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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.

Ask a specific question about this device

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.

Ask a specific question about this device

The STARband 3D is intended for medical purposes for use on infants from three to 18 months of age, with moderate to severe non-synostotic positional plagiocephaly, 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.

The STARband® redirects the head growth to improve proportion and symmetry. The practitioner takes a 3-dimensional captured image of the infant's head to acquire the existing shape. The 3-dimensional positive model is modified to obtain greater symmetry and space in the areas of flattening. The STARband® provides total contact over the prominent or bossed areas of the baby's head to discourage growth there. Over the course of treatment, the inside of 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 STARband® directs growth into the areas of least resistance and creates a precise pathway for the head shape to improve in symmetry and proportion.

The STARband® 3D™ cranial orthosis device proposed in this submission has identical indications for use to the predicate submission K211376. The difference with this proposed device is a structural change with a bilateral side opening design and two latch closure mechanisms at each opening. The indications for use, the intended use, and the underlying principles of operation of the STARband® cranial orthosis remain the same.

The provided text is a 510(k) summary for the STARband 3D cranial orthosis, which is a medical device for treating infants with abnormal head shapes. This document does not include information about a study that proves the device meets acceptance criteria related to AI/algorithm performance or human reader improvement, as it is not an AI-powered device.

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this document refer to the non-clinical performance testing conducted for the STARband 3D. The device is a physical cranial orthosis, and its evaluation revolves around its physical characteristics, manufacturing process, and safety, not AI diagnostic performance.

Therefore, many of the requested points regarding AI/algorithm performance, multi-reader multi-case studies, ground truth establishment for AI, and sample sizes for training sets of AI models are not applicable to this device and the provided document.

However, I can extract information related to the physical device's performance testing and "acceptance criteria" from the document.

Here's the relevant information from the provided text, adapted to the closest interpretations of your questions for a non-AI device:

Acceptance Criteria and Device Performance (for a physical medical device)

The device is a cranial orthosis (a helmet) designed to improve cranial symmetry and/or shape in infants. The "acceptance criteria" for a physical device like this are met through demonstrating that its design, manufacturing process, and materials are safe and perform as intended, comparable to a predicate device.

Here's a table summarizing the non-clinical performance and acceptance criteria for the STARband 3D, as reported in the 510(k) summary:

Here are the answers to your specific questions, indicating where the information is not applicable (N/A) for this type of device submission:

1. A table of acceptance criteria and the reported device performance

   • See the table above.

2. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

   • Sample Size: The document refers to "test samples" for Dimensional Analysis, Fit Assessment, and Mechanical Testing, and "test samples" or "finished, fully assembled additively manufactured device" for Biocompatibility. However, specific numerical sample sizes for these tests are not provided in this 510(k) summary.
   • Data Provenance: The document does not specify the country of origin of the data or whether the studies were retrospective or prospective. Given that these are non-clinical (bench/lab) tests for a physical device, the concepts of retrospective/prospective clinical data are not directly applicable. These appear to be laboratory-based validation studies.

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)

   • N/A. This device does not involve "ground truth" derived from expert interpretation of medical images or patient data in the typical sense of AI/diagnostic device evaluation. The "ground truth" for these tests comes from engineering specifications, known dimensions, mechanical properties of materials, and successful operation based on design intent. For example, the "unmodified patient matched mold" serves as a reference for the fit assessment.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

   • N/A. Adjudication methods are typically relevant for clinical studies or studies where multiple human readers interpret data to establish a consensus "ground truth." This is a non-clinical, bench testing report for a physical device.

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

   • N/A. This is not an AI-powered diagnostic device, and therefore, no MRMC study or assessment of human reader improvement with AI assistance was conducted or would be applicable.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

   • N/A. This is a physical cranial orthosis, not a software algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

   • N/A in the typical AI sense. For this physical device, "ground truth" is established by:
     • Engineering Specifications/Design Files: For Dimensional Analysis (comparison of 3D printed part to original design file).
     • Physical Models/Molds: For Fit Assessment (fitting to an "unmodified patient matched mold").
     • Predicate Device Performance: For Pressure Test (comparing pressure force to the predicate device).
     • Defined Mechanical Criteria: For Latch Closure tests (e.g., specific cycle counts, exceeding a defined pull strength threshold).
     • International Standards: For Biocompatibility (conformance to ISO 10993-5 and ISO 10993-10).

