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PF KEEP / CAD CAM BLOCK IS A THERMO PLASTIC MATERIAL. THEY ARE INTENDED TO BE USED FOR THE MAANUFACTURE OF: I) FULL AND PARTIAL REMOVABLE DENTURES AND IMPLANT OVERDENTURES II)COPINGS, SUBSTRUCTURES (CEMENTED OR UNCEMENTED), FRAMEWORKS FOR PERMANENT AND TRANSITIONAL ANTERIOR OR POSTERIOR CROWNS AND BRIDGEWORKS.

PF KEEP is a thermoplastic polymer, made from the polymer peek, is available as a granular material (so-called pellets) contained in plastic box with 45 g. that are used for manufacture of removable dental protheses. In case of CAD CAM PEEK BLOCK is for used with CAD CAM techniques. The material is provided nonsterile, without any accessories, and is a single use. The CAD CAM PEEK BLOCK are provided in different sizes.

The provided document is a 510(k) Premarket Notification for a dental device, specifically a thermoplastic material (PF Keep and CAD CAM PEEK BLOCK) used for manufacturing dental prostheses. It details the device's characteristics, indications for use, and a comparison to a predicate device to establish substantial equivalence.

Based on the content of this FDA 510(k) summary, the device is a material used for manufacturing, not an AI/software-driven diagnostic or assistive device that would typically have acceptance criteria such as accuracy, sensitivity, specificity, or require MRMC studies, expert consensus for ground truth, or training/test sets in the manner usually associated with AI/ML medical devices.

The "study that proves the device meets the acceptance criteria" in this context refers to nonclinical bench testing to demonstrate the material's properties and biocompatibility.

Therefore, the requested information about acceptance criteria and the study that proves the device meets those criteria will be interpreted in the context of a material for manufacturing dental devices, rather than an AI/software product.

Here’s the information gleaned from the document:

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

For a material-based device, "acceptance criteria" relate to physical and chemical properties and biocompatibility, often compared against a predicate device or international standards.

Note: The document states "is substantially equivalent to the legally marketed predicate device." This implies that the new device's performance is acceptable if it is comparable to or performs within acceptable limits relative to the predicate, especially when considering the totality of the data in the context of the intended use.

Regarding the other points, they are not applicable to this type of medical device submission (material for manufacturing dental devices) as they are typically relevant for AI/ML-driven diagnostic or assistive software.

• 2. Sample size used for the test set and the data provenance: Not applicable. For material testing, these would typically be lab samples tested according to specific standards (e.g., ISO). The document does not specify sample sizes or data provenance beyond "nonclinical testing."
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for material properties is established by standardized physical/chemical testing, not expert consensus.
• 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
• 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 is for AI-assisted diagnostic tools.
• 6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not a software device.
• 7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): For this device, the "ground truth" would be the measured physical and chemical properties and biocompatibility as determined by standardized laboratory methods (e.g., ISO standards), not clinical expert consensus or pathology data.
• 8. The sample size for the training set: Not applicable. There is no "training set" for a material device in the AI/ML sense.
• 9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document describes a 510(k) submission for a dental manufacturing material, where the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are based on nonclinical bench testing and biocompatibility assessments to demonstrate substantial equivalence to a predicate device as per relevant ISO standards (ISO 20795 for bench testing of dental polymers and ISO 10993 for biocompatibility). The detailed aspects of AI/ML software evaluation (such as test sets, expert ground truth, MRMC studies) are not relevant to this type of submission.

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