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To isolate water delivery lines in the dental operatory unit and reduce the contamination due to biofilm to improve the quality of water supplied to dental handpieces and other dental instruments.

Accessory to dental unit, dental line-cleaner.

The provided text is a 510(k) summary for the Eradic-All™ device, a dental line cleaner. It establishes substantial equivalence to previously cleared devices. However, it does not contain any information about acceptance criteria or a study proving device performance against such criteria.

The document focuses solely on:

• Identifying the device and its classification.
• Stating its intended use.
• Listing predicate devices.
• Asserting substantial equivalence based on intended use, technological characteristics (with stated differences in methods of use but same intent), and material composition of the delivery unit.
• Mentioning that the product does not contact patients and operating instructions require adequate flushing.

Therefore, I cannot provide the requested information from the given text. The text does not describe:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts used to establish ground truth or their qualifications.
4. Adjudication method.
5. MRMC comparative effectiveness study or effect size.
6. Standalone (algorithm only) performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The summary states that the manufacturer has "not been able to locate specific guidance documents applying to biofilm removal from dental lines," suggesting that formal performance testing against specific criteria related to efficacy might not have been a requirement or was addressed through the substantial equivalence argument rather than a direct performance study.

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