8. The sample size for the training set

   • N/A. This device does not involve machine learning or a "training set."

9. How the ground truth for the training set was established

   • N/A. This device does not involve machine learning or a "training set."

Ask a specific question about this device

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.

Ask a specific question about this device

Intended for medical purposes to apply static or gentle pressure to prominent regions of an infant's cranium to improve cranial symmetry or shape. To treat infants from three to eighteen months of age with moderate to severe non-synostotic positional plagiocephaly, including plagiocephalic-, brachycephalic-, scaphocephalic-shaped heads.

The Hanger Cranial Band 3D is a cranial remolding orthosis comprised of an additivemanufactured outer shell with a polyethylene foam inner lining.

The device is custom fabricated for individual patients by obtaining measurements via a handheld 3D laser scanner. Clinical measurements of the infant's cranium are taken from the digital file. The scan is then modified utilizing a CAD/CAM technology package—to add or remove material, increase or decrease the circumference of model to aid in fit and functionality of the cranial orthosis. The 3D image is used to produce a positive mold using a routing machine, to which the foam liner is pulled onto. The 3D file is also used manufacture the outer shell, which is then attached to the foam-lined positive model.

The completed device applies gentle pressure to the elevated areas of the skull while leaving space for cranial growth in the depressed regions. It is open at one side and closed with a fastener to provide the selected fit and proper stability.

The provided document describes a 510(k) submission for the Hanger Cranial Band 3D, a cranial orthosis, and does not contain information about acceptance criteria and a study proving a device meets them. Instead, it focuses on demonstrating substantial equivalence to a predicate device.

Therefore, I cannot provide the requested information about acceptance criteria and a study for this specific document.

Here's why and what information is available:

• No Acceptance Criteria or Study for Performance: The document explicitly states: "There was no clinical testing required to support the medical device as the indications for use is equivalent to the predicate device. The predicate device has been on the market for years with a proven safety and efficacy for the use of the device." This indicates that a study proving the device meets specific performance acceptance criteria was not conducted or presented in this submission because the device's performance is assumed to be substantially equivalent to the predicate.

• Focus on Substantial Equivalence: The primary goal of a 510(k) submission is to demonstrate that a new device is as safe and effective as a legally marketed predicate device. This is often achieved by showing similar intended use, technological characteristics, and principles of operation, rather than rigorous new performance testing against specific acceptance criteria.

What information is present in the document that somewhat relates to testing, even if not a formal performance study:

• Non-Clinical Performance Data (Section VII):
  • Biocompatibility: Both the outer shell and inner foam lining were tested and found to be biocompatible (reference Section 15, which is not provided).
  • Tensile Stress Testing: Conducted on the outer shell material of the subject device, showing average tensile strength was higher than the predicate device's outer shell material (copoly plastic). This is a comparative test, not a performance test against acceptance criteria.
  • Drop and Chemical Tests: Performed on the outer shell and "had passed the attribute acceptance criteria." However, what those acceptance criteria were (e.g., specific thresholds for impact or chemical resistance) is not detailed.
  • Validation of Manufacturing: "Validation activities were performed and demonstrated that the device can be reliably manufactured with the intended geometry and dimensional tolerances based upon patient-specific scan information." No specific metrics or acceptance criteria for these tolerances are provided.

In summary, based on the provided document, I cannot fill out the requested table and answer the study-related questions because a formal study proving the device meets specific performance acceptance criteria was explicitly not required or conducted for this 510(k) submission. The submission relies on establishing substantial equivalence to a predicate device that is already deemed safe and effective.

Ask a specific question about this device

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-, and scaphocephalic-shaped heads by applying mild pressure to prominent regions of an infant's cranium in order to improve cranial symmetry and/or shape. These devices are also indicated for adjunctive use for infants from 3 to 18 months of age synostosis has been surgically corrected, but who still have moderate-to-severe cranial deformities including plagiocephalic-, and scaphocephalic- shaped heads.

