(107 days)
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
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety: Device is as safe as the predicate device (DOC Band). | "Clinical data demonstrate that the DOC Band-PostOp... is as safe and effective as the DOC Band." |
| (Specific metrics or thresholds for safety are not provided in this summary. Safety is implied through substantial equivalence to a previously cleared device, which would have established its safety.) | |
| Effectiveness: Device is as effective as the predicate device (DOC Band) in improving cranial symmetry or shape for the specified indications. | "Clinical data demonstrate that the DOC Band-PostOp... is as safe and effective as the DOC Band." |
| (Specific metrics or thresholds for effectiveness, such as percentage improvement in cranial symmetry or specific measurements like Cephalic Index, are not provided. Effectiveness is implied through substantial equivalence to a previously cleared device, which would have established its effectiveness.) | |
| Intended Use: Device performs its intended function. | The device has the "same intended uses." Its function is to "apply pressure to prominent regions of an infant's cranium to improve cranial symmetry or shape." |
| (Performance is inferred from the statement of substantial equivalence rather than explicit new performance data.) | |
| Biocompatibility: Device materials are biocompatible. | "Yes." (Confirmed to be biocompatible, same as predicate device. No specific test results or acceptance criteria for biocompatibility are detailed in this summary.) |
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.
§ 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)).