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Used for extraoral etching of various types of resin bonded porcelain/ceramic restorations (veneers, crowns, and inlays) prior to the bonding and cementation procedure.

HF-Etchant Hydrofluoric Acid Etching Gel is composed of water, hydrofluoric acid, thickening agent and pigment. It is a water soluble and miscible flowable gel. Using a disposable dispensing tip, the Hydrofluoric acid etching gel can be directly applied onto the porcelain/ceramic surface. Its color is red, which can be identified easily on tooth or a repairing surface with contrast. HF-Etchant Hydrofluoric Acid Etching Gel is delivered in syringes.

Here's a breakdown of the requested information, based on the provided FDA 510(k) summary for the HF-Etchant Hydrofluoric Acid Etching Gel.

Important Note: The provided document is a 510(k) summary for a medical device (HF-Etchant Hydrofluoric Acid Etching Gel), not an AI/ML-based medical device. Therefore, many of the requested fields related to AI/ML studies (like expert adjudication, MRMC studies, training/test set sample sizes, and ground truth establishment for AI) are not applicable to this type of submission and will be marked as such. The device described is a chemical etching gel, not a software algorithm.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not specified for formal "test sets" as would be done for an AI/ML algorithm. The performance was determined through internal testing of the device itself.
• Data Provenance: Not explicitly stated, but the testing was "according to Internal standard SOP of the company." This implies in-house testing by Rizhao HuGe Biomaterials Company, Ltd. (China).
• Retrospective or Prospective: Not applicable in the context of an AI/ML algorithm. The performance testing appears to be prospective (i.e., conducted on the manufactured device).

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

• Not Applicable. This is a chemical device, not an AI/ML system requiring expert-established ground truth for a test set. The "ground truth" for its properties (like pH, viscosity) is determined by standard chemical and physical measurement techniques.

4. Adjudication Method for the Test Set

• Not Applicable. See point 3.

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

• No. This is not an AI/ML device. An MRMC study is not relevant.

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

• Not Applicable. This is not an algorithm.

7. The Type of Ground Truth Used

• For physical and chemical properties (Thermostability, Hydrofluoric acid content, Rotational viscosity value, pH value): The ground truth is established by quantitative measurements against the company's internal standard operating procedures (SOPs).
• For shelf life: The ground truth is established through real-time stability testing over a 2-year period.

8. The Sample Size for the Training Set

• Not Applicable. This is not an AI/ML device, so there is no "training set."

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

• Not Applicable. See point 8.

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TopCEM Ceramic Primer Ceramic Coupling Agent serves as priming agent and is used to create a durable adhesion between luting composites and glass/oxide ceramic, metal, composite and fiberreinforced composite restorations.

TopCEM Ceramic Primer Ceramic Coupling Agent is common oral cementation repair auxiliary materials. In the process of using the product, TopCEM Ceramic Primer Ceramic Coupling Agent is placed between the prosthesis and resin adhesives, which can form the bonding layer of tooth tissue - light cure dental adhesive layer - resin cement layer - ceramic coupling agent - prosthesis, so as to achieve better bonding effect. TopCEM Ceramic Primer Ceramic Coupling Agent does not have direct contact with tooth tissue during use. TopCEM Ceramic Primer Ceramic Coupling Agent is mainly composed of silane coupling agent, acid acrylate and volatile organic solvent.

The provided document is a 510(k) Premarket Notification from the FDA for a dental bonding agent. It describes the device, its intended use, and compares it to a predicate device to establish substantial equivalence.

However, the document does not contain any information about a study that proves the device meets specific acceptance criteria based on performance metrics such as sensitivity, specificity, or accuracy, as would be expected for an AI/ML medical device. The device described is a "Ceramic Primer Ceramic Coupling Agent," which is a chemical product used in dentistry, not an AI/ML-driven diagnostic or prognostic device.

