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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

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.

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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)

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.

1. 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).

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. 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.

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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:

• 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.

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