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DESS Dental Smart Solutions abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for prosthetic restorations.

All digitally designed custom abutments for use with DESS Bases or Pre-milled Blanks are to be sent to a Terrats Medical validated milling center for manufacture, or to be designed and manufactured according to the digital dentistry workflow. The digital dentistry workflow integrates multiple components: scan files from intra-oral and lab (desktop) scanners, CAD software, CAM software, ceramic material, milling machine, and associated tooling and accessories.

The purpose of this submission is to expand the DESS Dental Smart Solutions abutment system cleared under K221301 and K240982 to allow additional options of zirconia material, scanners, CAM software, and milling machines to the digital dentistry workflow. The subject devices are to be sent to Terrats Medical validated milling centers for manufacture, or to be designed and manufactured via a digital dentistry workflow. The digital dentistry workflow integrates multiple components: scan files from intra-oral and lab (desktop) scanners, CAD software, CAM software, titanium and ceramic material, milling machine, and associated tooling and accessories. There are no changes to the abutment design, implant compatibilities, or design parameters. All part numbers have been cleared for manufacturing via a validated milling center and digital dentistry workflows (also referred to as point of care) under K221301 and K240982.

The subject device DESS Dental Smart Solutions abutments provide a range of prosthetic solutions for dental implant restoration. DESS abutments are offered in a variety of connection types to enable compatibility with currently marketed dental implants. All abutments are provided non-sterile, and each abutment is supplied with the appropriate abutment screw (if applicable) for attachment to the corresponding implant.

Subject device Base Abutments are designed for fabrication of a patient-specific CAD/CAM zirconia superstructure on which a crown may be placed. They are two-piece abutments for which the second part (or top half) is the ceramic superstructure. They also may be used for support of a crown directly on the abutment.

All patient-specific custom abutment fabrication for Base Abutments and Pre-milled (Blank) Abutments is by prescription on the order of the clinician. The subject device Pre-milled (Blank) Abutments and all zirconia superstructures for use with the subject device Ti Base Interface, DESS Aurum Base, ELLIPTIBase, and DESS C-Base will be manufactured using a validated milling center or a digital dentistry workflow. A validated milling center will be under FDA quality system regulations. The digital dentistry workflow scans files from intra-oral and lab (desktop) scanners, CAD software, CAM software, titanium and ceramic material, milling machine and associated tooling and accessories.

The digital dentistry workflow uses scan files from intra-oral and lab (desktop) scanners, CAD software, CAM software, ceramic material, milling machine and associated tooling and accessories.

The provided 510(k) summary for DESS Dental Smart Solutions focuses on demonstrating substantial equivalence to predicate devices for dental implant abutments. It primarily addresses the expansion of compatible materials, scanners, CAM software, and milling machines within an existing digital dentistry workflow. The document does not describe an AI/ML-based device that would typically have acceptance criteria related to diagnostic performance.

Therefore, many of the requested items related to AI/ML device performance (like acceptance criteria for diagnostic metrics, sample size for test sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, and training set details) are not applicable to this submission.

The acceptance criteria and supporting "study" (non-clinical data) for this device are related to its mechanical performance, biocompatibility, and integration within the digital workflow, demonstrating that the expanded components maintain the safety and effectiveness of the previously cleared predicate devices.

Here's a breakdown based on the information provided and the non-applicability of AI/ML-specific questions:

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

Since this is not an AI/ML diagnostic device, the acceptance criteria are not in terms of traditional diagnostic metrics (sensitivity, specificity, AUC). Instead, they are related to material properties, mechanical integrity, and the digital workflow's accuracy.

