(58 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 plagiocephalicand 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 PostOp) has contact with the head in the prominent regions, an 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 Remolding Orthosis is made individually as a patient-specific device according to the type of deformity and disposition of the patient. The adjustments are made to the device as needed to accommodate growth and/or optimize the function of the Cranial Orthosis.
The Cranial Remolding Orthosis is made by 3D printing from thermoplastic material with inner soft foam layer.
This document describes a 510(k) premarket notification for a medical device called "Talee, Talee PostOp," which are Cranial Remolding Orthoses. The submission seeks to demonstrate substantial equivalence to a previously cleared predicate device (K230444). The provided text focuses on the device's technological characteristics and non-clinical performance testing. It does not describe a study involving an AI algorithm and human readers, nor does it contain information about the performance of a device that uses AI. Therefore, I cannot extract information related to AI acceptance criteria, human reader improvement, or training/test set details for an AI model from this document.
The document primarily focuses on the physical characteristics and non-clinical testing of the cranial orthoses to demonstrate substantial equivalence to a predicate device.
However, I can provide a table of the acceptance criteria and the claimed performance based on the non-clinical tests mentioned, as well as general information about the study type.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Name | Acceptance Criteria (Predetermined per document) | Reported Device Performance (Implied by "All testing passed acceptance criteria and demonstrated that the subject device is substantially equivalent") |
|---|---|---|
| Sensitization testing (ISO 10993-10:2010) | Met criteria of ISO 10993-10:2010 | Passed (Non-sensitizing) |
| Cytotoxicity testing (ISO 10993-5:2009) | Met criteria of ISO 10993-5:2009 | Passed (Non-cytotoxic) |
| Irritation testing (ISO 10993-10:2010) | Met criteria of ISO 10993-10:2010 | Passed (Non-irritant) |
| Accuracy and Capabilities Study | Predetermined acceptance criteria met | Passed (Device demonstrated accuracy and capabilities) |
| Impact strength mechanical test | Predetermined acceptance criteria met | Passed (Device exhibited sufficient impact strength) |
| Structural stiffness mechanical test | Predetermined acceptance criteria met | Passed (Device exhibited sufficient structural stiffness) |
| Manufacturing Test - Dimensional Accuracy of Laser Plotter | Predetermined acceptance criteria met | Passed (Laser plotter demonstrated required dimensional accuracy) |
| Accuracy Test - Manufacturing of Cranial Remolding Orthosis | Predetermined acceptance criteria met | Passed (Manufactured orthoses met accuracy specifications) |
| New material PA (polyamide) inhalation and dermal exposure (off-gassing and wipe tests) | Predetermined acceptance criteria met | Passed (New PA material met safety standards for inhalation and dermal exposure) |
| Biological evaluation of medical devices ISO 10993-1:2018-08 (Risk Management) | Met criteria of ISO 10993-1 | Passed (Biological risk managed effectively) |
| Biological evaluation of medical devices ISO 10993-17:2002-12-01 and 2023-09 (Leachable Limits) | Met criteria of ISO 10993-17 | Passed (Leachable substances were within allowable limits) |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify the sample size for any of the non-clinical tests. These tests typically involve a defined number of material samples or manufactured devices rather than a patient test set in the way an AI model would be evaluated.
- Data Provenance: Not applicable in the context of this device's non-clinical testing. The tests are general material and mechanical property tests conducted in a lab setting, not on patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable to the provided document. The device is a physical cranial orthosis, not an AI diagnostic/prognostic device that requires expert-established ground truth from medical images or patient data. The "ground truth" for these tests relates to established material science and mechanical engineering standards (e.g., ISO standards for biocompatibility, material strength).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not applicable. Adjudication methods are typically used in clinical studies or expert review processes for AI/diagnostic devices, not for non-clinical material and mechanical property testing.
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:
This information is not applicable. The device (cranial orthosis) is not an AI-assisted diagnostic tool that human readers would use.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
This information is not applicable. There is no AI algorithm discussed in the context of the device's performance that would require standalone testing. The document refers to "CAD software" used for design, but this is a design tool, not a medical AI algorithm subject to performance validation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the non-clinical tests described is based on established scientific and engineering standards (e.g., ISO 10993 for biocompatibility, standard methods for mechanical testing). These standards define acceptable performance metrics.
8. The sample size for the training set:
This information is not applicable. The document does not describe an AI model that would require a training set. The device is a physical medical device.
9. How the ground truth for the training set was established:
This information is not applicable. As there is no AI training set, there is no ground truth establishment process for it.
§ 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)).