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Customized Abutment and Screw is used as a complement component for dental implants placed in the jawbone after tooth loss, to connect, support and retain the restoration or implant superstructure. Customized Abutment and Screw is indicated for single unit restorations.

Customized Abutment and Screw is compatible with following Implant Systems:

All digitally designed abutments for use with Customized Abutment and Screw are intended to be manufactured at a BESMILE validated milling center.

The Customized Abutment and Screw is composed of two parts: the customized abutment and screw. Among them, the customized abutment is machined from Ti-6Al-4V titanium alloy material in accordance with ASTM F1472, and the screw is machined from Ti-6Al-4V ELI titanium alloy material in accordance with ASTM F136. And the surface of product is not modified. The lower part of the product has a fixed interface shape, and the upper part is machined according to the needs of the patient. In the process of dental implant surgery, as the upper structure of the implant, it is installed on the implant platform anchored in the bone, which plays the role of supporting, retaining and stabilizing the prosthesis.

Customized Abutment and Screw is created via use of the Pre-milled Blank.

The information of the Implant Systems compatible with the product is detailed in Table 1.

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It is only used for coloring Zirconia Dental Ceramics of our company to achieve clinical aesthetic restoration.

Pre-Sintered Zirconia Coloring Liquid is mainly divided into 16 colors, 26 colors and special colors. The product is mainly composed of purified water(55%95%), ferric chloride (09%), Erbium Chloride(0~17%), polyethylene glycol(2%~6%),Polydextrose(0.5%~8%),Gluconic acid(1%~2%),Citric acid(0%1%) and Yttrium chloride(012%).

The document describes the Pre-Sintered Zirconia Coloring Liquid and its non-clinical testing for safety and performance.

Here's an analysis of the provided information regarding acceptance criteria and the study:

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

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

The document does not specify the exact sample size used for each physical and biocompatibility test. It mentions "dental specimens" for the post-dyeing comparison and implies testing on samples for heavy metal content, cytotoxicity, hypersensitivity, intradermal reaction, and systemic toxicity. The provenance of the data is not explicitly stated beyond being "non-clinical testing" conducted on the subject device. It is assumed to be internal testing by Chengdu Besmile Medical Technology Co., Ltd.

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

The document does not mention the involvement of experts for establishing ground truth in the non-clinical tests described. The "ground truth" for these tests would be defined by the standardized methodologies (e.g., ISO standards for biocompatibility, instrumental measurements for heavy metals, visual comparison against color guides for post-dyeing).

4. Adjudication method for the test set

Not applicable for these types of non-clinical tests. The tests rely on objective measurements and adherence to specified standards rather than expert 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

Not applicable. This device is a pre-sintered zirconia coloring liquid, not an AI-powered diagnostic device, so MRMC studies are not relevant.

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

Not applicable. This is a material product, not a software algorithm.

7. The type of ground truth used

• Physical Testing: Ground truth is established by:
  • Specification: Product technical requirements.
  • Appearance: Visual inspection against established criteria (homogeneous and impurity-free).
  • Post-dyeing comparison: Comparison against VITA veneer colorimeter or standard dental specimens.
  • Heavy metal content: Analytical measurement against a specified threshold (less than 10 mg/L in Pb).
• Biocompatibility Testing: Ground truth is established by adherence to the criteria defined in the specific ISO standards (e.g., ISO 10993-5, ISO 10993-10, ISO 10993-11) for non-cytotoxicity, non-hypersensitivity, non-intradermal reaction, and non-systemic toxicity.

8. The sample size for the training set

Not applicable. This device is a material product, not an AI model that requires a training set.

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

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

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Dental Glass Ceramics are indicated for fabrications such as veneers, inlay/ onlay/ onlay/ partial crowns, anterior crowns, posterior crowns, using the hot press technique or CAD/CAM system.

This product is composed of SiO2 , Al2O3 , Li2O , K2O , Na2O , CeO2 , Pr6O11 , ZrO2 , P2O5 , СаО , МпО2 , Ег2Оз .