• Abutment design library validated to demonstrate established design limitations are locked and cannot be modified by the user. (Implies successful implementation and verification of design constraints.) |
  | CAM Restriction Zones / Manufacturing Accuracy | - Validation testing of CAM restriction zones conducted, including verification to show avoidance of damage or modifications of the connection geometry, and locking of restriction zones from user editing in CAM software. (Implies successful validation to ensure manufacturing precision and prevent damage.) |
  | Material Conformance | - Zirconia materials conform to ISO 6872.
• Titanium alloy conforms to ASTM F136.
• Co-Cr-Mo alloy conforms to ASTM F15337. (Implies materials meet standards.) |
  | Physical Dimensions | - Device encompasses the same range of physical dimensions as the predicate device. (Implies dimensional equivalence.) |

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 in terms of a "test set" for diagnostic performance. The validation involved physical testing of components (e.g., fatigue testing) and software verification. The specific number of abutments or digital design instances used for these non-clinical tests is not detailed in this summary.
• Data Provenance: Not applicable in the context of patient data for an AI/ML device. The "data" here refers to engineering and material testing results, likely conducted in controlled lab environments (implied to be in accordance with international standards like ISO and ASTM). The manufacturer is Terrats Medical SL, in Spain, so testing would likely originate from their facilities or contracted labs.

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)

Not applicable. This is not a diagnostic device requiring expert interpretation for ground truth. The "ground truth" for this device relates to engineering specifications and material science.

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

Not applicable. This is not a diagnostic device involving expert review 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 not an AI-assisted diagnostic tool.

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

Not applicable. This is not an AI/ML algorithm.

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

For this device, the "ground truth" is based on:

• Engineering Specifications: Defined design parameters (e.g., minimum wall thickness, post height, angulation limits).
• Material Standards: Conformance to international standards such as ASTM F136, ISO 6872.
• Benchmarking/Predicate Equivalence: Performance is assessed against established performance of the predicate devices and OEM implant systems.
• Software Validation Logic: Verification that software correctly enforces design rules and CAD/CAM restrictions.

8. The sample size for the training set

Not applicable. This device does not involve a machine learning training set.

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

Not applicable. This device does not involve a machine learning training set.

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Dental Zirconia Blank are used for dental restorations using different CAD/CAM or manual milling machines. All blanks are processed through dental laboratories or by dental professionals.

Dental Zirconia Blank are derived from zirconia powder that has been processed into their final shapes. These blanks are then being further fabricated into all-ceramic restorations such as crowns, bridges, veneers, inlay/onlay. The zirconia powder is composed of ZrO2+ Y2O3+ HfO2+ Al2O3 with its composition conforms to ISO 13356, Implants for surgery - Ceramic materials based on yttriastabilized tetragonal zirconia (Y-TZP). The performance of the dental blanks conforms to ISO 6872. Dentistry - Ceramic materials.

Dental Zirconia Blank are derived from the same Zirconia powder as the regular Dental Zirconia Blank with the addition of very small amount of inorganic pigments before the composite material is processed into their final net shapes. These blanks are then being further fabricated into all-ceramic restorations such as crowns, bridges, veneers, inlay/onlay. The purpose of the inorganic pigments is to generate the color on the prosthetic dental devices, after sintering at dental labs, that matches natural color of patient's teeth. The performance of the dental blanks conforms to ISO 6872, Dentistry - Ceramic materials.

The retrieved document is a 510(k) summary for a dental device (Dental Zirconia Blank). It is a regulatory submission demonstrating substantial equivalence to a predicate device, not a study designed to prove the device meets specific performance acceptance criteria for an AI/software product. Therefore, much of the requested information (sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) is not applicable to this document.

However, the document does contain information about non-clinical testing and general acceptance of these tests based on existing standards.

Here's a breakdown of the relevant information from the document:

1. Table of acceptance criteria and the reported device performance:

The document states that "Bench testing was performed per ISO 6872:2015 and internal procedures to ensure that the Dental Zirconia Blank met its specifications. All tests were verified to meet acceptance criteria." While specific numerical acceptance criteria are not tabulated, the document explicitly states that the tests passed these criteria. The relevant tests and their reported performance are:

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

The document primarily discusses non-clinical bench testing and in vitro and in vivo biocompatibility tests, not a "test set" in the context of an AI/software solution. Therefore, information about a test set sample size or data provenance in that sense is not provided. The biocompatibility tests, however, would have involved animal models (Syrian hamsters, guinea pigs, rats, ICR mice, rabbits), which would constitute the "test set" for those specific biological evaluations. The document does not specify the number of animals used for each test. The testing was conducted by or on behalf of HUNAN CERAMASTER MATERIAL TECHNOLOGY CO.,LTD, located in China. The "provenance" of the data is therefore China. The nature of these tests is prospective for the specific evaluations conducted.