Therefore, I cannot provide the requested information regarding:

• A table of acceptance criteria and reported device performance (e.g., sensitivity, specificity, accuracy).
• Sample sizes for test sets or data provenance.
• Number of experts for ground truth establishment or their qualifications.
• Adjudication methods.
• MRMC comparative effectiveness studies or effect sizes.
• Standalone algorithm performance.
• Type of ground truth used (e.g., expert consensus, pathology, outcomes data).
• Sample size for the training set.
• How ground truth for the training set was established.

The document primarily focuses on non-clinical testing of physical properties and biocompatibility for a chemical product. It states:

• "Summary of Non-clinical testing": "The physical properties of the subject device, including Appearance, Solid Content, Bond Strength (MPa), Whether there are traces left on the glass panel surface, Packing Amount Tolerance and Detection of Infrared Characteristic Peaks, were determined and tested according to Internal standard SOP of the company, and the test results demonstrated the qualification and substantial equivalence when compared to the predicate device."
• "Summary of Clinical testing": "Clinical test is not applicable."

This indicates that the "acceptance criteria" and "proof" in this context relate to chemical and physical properties, and biocompatibility, as evaluated through internal SOPs and comparison to a predicate device, rather than the performance metrics typically associated with AI/ML diagnostic tools.

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· Pretreatment etchant before resin (help to having a strong bonding strength between resin and teeth)
· Remove smear layer of dentin and enamel
• Pretreatment etchant before sealant (help to having a strong bonding strength between sealant and teeth)

FineEtch - 10, 37 is a phosphoric acid (H3PO4) semi-gel-type agent intended for use on dentin and enamel. FineEtch will effectively remove the smear layer and help successful bonding.

The provided text is a 510(k) premarket notification for a dental etchant called "FineEtch." It discusses the device's classification, indications for use, comparison to a predicate device, and performance testing. However, it does not include the information requested regarding acceptance criteria and the study proving the device meets those criteria for an AI/ML device.

Specifically, the document states: "9. Performance Testing-Clinical tests Not Applicable". This indicates that no clinical studies, which would typically involve human subjects or human readers (as implied by questions 3-5), were conducted or submitted for this device. The non-clinical tests mention pH, viscosity, shape retention, and etching effect, comparing the device to a predicate and another dental etchant. This type of testing is characteristic of a substance or instrument, not an AI/ML diagnostic or assistive device that would rely on human expert interpretation of data.

Therefore, I cannot provide the requested information about acceptance criteria for an AI/ML device, ground truth establishment, expert consensus, MRMC studies, or training/test set details, as this document pertains to a chemical dental product, not an AI/ML software device.

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Ceramic Etchant is intended for etching the porcelain veneers, crowns, and inlays extraorally. It is also used for pretreating the porcelain veneers, crowns, and inlays extraorally before bonding.

Not Found

I am sorry, but the provided text from the FDA 510(k) clearance letter for the Ceramic Etchant (HF-5 and HF-9) does not contain any information about acceptance criteria, device performance testing, or a study that proves the device meets specific criteria in the way described in your request.

The document is a standard FDA clearance letter confirming substantial equivalence to a predicate device. It discusses regulatory compliance, general controls, quality system regulations, adverse event reporting, and unique device identification. It also includes the "Indications for Use" for the Ceramic Etchant.

The information you are looking for, such as sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth, and training set details, would typically be found in the device's 510(k) summary or a more detailed biocompatibility/performance testing report submitted as part of the 510(k) application, not in the clearance letter itself.

Therefore, I cannot populate the table or answer the specific questions based on the provided text. The letter only states that the device is "substantially equivalent" to legally marketed predicate devices, which means the FDA has determined it is as safe and effective as a device already on the market. This determination is based on the information provided in the 510(k) submission, which is not fully detailed in this clearance letter.

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-Bonding of all direct composite restorations
-Bonding of dual/self cure composite and core build-ups
-Repairs of composite fillings
-Root surface desensitization

K-Bond Universal is a bonding system that offers exceptional bonding strength through a convenient single bottle application. This single-component bonding agent is specifically formulated to effectively bond various types of direct composite restorations to dentin, enamel, as well as composite.

