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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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The O&P Bivalve Cranial Molding Helmet is intended for medical purposes to apply pressure to prominent regions of an infant's cranium in order to improve cranial symmetry and/or shape in infants from 3 to 18 months of age, with moderate to sever nonsynostotic positional plagiocephaly, including infants with plagiocephalic, brachycephalic and scaphocephalic shaped heads.

O&P Bivalve Cranial Molding Helmets are custom made at the direction of a physician's prescription. Helmets are made by hand for each infant by taking a cast of the baby's head. The cast is filled with plaster and a positive mold of the infant's head is created. The flattened areas of the positive mold (corresponding to the flattened areas of the infants head) are then built up and made round creating a void. As the child's head grows, the skull is slowly reshaped and rounded by growing into the open voids created in the helmet for this purpose. The finished helmet has a foam-lined interior and has rigid plastic exterior. The helmet is bivalve with the anterior section overlapping the posterior section. The helmet is secured by means of a rivet on one side and an elasticized Velcro closure on the opposite side.

The provided 510(k) summary for the O&P Bivalve Cranial Molding Helmet (K063395) describes the device's substantial equivalence to a predicate device rather than presenting a de novo study with specific acceptance criteria and performance data for the new device. Therefore, much of the requested information regarding acceptance criteria and a dedicated study proving performance for this specific device is not present in the provided text.

However, I can extract information related to the predicate device and the general evidence used to support the effectiveness of cranial orthoses.

1. Table of Acceptance Criteria and Reported Device Performance

As this submission relies on substantial equivalence and does not establish new acceptance criteria for the O&P Bivalve Cranial Molding Helmet, a direct table of acceptance criteria and performance for this device cannot be generated.

Instead, the submission refers to the performance of its predicate device and the general effectiveness of cranial orthoses. The "performance" in this context refers to clinical outcomes observed with similar devices.

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

• Test Set Sample Size: Not applicable. There was no specific "test set" for the O&P Bivalve Cranial Molding Helmet, as its performance was not evaluated through a new clinical study.
• Data Provenance: The submission references:
  • Retrospective clinical experience with the predicate device (Precision Prosthetics' Orthotic Molding Helmet), stating "Precision Prosthetics treated over 2,340 children with their orthotic molding helmet" over nine years. No specific country of origin is mentioned for this experience, but given the company's location (Missouri, USA), it's highly likely to be US-based.
  • Published scientific literature on cranial orthoses by Clarren et al. (1979, 1981, 1977), Persing et al. (1986), Kane et al. (1996), and especially Littlefield et al. (1998). These studies describe general findings on the effectiveness of cranial orthoses. The Littlefield et al. study described monitoring "more than 750 infants." Specific country of origin for these studies is not detailed in the summary, but given the journals and authors often published in English, they are likely from Western countries (e.g., USA).

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

Not applicable. No specific test set was created for this device where expert ground truth was established. The effectiveness claims are based on prior clinical experience with a substantially equivalent device and existing scientific literature on the general class of devices.

4. Adjudication Method for the Test Set

Not applicable, as no dedicated test set was used for this 510(k) submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. This submission does not describe an MRMC comparative effectiveness study, as it is centered on substantial equivalence rather than a new clinical trial comparing human readers with and without AI assistance. This device is a physical medical device, not an AI/software device that would involve human readers.

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

Not applicable. This is a physical cranial orthosis, not an algorithm or AI device.

7. The Type of Ground Truth Used

The "ground truth" for the effectiveness claims cited comes from:

• Clinical outcomes data: From the past 9 years of treating over 2,340 children with the predicate device, implying observed improvement in cranial shape.
• Published clinical studies: Which documented "complete or near complete correction of asymmetry" based on measurements or assessments of infants' head shapes over time (e.g., Littlefield et al. 1998 study). This would typically involve clinical assessment and anthropometric measurements by medical professionals.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device that requires a training set. If interpreted as the "experience" pool for the predicate device, it would be "over 2,340 children" and "more than 750 infants" from the cited studies.

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

Not applicable, as there is no training set in the context of an AI/ML device. For the clinical experience and studies cited, the "ground truth" (i.e., whether the treatment was effective) was established through clinical observation, anthropometric measurements, and follow-up assessments by medical professionals involved in the treatment of positional plagiocephaly.

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The Static Cranioplasty Orthosis is intended for medical purposes to passively hold prominent cranial regions of an infant's skull in order to improve cranial symmetry and/or shape in infants from three to 18 months of age, with nonsynostotic positional plagiocephaly, including infants with plagiocephalic, brachycephalic, and scaphocephalic patterned head shapes.

The Static Cranioplasty Orthosis is a cranial orthosis used to treat abnormally shaped craniums in infants three to 18 months of age. This condition is clinically known as positional or Deformational Plagiocephaly. 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 Static Cranioplasty Orthosis is only available if prescribed by a physician.

The orthosis is custom designed for each patient from a mold of the infant's head. The mold is modified and prepared for fabrication by the treating practitioner using mathematical analyses and plaster modification techniques. Each orthosis is composed of an outer shell of thermoformable plastic, an inner lining of hypoallergenic foam, a strap for securing the orthosis, and a polymer hinge and guiding system to maintain proper alignment of the orthosis. Optimum fit and alignment is insured and monitored by the same clinical practitioner.