The provided document is a 510(k) Premarket Notification for a medical device called "Dental Glass Ceramics". This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel effectiveness or developing an AI algorithm. Therefore, many of the requested categories for AI-based device studies are not applicable to this document.

Here's an analysis based on the information available:

1. Table of acceptance criteria and the reported device performance

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 for Test Set:
  • For material composition, appearance, porcelain block density, radioactivity, linear expansion coefficient, and glass transition temperature, individual measurements are reported.
  • For Flexural strength, the testing involved 10 samples.
  • For Size requirement, 5 measurements each for length, width, and height are reported.
  • For Biocompatibility testing (Cytotoxicity, Delayed hypersensitivity, Intradermal reaction, Acute systemic toxicity, Subchronic systemic toxicity, Genotoxicity), the document states "Pass" for each, implying sufficient samples were used to meet the ISO standards' requirements, but specific numbers are not provided.
• Data Provenance: The document does not explicitly state the country of origin for the test data. However, the submitter is Chengdu Besmile Medical Technology Co., Ltd. from Chengdu, Sichuan, China. The testing is described as "Non-clinical Testing (Bench)," indicating laboratory testing rather than data from human subjects. The data is retrospective in the sense that it's generated from manufactured samples for submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This is a non-clinical, material properties testing submission, not an AI or diagnostic device that requires expert-established ground truth. The acceptance criteria are based on recognized consensus standards (e.g., ISO 10993 series) and product technical requirements for dental materials. Therefore, no human experts were involved in establishing "ground truth" in the diagnostic sense.

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

Not applicable. This is not a study requiring adjudication of diagnostic outcomes.

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 a material science device, not an AI-based diagnostic tool.

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

Not applicable. This is a material science device, not an AI-based diagnostic tool.

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

The "ground truth" here is defined by the acceptance criteria established by recognized consensus standards (e.g., ISO 10993 for biocompatibility) and internal product technical requirements for dental glass ceramics. These are objective, measurable physical, chemical, and biological properties, not human-interpreted diagnostic outcomes.

8. The sample size for the training set

Not applicable. This device is a material, not an AI model that requires a training set.

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

Not applicable. This device is a material, not an AI model that requires a training set.

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This product is indicated for use as a veneering material for fixed prosthesis in crowns, bridges.

This product includes Porcelain Powder, Stain/Glaze and Blending liquid. The porcelain powder is composed of silica (SiOz), alumina (AlzOs), potassium oxide (K2O), sodium oxide (Na2O), boron trioxide (B2O3), calcium oxide (CaO), barium oxide (BaO), zirconia (ZrO2), zinc oxide (ZnO) , lithium oxide (Li₂O), tin oxide (SnO₂), magnesium oxide (MgO), Yttrium oxide (Y2O3) and terbium oxide (Tb2Os).. The blending liquid is composed of purified water, 1, 3-butanediol and diethanolamine. The Stain/Glaze is composed of the porcelain powder and the blending liquid in accordance with the mass ratio of 1:1.

The provided text describes a 510(k) premarket notification for a "Dental Porcelain Powder" device and outlines its acceptance criteria and non-clinical testing results. It does not describe an AI/ML powered medical device, an imaging device, or a study involving human readers. Therefore, many of the requested categories are not applicable to this document.

However, I can extract and present the information that is relevant to the acceptance criteria and non-clinical testing of this specific medical device.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is not an AI/ML-powered or imaging device, the following categories are not applicable to the provided document. The device is a "Dental Porcelain Powder" and the testing described is non-clinical bench testing and biocompatibility testing.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable for this type of non-clinical, bench testing. The document does not specify sample sizes for individual tests but rather the acceptance criteria for material properties.
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 testing methods, not expert consensus in this context.
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. No AI component.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. No algorithm involved.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Ground truth for the non-clinical tests is based on the specified physical, chemical, and biological properties as defined by relevant ISO standards and product technical requirements.
8. The sample size for the training set: Not applicable. There is no training set as this is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable.

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