The Ottobock MyCRO Band is a non-sterile temporary orthosis to aid in the correction of head shape caused by positioning in infants three (3) to eighteen (18) months of age. As such, this device is manufactured to match patient anatomy and may only be used on the patient for which the cranial orthosis was designed. The orthosis uses contact and growth zones to guide the growth of the head. The contact zones define limits for growth, while the growth zones leave space in areas required for forming the natural head shape. An adaptable closure allows for adjustability as the child grows. The orthosis is made of thermoplastic material with a soft, washable lining on the interior.

The provided text describes a 510(k) submission for a medical device called "MyCRO Band," a cranial orthosis used for infants with positional plagiocephaly. However, the document does not contain the information necessary to describe acceptance criteria and a study proving device performance as requested in the prompt.

Specifically, the document focuses on demonstrating substantial equivalence to a predicate device (STARband®) based on similar indications for use, intended use, basic principles of operation, and basic design, along with non-clinical testing. It mentions "Scanner Evaluation utilized a worst-case challenge reference object of known dimensions to assess 3D imaging devices for adequate accuracy, repeatability, and reproducibility" and "Verification testing included dimensional analysis, fit assessment, and mechanical testing of test samples," but it does not provide:

• A table of specific acceptance criteria and reported device performance values related to clinical outcomes or direct head shape correction metrics.
• Sample sizes for a clinical test set (as the described tests are non-clinical).
• Data provenance (country of origin, retrospective/prospective).
• Information on experts establishing ground truth or adjudication methods.
• Any multi-reader multi-case (MRMC) comparative effectiveness study.
• Standalone algorithm performance (as this is a physical orthosis, not an AI/algorithm-based device).
• Type of ground truth used related to clinical efficacy.
• Training set sample size or ground truth establishment for a training set (again, not an AI/algorithm device).

The "Summary of Testing" section lists:

1. Biological evaluation per ISO 10993-1:2018
2. Cytotoxicity testing per ISO 10993-5:2009
3. Irritation and Sensitization testing per ISO 10993-10:2010
4. Scanner evaluation, including repeatability/reproducibility study
5. Verification testing

While these tests "successfully met the predetermined acceptance criteria," the specific criteria and the detailed results demonstrating the device's efficacy in correcting cranial deformities (beyond dimensional accuracy of the scanner or fit of the orthosis) are not provided in this 510(k) summary. These are typically covered in a more detailed study report that is part of the full 510(k) submission but not included in this high-level summary.

Therefore, I cannot fulfill your request for the specific details of acceptance criteria and proven device performance based solely on the provided text. The text focuses on the engineering and biocompatibility aspects for demonstrating substantial equivalence rather than a detailed clinical performance study as would be seen for an AI/algorithm device or a device with novel mechanisms of action requiring extensive clinical validation.

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The SnugKap is intended for medical purposes for use on infants from 3 to 18 months of age, with moderate to severe nonsynostotic 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. The 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 SnugKap devices are cranial orthoses intended to be utilized on infant patients that suffer from head shape abnormalities. The SnugKap devices are additively manufactured from a 3D scan file of the patient's head. The scan file is digitally modified to address the anatomical/shape abnormalities in the skull. The SnugKap is then 3D printed and fabricated according to the case plan approved by the orthotist. The SnugKap is manufactured from a copolymer made of polylactic acid; additional parts are made of a variety of materials including thermoplastic polyurothane, polypropylene, and Plastazote® (white or pink) polymer foam.

This FDA 510(k) summary for the SnugKap cranial orthosis does not contain specific acceptance criteria or a detailed study report with performance metrics in the format requested. The document focuses on demonstrating substantial equivalence to predicate devices rather than providing a standalone performance study with defined acceptance criteria and calculated performance.

However, based on the information provided under "Performance Testing Summary" and the "Substantial Equivalence Summary" table, we can infer the types of testing performed and the general intent, but not specific numerical acceptance criteria or quantitative performance results.

