(89 days)
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.
The purpose of this submission is to add components to the DESS Dental Smart Solutions system, which includes abutments compatible with a variety of original equipment manufacturers (OEM) of dental implants. This submission adds abutments, designated DESS Multi-Unit Abutments, for implant lines from Zimmer Dental and Biomet 31 (now collectively, ZimVie Dental). The subject device abutments include Multi-Unit Abutments in straight, 17° angled, and 30° angled designs, which are compatible with implants having internal hex connections. This submission is also to change how previously cleared devices are provided; the change is from previously provided nonsterile to now provided sterile. All abutments are provided with the appropriate abutment screw (if applicable) for attachment to the corresponding implant. The subject device is only intended for multi-unit restorations such as bridges and bars.
It appears there might be a misunderstanding of the provided text. The document is a 510(k) premarket notification for a dental implant abutment, not an AI/ML medical device. Therefore, the information typically required for describing an AI/ML device's acceptance criteria and study data (like sample sizes for test and training sets, expert qualifications, ground truth establishment, MRMC studies, or standalone performance) is not present.
The document discusses the substantial equivalence of the DESS Dental Smart Solutions abutment to legally marketed predicate devices. The "performance data" section refers to non-clinical testing to demonstrate the device's physical properties and compatibility, not a study evaluating an AI algorithm's diagnostic or predictive performance.
Let's break down what can be extracted from the provided text relevant to the device's acceptance, and then explain why the AI/ML specific questions cannot be answered.
Understanding the Device and its "Acceptance":
The "acceptance" in this context refers to the FDA's determination that the new DESS Dental Smart Solutions abutments are "substantially equivalent" to predicate devices already on the market. This determination is based on the device having the same intended use and similar technological characteristics (design, materials, performance via non-clinical testing).
Here's a summary of the information available in the document:
1. Table of Acceptance Criteria (or rather, Equivalence Criteria) and Reported Device Performance:
The document doesn't present acceptance criteria in a quantitative table with performance metrics like sensitivity, specificity, or accuracy, as would be common for an AI/ML device. Instead, "acceptance" is based on demonstrating substantial equivalence to predicate devices across several characteristics. The performance is shown through non-clinical testing to ensure safety and functionality.
| Characteristic | Subject Device (DESS Dental Smart Solutions, K231434) | Primary Predicate (K230143, DESS Dental Smart Solutions) | Reference Device (K213063, TLX SRAs and TLX Gold Abutments) | Reported Performance (Non-Clinical Data) |
|---|---|---|---|---|
| Intended Use | 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. | DESS Multi-Unit Abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for prosthetic restorations. | Functional and esthetic rehabilitation of the edentulous mandible or maxilla | Stated as "same intended use" as predicates. |
| Abutment Designs/Types | Multi-Unit, straight (0°), 17° angled, 30° angled | Multi-Unit, straight (0°), 17° angled, 30° angled | Multi-Unit, TLX SRA: 17°, 30°; TLX Gold: 0°, and up to 30° | Similar to predicates. |
| Prosthesis Attachment | Screw Retained | Screw Retained | Screw Retained | Similar to predicates. |
| Restoration | Multi-unit | Multi-unit | Multi-unit | Similar to predicates. |
| Prosthetic Interface Connections | Internal hex, External hex | Internal hex, Internal conical | Internal conical | Similar to predicates, with some variations noted and justified. |
| Abutment/Implant Platform Diameter | 2.9 - 5.7 mm | 3.0 - 4.5 mm | TLX SRA: 6 mm; TLX Gold: 4.0 (NT), 5.0 (RT), and 7.0 (WT) | Within similar ranges or justified compatibility. |
| Prosthetic Platform Diameter | 4.8 mm | 4.8 mm | TLX SRA: 4.6 mm; TLX Gold: not provided in 510(k) Summary | Similar to predicates. |
| Gingival Height | 1 mm - 5 mm | 1 mm - 5 mm | Not provided in 510(k) Summary | Similar to predicates. |
