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Calibra Abutment Resin Cement is indicated for the cementation of: Extraoral assembly of prosthetic components, e.g., structures made of ceramic or zirconia onto custom or pre-fabricated titanium/titanium alloy or zirconia bases/implant inserts/abutments, e.g., InCoris ZI and CEREC Tessera™ Abutment Block prostheses and mesostructures to TiBases.

Calibra Abutment Resin Cement is a two-component, self-cure, high strength self-adhesive cement. Calibra Abutment Resin Cement has the ability to bond to titanium and is chemically compatible with silanated ceramic materials, making it suitable for extraoral assembly of prosthetic components. This self-cure only, opaque shade has been optimized for extraoral assembly when blocking of metal graying or show-through is desired. Cured Calibra Abutment Resin Cement is essentially hydrophobic, minimizing post-cure water sorption, solubility and hygroscopic expansion.

This document describes the Calibra Abutment Resin Cement and its substantial equivalence to predicate devices, based on non-clinical performance testing. It focuses on the physical and chemical properties of the cement rather than an AI/ML powered device. Therefore, a direct response to your detailed questions regarding acceptance criteria and studies that are typical for AI/ML devices involving human readers, training sets, and ground truth establishment (such as those for image analysis, diagnostics, etc.) is not entirely applicable in this context.

However, I can extract the information relevant to non-clinical testing which serves as the "study" demonstrating the device meets its "acceptance criteria" through comparison with existing, legally marketed devices.

Here's a summary of the non-clinical test data and conclusions provided:

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

The document does not explicitly present a table of acceptance criteria with specific numerical targets and the device's reported performance against those targets. Instead, it states that "The results show that the proposed device meets the requirements of the non-clinical bench testing conducted to support substantial equivalence."

The tests conducted and generally accepted properties for dental cements are:

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

This information is not provided in the document. The document refers to "non-clinical bench testing" which typically involves laboratory-controlled conditions. Details on sample sizes for each test, country of origin, or whether the data was retrospective or prospective are not mentioned.

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 information is not applicable as this is not a study involving human interpretation or subjective assessment that would require expert adjudication. The tests are for material properties of a dental cement, assessed objectively in a laboratory setting.

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

This information is not applicable for the reasons stated in 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

This information is not applicable as this is not an AI/ML powered device or a study involving human readers' performance.

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

This information is not applicable as this is not an AI/ML powered device.

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

For the non-clinical tests conducted, the "ground truth" would be established by standardized test methods and material specifications (e.g., ISO standards for dental materials). The performance criteria are derived from these industry standards and the properties of predicate devices.

8. The sample size for the training set

This information is not applicable as this is not an AI/ML device that requires a training set.

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

This information is not applicable as this is not an AI/ML device that requires a training set.

Summary of Relevant Information from the Document:

The regulatory submission for Calibra Abutment Resin Cement (K240888) is based on demonstrating "substantial equivalence" to predicate devices. This is achieved through non-clinical bench testing of the cement's physical and chemical properties and a comparison of its indications for use and technological characteristics with those of established predicate and reference devices.

• Predicate Device: Multilink Hybrid Abutment Cement (K130436)
• Reference Device: Self-Adhesive Resin Cement (K073173)
• Tests Performed: Work time, set time, film thickness, consistency, flexural strength, bond strength to multiple prosthetic components, and biological risk assessment.
• Conclusion: The tests confirmed that the proposed device "meets the requirements of the non-clinical bench testing conducted to support substantial equivalence." The device shares the same intended use, fundamental technology, and similar indications for use as the predicate.

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CEREC Guides are intended to support the dentist or oral surgeon when drilling for placement of dental implants. CEREC Guides are intended to be designed and fabricated using the Sirona Dental CAD/CAM System's CEREC Chairside software and CAM equipment, Galileos Implant dental implant planning software, and Calibra Universal Self-Adhesive Resin Cement.

The CEREC Guide dental surgical guides are milled poly(methyl methacrylate) [PMMA] devices which are designed and fabricated utilizing the Sirona Dental CAD/CAM System with CEREC Chairside Software (K181520) and are intended to act only as dental implant placement templates. The CEREC Guides are designed in the Sirona Dental CAD/CAM System's CEREC Chairside Software utilizing, as an input, a completed dental implant treatment plan which is developed in the "Galileos Implant treatment planning software as cleared under premarket notification K093090.

The CEREC Guide surgical guides are offered in two variants, the CEREC Guide 2 and CEREC Guide 3. Both the CEREC Guide 2 and CEREC Guide 3 are milled from the CEREC Guide Bloc milling blocks. The CEREC Guide Blocs are clear, PMMA blocks intended for milling utilizing the CEREC MC XL family of milling units. CEREC Guide Blocs are offered in two size variants, "medi" and "maxi".

The CEREC Guide 2 surgical guides consist of the surgical guide body milled from the CEREC Guide Bloc PMMA milling blocks. The CEREC Guide 2 surgical guides are used in conjunction with CEREC Guide Drill Keys. CEREC Guide Drill Keys are stainless steel, reusable drill guide instruments which are offered in variants with internal diameters ranging from 2.0 mm to 4.85 mm.