Here's an attempt to structure the answer based on the available information, noting where specific details are missing:

The provided FDA 510(k) summary for the SnugKap cranial orthosis primarily demonstrates substantial equivalence to predicate devices, rather than a standalone performance study with explicit acceptance criteria and quantitative performance results for clinical metrics. The performance testing described is focused on ensuring the device functions as intended and is safe.

1. Table of Acceptance Criteria and Reported Device Performance

As specific numerical acceptance criteria and direct performance metrics (e.g., success rates for cranial symmetry improvement) are not reported in this 510(k) summary, the table below reflects what types of testing were performed and the implied "acceptance" as demonstrated by the conclusion of substantial equivalence.

Missing Information:

• Specific numerical acceptance criteria for strength, durability, and pressure tests (e.g., minimum force, number of cycles, pressure range).
• Quantitative results for any of the performance tests.
• Clinical efficacy outcomes (e.g., percentage of infants achieving a certain degree of cranial symmetry improvement).

2. Sample Size Used for the Test Set and Data Provenance

The document does not detail specific sample sizes for test sets in the context of clinical efficacy, as it's not a clinical trial report. The performance tests mentioned (strength, durability, pressure, biocompatibility) would have involved samples of the device materials or finished products for engineering and lab testing. The sample size for these lab tests is not specified.

Data provenance (country of origin, retrospective/prospective) is not applicable or detailed for efficacy/test sets, as there is no human clinical data presented for this purpose in the summary.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable, as a test set requiring expert ground truth (e.g., for image interpretation or diagnosis) is not described in this 510(k) summary. The ground truth for biocompatibility and mechanical tests would be established by standardized testing protocols and analytical results.

4. Adjudication Method for the Test Set

Not applicable, as there is no expert-adjudicated test set described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study is not mentioned or described in this 510(k) summary. The device is a physical cranial orthosis, not an AI-assisted diagnostic tool typically assessed with MRMC studies.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable in the conventional sense of an AI algorithm. The device itself is the physical orthosis. While there is "Software Validation" and "3D Printing Validation" mentioned, these refer to the manufacturing process for creating the custom orthosis and not an independent, standalone diagnostic or assistive algorithm.

7. The Type of Ground Truth Used

For the engineering and biocompatibility tests:

• Mechanical Performance: Ground truth would be established by engineering specifications, material properties, and relevant industry standards.
• Biocompatibility: Ground truth would be established by recognized standards for biological evaluation of medical devices (e.g., ISO 10993 series) using established laboratory tests.

For overall effectiveness for the Indications for Use:

• The primary ground truth for demonstrating the device's acceptable performance is its substantial equivalence to legally marketed predicate devices that have established safety and effectiveness. The assumption is that if the new device is substantially equivalent in design, materials, and intended use, it will have similar effectiveness.

8. The Sample Size for the Training Set

Not applicable, as this is not an AI/machine learning device requiring a training set for an algorithm.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set mentioned.

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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-, and scaphocephalic-shaped heads by applying mild pressure to prominent regions of an infant's cranium in order to improve cranial symmetry and/or shape. These devices are 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 Ottobock MyCRO Band is a non-sterile temporary orthosis to aid in the correction of head shape caused by positioning in infants three (3) to eighteen (18) months of age. As such, this device is manufactured to match patient anatomy and may only be used on the patient for which the cranial orthosis was designed. The orthosis uses contact and growth zones to guide the growth of the head. The contact zones define gentle limits for growth, while the growth zones leave space in areas required for forming the natural head shape. An adaptable closure allows for adjustability as the child grows. The orthosis is made of thermoplastic material with a soft, washable lining on the interior.

The MyCRO Band is a cranial orthosis intended for infants aged 3 to 18 months with moderate-to-severe non-synostotic positional plagiocephaly, including plagiocephalic, brachycephalic, and scaphocephalic-shaped heads. It works by applying mild pressure to prominent regions of an infant's cranium to improve cranial symmetry and/or shape. It is also indicated for adjunctive use in infants with surgically corrected synostosis who still have moderate-to-severe cranial deformities.

