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PMMA BLOCK is used for the fabrication removable or temporary dental structures, such as crowns and bridges using milling technology using CAD/CAM.

Indications for Use:

• Temporary anterior and posterior crowns;
• Temporary anterior and posterior bridges;
• Removable structures for dentures;
• Removable structures for therapeutic restorations (night guards, bite splints or occlusal splints).

PMMA BLOCK is a circular solid (disc) or rectangular solid (block) of PMMA with or without post attachment for use in a CAD/CAM milling machine for production of provisional restorative prostheses such as dental crowns and bridges and removable dental structures. These blocks are available in a variety of shapes for different milling systems and are also available in variety of dental shades.

The provided text is a 510(k) Summary for a medical device called "PMMA BLOCK." This document describes the device, its intended use, and compares it to a predicate device to demonstrate substantial equivalence, primarily focusing on physical and chemical properties and biocompatibility.

Here's an analysis of the provided information concerning acceptance criteria and supporting studies:

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

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The device is 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.

The PMMA Blocks for Dental Use is a homogeneous high polymer material made from PMMA (polymethylmethacrylate) added with cross-linking agents to improve the network structure through a unique polymerization molding technology. The device is for the fabrication of temporary crowns and bridges and is intended for use in the oral cavity for up to six months while awaiting a permanent restorations are designed and manufactured by a dental professional (such as a dentist) using CAD technology.

The proposed device contains two models with different shape: Cylinder and Cuboid. There are 39 specifications for Cylinder model (variation in different diameters and heights), and 44 specifications for Cuboid model (variation in different lengths, widths, and heights).

There are 20 various shades of the proposed device: 1 is transparent (without color added), the other 19 shades are colored (with different coloring matters added). The 19 shades created based on 19 Vita Shades contain A1, A2, A3, A3.5, A4, B1, B2, B3, B4, C1, C2, C3, C4, D2, D3, D4 and OM1,OM2,OM3.

The PMMA Blocks for Dental Use would be produced on the 39 specifications of Cylinder model or 44 specifications of Cuboid model, with a shade chosen from the 20 various shades.

The PMMA Blocks for Dental Use is provided as non-sterile.

This document describes acceptance criteria and provides results from non-clinical testing of "PMMA Blocks for Dental Use". The document does not contain information about a study that proves the device meets the acceptance criteria, nor does it contain information about clinical studies with human readers or AI.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding device performance values against those criteria. Instead, it refers to compliance with international standards for performance and biocompatibility.

Performance Test Standards:

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

The document describes non-clinical testing of a dental material. Information regarding "sample size used for the test set" typically refers to the number of individual test specimens or batches tested for each specific test mentioned (e.g., number of specimens for flexural strength, number of samples for cytotoxicity assay). However, this specific detail (the exact number of specimens per test) is not provided in the document.

Data provenance (country of origin, retrospective/prospective) is not applicable in the context of this non-clinical, in-vitro/materials testing. The tests are laboratory-based and performed on the device material itself, not on patient data.

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

This information is not applicable as the document describes non-clinical material testing, not human-reviewed data where "ground truth" would be established by experts.

4. Adjudication Method for the Test Set

This information is not applicable as the document describes non-clinical material testing, not a study involving human interpretation or adjudication.

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

An MRMC comparative effectiveness study was not done. The document focuses on the non-clinical performance and biocompatibility of a dental material, not on the effectiveness of human readers or AI assistance.

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

A standalone algorithm performance study was not done. The device is a material, not a software algorithm.

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

This information is not applicable as the document pertains to non-clinical material testing, where "ground truth" is typically defined by scientific measurement against established standards (e.g., specific chemical composition, physical properties, or biological reactions measured in a lab setting), rather than clinical interpretation or outcomes.

8. The sample size for the training set

This information is not applicable. The document describes the testing of a physical medical device (PMMA Blocks), not an AI algorithm that would require a training set.

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

This information is not applicable. As in point 8, there is no training set mentioned or implied in this document.

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PMMA BLOCK particularly suitable for making removable or temporary dental structures such as crowns and bridges using milling technology using CAD/CAM.

Indications for Use:

• Temporary anterior and posterior crowns;
• Temporary anterior and posterior bridges;
• Implant surgical guide;
• Removable structures for dentures;
• Removable structures for therapeutic restorations (night guards, bite splints or occlusal splints).

PMMA BLOCK is a circular solid (disc) or rectangular solid (block) of PMMA with or without post attachment for use in a CAD/CAM milling machine for production of provisional restorative prostheses such as dental crowns and bridges and removable dental structures. These blocks are available in a variety of shapes for different milling systems and are also available in variety of dental shades.