The CEREC Guide 3 surgical guides consist of the CAD/CAM surgical guide body milled from the CEREC Guide Bloc PMMA milling blocks. CEREC Guide 3 surgical guides feature integral titanium guide sleeves that are bonded the CEREC Guide 3 surgical guide body using Dentsply Sirona Calibra® Universal adhesive (K073173). The CEREC Guide 3 Guide Sleeves are single use and are offered in 4 size variants, with outer diameters ranging from 5.5 mm to 6.0 mm, and internal diameters ranging from 4.48 mm - 5.2 mm.

The provided FDA 510(k) premarket notification for "CEREC Guides" focuses on demonstrating substantial equivalence to a predicate device ("SIMPLANT Guide," K170849) through non-clinical performance data. It does not involve a multi-reader multi-case (MRMC) study or artificial intelligence (AI) performance evaluation. Therefore, many of the requested elements for an AI-based device, such as ground truth establishment by experts, adjudication methods, and MRMC study details, are not applicable here.

Here's a breakdown of the available information relevant to acceptance criteria and study proving device performance:

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

The document does not present a formal table of acceptance criteria with specific numerical thresholds and corresponding performance results in the format requested, typical for AI/ML device submissions. Instead, it describes various non-clinical tests conducted to support substantial equivalence. The "acceptance criteria" are implied by the successful completion of these validation tests.

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

The document describes non-clinical bench and validation tests rather than a test set of patient data. Specific sample sizes for these engineering and material tests (e.g., number of guides milled for accuracy, number of drill sleeves tested for retention) are not detailed in this summary. The data provenance is from the manufacturer's internal testing as part of the regulatory submission process.

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

Not applicable. This submission relies on non-clinical engineering and performance testing, not on interpretative performance (like image reading) where expert ground truth is typically established. The "ground truth" for the device's function is its design specifications and physical properties, tested through controlled experiments.

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

Not applicable. There's no human adjudication process described, as it's not a study evaluating human interpretation or AI output against a consensus.

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 MRMC study was done. This device, CEREC Guides, is a physical, milled surgical guide, not an AI or software-assisted diagnostic tool that would typically undergo an MRMC study to assess reader performance. The submission explicitly states: "No human clinical data was included in this premarket notification to support the substantial equivalence of the subject CEREC Guides."

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

Not applicable. This is not an AI algorithm. Its performance is evaluated based on its physical properties, manufacturing accuracy, and integration with existing approved software and hardware. The "device" itself is the physical CEREC Guide.

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

The "ground truth" for the performance tests is based on:

• Design Specifications and Reference Standards: The intended design dimensions and functionalities derived from the Galileos Implant treatment planning software served as the reference for accuracy testing.
• Established Material Properties and Biocompatibility Standards: ISO standards (e.g., ISO 10477, ISO 10993-1) and published literature for material strength and biocompatibility served as the benchmark.
• Validated Disinfection Protocols: FDA and industry guidelines for high-level disinfection processes.

8. The sample size for the training set

Not applicable. This device is not an AI/ML model that requires a training set.

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

Not applicable. As there is no AI/ML model, there is no training set or associated ground truth establishment for a training set.

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DIO CAD/CAM Abutment is intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.

Patient specific abutment is intended for use with the UF Implant Systems provided in the chart. All digitally designed abutments for use with DIO CAD/CAM Abutments are intended to be manufactured at a DIO Corporation validated milling center.

The DIO CAD/CAM Abutment includes two CAD/CAM abutment designs, Hybrid Link Abutment and Patient-Specific Abutment.

1. Hybrid Link abutment: Hybrid Link abutment is intended to provide support for customized prosthetic restorations such as crowns and bridges. The hybrid link abutment is composed of two-piece abutment that is a hybrid link at the bottom and a coping (CAD/CAM patient specific superstructure) at the top. The hybrid link abutments are pre-manufactured (stock) abutments, made from a titanium alloy conforming to ASTM F136. The diameters of Hybrid Link Abutment are 4.0/4.5/5.5mm. Hybrid Link abutment is provided non-sterile therefore must be sterilized after the cementation of the patient-specific superstructure on the Hybrid Link Abutment.

2. Patient-Specific Abutment: Patient-specific abutment is made from titanium alloy conforming to ASTM F136 titanium abutment to be used in fabricating patient-specific abutments. The subject abutments are indicated for cemented or "Screw-and Cement-Retained Prosthesis(SCRP)" restorations. Each patient-specific abutment is individually prescribed by the clinician. The diameters of patient-specific Abutment are 3.0/3.3/3.8/4.0/4.5/5.0/5.5/6.0/6.5/7.0 and two connection designs (Hex, Non-hex). Patient-specific abutments are supplied with an abutment screw previous cleared device as K122519 and K161987 and provided non-sterile.

The document provided is a 510(k) Premarket Notification from the FDA for a dental implant abutment. It does not describe a study involving an AI/ML device, nor does it provide acceptance criteria or performance metrics in the format requested. The document focuses on demonstrating substantial equivalence to predicate devices through material properties, design specifications, and non-clinical testing for dental implant abutments.

Therefore, I cannot provide the requested information regarding acceptance criteria and device performance from this document. The sections you asked for, such as sample size, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details, and ground truth establishment, are not applicable to the content of this 510(k) summary for a physical medical device.

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