Because the MyCRO Band functions similarly to the predicate device (Orthomerica Products, Inc., STARband® K180109), the acceptance criteria are based on comparative testing rather than specific performance metrics. The summary provided outlines the types of non-clinical tests conducted and their successful completion, rather than specific numerical acceptance criteria.

Here's the information about the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not explicitly state the specific sample sizes for each test set (e.g., number of test samples for fit assessment, number of scans for scanner evaluation). It refers to "test samples" and "representative simulated cranial shapes."

The data provenance (country of origin, retrospective/prospective) is not provided in the document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. The testing described appears to be primarily technical and comparative against established standards or predicate device characteristics, rather than requiring expert adjudication for ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

An adjudication method is not mentioned, likely because the tests are technical and objective (e.g., passing a specific ISO standard, dimensional analysis, repeatability metrics).

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is a physical cranial orthosis, not an AI or imaging diagnostic tool that would involve human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This concept is not applicable as the device is a physical cranial orthosis, not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the tests appears to be:

• Biocompatibility: Established ISO standards (ISO 10993-5:2009, ISO 10993-10:2010).
• Scanner Evaluation: Known dimensions of a "worst-case challenge reference object" and the performance of previously cleared devices.
• Software Validation: Internal device specifications and criteria for interoperability.
• Simulated Cranial Fit Assessment: The fit of manufactured samples to "representative simulated cranial shapes" derived from 3D images.
• Manufacturing Process Validation: Dimensional analysis and mechanical testing, compared to the process used for the predicate device.

8. The sample size for the training set

This information is not applicable and not provided. The development and testing of this physical orthosis does not involve a "training set" in the context of machine learning.

9. How the ground truth for the training set was established

This information is not applicable and not provided.

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The KidCap™ is a cranial orthosis used to treat abnormally shaped craniums in infants between the ages of three (3) months to eighteen (18) months of age. It is designed to address abnormal cranial configurations classified as nonsynostotic positional plagiocephaly and post-operative nonsynostotic plagiocephaly. It includes infants with plagiocephalic, brachycephalic and scaphocephalic patterned head shapes, and post-operative craniosynostosis management. The KidCap™ utilizes the principles of static equilibrium to influence the cranial plates while utilizing an anatomical kinetic chain to influence the bones comprising the orbits, cheek structure, and lower mandible. The orthosis is designed to intimately contact the prominences of the expanding cranium, but will not initiate a force upon the cranium. The KidCap™ is only available if prescribed by a physician.

The KidCap" is a cranial orthosis used to treat abnormally shaped craniums in infants three (3) to eighteen (18) months of age. The orthosis contains the protruding aspects of the cranium in a static equilibrium while guiding the growth of the flattened areas of the skull into the created spaces.

The orthosis is custom designed for each patient by obtaining a three-dimensional scan of the patient cranium using the Omega Scanner. The scan of the cranium is translated into a digital image of the shape in the Computer Aided Design (CAD) software. From the digital image a positive model is generated by Ohio Willow Wood using a CAD carver. The positive model is then used to manufacture the KidCap". The orthosis is composed of a rigid polymer shell, Durr Plex™ with biocompatible foam padding. The orthosis is held together with a polyethylene hinge, and two lateral guides composed of Polypropylene. The external pieces are adhered to the orthosis with polymer rivets that are countersunk into the interior for a smooth, unobtrusive transition with the orthosis.

The anterior and posterior sections of the orthosis are held secure with a 3/4" Velcro™ strap that encircles the posterior hemisphere of the orthosis has ventilation apertures to promote convectionary cooling as the patient perspires

The provided text describes the KidCap™ cranial orthosis and its substantial equivalence to a predicate device (Static Cranioplasty Orthosis K020448). However, it does not include detailed acceptance criteria or a study dedicated to proving the device meets specific performance criteria in terms of efficacy for treating cranial deformities.

