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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 Ti Base abutments or Pre-Milled Blank abutments are to be sent to a Terrats Medical validated milling center for manufacture.

The purpose of this submission is to add components to the DESS Dental Smart Solutions system, which includes abutments, and prosthetic components cleared previously in various submissions. The previously cleared abutments and prosthetic components are compatible with a variety of original equipment manufacturer (OEM) dental implants as well as DESS Dental Smart Solutions dental implants.

This submission adds various abutments to the OEM implant lines as summarized on the following pages in Table 1 Summary of Subject Device Abutment Designs, and Table 2 Summary of Subject Device Abutment Sizes.

The subject device abutment designs include Healing Abutments, Temporary Abutments, Straight Abutments, Ti Base Abutments, AURUM Base Abutments with a screw channel design that allows easier instrument access to the abutment screw), C-Base Abutments, ELLIPTIBase CoCr Base Abutments, Pre-Milled Blank Abutments, Multi-Unit Abutments (straight), DESSLoc Abutments (Locator-type abutments), and abutment screws.

The provided document is an FDA 510(k) clearance letter for the DESS Dental Smart Solutions, which are endosseous dental implant abutments. This document primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than providing detailed performance data from studies against specific acceptance criteria.

Therefore, the document does not contain the information required to populate a table of acceptance criteria and proven device performance as typically expected for studies proving device efficacy or safety against performance metrics. It does not present specific quantitative performance data for the device.

Based on the content, here's what can be inferred or explicitly stated regarding the study that proves the device meets acceptance criteria:

1. Table of Acceptance Criteria and Reported Device Performance:

As noted above, the document does not present a table of specific performance acceptance criteria (e.g., accuracy, sensitivity, specificity, or other quantitative measures) and the device's reported performance against these criteria. The "Performance Data" section primarily describes non-clinical tests (MR compatibility, dimensional analysis, sterilization validation, shelf-life testing) that demonstrate that the device meets the design specifications and regulatory requirements for substantial equivalence, rather than clinical efficacy or diagnostic accuracy.

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

• Test Set Sample Size: Not applicable in the context of clinical performance data. The non-clinical tests would have their own sample sizes for their specific assessments (e.g., a certain number of abutments for sterilization validation, a certain number of parts for dimensional analysis). These specific numbers are not provided in this summary.
• Data Provenance: The "reverse engineering dimensional analysis" was done for BlueSkyBio implant connections and for Strawmann bone level connections (referenced from previous submissions). For Alpha dent, a contractual agreement provided measurements. No specific country of origin is mentioned for the data itself, but Terrats Medical SL is based in Barcelona, Spain. The document states "No clinical data were included in this submission," indicating a reliance on non-clinical testing and substantial equivalence. The studies referenced are non-clinical in nature.

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

This information is typically relevant for studies involving human interpretation or subjective assessment (e.g., imaging studies). Since "No clinical data were included in this submission," and the evaluation relies on non-clinical testing and engineering analyses, this concept of "experts establishing ground truth" as it pertains to medical image interpretation or clinical outcomes is not applicable here. Ground truth in this context would be engineering specifications and validated test methods.

4. Adjudication Method for the Test Set:

Not applicable, as there is no human interpretation or subjective assessment being adjudicated in the described non-clinical studies.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No. The document explicitly states: "No clinical data were included in this submission." Therefore, an MRMC study comparing human readers with or without AI assistance was not performed or submitted.

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 abutment, not an AI algorithm or software that performs standalone analysis. The "DESS Dental Smart Solutions" in the product name refers to the brand of these physical components, not an intelligent software.

7. The Type of Ground Truth Used:

For the non-clinical tests described:

• Dimensional Analysis: The "ground truth" was established by reverse engineering dimensional analysis of OEM implant bodies, OEM abutments, and OEM abutment screws, or by contractual agreement providing measurements from the OEM manufacturer. This means the OEM specifications and existing components served as the reference.
• Sterilization: The ground truth for sterilization was meeting the sterility assurance level of 10-6 according to ANSI/AAMI/ISO 17665-1 and ANSI/AAMI/ISO TIR 17665-2 for moist heat, and ISO 11137-1 and ISO 11137-2 for gamma irradiation, and bacterial endotoxin testing according to ANSI/AAMI ST72.
• Material properties: Conformance to ASTM F136 for Ti-6Al-4V alloy and ASTM F1537 for Co-Cr-Mo alloy, and ISO 13356 for zirconia.

8. The Sample Size for the Training Set:

Not applicable. This is a physical medical device, not a machine learning or AI algorithm that requires a training set.

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

Not applicable, as no training set was used.