The provided text describes the regulatory clearance of a dental bonding agent, K-Bond Universal, and not an AI/ML powered medical device. Therefore, information regarding acceptance criteria and studies for AI/ML devices, such as sample size for test/training sets, expert qualifications, and details about MRMC studies, is not present.

However, I can extract information related to the performance testing described for the K-Bond Universal device:

Here's a summary of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not specified.
• Data Provenance: Not specified (implied to be laboratory testing of the device and predicate).

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

• Not applicable as this is a material performance test, not a diagnostic device requiring expert opinion for ground truth.

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

• Not applicable. Performance was measured against ISO standards and internal requirements.

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 not an AI/ML device.

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

• Not applicable. This is not an AI/ML device.

7. The type of ground truth used:

• Performance criteria based on ISO 29022 standard for shear bond testing and internal requirements (for dentin and enamel shear bond strength).
• For root surface desensitization, the ground truth was established by confirming dentin tubule blockage.

8. The sample size for the training set:

• Not applicable as this is not an AI/ML device.

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

• Not applicable as this is not an AI/ML device.

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Light Cure Adhesive can be used as a strict self-etch dental bonding agent, or in combination with the traditional total etch or enamel etch procedures:

• Direct bonding under a light-cured composite or compomer fillings/resin modified glass ionomer restoratives;
• Repair of dental restorations of ceramic, composites and/or metal alloys;
• Indirect dental restoration applications in combination with resin cement for cementation of all sorts of dental restorations including crowns, bridges, inlays/onlays, veneers, dental posts and other restorations made from materials of metals/alloys, metal-ceramic and/or porcelain, composites, and their combinations.

Not Found

I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter for a "Light Cure Adhesive" device, which is a dental bonding agent. It discusses regulatory matters, such as substantial equivalence, general controls, and good manufacturing practices.

It does not include details about:

• Acceptance criteria table and reported device performance for a study proving the device meets the criteria.
• Sample sizes or data provenance for a test set.
• Number and qualifications of experts for ground truth establishment.
• Adjudication methods.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness studies or their effect sizes.
• Standalone algorithm performance.
• Type of ground truth used.
• Training set sample size or how its ground truth was established.

This document is a regulatory approval, not a clinical or performance study report for an AI/software-based medical device. Therefore, I cannot extract the requested information from the given text.

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KATANA Zirconia ONE For IMPLANT is intended for use in partially or fully edentulous mandibles and maxillae in support of single cement-retained restorations.

For the SBL 3.3 L titanium bases, the indication is restricted to the replacement of single lateral incisors in the maxilla and lateral and central incisors in the mandible.

KATANA Zirconia ONE For IMPLANT is used in combination with the TiBase and Sirona Dental CAD/CAM System. KATANA Zirconia ONE For IMPLANT cemented to the TiBase is recommended for two-piece hybrid abutments for single tooth restorations and hybrid abutment crowns, used in conjunction with endosseous dental implants.

Compatible implant systems and TiBase are as follows.

The KATANA Zirconia ONE For IMPLANT mesostructure material (conforming to ISO 6872:2015) is a pre-sintered zirconia block to be used as the ceramic mesostructure component of a two-piece titanium base abutment. KATANA Zirconia ONE For IMPLANT is compatible with the specified TiBase and the CAD/CAM component of the Sirona Dental CAD/CAM system (K193408, K200191) as identified in the Indications for Use. This device is further processed by the trained professional to make individually designed mesostructure that are milled into the desired shape of a hybrid abutment or hybrid abutment crown.

The Zirconia block has identical composition as our own previously cleared reference device, KATANA Zirconia Block (K190436) under product code "EIH".

