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510(k) Data Aggregation
(195 days)
TN-Brush is a debridement instrument for titanium dental implants subjected to peri-implantitis. It is indicated for the open debridement of titanium implant surfaces in bone defects caused by peri-implantitis.
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I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves the device meets acceptance criteria for the "TN-Brush." The document is an FDA 510(k) clearance letter for the device, which primarily addresses its substantial equivalence to a predicate device and general regulatory compliance.
The document does not contain details about:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for a test set or data provenance for any studies.
- The number or qualifications of experts used for ground truth.
- Adjudication methods for a test set.
- Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or any effect sizes related to human reader improvement with AI assistance.
- Whether a standalone (algorithm only) performance study was done.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
- The sample size for a training set.
- How ground truth for a training set was established.
The provided text focuses on the regulatory clearance process for a dental device (TN-Brush) and its indicated use for debridement of titanium dental implants. It does not delve into the specifics of performance studies or acceptance criteria that would fall under the scope of AI/ML device validation.
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(301 days)
rainbow™ Shine is used in the manufacture of a dental core through milling by machine (MAD/ MAM or CAD/CAM) followed by sintering.
rainbow™ Shine is a partially sintered dental ceramic made out of colored ZrO2(Y-TZP). These blanks are fabricated into dental core (zirconia substructure) of crowns and bridges. The core can be used as final prosthesis by itself or can be layered with porcelain. rainbow™ Shine is fabricated by CAD/CAM or MAD/MAM machining processes. At the dental lab, the blanks are held to the milling machine which is used to machine to the final dental restoration. After machining steps, the dental restoration is fully sintered in the furnace to harden the ZrO2. and fitted to the patients as crowns and bridges. rainbow™ Shine is available in numerous shapes and sizes in order to be compatible with multiple milling machines. According to the shapes, they are used for fabricating of each intended dental restoration, such as single crowns, bridges including from 2-bridge to 16bridge(full arch). It is also supplied in six different colors (A0, A0.5, A1, A2, A3, A4) for each shapes. rainbow™ Shine is not for use or intended for use to fabricate the top-half of an abutment/titanium base and is for the fabrication of dental restorations only.
This document is a 510(k) summary for the rainbow™ Shine dental ceramic. The document asserts the device's substantial equivalence to a predicate device based on non-clinical testing.
Here's an analysis based on your requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (ISO 6872:2008) | Reported Device Performance (rainbow™ Shine) | Reported Predicate Performance (rainbow™ High Shine) | Comparison to Acceptance Criteria |
|---|---|---|---|---|
| Bending Strength (Flexural Strength) | > 500 MPa (for Class 5 dental ceramics) | 865 MPa | 706 MPa | Meets and exceeds |
| Sintering Density | (Not explicitly stated in document, but "Same" for both devices implies meeting a standard) | 6 g/cm³ | 6 g/cm³ | Assumed to meet |
| Radioactivity | < 1.0 (Bq/g) | < 1.0 Bq/g | < 1.0 Bq/g | Meets |
| Linear thermal expansion (10⁻⁶ K⁻¹) | (Not explicitly stated in document, but "Same" for both devices implies meeting a standard) | 10.4 (±0.5) | 10.4 (±0.5) | Assumed to meet |
| Chemical Solubility | < 100 µg/cm² (for Class 6 dental ceramics, though rainbow™ Shine is Class 5. This appears to be a slight discrepancy in the document's wording but implies a stringent standard) | 0 µg/cm² | 3 µg/cm² | Meets and exceeds |
| Biocompatibility | ISO 10993-1:2009 standards (Cytotoxicity, Irritation, Sensitization, Acute systemic toxicity, Genotoxicity) | Biocompatible | Biocompatible | Meets |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for the non-clinical tests (bending strength, chemical solubility, etc.). It only mentions that "Non-clinical device testing was conducted to confirm the performance of the subject device" and "Bench tests for performance comparison...includes the following testing." The data provenance is not specified, but since Genoss Co., Ltd. is based in Korea and the submission is to the FDA, it is likely the testing was conducted in a laboratory setting, potentially in Korea or by a contracted lab. The study is retrospective in nature, presenting the results of pre-market testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not provided in the document. The tests described are non-clinical, benchtop tests (e.g., material property measurements) and biocompatibility assessments, which are performed in a laboratory settings and do not directly involve human experts in establishing a "ground truth" for clinical outcomes in the same way an imaging study might. The "ground truth" for these tests are the established scientific and engineering principles and the recognized consensus standards (like ISO 6872:2008 and ISO 10993-1:2009).
4. Adjudication Method for the Test Set
This information is not applicable as the tests described are non-clinical and do not involve human interpretation or subjective assessment that would 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
No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This device is a dental ceramic block, not an AI-powered diagnostic or assistive technology. Therefore, the concept of human readers improving with AI assistance is not relevant to this submission.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a material, not an algorithm.
7. The Type of Ground Truth Used
For the non-clinical tests (bending strength, chemical solubility, etc.), the "ground truth" is defined by the recognized consensus standards, specifically ISO 6872:2008 (Dentistry - Ceramic materials) and ISO 10993-1:2009 (Biological evaluation of medical device - Part 1: Evaluation and testing within a risk management process). These standards define the methods for testing and the acceptable ranges for the performance characteristics of dental ceramic materials.
8. The Sample Size for the Training Set
This information is not applicable. This device is a dental ceramic and does not involve machine learning or AI, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
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