Executive Summary

The device in question is the "Static Cranioplasty Orthosis" (also referred to as "Cranial Molding Orthosis"), intended to treat abnormally shaped craniums in infants aged three to 18 months with nonsynostotic positional plagiocephaly. The submission indicates that no specific quantitative acceptance criteria or detailed study protocols were provided within the summary. Instead, the effectiveness was established by asserting its performance was "significantly effective" and "almost uniformly" to a predicate device based on a "pilot study" and "statistical analyses."

Acceptance Criteria and Device Performance

Study Details

The provided document describes the study in very general terms, lacking specific quantitative data, methodologies, or detailed results typically found in full clinical trials.

1. Sample Size and Data Provenance:

   • Test Set Sample Size: Not specified. The document mentions "clinical trials" and a "pilot study" but does not provide the number of subjects included in these studies.
   • Data Provenance: Not specified (e.g., country of origin, specific institutions). The studies are described as "conducted using the Static Cranioplasty Orthosis," implying they are specific to this device, but details are absent. It's noted they were "identical to those conducted using the predicate device." It's reasonable to infer a retrospective approach given the limited details provided about the study setup.

2. Number and Qualifications of Experts for Ground Truth: Not specified. There is no mention of experts establishing ground truth or their qualifications.

3. Adjudication Method: Not specified.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not performed or reported. This device is a physical orthosis, not an AI or imaging device where MRMC studies are typically applied.

5. Standalone Performance Study (Algorithm Only): Not applicable. This is a physical medical device, not an algorithm.

6. Type of Ground Truth Used: Not explicitly stated. Given the nature of plagiocephaly treatment, the "ground truth" would likely be based on clinical assessments and measurements of cranial symmetry and shape, probably verified by medical practitioners. However, the exact methods are not detailed.

7. Training Set Sample Size: Not applicable. This device is not an AI/ML algorithm that requires a training set. The "device" itself is a physical orthosis, custom-designed for each patient.

8. How Ground Truth for Training Set Was Established: Not applicable, as there is no training set for this type of device. The custom design for each patient involves mathematical analyses and plaster modification techniques by the treating practitioner based on a mold of the infant's head.

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The indications for use would include infants from three to eighteen months of age to be treated for Plagiocephalic, Brachycephalic, or scaphocephalic shaped heads by a medical physician. The purpose of the P.A.P. Orthosis is to apply pressure to prominent regions of an infant's cranium to improve cranial symmetry and/or shape. This device is to be prescribed by a physician in writing indicating the need for cranial positional molding due to the above diagnoses. The device is indicated to treat moderate to severe nonsynostotic positional plagiocephaly.

It is a proprietary transparent ionomer based thermoplastic molded orthosis extended for medial purposes to apply pressure to the prominent regions of an infants cranium to improve cranial symmetry and to shape. This orthosis is used to treat infants from three to eighteen months of age with a diagnosis of moderate to severe non-synastolic positional Plagiocephaly.

This 510(k) summary (K012804) for the Plagiocephalic Applied Pressure (P.A.P.) Orthosis does not provide the detailed information requested regarding acceptance criteria, study design, or performance metrics in the way that would be expected for a device proving performance against specific acceptance criteria. This type of submission focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets predefined performance benchmarks through a clinical study.

Therefore, many of the requested sections cannot be filled from the provided text.

Here's a breakdown of what can and cannot be extracted:

1. Table of acceptance criteria and the reported device performance:

This information is not provided in the document. The submission focuses on substantial equivalence based on function, purpose, and intended use to existing predicate devices (D.O.C. band K964992 and STARband K001167). There are no specific performance criteria or benchmarks listed for the P.A.P. Orthosis itself.

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

This information is not provided. As this is a substantial equivalence submission, it does not detail a clinical study with a test set.

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):

This information is not provided. There is no mention of a test set or ground truth establishment by experts for performance evaluation.

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

This information is not provided. No test set 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:

This information is not provided. The device is an orthosis, not an AI-assisted diagnostic tool, so an MRMC study would not be applicable.

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

This information is not provided. The device is an orthosis, not an algorithm.

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

This information is not applicable as there is no described study with a ground truth. The "ground truth" in a substantial equivalence submission is essentially the proven safety and efficacy of the predicate devices.

8. The sample size for the training set:

This information is not provided. There is no mention of a training set as would be found in an algorithm-based device.

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

This information is not provided. No training set is described.

Summary based on the provided text:

The submission for the P.A.P. Orthosis (K012804) is a 510(k) premarket notification demonstrating substantial equivalence to two legally marketed predicate devices: the D.O.C. band (K964992) and the STARband (K001167).

• Acceptance Criteria & Performance: The document does not specify quantitative acceptance criteria or detailed performance data for the P.A.P. Orthosis itself. Instead, it argues that the device is "similar in function and purpose" and has the "same intended use" as the predicate devices, implying that their established safety and effectiveness are the basis for acceptance. The performance is indirectly "reported" by stating it "more completely encompasses the cranium with clear copolymer plastic" compared to the predicate, while serving the same purpose.
• Study Data: No specific study data, sample sizes, or ground truth establishment methods are detailed because this type of submission relies on demonstrating similarity to existing, approved devices rather than presenting novel clinical study results.
• Ground Truth (Implicit): The "ground truth" for the P.A.P. Orthosis's suitability is the regulatory history and proven safety/efficacy of the predicate devices (D.O.C. band and STARband) for treating moderate to severe nonsynostotic positional plagiocephaly, brachycephaly, or scaphocephaly in infants aged three to eighteen months.

In essence, the "study" proving the device meets "acceptance criteria" here is the comparison made by the applicant to existing predicate devices, and the FDA's subsequent determination that this comparison is valid for substantial equivalence.

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