The mesostructure material of KATANA Zirconia ONE For IMPLANT is available in shades, A1, A2, A3, A3.5, B1, B2, C1, C2, D2 and NW for flexibility and application variety to meet individual patient needs. The mesostructure material of KATANA Zirconia ONE For IMPLANT is available with one block size and two sizes of access hole, which is small (S) and large (L).

The abutment must be sterilized after the cementation of the CAD/CAM patient matched mesostructure on the pre-manufactured titanium base component. PANAVIA SA Cement Universal (K183537) is used as the cement to set the mesostructure material to TiBase when the mesostructure material of the subject device set to TiBase prior to sterilization.

Dentsply Sirona has issued a letter of authorization indicating that the subject mesostructure material of the subject device can be selected in combination with the CAD/CAM system. Kuraray Noritake Dental and Dentsply Sirona have a business agreement for adding this new material to the Sirona CAD/CAM system. Kuraray Noritake Dental has worked with Dentsply Sirona to implement their new material into the Sirona CAD/CAM system libraries.

KATANA Zirconia ONE For IMPLANT which is the subject of this premarket notification consists of:

• Sirona Dental CAD/CAM System with CEREC Chairside Software or with inLab Software
• Sirona TiBase
• . KATANA Zirconia ONE mesostructured blocks

The provided text is a 510(k) summary for a dental device, specifically a zirconia block for implant mesostructures. It details the device's indications for use, design, material composition, and technical characteristics, comparing it to predicate and reference devices.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state a specific "test set" sample size for a clinical study. The performance evaluation relied on non-clinical testing and comparison to predicate devices, referencing international standards and scientific literature.

• Data Provenance: The document does not specify a country of origin for any data beyond the manufacturer being in Japan. The studies are non-clinical, involving material testing and compatibility assessments. There is no mention of retrospective or prospective data as no human clinical testing was performed.

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

Not applicable. No human clinical testing was performed, and thus no expert ground truth was established for a clinical test set. The ground truth for material properties and performance would be derived from adherence to international standards and non-clinical testing protocols.

4. Adjudication Method for the Test Set

Not applicable. As no clinical test set requiring human interpretation or adjudication was used, this information is not relevant.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states: "No human clinical testing was performed to support the substantial equivalence of the subject device."

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This device is not an AI algorithm. It is a physical dental material (zirconia block) used in a CAD/CAM system. Therefore, the concept of "standalone (algorithm only)" performance is not applicable. The performance is related to the material's physical and mechanical properties, its compatibility with the CAD/CAM system, and its ability to meet structural requirements when fabricated into an abutment.

7. The Type of Ground Truth Used

The ground truth for this device is based on:

• International Standards: Adherence to established ISO standards for ceramic dental materials (ISO 6872:2015) and dynamic fatigue testing for dental implants (ISO 14801:2016).
• Material Composition: Verification of identical chemical composition to a previously cleared reference device (KATANA Zirconia Block, K190436).
• Biocompatibility Standards: Evaluation against ISO 10993 series and ISO 7405.
• Engineering Design Parameters: Validation against specified design parameters for abutment post height, angulation, wall thickness, diameter, and gingival height, consistent with CAD/CAM system requirements and FDA recommendations.
• Compatibility: Confirmation of functional compatibility with the predicate CAD/CAM system (Dentsply Sirona) and associated TiBase components through a business agreement and technical specifications.

8. The Sample Size for the Training Set

Not applicable. This device is a physical material, not an AI/ML algorithm that requires a "training set."

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

Not applicable, as there is no training set for this type of device.

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Use for virtually all etching and bonding needs in restorative dentistry for patients of all ages. Peak Universal Bond is used for desensitizing/sealing of tooth structure.

Peak Universal Bond adhesive bonds to the following materials:

• · Dentin and Enamel
• · Porcelain, Zirconia
• Metal
• · Composite

Peak™M Universal Bond is a bottle, syringe, or unit dose delivered bonding resin. It can be used with selfetch or with total etch techniques. It is 7.5% filled with an ethyl alcohol solvent carrier and will cure with most high intensity lights including LEDs. Peak Universal Bond adhesive contains 0.2% chlorhexidine which may ensure long term bond strengths. Its mode of action produces a mechanical occlusion of dentin tubules by the resins, thus reducing tooth hypersensitivity.

