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

All digitally designed custom abutments for use with Ti Base abutments are to be sent to a Terrats Medical validated milling center for manufacture.

The purpose of this submission is to expand the DESS Dental Smart Solutions abutment system cleared under K170588 and K173908 to add additional components for previously cleared OEM platform compatibilities and to add additional OEM platform compatibilities for previously cleared DESS abutment designs. In total, this submission includes abutments compatible with 43 implant platforms from 16 OEM implant systems. Note that, because Nobel Active and NobelParallel Conical Connection implants share conical connection platforms, we have shown them as one system for purposes of this submission.

This submission includes abutments compatible with five (5) additional OEM implant systems (11 platforms) and abutments compatible with six (6) additional platforms for OEM implant system compatibilities that were cleared in K170588.

Additional subject device components for previously cleared compatibilities include addition of gingival heights of 1.5 mm and 3.0 mm for titanium bases and addition of 17° and 30° angled multi-unit abutments to the previously cleared straight multi-unit abutments.

Abutment designs and the correlation between each subject device abutment design and the corresponding compatible implant platforms are shown in Table 1 Summary of DESS Components and Abutment Platforms for Compatible Implant Systems.

All abutments are provided non-sterile and each abutment is supplied with the appropriate abutment screw (if applicable) for attachment to the corresponding implant.

All subject device abutments are made of titanium alloy conforming to ASTM F136, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401) or Co-Cr-Mo alloy conforming to ASTM F1537 Standard Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539). All ceramic components of the Ti Base abutments are composed of zirconia conforming to ISO 13356 Implants for surgery - Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP).

This document is a 510(k) premarket notification for DESS Dental Smart Solutions, specifically for endosseous dental implant abutments. It focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a de novo clinical study with acceptance criteria and performance data like a typical medical device AI/ML submission would.

Therefore, the requested information regarding acceptance criteria and performance data in the context of an AI/ML study (e.g., sample sizes for test and training sets, expert qualifications, ground truth establishment, MRMC study, standalone performance) is not applicable to this type of regulatory submission.

The "study that proves the device meets the acceptance criteria" in this context refers to non-clinical testing performed to demonstrate the device's functional equivalence and safety compared to predicates.

Here's a breakdown of the relevant information provided in the document:

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

The document does not present quantitative acceptance criteria or performance metrics in a table. Instead, it relies on demonstrating substantial equivalence to predicate devices through various non-clinical tests and comparisons.

The "acceptance criteria" here are implied to be that the new abutment designs and expanded compatibilities perform equivalently to the predicate devices and meet established standards for dental implants.

The "reported device performance" is described qualitatively as:

• Sterilization validation: According to ISO 17665-1 and ISO 14937.
• Biocompatibility: According to ISO 10993-12. (No new testing performed as materials are identical to cleared predicates).
• Reverse engineering analysis: Of OEM implant bodies, OEM abutments, and OEM abutment screws to confirm compatibility.
• Static compression and compression fatigue testing: According to ISO 14801.
• Dynamic testing: For Multi-unit Abutments Angled according to ISO 14801.

The conclusion states that minor differences in design, dimensions, sizes, or compatible OEM implant lines do not affect substantial equivalence because these differences are either related to compatible OEM implant designs or are mitigated by mechanical performance testing.

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

• Sample Size: The document does not specify exact sample sizes for the mechanical tests (static compression, fatigue, dynamic testing). For instance, ISO 14801 typically requires a minimum of 5 samples for fatigue testing and 3 for static testing, but the document does not provide the exact numbers used for this submission.
• Data Provenance: The tests are non-clinical, likely conducted in a laboratory setting by the manufacturer (Terrats Medical SL) or outsourced labs. The country of origin of this test data is not explicitly stated but would presumably align with the manufacturer's location (Barcelona, Spain) or the testing facilities they contracted. The data is "prospective" in the sense that it was generated for this specific submission, but it's not "clinical" data from patient cohorts.

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

This is not applicable. For this type of mechanical device clearance, "ground truth" is established by engineering specifications, material standards (e.g., ASTM, ISO), and established testing methodologies, not by expert consensus on clinical data. No human experts are used to "read" or "interpret" test results in the same way they would for medical images.

4. Adjudication method for the test set

This is not applicable. "Adjudication" typically refers to resolving discrepancies in expert interpretations of clinical data (e.g., for ground truth establishment). Since this submission involves non-clinical mechanical testing, there is no need for such an adjudication method. Test results are compared against predetermined engineering specifications and standards.

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 is not applicable. This submission is for dental implant abutments, a physical medical device, not an AI/ML algorithm that assists human readers.

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

This is not applicable. This is a hardware device, not a software algorithm.

7. The type of ground truth used

The "ground truth" for demonstrating substantial equivalence for this device is based on:

• Engineering specifications and design parameters: For abutment dimensions, materials, and connections.
• International standards: Such as ISO 14801 (dynamic fatigue test), ISO 17665-1 (sterilization), ISO 14937 (sterilization), and ISO 10993-12 (biocompatibility).
• Material specifications: Conforming to ASTM F136 (titanium alloy), ASTM F1537 (Co-Cr-Mo alloy), and ISO 13356 (zirconia).
• Compatibility analysis: Through reverse engineering of OEM implant bodies and abutment screws.

8. The sample size for the training set

This is not applicable. There is no "training set" in the context of an AI/ML model for this device.

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

This is not applicable. There is no "training set" for this device.

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