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The DOC Band is indicated for use on infants from three to eighteen months of age with moderate to severe nonsynostotic cranial deformation, infants with plagiocephalic-, and scaphocephalic-, and scaphocephalic-shaped heads, or a combination thereof.

The DOC Band 3D is also indicated for adjunctive use for infants from three to eighten 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, or a combination thereof.

The DOC Band 3D is a cranial orthosis intended to treat positional plagiocephaly in infants from 3 to 18 months of age. The band is intended to apply a mild pressure to the prominent regions of an infant's cranium and to improve cranial symmetry, proportion, and/or shape.

The provided text describes the DOC Band 3D, a cranial orthosis, and its substantial equivalence to predicate devices, focusing on changes in manufacturing processes and materials rather than a clinical performance study. Therefore, robust information regarding acceptance criteria and a detailed study proving the device meets those criteria, particularly for clinical effectiveness, is limited.

However, based on the non-clinical data provided, we can infer some "acceptance criteria" related to device properties and the "study" that addresses them.

1. Table of Acceptance Criteria and Reported Device Performance

Given the information, the acceptance criteria are largely focused on ensuring the new manufacturing process and material for the outer shell maintain the essential performance characteristics, biocompatibility, and clinical usability of the predicate devices.

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

The provided text does not include information on a clinical test set sample size or its data provenance. The evaluation for this submission focuses on non-clinical data.

• Mechanical Testing: The sample size for mechanical tests (shear, flexural, stiffness, fatigue, bond strength) is not specified.
• Clinician Evaluation: The number of "Senior clinicians" who evaluated the device for usability is not specified.
• Biocompatibility Testing: The sample size for materials tested per ISO 10993 is not specified.

All data described appears to be prospective bench testing and expert evaluation conducted by Cranial Technologies, Inc. (the applicant). The country of origin for this data is not explicitly stated but would presumably be the USA where the company is based.

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

• Number of Experts: The text refers to "Senior clinicians" who evaluated the device for substantial equivalence in fit and treatment protocols. The exact number of these clinicians is not specified.
• Qualifications of Experts: The term "Senior clinicians" is used, implying experienced medical professionals relevant to the application of cranial orthoses. Specific qualifications (e.g., "radiologist with 10 years of experience") are not provided.

4. Adjudication Method for the Test Set

Given that the evaluation described is one of "Senior clinicians" confirming equivalence in procedures, a formal adjudication method like MRMC (e.g., 2+1, 3+1) is not applicable or described. The assessment was likely a qualitative endorsement of equivalence in handling and fit by these clinicians.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or described in this submission. The device is cleared based on substantial equivalence to predicate devices, primarily through non-clinical testing of its modified manufacturing process and material, and an expectation of comparable clinical performance. There is no mention of human readers or AI assistance in the context of this submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The DOC Band 3D is a physical cranial orthosis, not an algorithm or software device. Therefore, a standalone (algorithm-only) performance study is not applicable to this device.

7. The Type of Ground Truth Used

For the non-clinical evaluations:

• Mechanical Properties: The "ground truth" (or reference) for mechanical performance was the predicate DOC Band's mechanical properties. The new device's performance was measured against these established properties.
• Biocompatibility: The "ground truth" was established ISO 10993 standards for cytotoxicity, irritation, and sensitization.
• Clinical Usability: The "ground truth" for clinical usability (donning, doffing, trims, adjustments) was the established procedures and fit characteristics of the predicate DOC Band, as assessed by senior clinicians.

8. The Sample Size for the Training Set

This submission describes a medical device (cranial orthosis), not an AI/ML algorithm that requires a "training set." Therefore, the concept of a training set sample size is not applicable.

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

As noted above, the concept of a "training set" is not applicable to this device.

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This DOC Band-PostOp is intended for medical purposes to apply pressure to prominent regions of an infant's cranium to improve cranial symmetry or shape. The device is indicated for adjunctive use for infants from three to eighteen 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 device is contraindicated for use on infants with craniosynostosis or hydrocephalus.

The DOC Band-PostOp consists of a plastic band, a fastener with Velcro strap, and, in some models, a strut to hold height at the top of the head.

The provided text (KD42385) is a 510(k) summary for the DOC Band-PostOp™. It primarily focuses on demonstrating substantial equivalence to a predicate device (the DOC Band, K964992) rather than providing detailed acceptance criteria and a comprehensive study report in the format requested.

Therefore, much of the requested information regarding specific acceptance criteria, study design parameters (sample sizes, expert qualifications, adjudication methods), and detailed performance metrics is not explicitly available within this document. The document states that "clinical data demonstrate that the DOC Band-PostOp, as indicated for use post-operatively, in the absence of craniosynostosis, is as safe and effective as the DOC Band." However, it does not provide the specifics of that clinical data.

Here’s an attempt to answer based on the provided text, with clear indications where information is not present.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: Not specified in the provided document. The document refers to "clinical data" but does not detail the size or characteristics of the test population.
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

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 summary. For a device like a cranial orthosis, "ground truth" would likely be derived from anthropometric measurements, clinical assessments by pediatric specialists, or imaging. However, the summary does not detail the methodology for establishing such ground truth for any clinical study mentioned.

4. Adjudication method for the test set

• This information is not provided in the summary, as a specific "test set" with adjudication is not described.

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. This device is a physical medical device (cranial orthosis), not an AI/software device that involves human readers or AI assistance in interpretation. Therefore, an MRMC study with AI assistance is not applicable and was not performed.

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

• No. This device is a physical medical device; it does not involve algorithms or standalone performance in the context of AI.

7. The type of ground truth used

• The document implies that "clinical data" supported the claim of safety and effectiveness. For a cranial orthosis, ground truth regarding effectiveness would typically come from anthropometric measurements (e.g., cranial index, diagonal measurements) and clinical assessments of head shape by medical professionals. However, the specific methodology or the nature of this "ground truth" for the supporting data is not detailed in this summary.