This is a 510(k) premarket notification for a resin tooth bonding agent, not an AI/ML device. Therefore, the requested information regarding acceptance criteria and study details for AI/ML performance is not found in this document.

The document discusses the substantial equivalence of the "Peak Universal Bond" device to a predicate device, focusing on its physical properties, technological characteristics, and indications for use in dentistry. It references non-clinical testing performed to establish this equivalence, specifically to ISO standards for bonding agents.

Here's why the requested information cannot be provided from this document:

• No AI/ML Component: The device, Peak Universal Bond, is a traditional medical device (a resin tooth bonding agent). It does not involve artificial intelligence or machine learning for diagnosis, prognosis, or treatment.
• Non-Clinical Testing: The "study" mentioned is "verification and validation testing" to show substantial equivalence. This involves testing physical properties according to ISO standards (e.g., ISO 29022 for shear bond strength, SEM imaging for dentinal tubule blockage) and simulated use by dental professionals. This is not a clinical study in the typical sense for AI/ML performance, nor does it generate the metrics you've requested.

Therefore, the specific points of inquiry about acceptance criteria, device performance, sample size for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth types are not applicable and not present in this regulatory submission for a conventional dental bonding agent.

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• [1] Direct restorations using light-cured composite resin
• [2] Sealing of a prepared cavity or abutment tooth as a pretreatment for indirect restorations
• [3] Treatment of exposed root surfaces
• [4] Treatment of hypersensitive teeth
• [5] Intraoral repairs of fractured restorations
• [6] Post cementation and core build-ups
• [7] Cementation of indirect restorations

CLEARFIL Universal Bond Quick 2 consists of BOND and K-ETCHANT Syringe. BOND is a light-cure bonding agent that allows for the treatment of dentin, enamel, and prosthetic materials. Depending on the indication, BOND is used as self-etching or with K-ETCHANT Syringe for selective enamel etching or total-etching procedures. BOND is intended to be used for both direct and indirect restorations. CLEARFIL DC Activator activates the dual-curing mechanism of BOND; however, the addition of CLEARFIL DC Activator to the adhesive is not required when using BOND with CLEARFIL DC CORE PLUS, self-adhesive resin cements manufactured by Kuraray Noritake Dental Inc. (Kuraray's self-adhesive cements, e.g. PANAVIA SA Cement Universal) or PANAVIA Veneer LC. K-ETCHANT Syringe is an etching gel that consists of 35 % phosphoric acid aqueous solution and colloidal silica.

This document is a 510(k) Premarket Notification from the FDA regarding a dental bonding agent, CLEARFIL Universal Bond Quick 2. It details the device's indications for use, its substantial equivalence to predicate devices, and the testing performed to demonstrate this equivalence.

Here's an analysis of the acceptance criteria and the study proving the device meets them:

1. Acceptance Criteria Table and Reported Device Performance:

2. Sample Size and Data Provenance:

The document does not explicitly state the sample sizes used for the shear/tensile bond strength or fluoride release testing. It states that "certain tests were performed on this device, in comparison with the primary predicate device..." and references "the results of comparative study."

Regarding data provenance: The applicant, Kuraray Noritake Dental Inc., is based in Japan (1621 Sakazu, Kurashiki, Okayama 710-0801, Japan). The testing appears to be in-house testing performed by the manufacturer to demonstrate substantial equivalence, rather than a large-scale clinical trial with specific regional data. The document mentions "in-house standard" for compliance. The data is retrospective in the sense that it represents a snapshot of the device's performance at the time of submission.

3. Number of Experts and Qualifications:

The document does not mention the use of experts to establish ground truth for a test set. This type of submission relies on physical and chemical performance testing against defined quantitative criteria (e.g., bond strength in MPa). There were no human studies (e.g., diagnostic studies) mentioned that would require expert adjudication.

