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PMMA Block is a device made from PMMA (polymethylmethacrylate) for the fabrication of temporary crowns and bridges and is intended for use in the oral cavity for up to six (6) months while awaiting a permanent restorations are designed and manufactured by a dental Professional (Technician) using CAD technology.

This product is a kind of homogeneous high polymer material made from quality polymethylmethacrylate added with cross-linking agents to improve the network structure through a unique polymerization molding technology. It is mainly used for the fabrication of multi-unit, fully or partially anatomical long-term temporary bridge restorations with up to two pontics by CAD/CAM systems. Both anterior and posterior crown & bridge are recommended.

This document describes the premarket notification (510(k)) for the PMMA Block, a device used for fabricating temporary crowns and bridges. The information provided focuses on demonstrating substantial equivalence to a predicate device, rather than a standalone study proving the device meets specific acceptance criteria based on human-in-the-loop performance or clinical outcomes.

Here's an analysis based on the provided text, addressing your questions where information is available:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily defined by ISO standards and comparison to a predicate device.

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: The document does not specify a "test set" in the context of clinical studies with patient data. The testing was non-clinical, primarily physical property and biocompatibility tests. The sample size for these non-clinical tests is not provided in this summary.
• Data Provenance: The data is from non-clinical laboratory testing (physical, chemical, and biological) conducted by Rizhao Huge Dental Industry Co., Ltd. The country of origin for the data generation would be China, where the manufacturer is located. The nature of these tests is not "retrospective" or "prospective" in the typical clinical sense, but rather laboratory evaluations.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable. Ground truth, in the context of clinical studies, refers to a definitive diagnosis or outcome. For this device, the "ground truth" for non-clinical testing is adherence to established international standards (ISO, AAMI/ANSI/ISO). Expert consensus for ground truth is not relevant for this type of submission.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods (e.g., 2+1) are used in clinical studies to resolve discrepancies among expert readers. Since this submission relies on non-clinical testing against standards and comparison to a predicate, such methods are not relevant.

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

This information is not applicable. The PMMA Block is a material for dental restorations, not an AI-powered diagnostic or assistive device for human readers. Therefore, an MRMC study with AI assistance is not relevant to this submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This information is not applicable. The PMMA Block is a physical product (material) and not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" used for this submission is adherence to international standards for dental materials (ISO 10477) and biocompatibility (ISO 10993 series), and demonstration of comparable characteristics to a legally marketed predicate device. There is no clinical "ground truth" data (like pathology or outcomes data) presented in this 510(k) summary.

8. The Sample Size for the Training Set

This information is not applicable. There is no AI component involved, and thus no "training set" in the context of machine learning.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable, as there is no training set for an AI algorithm.

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The product is indicated for the production of artificial teeth in fixed or removable dentures, or for jacket crowns,facings, and veneers.

The product is casted by cold isostatic cool pressuring and processed by pre-sintering with zirconia powder as the material.
There are two product families within our subject device - HS Series and HTIII Series, which are quite similar in Physical & Mechanical Properties. And the two product families all boast two shapes - the ones without steps and the ones with 2 steps, and eight sizes - 98×10mm for the ones without steps and 98×12mm, 98×14mm, 98×16mm, 98×18mm, 98×20mm, 98×22mm and 98×25mm for the ones with 2 steps.

This document is a 510(k) premarket notification for an All-Ceramic Zirconia Block, a type of dental material. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the demonstration of substantial equivalence to a legally marketed predicate device, rather than a clinical study evaluating the performance of a new diagnostic algorithm.

Here's a breakdown of the provided information, focusing on how the device demonstrates compliance with standards:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria here are derived from the characteristics of the predicate device and relevant international standards for dental materials. The study proves the device meets these criteria by demonstrating similar properties to the predicate and compliance with specified ISO standards.

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

• Sample size: Not explicitly stated for specific tests (e.g., how many blocks were tested for density or fracture toughness). This is common for material testing where results are often presented as mean values from a batch or specific number of samples required by the standard.
• Data Provenance: The document states "The subject device was tested to evaluate its safety and effectiveness according to the following standards". It doesn't specify the country of origin for the testing data, but the manufacturer is based in Rizhao City, Shandong Province, China. The tests are non-clinical (laboratory-based), not clinical.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is a material science characterization and equivalence study, not a study involving human expert interpretation of data or images to establish ground truth for a diagnostic device. The "ground truth" here is defined by the physical, mechanical, and biological properties measured and compared against established international standards and the predicate device's characteristics.

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

Not applicable, as this is not a study involving human interpretation or adjudication. The "adjudication" is done through direct measurement and comparison with predefined specifications and standards.

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 document pertains to an All-Ceramic Zirconia Block, a dental material, not an AI-powered diagnostic device.

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

Not applicable. This document pertains to an All-Ceramic Zirconia Block, a dental material, not an algorithm.

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

The "ground truth" for the non-clinical tests (biocompatibility and effectiveness parameters like density, fracture toughness) are the specifications and requirements defined by the referenced international standards (ISO 6872, ISO 10993 series) and the characteristics of the predicate device. Compliance with these standards and similarity to the predicate establishes the "truth" of the device's acceptable performance for regulatory purposes.

8. The sample size for the training set

Not applicable. This is a material characterization study for substantial equivalence, not a machine learning model.

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

Not applicable. This is a material characterization study for substantial equivalence, not a machine learning model.

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A Silicone Dentistry-Elastic Impression Material, with the trade name of PERFIT, is an addition-cure vinyl polysiloxane dental inyression material that is used for all crown und bridge, edentulous, orthodonic and impliant impression techniques.

A Silicone Dentistry-Elastic Impression Material, with the trade name of PERFIT, is an addition-cure vinyl polysiloxane dental inyression material

This document is concerned with the 510(k) premarket notification for a dental impression material, specifically "A Silicone Dentistry-Elastic Impression Material" with the trade name PERFIT (K133071). It is not a medical device that relies on AI or algorithms, and therefore, the requested information (acceptance criteria, study details relating to AI performance, ground truth, expert consensus, etc.) is not applicable to this submission.

The FDA 510(k) clearance process for devices like impression materials typically involves demonstrating substantial equivalence to a legally marketed predicate device through performance testing (e.g., physical and chemical properties as per ISO standards) and biocompatibility testing, rather than clinical studies with human readers or AI performance metrics.

Therefore, I cannot provide the requested table and details because they are not part of the information typically submitted or reviewed for a conventional dental impression material like the one described.

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