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Parallax Cranioset is a resinous material for repair of cranial defects.

Parallax Cranioset is a resinous material for repair of cranial defects.

The provided 510(k) summary for the Parallax Cranioset, a methyl methacrylate for cranioplasty, does not contain detailed information about specific acceptance criteria or an analytical study. Instead, it focuses on demonstrating substantial equivalence to a predicate device.

Here's an analysis of the provided information based on your requested categories:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly list quantitative acceptance criteria with reported performance values. It states: "Performance testing demonstrated that Parallax Cranioset is substantially equivalent to Cranioplastic with regard to functional characteristics." This implies that the device met the functional characteristics of the predicate, but specific quantitative metrics are not provided.

2. Sample size used for the test set and the data provenance

The document does not specify a sample size for any "test set" in the context of clinical or analytical performance. It describes "performance testing" but does not detail the methodology. There is no information on data provenance (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. The study focuses on material properties and functional equivalence to a predicate device, not on diagnostic accuracy requiring expert ground truth for a test set.

4. Adjudication method for the test set

This information is not provided.

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 such study was conducted or described. The device is a material for cranioplasty, not an AI-assisted diagnostic tool for human readers.

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

This is not applicable. The device is a medical material, not an algorithm.

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

Given the nature of the device (methyl methacrylate for cranioplasty), the "ground truth" for demonstrating substantial equivalence would likely involve established material standards and the performance characteristics of the predicate device. This would typically not involve expert consensus, pathology, or outcomes data in the way a diagnostic device would. It would likely involve:

• Material composition analysis: Verifying that the composition is the same as the predicate.
• Physical and mechanical property testing: Comparing properties like tensile strength, compressive strength, setting time, biocompatibility, etc., against the predicate device and relevant standards.

8. The sample size for the training set

This information is not provided and is not applicable for this type of device. There is no "training set" as it is not a machine learning or AI device.

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

Not applicable, as there is no training set for this device.

Summary of the Study and Equivalence:

The study proving the device meets the acceptance criteria is described as "Non-clinical Test Results: Performance testing demonstrated that Parallax Cranioset is substantially equivalent to Cranioplastic with regard to functional characteristics." The basis for this equivalence is that "The materials contained within Parallax Cranioset are all materials that appear in the predicate device." This suggests a comparative study against the predicate device (Codman Cranioplastic™, Acrylic Cranioplasty Material (K873689)) for material composition and functional characteristics (e.g., mechanical properties, setting properties). The specific details of this testing (e.g., number of units tested, specific tests performed, quantitative results) are not included in this summary. The key "acceptance criterion" was achieving substantial equivalence to the legally marketed predicate device.

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