4. Adjudication Method:

Not applicable. As described above, this submission focuses on objective laboratory performance metrics, not human-read subjective assessments that would require adjudication.

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

No MRMC study was conducted or mentioned. This is a dental bonding agent, not an AI-assisted diagnostic tool. Therefore, there's no concept of human readers improving with AI assistance.

6. Standalone Algorithm Performance:

Not applicable. This is a physical and chemical product, not a software algorithm.

7. Type of Ground Truth Used:

The "ground truth" for this device's performance evaluation is based on pre-defined quantitative performance metrics and physical/chemical properties established through laboratory testing. For example:

• Shear/Tensile Bond Strength: Measured values against a minimum acceptable MPa.
• Depth of Cure: Measured value against a minimum acceptable mm.
• pH: Measured value within a specified range.
• Appearance/Ease of Application/Occlusion of Dentinal Tubules: Qualitative assessment against defined criteria (e.g., "COMPLIES").

These are not "expert consensus," "pathology," or "outcomes data" in the typical sense of a diagnostic or therapeutic clinical study, but rather engineering and material science specifications.

8. Sample Size for the Training Set:

Not applicable. This document describes a traditional medical device (dental material) and its performance validation, not a machine learning model that would require a training set.

9. How Ground Truth for Training Set Was Established:

Not applicable, as there is no training set for this type of device.

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1.Bonding for all Classes of direct composite restoration 2.Bonding for indirect procedures involving metal, porcelain, and composite

DX. Bond V Dental Bonding Adhesive is a multi-purpose dental bonding adhesive for all classes of direct composite restoration as well as for indirect procedures involving metal, porcelain and composite. DX. Bond V is also used for amalgam, self- cure composite and orthodontic brackets bonding. DX. Bond V consists of methylmethacrylates and solvent. After applied to bonding area with thin layer, methylmethacrylates are initiated by free radical with blue light and then polymerized to form cross-linking polymer network resulting in solid and strong bonding membrane. The adhesive is dropped onto a mixing pad before application.

While the provided text describes the 510(k) submission for the DX. Bond V Dental Bonding Adhesive, it does not contain the information requested about acceptance criteria and a study proving the device meets those criteria for an AI/ML-enabled medical device.

The document details the substantial equivalence determination for a dental bonding adhesive, which is a material, not a software-driven or AI-enabled device. Therefore, the questions related to AI/ML device performance, such as:

• Table of acceptance criteria and reported device performance (in terms of AI metrics like sensitivity, specificity, etc.)
• Sample size for test set and data provenance for an AI model
• Number of experts and their qualifications for AI ground truth
• Adjudication method for an AI test set
• Multi-reader multi-case (MRMC) comparative effectiveness study for AI
• Standalone (algorithm-only) performance
• Type of ground truth (e.g., pathology, outcomes data for AI)
• Training set sample size and ground truth establishment for AI

cannot be answered from the provided text.

The document does mention performance data, but these refer to bench testing for a physical material, not an AI algorithm:

• Biocompatibility testing: Cytotoxicity, Sensitivity, Irritation, Acute Systemic toxicity, Genotoxicity (ISO standards)
• Non-clinical performance data (bench testing):
  • Film thickness: ISO 4049:2010
  • Shear bonding: ISO/TS 11405:2015; ISO29022:2013
  • Light sensitivity: ISO 4049:2010
  • Microleakage: ISO/TS 11405:2015

The text explicitly states:

• "Clinical performance data. This section is not applicable."
• "Software verification and validation testing. This section is not applicable."
• "Electrical safety and electromagnetic compatibility (EMC). This section is not applicable."
• "Mechanical and acoustic testing. This section is not applicable."

This further confirms that the device is not software-based or AI-enabled, and therefore, the requested information for AI/ML device evaluation is not present.

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