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510(k) Data Aggregation
(211 days)
s-Clean Pre-Milled Abutment Mini
s-Clean Pre-Milled Abutment Mini 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.
All digitally designed abutments for use with s-Clean Pre-Milled Abutment Mini 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).
s-Clean Pre-Milled Abutment Mini are supplied with s-Clean abutment screw Mini, previously cleared in K210080 and provided non-sterile.
The provided text describes a 510(k) premarket notification for a dental device, the "s-Clean Pre-Milled Abutment Mini." It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study of the device's performance against specific acceptance criteria in the context of a diagnostic or AI-driven system.
Therefore, many of the requested details about acceptance criteria, study design for performance, sample sizes, expert qualifications, and ground truth establishment are not applicable or available in this document. This is because the device is a dental abutment, not a diagnostic or AI-powered system that requires performance metrics like sensitivity, specificity, or human reader improvement.
However, I can extract information related to the device's testing and the conclusion of its substantial equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
For a physical device like a dental abutment, "acceptance criteria" typically refer to meeting specified engineering and materials standards, rather than diagnostic performance metrics. The "performance" is demonstrated by passing these tests.
| Acceptance Criteria (Standards) | Reported Device Performance |
|---|---|
| Fatigue Resistance: ISO 14801:2016 (Determination of dynamic fatigue properties of endosseous dental implants) | The subject device underwent fatigue tests under a worst-case scenario according to ISO 14801:2016. |
| The results met the criteria of the standards and demonstrated substantial equivalence with the predicate device. | |
| Biocompatibility: ISO 10993-1:2009 (Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process) | Biocompatibility testing for predicate devices (referenced in K200099) was leveraged for the subject device. |
| Sterilization Validation: ANSI/AAMI ST79, ISO 17665-1, ISO 17665-2, ISO 11737-1, ISO 11737-2, and ISO 11138-1 | End User Sterilization Validation Test Report for predicate devices (referenced in K111364) was leveraged. A worst-case evaluation showed that the previously cleared device was able to be leveraged for the steam sterilization of the subject device. |
| The subject device is supplied non-sterile and requires steam sterilization by the user. | |
| FDA Guidance Compliance: "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 the recommendations of this FDA Guidance, consisting of testing finished assembled implant/abutment systems of the worst-case scenario (smallest diameter with maximum angulation) through fatigue testing. |
| The results of the tests met the criteria of the standards and demonstrated substantial equivalence with the predicate device. |
2. Sample size used for the test set and the data provenance
The document does not specify a distinct "test set" in the way a diagnostic study would. For the fatigue testing, it refers to "the worst-case scenario" (smallest diameter with maximum angulation) but does not provide the specific number of units tested. The provenance of this data is from the manufacturer's (Dentis Co., Ltd.) non-clinical testing, which is implicitly prospective testing done for the 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is a physical dental abutment, not a diagnostic tool requiring expert interpretation or ground truth establishment.
4. Adjudication method for the test set
Not applicable. There is no diagnostic "test set" or human interpretation involved to require an adjudication method.
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 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 is not an algorithmic device.
7. The type of ground truth used
For a physical medical device, "ground truth" would refer to its adherence to engineering specifications and material properties, validated through physical testing against established technical standards (like ISO or ASTM standards) rather than expert consensus on diagnostic images or pathology. The "ground truth" here is compliance with these standards.
8. The sample size for the training set
Not applicable. This is a physical device, not a machine learning model.
9. How the ground truth for the training set was established
Not applicable. There is no training set for a machine learning model. The "ground truth" for the device's design and manufacturing is established by adherence to recognized engineering standards and quality control processes.
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