical device whose performance is being evaluated in this manner. The Cranial Comparison App (CCA) is mentioned as a "separate reporting software program" for measurements, but its function as a standalone diagnostic algorithm is not the focus of this submission.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this submission is based on established industry standards and regulatory requirements for medical devices, specifically:
- Biocompatibility standards: ISO 10993 series.
- Mechanical properties: Engineering specifications and performance metrics.
- Manufacturing accuracy: Dimensional tolerances and verification against CAD models.
- There is no "clinical ground truth" in the sense of diagnosing a disease, as this is a treatment device.
- The "ground truth" for this submission is based on established industry standards and regulatory requirements for medical devices, specifically:
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The sample size for the training set:
- Not applicable. This device is manufactured individually based on a 3D scan of a patient's head using CAD software and 3D printing. There is no "training set" in the context of machine learning or AI algorithm development for the device itself.
- The CAD software (R4D CADCAM software) is presumably a commercial product and its "training" or development data would precede this submission.
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How the ground truth for the training set was established:
- Not applicable, as there is no training set for an AI/algorithm related to the device's efficacy. The manufacturing process relies on 3D scanning and CAD/CAM, which are established digital design and manufacturing technologies, not machine learning that requires a "ground truth" for a training set in this context.
§ 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)).