(743 days)
The Danmar Products Cranial Adjustive Prosthesis is intended for prescription use to be used to apply pressure to prominent regions of an infant's cranium in order to improve cranial symmetry andlor shape in infants from 3 to 14 months of age, with moderate to severe nonsynostotic positional plagiocephaly, including infants with plagiocephalic- and brachycephalic-shaped heads.
The Danmar Products Cranial Adjustive Prosthesis is constructed with front and rear sections that are comprised of an inner, soft foam that is %" to ¼" thick, and an outer shell made of a semi-rigid plastic.
The provided document is a 510(k) summary for the Danmar Products Cranial Adjustive Prosthesis. It does not contain information about acceptance criteria or a study that proves the device meets specific performance metrics as would typically be found for a diagnostic or AI-driven device.
Instead, the document focuses on demonstrating substantial equivalence to predicate devices. This means that instead of proving quantitative performance metrics, the submission aims to show that the new device is as safe and effective as a device already legally marketed.
Here's a breakdown of the requested information based solely on the provided text, highlighting what is present and what is absent:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Stated/Inferred) | Reported Device Performance |
|---|---|
| The device performs as intended. | "The literature on this and similar devices demonstrates that the Danmar Products Cranial Adjustive Prosthesis performs as intended." |
| Biocompatibility: nonirritating and nontoxic. | "Biocompatibility data demonstrates that the device's inner lining is nonirritating and nontoxic." |
| Durability: will not break or shatter when subjected to impact. | "Test data demonstrates that the device will not break or shatter when subjected to impact." |
| Substantial equivalence to predicate devices (Cranial Technologies Dynamic Orthotic Cranioplasty—DOC Band, Michigan Cranial Helmet). | "The Danmar Products Cranial Adjustive Prosthesis has the same technological characteristics as the predicate devices." |
2. Sample Size Used for the Test Set and Data Provenance
- The document mentions "The literature on this and similar devices," "Biocompatibility data," and "Test data." However, no specific sample sizes for any test sets are provided.
- Data provenance (country of origin, retrospective/prospective) is not mentioned.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not applicable. The document does not describe a study involving expert-established ground truth for a test set. This type of evaluation is common for diagnostic devices where "truth" is often expert consensus or pathology. The Cranial Adjustive Prosthesis is a physical medical device (orthosis).
4. Adjudication Method for the Test Set
- Not applicable. No test set requiring expert adjudication is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size with AI Assistance
- Not applicable. The device is a Cranial Adjustive Prosthesis, not an AI-driven or diagnostic imaging device. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
- For biocompatibility: Likely laboratory test results (e.g., cytotoxicity, sensitization tests) demonstrating non-irritating and non-toxic properties. The "ground truth" is established by the results adhering to predefined safety thresholds in these tests.
- For durability: Likely mechanical stress tests (e.g., impact tests) demonstrating the device's structural integrity. The "ground truth" is the device surviving these tests without breaking or shattering.
- For "performs as intended": This typically refers to the mechanism of action and clinical function being consistent with the intended use. In the context of a 510(k), this is often supported by technical characteristics matching those of predicate devices and general understanding of how such devices work. No specific "ground truth" (like pathology or outcomes data) is explicitly described in terms of a clinical study for this device. The "literature" serves as the evidence.
8. The Sample Size for the Training Set
- Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. (See point 8.)
Summary of the Study Discussed in the Document:
The document describes the "Summary of Device Evaluation" as:
- Review of literature on this and similar devices to demonstrate intended performance.
- Biocompatibility data to show the inner lining is non-irritating and non-toxic.
- Test data to demonstrate the device will not break or shatter when subjected to impact.
This is a traditional 510(k) submission, where the focus is on showing equivalence to predicate devices and fulfilling basic safety tests, rather than conducting complex clinical trials with defined acceptance criteria and ground truths as would be expected for novel diagnostic technologies or AI/ML devices.
§ 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)).