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Partial Flex® is indicated for the fabrication of partial or full removable dentures, as well oclusional splints or night guards.

Partial Flex® dental resin is a polymer base material used for the fabrication of partial removable dentures and prosthesis. Partial Flex is made from a resin of polypropylene that is designed and manufactured for injection molding. Partial Flex® is available in two shades as a granular material (so-called pellets) contained in an aluminum tube with 27 g or in a plastic bag of 250 g. In addition to high biocompatibility, Partial Flex® material features hypoallergenic properties, no risk of discoloration and the dental prosthesis made are unbreakable, which differentiates the from acrylic materials. The resin material is pigmented in one color and without pigment presentation: Light pink and Natural color (without pigment).

The provided FDA 510(k) Clearance Letter for the device "Partial Flex" does not describe acceptance criteria, the study that proves the device meets acceptance criteria, or any details about AI/human reader studies.

The document primarily focuses on regulatory approval based on demonstrating substantial equivalence to a predicate device. It confirms that the device is a "Denture Relining, Repairing, Or Rebasing Resin" and lists some non-clinical performance tests conducted to show compliance with ISO standards (ISO 20795 and ISO 10993 for biocompatibility), but it does not provide specific acceptance values or the actual results of these tests beyond "passed the acceptance criteria" or "complies with the requirements."

Therefore, it's impossible to fill in the requested information based solely on the provided text. The prompt asks for details that are typically found in a clinical study report or a more detailed section of a 510(k) submission, neither of which is present in the provided clearance letter.

However, I can illustrate what a hypothetical response would look like if the information were available, using the structure of your request.

Hypothetical Response (Illustrative, as the provided document lacks the necessary data):

This document, an FDA 510(k) Clearance Letter, primarily focuses on demonstrating substantial equivalence to a predicate device for regulatory clearance. It details non-clinical performance testing but does not contain the specific acceptance criteria, detailed study results, or information pertaining to AI performance, human reader studies, or ground truth establishment that would be required to fully answer the prompt. The information below is hypothetical and structured as if the data were present in the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Sizes and Data Provenance

The provided document describes non-clinical bench testing and biocompatibility testing. It does not specify sample sizes for these tests, nor does it refer to patient data (e.g., medical images, clinical outcomes) that would typically have provenance data.

• Test Set Sample Size: Not applicable/Not specified in the provided document for human data or AI model evaluation. For bench tests, typical sample sizes are per ISO standards but not detailed here.
• Data Provenance: Not applicable for the type of testing described (bench and biocompatibility). No mention of country of origin or retrospective/prospective data collection.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. The provided document describes material testing and biocompatibility. It does not involve human readers, clinical data interpretation, or AI ground truth establishment.

4. Adjudication Method for the Test Set

Not applicable. No expert review or clinical test set adjudication is described in the provided document.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This is a material science device (dental resin), not a diagnostic imaging or AI-assisted interpretation device. No MRMC study was performed or is relevant to this device's 510(k) submission as described.

6. Standalone Algorithm Performance

Not applicable. This device is a physical dental resin, not an algorithm or software.

7. Type of Ground Truth Used

The "ground truth" for the non-clinical tests described in the document (material properties and biocompatibility) would be based on:

• Established ISO Standards (e.g., ISO 20795 for dental base polymers, ISO 10993 for biocompatibility): These standards define the test methodologies and acceptable performance limits.
• Laboratory Measurements and Biological Assays: Objective, quantitative measurements performed in a laboratory setting (e.g., measuring flexural strength, assessing cell viability, observing tissue reactions in animal models).

There is no "expert consensus," "pathology," or "outcomes data" ground truth in the context of this 510(k) submission.

8. Sample Size for the Training Set

Not applicable. This device is a manufactured resin, not an AI model requiring a training set.

9. How Ground Truth for the Training Set Was Established

Not applicable. This device is a manufactured resin, not an AI model.

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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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