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Blue Sky Bio CAD-CAM Abutments are intended to be used in conjunction with Blue Sky Bio endosseous dental implants in the maxillary or mandibular arch to provide support for single-unit or multi-unit prosthetic restorations. All digitally designed abutments for use with Blue Sky Bio CAD-CAM Abutments are intended to be sent to a Blue Sky Bio validated milling center for manufacture.

The purpose of this submission is to obtain marketing clearance for Blue Sky Bio CAD-CAM Abutments, to be used with compatible components from the Blue Sky Bio Dental Implant System cleared in K051507. K060957, and K102034. The subject device includes Titanium Base Abutments, Cobalt Base Abutments, and Titanium Blank Abutments. For the Titanium Base Abutments and the Cobalt Base Abutments, the final finished device is intended to be used as a two-piece abutment composed of the base bottom-half (titanium base or cobalt base) bonded to a CAD-CAM zirconia top-half. Each abutment type provided in six (6) internal implant connections to the previously-cleared compatible Blue Sky Bio implants (BIO | MAX; BIO | Internal Hex; BIO | Conus 12; BIO | One Stage; and BIO | Trilobe). Titanium Base Abutments are designed for retention of a CAD-CAM fabricated zirconia superstructure and are provided in both straight and 15° angled base designs, and with engaging, non-engaging, and nonengaging conical implant connections. Cobalt Base Abutments are provided in both straight and 15° angled base designs, and with engaging and non-engaging implant connections. Cobalt Base Abutments (Straight) are designed to be a base for a final abutment fabricated by either of two methods. The first method is the same as for the Titanium Base Abutments: a CAD-CAM fabricated zirconia superstructure is bonded to the Cobalt Base Abutment (Straight) and the final two-piece abutment is used for the prosthetic restoration. For the second method, the Cobalt Base Abutments (Straight) can be cast to a straight abutment only, no angulation. The design of the final abutment can be by CAD-CAM, fabricated in wax, and fixed to the Cobalt Base Abutment, or the final design be done using traditional wax-up technique. The final one-piece abutment is fabricated using standard lost wax casting techniques. Cobalt Base Abutments (Angled 15°) are designed to be a base for a CAD-CAM fabricated zirconia superstructure bonded to the Cobalt Base Abutment (Angled 15°) and the final two-piece abutment is used for the prosthetic restoration. Cobalt Base Abutments (Angled 15°) are not to be cast to a final abutment. Titanium Blank Abutments are designed for fabrication of a customized all titanium alloy abutment by CAD-CAM processes. Titanium Blank Abutments have an engaging implant connection. The subject device abutments are made of titanium alloy conforming to ASTM F136 , or cobaltchromium alloy conforming to ASTM F1537. The titanium alloy subject device components are manufactured from identical materials, in the identical facilities using the identical manufacturing processes as used for Blue Sky Bio products cleared previously in K051507, K060957, and K102034. All zirconia superstructures (copings) for use with the subject devices Titanium Base Abutments and Cobalt Base Abutments will be made at a Blue Sky Bio validated milling center under FDA quality system regulations, and the material will conform to ISO 13356. All wax designs for casting to the subject device Cobalt Base Abutments also will be made at a Blue Sky Bio validated milling center. For the lost wax technique, final one piece abutment may be cast in cobalt-chromium alloy or nickel-chromium alloy.

The provided text is a 510(k) Summary for Blue Sky Bio CAD-CAM Abutments, which is a dental device. It focuses on demonstrating substantial equivalence to legally marketed predicate devices rather than providing detailed acceptance criteria and study results for a novel AI/ML device.

Therefore, the document does not contain the information requested in points 1-9 regarding acceptance criteria and a study proving a device meets these criteria for an AI/ML product.

The text describes:

• Device: Blue Sky Bio CAD-CAM Abutments (dental implant components).
• Indications for Use: To be used with Blue Sky Bio endosseous dental implants to support single-unit or multi-unit prosthetic restorations. Digitally designed abutments are sent to a Blue Sky Bio validated milling center for manufacture.
• Performance Data (Non-clinical): Mentions sterilization validation (ISO 17665-1, ISO 17665-2), biocompatibility testing (ISO 10993-5, ISO 10993-12), and static and dynamic compression-bending testing (ISO 14801).
• Clinical Data: Explicitly states "No clinical data were included in this submission."
• Substantial Equivalence: Compares the subject device to various predicate and reference devices in terms of indications for use, design principles, materials, physical dimensions, packaging, and sterilization methods. The mechanical testing (ISO 14801) is mentioned as mitigating minor design differences.

Without information specific to an AI/ML device, I cannot fulfill the request to describe acceptance criteria and a study proving an AI/ML device meets them, nor can I populate the table or provide details on sample size, data provenance, expert involvement, adjudication, MRMC studies, standalone performance, ground truth, or training set details.

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