PMMA BLOCK are made with the same material (Hot cured PMMA) that is used for the manufacture of the HUGE Synthetic Polymer Teeth (K101029) and HUGE PMMA Block(K141421). These polymer discs or blocks are especially suited for creating dental structures by means of milling CAD/CAM techniques commonly used in the dental laboratories and in dental practice. The elaboration is designed by a professional, a dental technician or a dentist. This guarantees their correct use, since it is an intermediate product in order to manufacture a custom-made product.

The provided text is a 510(k) summary for the PMMA Block, a dental material. It outlines the device's characteristics and compares it to predicate devices to establish substantial equivalence.

However, the document does not contain any information about a study proving the device meets acceptance criteria related to AI or machine learning performance. The "acceptance criteria" discussed in the document pertain to the physical and chemical properties of the PMMA Block and its compliance with ISO standards for dental materials.

Therefore, I cannot provide the requested information regarding:

• A table of acceptance criteria for AI performance and reported device performance.
• Sample sizes, data provenance, number of experts for ground truth, adjudication methods for a test set.
• Multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
• Type of ground truth used related to AI.
• Training set sample size or how ground truth for training was established.

The document focuses on the material's properties, chemical composition, and manufacturing process, asserting substantial equivalence to existing dental materials, not on the performance of an AI-powered device.

Summary of relevant information from the document (not directly answering the AI-related questions):

• Device: PMMA Block (dental polymer blanks)
• Purpose: For making removable or temporary dental structures (crowns, bridges, surgical guides, dentures, night guards/bite splints) using CAD/CAM milling.
• Study Type: This is a 510(k) premarket notification based on substantial equivalence to predicate devices, not a clinical performance study of a novel AI or medical imaging device.
• "Acceptance Criteria" presented: Primarily physical and chemical properties of the material, tested against ISO standards (ISO 10477, ISO 20795-1, ISO 22112).
  • Flexural strength: The new device must meet $\ge$ 50 MPa (ISO 10477) and $\ge$ 65 MPa (ISO 20795-1).
  • Water absorption: The new device must meet $\le$ 0.040 mg/mm³ (ISO 10477) and $\le$ 0.032 mg/mm³ (ISO 20795-1).
  • Water solubility: The new device must meet $\le$ 0.0075 mg/mm³ (ISO 10477) and $\le$ 0.0016 mg/mm³ (ISO 20795-1).
  • Residual monomer content: The new device must meet $\le$ 2.2% (ISO 20795-1).
  • Dimensional stability: The new device must meet within ± 2% of original mesio-distal dimension (ISO 22112).
• Reported Device Performance (from Table 4):
  • Flexural strength: $\ge$ 50 MPa and $\ge$ 65 MPa (meeting the criteria).
  • Water absorption: $\le$ 0.040 mg/mm³ and $\le$ 0.032 mg/mm³ (meeting the criteria).
  • Water solubility: $\le$ 0.0075 mg/mm³ and $\le$ 0.0016 mg/mm³ (meeting the criteria).
  • Residual monomer content: $\le$ 2.2% (meeting the criteria).
  • Dimensional stability: 0.29% (meeting the criteria of ± 2%).
• Biocompatibility: Tests were performed according to ISO 10993 standards (Systemic Toxicity, Irritation, Sensitization, Cytotoxicity, In Vitro Mammalian Cell TK Gene Mutation Test, In Vitro mammalian chromosome aberration test, and Bacterial reverse mutation study). The document states the device is "Non cytotoxic."
• Clinical Performance Data: "Not applicable. Clinical performance testing has not been performed for the subject device." (Section 10).

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Evolux CAD/CAM PMMA Blocks are intended for making removable or temporary dental structures such as crowns and bridges using CAD/CAM milling technology.

Indications:

• Temporary anterior and posterior crowns
• Temporary anterior and posterior bridges with up to two adjacent pontics
• Implant supported temporary restorations
• Maximum recommended usage period: 12 months
• Removable structures for dentures (dental bases)
• Removable structures for therapeutic restorations (bite splints or occlusal splints)

Evolux CAD/CAM PMMA Blocks are intended for making removable or temporary dental structures such as crowns and bridges using CAD/CAM milling technology.

I am sorry, but the provided text does not contain any information about acceptance criteria or a study proving device performance for the "Evolux Cad/cam Pmma Blocks". The document is an FDA 510(k) clearance letter confirming that the device is substantially equivalent to legally marketed predicate devices, along with its indications for use. It does not include details of performance studies, sample sizes, expert qualifications, or ground truth establishment.

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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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