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The Danmar Products Michigan Cranial Reshaping Orthosis is intended for prescription use to apply pressure to prominent regions of an infant's cranium in order to improve cranial symmetry and/or shape. A mold is made of the baby's head to create the orthotic. A plaster cast or a laser-scanning accessory may be used to create a scan of the infant's head to create the mold. The device is indicated for infants from 3 to 18 months of age, with moderate to severe nonsynostotic positional plagiocephaly, including infants with plagiocephalic and brachycephalic shaped heads.

The Danmar Products Michigan Cranial Reshaping Orthosis a cranial orthosis that provides passive pressure to prominent regions of an infant's cranium to improve cranial symmetry and/or shape. It is fabricated from a positive mold, obtained from traditional manual casting methods or a 3-D scan of the infant's head, with front and rear sections that are comprised of an inner, hypoallergenic, soft foam that is ½ " to ¼" thick, and an outer shell made of a, semi-rigid plastic. The Michigan Cranial Reshaping Orthosis is essentially identical to the predicate device known as the Danmar Products Michigan Cranial Helmet, (K003630) with exceptions only to the validated manufacturing improvements noted herein. The new manufacturing methods vield a substantially equivalent device as compared with the Danmar predicate device and manufacturing method.

The provided text describes a 510(k) premarket notification for the Danmar Products Michigan Cranial Reshaping Orthosis. A 510(k) submission does not typically involve novel studies to prove device efficacy or pre-defined acceptance criteria with performance measurement against them in the same way a PMA (Premarket Approval) submission would. Instead, substantial equivalence to a predicate device is the primary pathway.

Therefore, the requested information elements related to device performance studies, acceptance criteria, sample sizes, expert involvement, and ground truth establishment are largely not applicable or not explicitly detailed in this type of submission. The focus is on demonstrating that the new device shares the same technological characteristics and intended use as an already legally marketed predicate device, with any modifications not raising new questions of safety or effectiveness.

Here's an analysis based on the provided document, addressing the points where information is available or indicating where it is not:

Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

This 510(k) submission for the Danmar Products Michigan Cranial Reshaping Orthosis declares substantial equivalence to predicate devices rather than presenting specific acceptance criteria and a study demonstrating performance against those criteria. The "study" in this context refers to the comparison of technological characteristics and intended use with predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

• Mechanical Performance: "Performance testing results demonstrate that the device will not break or shatter when subjected to impact." (Details of this testing are not provided in the summary).
• The claim is that the "validated fabrication modifications noted herein will yield a finished subject device equivalent to the Danmar predicate device (K003630)." The approval by the FDA via 510(k) implies that these claims were sufficient to establish substantial equivalence without raising new safety or effectiveness concerns. |

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

• Not applicable / Not provided. A formal "test set" for performance evaluation in the context of efficacy for patients (like a clinical trial) is not described in this 510(k) summary. The evaluation relies on comparison to predicate devices and general performance testing (biocompatibility, impact resistance), the details of which are not specified.

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)

• Not applicable / Not provided. The concept of "ground truth" established by experts for a test set (e.g., for diagnostic accuracy) is not relevant to this 510(k) submission.

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

• Not applicable / Not provided. No adjudication method is described as there is no specific test set of cases requiring such a process.

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

• Not applicable. This device is a cranial orthosis, not an imaging or AI-assisted diagnostic tool. Therefore, an MRMC study is completely irrelevant.

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

• Not applicable. This device is a physical orthosis, not an algorithm.

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

• Not applicable / Implicit. The "ground truth" in a substantial equivalence submission is primarily the established safety and effectiveness of the predicate devices. The assessment relies on a comparison of characteristics and intended use. For the performance testing mentioned (biocompatibility, impact), the "ground truth" would be standard engineering and material science specifications, but details are not provided. Clinical outcomes data to prove efficacy for patients is not typically required or presented in detail for a 510(k) where substantial equivalence is demonstrated.

8. The sample size for the training set

• Not applicable. This device does not involve a training set for an algorithm.

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

• Not applicable. No training set is used for this device.

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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

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.

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