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)

Not applicable. This is a material science and biocompatibility assessment for a dental zirconia blank, not an AI/software device requiring expert interpretation for ground truth establishment.

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

Not applicable. This type of adjudication is typically used for human-reviewed data in AI/software evaluations.

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 a physical dental material, not an AI-assisted diagnostic or therapeutic device.

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

Not applicable. This is not an algorithm or software device. Bench testing and biocompatibility studies evaluate the material's properties directly.

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

The "ground truth" for the non-clinical tests is established by recognized international standards (ISO 6872:2015 for material properties, ISO 10993 series and ISO 7405:2018 for biocompatibility). The acceptance criteria outlined in these standards serve as the "ground truth" to determine if the device meets its specifications. For biocompatibility tests, the outcomes observed in the biological test systems (e.g., cell viability, tissue response, animal health) against the defined parameters of the ISO standards constitute the "ground truth."

8. The sample size for the training set

Not applicable. There is no AI algorithm or "training set" involved in the testing described for this dental material.

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

Not applicable. Since there is no training set, this question is not relevant.

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s-Clean Link 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.

s-Clean Link Abutment is intended for use with the Dentis s-Clean s-Line and Dentis s-Clean s-Line Mini according to connector part in the chart. All digitally designed zirconia for use with s-Clean Link Abutment are intended to be manufactured at a Dentis validated milling center.

The s-Clean Link Abutment is intended to provide support for customized prosthetic restorations such as crowns and bridges. The s-Clean Link Abutment is composed of two-piece abutment that is a link abutment at the bottom, a coping (CAD/CAM patient specific superstructure) at the top and screw. The bottom link abutment portion of the s-Clean Link Abutment is pre-manufactured (stock) made from a titanium alloy conforming to ASTM F136. The Top half of the s-Clean Link Abutment is composed of zirconia conforming to ISO 6872 reference to prior cleared ceramic, K141724.

s-Clean Abutment Screw s-Line is made of Ti-6AI-4V ELI (ASTM F136)

The diameters of s-Clean Link Abutment are 4.5 and 4.8mm.

s-Clean Link Abutment is provided non-sterile therefore must be sterilized after the cementation of the patientspecific superstructure on the Link Abutment.

The proposed devices are compatible with the following device.

Raw material blanks

• K141724, Upcera Dental Zirconia Blank & Dental Zircornia Pre-Shaded Blank by Liaoning Upcera Co.. Ltd.
  Raw material cement
• K191122, 3M RelyX Pediatric Resin Modified Glass Ionomer Cement by 3M ESPE Dental Product .
  The coping that composes the final abutment should be designed and milled through the CAD/CAM software, according to the prosthetic planning and patient clinical situation. The coping and crowns designed using these or more recent versions of the CAD/CAM System, within the design limits as defined within the design software, are compatible with the link abutment.

The coping would be manufactured by Dentis only with design input using CAD/CAM Software from and by Dentis milling center.

Design Limitation for Superstructure:

| | Zirconia for s-Clean Link Abutment
Regular | Zirconia for s-Clean Link Abutment
Mini |
|-------------------------------------------------------------|-----------------------------------------------|--------------------------------------------|
| Minimum wall thickness | 0.5 | 0.5 |
| Minimum/Maximum Post Height for
single-unit restorations | 4.45 | 4.45 |
| Maximum gingival height in the
zirconia superstructure | 0 | 0 |
| Minimum gingival height in the Link
Abutment | 1 | 1 |
| Maximum angulation | 0 | 0 |

This FDA 510(k) summary focuses on demonstrating substantial equivalence of the s-Clean Link Abutment to a predicate device, rather than providing a detailed study proving the device meets specific performance acceptance criteria in the context of an AI/ML medical device. The document describes a dental implant abutment, which is a physical device, not an AI/ML algorithm.