8. The sample size for the training set

• This information is not provided as a "training set" is not relevant for this type of physical medical device and the nature of the substantial equivalence pathway presented.

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

• This information is not provided as a "training set" is not relevant for this type of physical medical device.

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This device is intended for medical purposes to apply 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 DOC Band is a cranial orthosis used to treat positional or deformational plagiocephaly in infants from 3 to 18 months of age. The devices works by applying a gentle holding pressure to the prominent regions of an infants' skull while leaving room for growth in the adjacent flattened regions. The orthosis is made from a three-dimensional (3D) digital model of an infants' cranium acquired with the C3D - Cranial Imaging System™. This system was developed to capture an accurate, 3D image of an infants' head shape. It is based upon the well-established field of photogrammetry, and utilizes structured light and triangulated CCD cameras to digitally reproduce the 3D model. The system uses a noncoherent (i.e. non-laser light) light source, and captures a complete 3D image of the infants' head-shape, including the face and top of the head, in 1/180th of a second with an accuracy of +/- 0.5 mm. During acquisition, a 3D photograph of the child is also captured and precisely laid over the model for confirmation of the patient's identity. The digital model is then sent electronically to Cranial Technologies who creates a positive model using computer aided machining software and a 5-axis CNC mill. The positive model is then used to create the DOC Band, which is fit clinically and monitored as described in K-964992.

This document describes the DOC Band, a cranial orthosis (helmet) used to treat positional plagiocephaly in infants. The provided text, however, does not contain a study that proves the device meets specific acceptance criteria in the manner typically described for modern medical devices, especially AI-driven ones. Instead, it focuses on demonstrating substantial equivalence to a previously cleared device.

Here's an analysis based on the provided text, addressing your points where possible, and highlighting what is not present:

Missing Information: It is crucial to understand that the provided text is a 510(k) summary (from 2002) for the DOC Band. This type of submission relies heavily on demonstrating substantial equivalence to a predicate device, rather than providing detailed, de novo clinical study results against predefined acceptance criteria, particularly for performance metrics like sensitivity, specificity, or improvement with AI assistance. The focus here is on the safety and effectiveness of the orthosis itself and the imaging system used to create it, not on an algorithm's diagnostic performance for which "acceptance criteria" and "study results" in the AI sense would be reported.

1. Table of Acceptance Criteria and Reported Device Performance

Because this is a substantial equivalence submission for a physical medical device (a cranial orthosis) and an imaging system for its creation, not an AI diagnostic algorithm, the typical "acceptance criteria" and "performance" metrics (like sensitivity, specificity, AUC) you'd expect are not present.

The key "performance" mentioned for the C3D - Cranial Imaging System™ (which creates the 3D model for the DOC Band) is its accuracy:

Note: The DOC Band itself is described as substantially equivalent to prior versions, implying it meets the same safety and effectiveness standards as those established devices. The "performance" of the DOC Band is the clinical outcome of correcting cranial asymmetry, but the document does not quantify this with specific acceptance criteria (e.g., "reduce asymmetry by X% in Y% of patients"). It relies on the clinical evidence of the predicate device (K-964992).

Relevant Sections from the Text:

• VII. Description: "The system uses a noncoherent (i.e. non-laser light) light source, and captures a complete 3D image of the infants' head-shape, including the face and top of the head, in 1/180th of a second with an accuracy of +/- 0.5 mm."
• X. Substantial Equivalence: "The DOC Band is substantially equivalent and virtually identical to the original DOC Band described in K964992..."
• XI. Clinical Discussion and Literature references and reprints: "Clinical Discussion and Literature references and reprints showing the safety and effectiveness of this device when used under the Special Controls prescribed by the FDAwere provided in the original 510(k)-K964992."

2. Sample size used for the test set and the data provenance

Not applicable/Not provided in this document. This submission document does not detail a "test set" for an algorithm's performance. The "accuracy of +/- 0.5 mm" for the C3D imaging system is stated as a specification, likely derived from internal testing or engineering validation, not a clinical test set in the context of AI performance.

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

Not applicable/Not provided in this document. No "test set" in the AI sense is described. The ground truth for the overall device effectiveness (the DOC Band) is the historical clinical acceptance of "safety and effectiveness" as shown in the predicate 510(k) (K-964992) and literature references, which would implicitly involve clinical experts.

4. Adjudication method for the test set

Not applicable/Not provided in this document. No "test set" requiring adjudication for an algorithm is described.

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. The device is a physical orthosis and an imaging system. It is not an AI diagnostic tool intended to assist human readers in interpreting medical images or data. Therefore, an MRMC study and effects of AI assistance are not relevant to this submission.

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

No. The C3D - Cranial Imaging System™ is a data acquisition device, not a standalone diagnostic algorithm. The DOC Band itself is a treatment device, not an algorithm.

7. The type of ground truth used

For the C3D - Cranial Imaging System™: The "accuracy of +/- 0.5 mm" (for 3D imaging) would likely be established against a physical measurement standard or a high-precision reference model through engineering validation, rather than an expert consensus or pathology in a clinical sense.

For the DOC Band: The "safety and effectiveness" referenced in the predicate 510(k) (K964992) would be based on clinical outcomes (e.g., improvement in cranial symmetry/shape) as observed by clinicians. This would be a form of outcomes data or expert clinical assessment from prior studies.

8. The sample size for the training set

Not applicable/Not provided in this document. No training set for an AI algorithm is mentioned as the C3D system is based on photogrammetry, which is a well-established field, not a machine learning model that requires a "training set" in the modern AI sense.

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

Not applicable/Not provided in this document. No training set described.

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