(263 days)
The T-8000 TherOzone Unit is intended for the reduction of microorganisms in dental unit water lines.
The T-8000 TherOzone Unit is a device intended to clean dental unit water lines. The device consists of an ozone generator and dispensing bottles.
The provided text does not contain the detailed acceptance criteria or the specific study details for the T-8000 TherOzone Unit that would allow for a comprehensive answer to all parts of your request.
Here's what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Microbial reduction (primary function) | "The performance testing conducted demonstrates that the T-8000 TherOzone Unit is substantially equivalent to the predicate devices." (This is a general statement, not a specific performance metric like "reduces microorganisms by X log") |
| Software Validation | Performed |
| Environmental Evaluation | Performed |
| Functional Verification | Performed |
| Material Compatibility Analysis | Performed |
| Usability Evaluation | Performed |
| Pressure Verification | Performed |
| Environmental Condition Verification | Performed |
What's missing for this table: Specific quantitative acceptance criteria (e.g., "reduce microorganisms by at least 99.9%") and the corresponding quantitative results obtained. The document only states that testing was performed and demonstrated substantial equivalence, but not the actual performance values against defined criteria.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size: Not specified. The document only mentions "test units representative of finished devices" for performance testing.
- Data provenance: Not specified. The document does not indicate the country of origin of the data or whether the studies were retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Number of experts: Not applicable/not specified. The device is a "dental unit water line cleaner." The "ground truth" for microbial reduction would typically be established through laboratory microbial challenge tests, not by human expert assessment of images or clinical cases.
- Qualifications of experts: Not applicable/not specified.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication method: Not applicable/not specified. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in diagnostic imaging studies where agreement among human readers is required. This device's primary function is microbial reduction, which relies on objective laboratory measurements.
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
- MRMC study: No. This is not an AI-assisted diagnostic device, so an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone performance: Yes, implicitly. The performance data section refers to "Performance Data" for the "T-8000 TherOzone Unit" itself, including "Microbial challenge." This suggests the device's ability to reduce microorganisms was tested independently. However, no specific details of the microbial challenge are provided (e.g., type of microorganisms, initial count, final count, methodology).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of ground truth: Most likely objective laboratory measurements of microbial count reduction. The device's indication for use is "reduction of microorganisms in dental unit water lines." This would be verified by standard microbiological testing methods (e.g., plating and colony counting). The document states "Microorganism reduction cycle" and "Microbial challenge" was performed.
8. The sample size for the training set
- Sample size for training set: Not applicable/not specified. This device is a physical water treatment unit, not an AI/machine learning algorithm that requires a "training set" of data.
9. How the ground truth for the training set was established
- How ground truth for training set was established: Not applicable, as there is no training set for this type of device.
In summary, the provided document is a 510(k) summary focusing on substantial equivalence to predicate devices for a physical medical device. It does not contain the detailed clinical study design, specific acceptance criteria, or quantitative performance metrics usually found for diagnostic devices or AI-driven systems. The performance data section broadly states that necessary testing was performed to demonstrate substantial equivalence, but lacks the granular details requested in your prompt.
§ 872.6640 Dental operative unit and accessories.
(a)
Identification. A dental operative unit and accessories is an AC-powered device that is intended to supply power to and serve as a base for other dental devices, such as a dental handpiece, a dental operating light, an air or water syringe unit, and oral cavity evacuator, a suction operative unit, and other dental devices and accessories. The device may be attached to a dental chair.(b)
Classification. Class I (general controls). Except for dental operative unit, accessories are exempt from premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.