Instead, the submission focuses on demonstrating substantial equivalence primarily through:

1. Identical Indications for Use and Target Population: The device treats the same conditions in the same age range as the predicate.
2. Similar Design and Materials: Both devices are bivalved polymer shells with padded interfaces and use similar materials.
3. Similar Safety Characteristics: This includes biocompatibility, mechanical safety (non-mechanical), chemical safety (non-reactive with skin), anatomical sites, and electrical safety.
4. Performance Claim: The predicate device "Effectiveness has been proven statistically significant by Paired T-tests of clinical data." For the KidCap™, performance is supported by "Software Validation, Process Validation, and Dimensional Equivalency Comparison for mold acquisition method."

The "studies" mentioned for the KidCap™ are primarily focused on validating the manufacturing process and the new mold acquisition method, not clinical efficacy or direct performance against acceptance criteria for treating cranial deformities.

Therefore, many of the requested sections about specific acceptance criteria and detailed study data for device performance in relation to those criteria cannot be fully extracted from the provided text for the KidCap™ itself, as the submission relies on substantial equivalence to the predicate's proven clinical effectiveness, and non-clinical testing for the manufacturing process.

Here's an attempt to answer the questions based only on the provided text, highlighting where information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria for clinical efficacy (e.g., specific reduction in cranial asymmetry indices). Instead, the "performance" for the KidCap™ is demonstrated through non-clinical validation of its manufacturing process and dimensional equivalency. The predicate device's performance is stated as "Effectiveness has been proven statistically significant by Paired T-tests of clinical data," implying the predicate met clinical acceptance criteria, which the KidCap™ is deemed equivalent to.

2. Sample Size Used for the Test Set and the Data Provenance

• Sample Size for Test Set: Not specified in the document.
• Data Provenance: Not specified for any clinical data. For the KidCap™ non-clinical testing (software, process, dimensional equivalency), the data is from internal validation studies.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

• This information is not provided. The non-clinical testing described does not involve expert-established ground truth in the context of clinical assessment.

4. Adjudication Method for the Test Set

• Not applicable as the described "studies" are non-clinical validations (software, process, dimensional equivalency) and not clinical trials with expert adjudication.

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 done for the KidCap™. The device is a cranial orthosis, not an AI-assisted diagnostic tool.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable as the device is a physical orthosis, not an algorithm. The software (Omega Tracer Software) is for scanning and mold design, but its "performance" is about accurate measurement and model creation, not autonomous clinical decision-making.

7. The Type of Ground Truth Used

• For Dimensional Equivalency Comparison: The "ground truth" would likely be the measurements obtained from the original method of plaster impressions, against which the 3D scan and CAD model measurements were compared. However, specifics are not provided.
• For Clinical Efficacy (for predicate, by inference): The predicate device's clinical data would have used clinical measures of cranial shape improvement as ground truth, likely assessed by medical professionals.

8. The Sample Size for the Training Set

• Not applicable as the device is a physical orthosis. The software (Omega Tracer) does not describe a "training set" in the context of machine learning.

9. How the Ground Truth for the Training Set was Established

• Not applicable as there is no mention of a training set or ground truth in the context of machine learning for this device.

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The STARband and STARlight are intended for medical purposes for use on infants from 3 to 18 months of age, with moderate-to-severe non-synostotic positional plagiocephaly, 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. These devices are 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 STARband and STARlight 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 3-dimensional 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 STARband and STARlight provide total contact over the prominent or bossed areas of the baby's head to discourage growth there. Over the course of treatment, the inside of 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 STARband and STARlight directs growth into the areas of least resistance and creates a precise pathway for the head shape to improve in symmetry and proportion.

The STARband Side Opening design and STARband Bi-Valve design is made with an outer shell of 5/32" polyethylene-polypropylene copolymer plastic with an inner liner made of 1/2" pelite polyethylene foam or 1/2" Aliplast foam (closed cell polyethylene). The STARlight Side Opening design and the STARlight Bi-Valve design are made of a plastic shell of 5/32" - 1/4" clear Surlyn or 1/8" - 7/32" Clear Co-Polyester. The STARlight PRO (Post-operative Remolding Orthosis) design is made of 1/4" to 3/8" clear Surlyn. Optional Aliplast (closed cell polyethylene) padding is available for the clear plastic bands and in addition, optional Reston (polyurethane - 3M Medical Product) foam is available for the STARlight PRO design.

