(417 days)
The TDS (TECHWIN DENTAL SYSTEM) are prefabricated prosthetic components for direct connection to endosseous dental implants and are intended to be used as an aid in prosthetic rehabilitation. It is intended for use in edentulous and partially edentulous patients with established bone and completed growth period to support single unit prosthetic restorations in the mandible or maxilla. It is intended for one-stage and two-stage surgical procedures. This system is intended for delayed loading.
The TDS (TECHWIN DENTAL SYSTEM), made of Ti-6A1-4V ELI alloy (ASTM F136), is intended for use in conjunction with the appliance in partially or fully edentulous mandibles and maxillae to support single-unit loading (i.e., crown). It consists of the Dual Abutment and Healing Abutment. The surface of the abutments is uncoated or partially or half coated with TiN using AIP (Arc Ion Plating). The implant-to-abutment interface remains uncoated. All abutments are supplied non-sterile and must be autoclaved by the end-user.
This looks like a 510(k) premarket notification for a dental implant abutment system, not a software or AI-enabled device. Therefore, the detailed information about acceptance criteria, study design, sample sizes, ground truth establishment, expert adjudication, or MRMC studies for an AI/software device wouldn't be present in this document.
The document describes the acceptance criteria for the TDS (TECHWIN DENTAL SYSTEM) primarily through demonstrating substantial equivalence to an existing predicate device (K160536, Chaorum Implant System / Medimecca Co., Ltd.) through non-clinical testing.
Here's a breakdown of the information that can be extracted relevant to acceptance criteria and the studies performed, while noting the absence of AI/software-specific details:
1. Table of Acceptance Criteria and Reported Device Performance
Instead of performance metrics like sensitivity, specificity, or AUC for an AI device, the "acceptance criteria" for this physical device are met by demonstrating comparable properties and performance to the predicate device through various non-clinical tests.
| Acceptance Criteria Category | Specific Criteria / Test Type | Reported Device Performance (TDS - TECHWIN DENTAL SYSTEM) |
|---|---|---|
| Biocompatibility | Adherence to ISO 10993-1, ISO 7405, ISO 10993-5, ISO 10993-10, ISO 10993-23, ISO 10993-6 requirements. | Fulfilled all required testing; demonstrated to be substantially equivalent to predicate device. |
| Surface Treatment | Chemical composition analysis, SEM, surface roughness, coating thickness/porosity, mean volume percent of voids, abrasion characteristics. | Conducted in-house analysis for these parameters. |
| Sterilization | Validation of moist heat sterilization according to ISO 17665-1 and ISO/TS 17665-2. | Demonstrated a Sterility Assurance Level (SAL) of 10^-6. |
| MRI Safety | Assessment of magnetically induced displacement force and torque based on FDA guidance and scientific rationale. | Non-clinical worst-case MRI review performed using scientific rationale and published literature. |
| Compatibility (Reverse Engineering) | Precise measurements of implant-abutment interfaces, tolerances, and connection geometries. | Performed to ensure compatibility with third-party implants (OEM implant bodies, OEM abutments, and OEM abutment screws). |
| Material | Ti-6Al-4V ELI Titanium Alloy (for mechanical properties and biocompatibility). | Ti-6Al-4V ELI offers improved mechanical properties and biocompatibility compared to predicate's Titanium Grade 4. |
| Intended Use | Aid in prosthetic rehabilitation for single-unit restorations in edentulous and partially edentulous patients with established bone and completed growth. Intended for one-stage surgical procedures and delayed loading. | Similar intended use to predicate, with a more conservative approach (single-unit loading only) which doesn't introduce additional risks. |
| Form/Fit/Function (Dimensions) | Comparison of various dimensions (diameter, post height, gingival height, total length) with predicate device. | Minor differences in dimensions (diameter, post height, gingival height, length) noted but deemed to meet individual patient needs without compromising performance or safety. These differences do not raise new safety or effectiveness issues. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable in the context of an AI/software test set. For the non-clinical tests, specific sample sizes for material tests or sterilization validation are not detailed in this summary but would be part of the full submission.
- Data Provenance: The tests are non-clinical, primarily laboratory-based, and compare the subject device's properties against established international standards and the predicate device's characteristics. The company is based in the Republic of Korea.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This is not applicable as there is no "ground truth" to be established by experts in the context of an AI/software's diagnostic performance. The evaluations are based on engineering and material science standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable as this is not an AI/software diagnostic performance study requiring expert 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
- No. This is a physical medical device (dental implant abutment system), not an AI-enabled device. Therefore, no MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable to this type of device submission. The "truth" is based on the adherence of the device's physical, chemical, and biological properties to established international standards and the characteristics of the legally marketed predicate device.
8. The sample size for the training set
- Not applicable. This is not an AI/software device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/software device.
§ 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.)