(192 days)
s-Clean Pre-Milled 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 Pre-Milled Abutment is intended for use with the s-Clean SQ-SL Fixtures in the chart. All digitally designed abutments for use with s-Clean Pre-Milled Abutment are intended to be manufactured at a Dentis validated milling center.
Patient-specific abutment is made from titanium alloy conforming to ASTM F136 titanium abutment to be used in fabricating patient-specific abutments. The subject abutments are indicated for cemented or "Screw-and Cement-Retained Prosthesis(SCRP)" restorations. Each patient-specific abutment is individually prescribed by the clinician.
The diameters of patient-specific abutment are 5.8, 6.8mm and two connection designs (Hex, Non-hex).
Patient-Specific Abutment is compatible with following Implant Systems:
Proprietary Name: Dentis s-Clean s-Line
Compatible Implants (K number): K210134
Implant diameter size: 5.8/6.8
Implant Interface Connection Type/Size (mm): Internal Connection type/ 2.5
Type of Implant-Abutment Connection: Hex/Non-Hex
Patient-Specific Abutments are supplied with s-Clean abutment screw and provided non-sterile.
Patient-Specific Abutment design Limitation (Unit :mm):
Model Name: DSCBA10H, DSCBA14H, DSCBA10N, DSCBA14N, DSCBM10H, DSCBM14H, DSCBM10N, DSCBM14N
Range (Diameter): 4.5-6.5
Range (Length): 7.3-17.9
Range (Angle): 0-30°
Materials:
S-Clean Pre-Milled Abutment and S-Clean Abutment Screw is fabricated from Ti-6A1-4V ELI (Conforming to ASTM Standard F136).
The provided text describes a medical device, the "s-Clean Pre-Milled Abutment," and its submission for FDA 510(k) clearance, which is based on demonstrating substantial equivalence to a legally marketed predicate device. This document does not detail acceptance criteria and a study proving device performance in the context of an AI/ML medical device, but rather the non-clinical testing performed for a dental implant abutment.
Therefore, many of the requested fields are not applicable to the information provided in the input, as the study described is a non-clinical, mechanical fatigue test for a physical dental device, not an AI/ML-based diagnostic or prognostic tool.
Here's a breakdown of the relevant information from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Non-Clinical Testing: | Meets Criteria: |
| Fatigue testing according to ISO 14801:2016 for the worst-case scenario. | "The results of the above tests have met the criteria of the standards and demonstrated the substantial equivalence with the predicate device." "The result say that device performance was substantial equivalent." |
| Biocompatibility testing according to ISO 10993-1:2009 (leveraged from predicate device K200099). | "The results of the above tests have met the criteria of the standards and demonstrated the substantial equivalence with the predicate device." |
| End User Sterilization Validation Test Report according to ANSI/AAMI ST79, ISO 17665-1, ISO 17665-2, ISO 11737-1, ISO 11737-2, and ISO 11138-1 (leveraged from predicate device K111364). | "The results of the above tests have met the criteria of the standards and demonstrated the substantial equivalence with the predicate device." |
| Compliance with FDA Guidance "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments." | "Non-clinical test data was conducted in accordance with FDA Guidance... and it consisted of testing finished assembled implant/abutment systems of the worst-case scenario, through fatigue testing." "The result say that device performance was substantial equivalent." |
2. Sample size used for the test set and the data provenance
The document states that fatigue tests were performed on the subject device "under the worst case scenario." It does not specify the exact number of samples used for this test. Data provenance is not specified, but it can be inferred that the testing was conducted for the purpose of this 510(k) submission, likely by or for Dentis Co., Ltd.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a physical device testing scenario (fatigue, biocompatibility, sterilization), not a diagnostic or AI/ML device requiring expert ground truth for interpretation or classification.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not a study requiring human adjudication. The "ground truth" for these tests comes from adherence to established engineering and biological 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
Not applicable. This is a non-clinical evaluation of a physical dental abutment, not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For fatigue testing, the ground truth is based on the failure criteria defined by ISO 14801:2016. For biocompatibility, it's based on ISO 10993-1:2009 standards. For sterilization, it's based on ANSI/AAMI ST79, ISO 17665-1, ISO 17665-2, ISO 11737-1, ISO 11737-2, and ISO 11138-1 standards. These are objective, quantifiable physical and biological standards.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device that requires a training set.
§ 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.)