| Abutment Material | Ti-6Al-4V ELI (Titanium alloy) | Ti-6Al-4V ELI (Titanium alloy) | TLX SRA: Ti-6Al-7Nb; TLX Gold: Ceramicor® | Similar (titanium alloys). Biocompatibility tested (ISO 10993-5 referenced). |
| Abutment Screw Material | Ti-6Al-4V ELI (Titanium alloy) | Ti-6Al-4V ELI (Titanium alloy) | Ti-6Al-7Nb | Similar (titanium alloys). |
| How Provided (Sterilization) | Non-sterile, and sterile by gamma irradiation | Non-sterile | TLX SRA: Sterile by gamma irradiation; TLX Gold: non-sterile | Both non-sterile and sterile options justified via reference devices/testing (e.g., K212538 for gamma, K22269 for moist heat). |
| Usage | Single patient, single use | Single patient, single use | Single patient, single use | Identical. |
| Mechanical Performance | Evaluated according to ISO 14801 (mechanical testing); Engineering analysis for new worst-case constructs. | Referenced | - | Demonstrated to not create a new worst-case or met ISO 14801. |
| MR Safety | Evaluated according to ASTM F2052, ASTM F2213, ASTM F2182, ASTM F2119. | - | - | Non-clinical analysis provided to evaluate metallic devices in MR environment. |
| Sterility & Shelf Life | Refer to K22269 (moist heat), K212538 (gamma irradiation, bacterial endotoxin, shelf life). | Referenced | - | Validated to SAL of 10^-6, met bacterial endotoxin limits, and 5-year shelf life after accelerated aging. |
Important Note: The "acceptance criteria" here are qualitative statements of substantial equivalence, backed by quantitative non-clinical engineering and materials testing, not performance metrics from a clinical study or an AI model's accuracy.
Regarding the AI/ML Specific Questions:
2. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not applicable. This document is for a physical medical device (dental implant abutment), not an AI/ML algorithm. There is no "test set" in the context of data for an AI/ML model. The "testing" refers to mechanical, material, and sterilization validation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth establishment by experts is relevant for AI/ML diagnostic devices. This device's performance is assessed through engineering standards and material properties. Compatibility with implant systems is established through design agreements and reverse engineering data (referenced from K170588).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are used in clinical studies or for establishing ground truth labels for AI/ML datasets.
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. MRMC studies are for evaluating diagnostic efficacy, particularly with AI assistance. This device is a passive prosthetic component.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. There is no algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. The "ground truth" for this device's performance is its adherence to engineering standards (e.g., ISO 14801 for mechanical properties, ASTM for materials/MR safety) and its demonstrated compatibility with specified implant systems, rather than a clinical ground truth like disease presence.
8. The sample size for the training set:
- Not applicable. There is no AI model or training set.
9. How the ground truth for the training set was established:
- Not applicable. As above, no AI model or training set.
Conclusion from the document:
The provided document describes a 510(k) submission for a Class II medical device, DESS Dental Smart Solutions abutments. The "acceptance criteria" revolve around demonstrating substantial equivalence to existing legally marketed predicate devices. This is achieved through:
- Identical intended use.
- Similar technological characteristics: This includes materials (Titanium alloy), design (multi-unit, screw-retained), and geometric parameters (diameters, gingival heights).
- Performance via non-clinical testing: This includes mechanical testing (ISO 14801), MR safety testing (ASTM standards), sterilization validation (ANSI/AAMI/ISO standards), bacterial endotoxin testing (ANSI/AAMI ST72), shelf-life testing (ASTM F1980), and biocompatibility testing (ISO 10993-5).
- Compatibility with specified implant systems: This is supported by contractual agreements with OEMs (ZimVie/Terrats Medical SL) and referenced reverse engineering data.
The document explicitly states: "No clinical data were included in this submission." This further confirms that the evaluation framework is entirely non-clinical and does not involve AI/ML performance metrics, studies with human readers, or expert ground truthing as one would see for an AI-powered diagnostic tool.
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)