(84 days)
Straumann® TiBrush 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.
The Straumann® TiBrush is made of Grade 5 Titanium and stainless steel for single patient use and is attached to a dental handpiece. It is used during open flap surgery to remove biofilms (plaque and calculus) from the surfaces of dental implants where the surface of the implant is exposed due to peri-implantitis. The TiBrush mechanically removes the biofilms from the surface of the implants without damaging the integrity of the roughened implant surface.
The provided document describes the acceptance criteria and performance testing for the Straumann® TiBrush. Here's a breakdown of the requested information:
1. Table of acceptance criteria and the reported device performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Bristle wear during cleaning | Free bristle length > 0.40 mm after implant cleaning | Passed |
| Damage to implant surface | Sand blasted, acid etched surface cleaned by TiBrush scratch the surface less than the stainless steel curette | Passed |
| Corrosion testing | No corrosion | Passed |
| Cleaning of implant surface | Removes more plaque than curette | Passed |
| Performance at different speeds; 600, 900, 1200, and 3000 rpm | No difference in performance | Passed |
| Biocompatibility testing | Met the requirements of ISO 10993, various parts | Met the requirements |
| Sterilization validation | Met the requirements of ISO 11137 | Met the requirements |
2. Sample size used for the test set and the data provenance
The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). The performance testing section mentions "implant cleaning" and "implant surface" but does not detail the number of implants or the source of this test data.
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 testing appears to be primarily bench testing (physical and mechanical properties, cleaning efficacy) rather than a study involving human expert assessment for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document, as the testing described does not appear to involve an adjudication process as typically understood in studies involving human reads.
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
There is no indication that a multi-reader multi-case (MRMC) comparative effectiveness study was done, nor is there any mention of AI assistance. The device is a mechanical cleaning instrument, not an AI or imaging diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable as the Straumann® TiBrush is a mechanical dental instrument, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance testing appears to be based on:
- Mechanical measurements/observations: Bristle length, scratch assessment, corrosion absence, plaque removal quantification (implicitly, through comparison to curette).
- Adherence to standards: ISO 10993 for biocompatibility and ISO 11137 for sterilization.
8. The sample size for the training set
This question is not applicable. The device is a mechanical instrument, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
This question is not applicable. The device is a mechanical instrument, not a machine learning algorithm.
§ 872.4840 Rotary scaler.
(a)
Identification. A rotary scaler is an abrasive device intended to be attached to a powered handpiece to remove calculus deposits from teeth during dental cleaning and periodontal (gum) therapy.(b)
Classification. Class II.