(76 days)
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.
| Feature/Parameter | Acceptance Criteria (Implied) | Reported Device Performance (DOC Band 3D) |
|---|---|---|
| Intended Use | Identical to predicate device (treating deformational plagiocephaly brachycephaly (DPB) as a cranial orthosis). | Met: "The DOC Band 3D (band) is a medical device known generically as a cranial orthosis. A cranial orthosis is used to treat a medical condition known as deformational plagiocephaly brachycephaly (DPB)." (Identical to predicate) |
| Indications for Use | Identical to predicate device (treatment of moderate to severe non-synostotic cranial deformation in infants 3-18 months, and adjunctive use post-surgical correction for synostosis). | Met: "The DOC Band 3D is indicated for use on infants from three to eighteen months of age with moderate to severe non-synostotic cranial deformation, including infants with plagiocephalic-, brachycephalic-, and scaphocephalic-shaped heads, or a combination thereof. The DOC Band 3D is also indicated for adjunctive use for infants from three to eighteen months of age whose synostosis has been surgically corrected..." (Identical to predicate) |
| Outer Shell Material Biocompatibility | New material (polyamide 12 resin) must be biocompatible as per ISO 10993 standards. | Met: "It is a polyamide 12 resin, which was tested per ISO 10993 for cytotoxicity, irritation and sensitization, passing all tests per standards." |
| Mechanical Properties | Mechanical properties (shear, flexural, stiffness, fatigue, bond strength) must be substantially equivalent to or exceed predicate devices. | Met: "Bench testing has demonstrated that the device's mechanical properties meet or exceed those of the predicate devices." (Confirmed for shear, flexural, stiffness, fatigue, and bond strength). |
| Clinical Usability | Donning, doffing, trims, and adjustment procedures must be equivalent to predicate devices. | Met: "Senior clinicians evaluated the proposed device against the predicate device to confirm equivalent donning and doffing procedures, trims and adjustment procedures, demonstrating substantial equivalence in the fit and treatment protocols." |
| Safety | Device must be safe. | Met: "The DOC Band 3D is made from biocompatible materials that have undergone ISO 10993 testing to ensure safety." (Implied by biocompatibility and mechanical testing results). |
| Effectiveness | Expected to be comparable to predicate devices. | Met (by inference): "The clinical performance of the DOC Band 3D is expected to be comparable to the predicate devices in the treatment of deformational plagiocephaly." (This is an expectation based on substantial equivalence of design and non-clinical data, not a direct clinical effectiveness study.) |
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.
§ 882.5970 Cranial orthosis.
(a)
Identification. A cranial orthosis is a device that is intended for medical purposes to apply pressure to prominent regions of an infant's cranium in order to improve cranial symmetry and/or shape in infants from 3 to 18 months of age, with moderate to severe nonsynostotic positional plagiocephaly, including infants with plagiocephalic-, brachycephalic-, and scaphocephalic-shaped heads.(b)
Classification. Class II (special controls) (prescription use in accordance with § 801.109 of this chapter, biocompatibility testing, and labeling (contraindications, warnings, precautions, adverse events, instructions for physicians and parents)).