Therefore, the requested information regarding AI/ML device performance, such as sample sizes for test/training sets, expert consensus for ground truth, MRMC studies, and human-in-the-loop performance, is not applicable to the provided document.

The document primarily addresses non-clinical testing for a physical medical device. Here's a breakdown of the relevant information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present "acceptance criteria" in the typical quantitative performance metrics sense for an AI/ML device (e.g., sensitivity, specificity thresholds). Instead, it demonstrates "substantial equivalence" to a predicate device based on design, materials, indications for use, and non-clinical testing.

The key "performance" is demonstrated through:

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

• Test Set (Non-Clinical): Not directly applicable in the terms of a "test set" for an AI/ML algorithm. For the physical device, non-clinical tests (sterilization, biocompatibility, cytotoxicity) were performed. The sample sizes for these specific lab tests are not detailed in this summary document, but standard methods for such tests typically involve a sufficient number of samples to ensure statistical validity for the physical properties being measured.
• Data Provenance: Not applicable as it's not a data-driven AI/ML study. The data provenance would refer to the lab where tests were conducted which is not specified.

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

• Not applicable. Ground truth, in the context of an AI/ML device, is established by expert annotation or clinical outcomes. For this physical dental abutment, "ground truth" is established by manufacturing specifications, material standards, and benchmark testing against established predicate devices and recognized international standards (e.g., ISO, ASTM, AAMI).

4. Adjudication method for the test set:

• Not applicable. This is relevant for clinical studies or expert labeling in AI/ML.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

• No. This is explicitly stated: "Clinical testing was not necessary to establish substantial equivalency of the device." MRMC studies are for assessing diagnostic or clinical performance with human readers.

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

• Not applicable. This device is a physical dental implant component, not an algorithm.

7. The type of ground truth used:

• For a physical device, "ground truth" refers to compliance with material specifications (e.g., ASTM F136 for titanium alloy, ISO 6872 for zirconia), design parameters, and the results of standardized non-clinical performance tests (e.g., sterilization effectiveness, biocompatibility). The predicate device (DIO CAD/CAM Abutment, K181037) also serves as a "ground truth" for substantial equivalence comparison.

8. The sample size for the training set:

• Not applicable. There is no "training set" for a physical device.

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

• Not applicable. There is no "training set" for a physical device.

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Dental Zirconia Blocks are intended for use for the production of artificial teeth in fixed or removable dentures, or for jacket crowns, facing, and veneers. All Blocks are processed through dental laboratories or by dental professionals.

The proposed device, Dental Zirconia Blocks, are derived from zirconia powder, usually using CAD / CAM (computer aided design / computer aided manufacturing) method of making all-ceramic restorations such as crowns.bridges.veneers.inlay, with high strength, hardness, good resistance to fracture toughness and wear resistance. They are available in different models that differ in various specification and color. Two main models for Dental Zirconia Block are CMW series and CMC series in which CMW series represents the White Zirconia(W1,W2 and W3) and the CMC series represents the Color Zirconia (A1,A2,A3,A3.5,A4,B1,B2, B3,B4,C1,C2,C3,C4,D1,D2,D3,D4,T1,T2 and T3). The white zirconia is composed of ZrO2+HfO2+YzOs and an additional inorganic pigment: Al₂O3 and Other oxide. The colour zirconia are derived from the same zirconia powder as the regular white zirconia powder, with the addition of very small amount of inorganic pigments: Fe2O3 +Pr2O3 +Er2O3. The inorganic pigments generate the color on the prosthetic dental device, after sintering at dental labs, that matches natural color of patient's teeth. The composition of the Dental Zirconia Blocks including the white zirconia and the colour zirconia conforms to ISO 13356:2015, Implants for surgery -Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP) and the performance conforms to ISO 6872:2015/Amd1:2018, Dentistry: Ceramic Materials. The Dental Zirconia Blocks are provided as non-sterile.