The STARband Side Opening design and the STARlight Side Opening design has a top opening and a side opening. The band is held in place by a Velcro® strap (1½' for STARband Side Opening and 1" for STARlight Side Opening) across the side opening. The STARlight PRO has two side openings, no top opening, and is held in place by a Velcro strap across each side opening. The STARlight Bi-Valve design and the STARband Bi-Valve design consist of two plastic shells that overlap with a superior sliding mechanism. The right and left overlap tabs are connected via a Velcro strap with chafe and loop.

The proposed device modification is the addition of a new 3-dimensional shape capture, specifically, the NetVirta SmartSoc™ System distributed by Orthomerica Products, Inc. This system 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.

The provided document describes the FDA 510(k) summary for the STARband and STARlight Cranial Orthosis, specifically focusing on the addition of the NetVirta SmartSoc™ System for 3-dimensional shape capture. The document outlines non-clinical performance data to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the provided information, structured according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative format for the SmartSoc System's performance in terms of cranial shape capture. Instead, it states that the conclusion of the studies was that the "Proposed device is substantially equivalent to predicate device." The studies were designed to compare the SmartSoc System against a cast and the predicate device (presumably the previously approved imaging devices for the STARband/STARlight).

However, the document does describe the types of tests performed and their general conclusions:

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for R&R and Accuracy Studies: The document states for R&R, it "Utilized uniform shapes with known dimensions that represent various sizes of pediatric patients between ages 3 to 18 months of age." For the Accuracy Study, it "Utilized a representative cranial shape that possesses a predefined shape with known dimensions." Crucially, the exact number of these "uniform shapes" or "representative cranial shapes" (i.e., the n for the test set) is not specified. This is a significant omission from the provided summary.
• Data Provenance: The studies appear to be in vitro or phantom-based studies ("uniform shapes," "representative cranial shape") rather than involving human subjects. Therefore, concerns about country of origin, retrospective/prospective, are not directly applicable in the way they would be for patient data.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Number of Experts: Not applicable or not specified. Ground truth appears to have been established by "known dimensions" of the uniform/representative shapes and comparison against physical casts. There's no mention of human expert involvement in defining the "truth" for these technical accuracy studies.
• Qualifications of Experts: N/A.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. The "ground truth" for the technical studies on shape capture involved predefined, known physical dimensions and comparisons to physical casts, not subjective human assessment requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC Study: No, there is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. The studies focus on the technical accuracy and consistency of the 3D capture system itself, not on how human readers/practitioners improve with or without AI assistance in diagnosis or treatment planning.

6. Standalone (Algorithm Only) Performance

• Standalone Performance: Yes, the studies described (Repeatability and Reproducibility, Cranial Shape Capture Accuracy) assess the performance of the SmartSoc System itself (algorithm and hardware) in capturing shapes accurately and consistently, independent of human interpretation of the captured data for clinical decision-making. The "device" in this context is the SmartSoc system which captures the 3D shape, and its output (the 3D image) is then used to manufacture the orthosis. The studies verify the fidelity of this capture process.

7. Type of Ground Truth Used

• Ground Truth Type:
  • For the Repeatability and Reproducibility (R&R) Testing Analysis and Cranial Shape Capture Accuracy Study, the ground truth was based on known physical dimensions of "uniform shapes" or "representative cranial shapes" with "predefined shape with known dimensions." The system's output was also compared to "cast and predicate device." This suggests a physical phantom/model comparison with known measurements.

8. Sample Size for the Training Set

• Training Set Sample Size: Not specified. This document is a 510(k) summary for a medical device (cranial orthosis) with a new imaging modality (SmartSoc System). It focuses on validation testing of the new modality. It does not provide details of any internal training data used by the SmartSoc system's algorithms, if applicable. The SmartSoc system uses "a customized non-repetitive printed pattern" on a flexible fabric sock; its internal algorithms for 3D reconstruction would have been developed and trained by NetVirta, but those details are not in this FDA summary.

9. How Ground Truth for the Training Set Was Established

• Training Set Ground Truth: Not specified in this document for the reasons mentioned in point 8.

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