The provided text describes the 510(k) summary for the "Dental Zirconia Blocks" device (K192262). This document focuses on demonstrating substantial equivalence to a predicate device, rather than performing a clinical study with acceptance criteria for a novel AI/software medical device.

Therefore, the requested information regarding acceptance criteria, study design, sample sizes, expert ground truth, adjudication methods, multi-reader multi-case studies, standalone performance, and training set details for an AI/software device cannot be extracted from this document.

This document describes a traditional medical device (dental zirconia blocks) and the testing performed is for physical and chemical properties, as well as biocompatibility, against established international standards.

For completeness, here's a summary of the testing performed and conclusions drawn from the provided text, adapted as much as possible to the prompt's structure, but it's important to reiterate that this is not an AI/software device study.

1. Table of Acceptance Criteria and Reported Device Performance

The device is evaluated against various ISO standards. The document states that the proposed device "met all design specifications" and "complies with" these standards. The "acceptance criteria" are implied by the requirements of these standards.

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New Century All-Ceramic Dental Zirconia Blocks (Un-Shaded & Pre-Shaded) are intended for use with CAD/CAM technology to produce all ceramic dental restorations (full contour crowns, bridges, inlays, and Veneers) as prescribed by a dentist.

New Century All-Ceramic Dental Zirconia Blocks (Un-Shaded) are derived from Zirconia powder that has been processed into their final net shapes. These blanks are then further fabricated into all-ceramic restorations such as crowns, bridges, veneers, inlay/ onlay. The zirconia powder is composed of ZrO2 + Y2O3 + HfO2 + A12O2. The performance of the dental blanks conforms to ISO 6872: 2008, Dentistry: Ceramic Materials. The shading effects of New Century All-Ceramic Dental Zirconia Blocks (Pre-Shaded) are achieved by blending different zirconia powder material, all from the same supplier; have almost identical composition, differing only in the trace amount of inorganic pigments to achieve the shading effects in dental blanks. The performance of the preshaded dental zirconia blanks also conforms to ISO 6872, Dentistry: Ceramic Materials.

The provided text describes a 510(k) premarket notification for "New Century All-Ceramic Dental Zirconia Blocks (Un-Shaded & Pre-Shaded)". This is a submission for a medical device used in dentistry, specifically for CAD/CAM technology to produce dental restorations. It is not a submission for an AI/ML device.

Therefore, most of the questions regarding acceptance criteria, study design for AI devices, sample sizes for test and training sets, expert ground truth, adjudication methods, MRMC studies, and standalone algorithm performance are not applicable to this document. The document focuses on demonstrating substantial equivalence to a predicate device (K140070 Luxer Shaded Zirconia) based on non-clinical performance testing and technological comparison.

However, I can extract the information that is present in the document which relates to performance and criteria.

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

The document states that bench testing was performed per ISO 6872:2008 and using internal testing procedures (for presintered and sintered density) to ensure that the device met specifications. It explicitly mentions:

"All tests were verified to meet acceptance criteria."

The specific acceptance criteria from ISO 6872:2008 are not detailed in the provided text, but the document confirms compliance. The device also underwent a biocompatibility assessment in accordance with ISO 10993-1.

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

The document does not specify sample sizes for the non-clinical bench tests. The tests were performed "per ISO 6872:2008 and using internal testing procedures." The provenance of the data is implied to be from the manufacturer, Shanghai New Century Dental Materials Co., Ltd. in China, as they performed the tests.

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 not applicable as it is not an AI/ML device requiring clinical expert ground truth for interpretation. The "ground truth" here refers to the measured physical and mechanical properties of the material against established standards (ISO 6872:2008).

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

Not applicable for a non-AI/ML device.

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 for a non-AI/ML device.

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

Not applicable for a non-AI/ML device.

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

The "ground truth" for this device's performance is objective measurement against established international standards for ceramic dental materials (ISO 6872:2008) and internal specifications for density.

8. The sample size for the training set

Not applicable for a non-AI/ML device.

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

Not applicable for a non-AI/ML device.

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