(86 days)
This product is intended to be used as an accessory to cleaning a toothbrush.
Not Found
I am sorry, but based on the provided document, I cannot extract the information required to describe the acceptance criteria and the study that proves the device meets those criteria.
The document is a 510(k) clearance letter from the FDA for a "Toothbrush Wash" device. It primarily states that the device has been found substantially equivalent to a predicate device and can therefore be marketed.
It does not contain any information regarding:
- Acceptance criteria for device performance.
- A study that demonstrates the device meets specific performance criteria.
- Sample sizes used for testing or training sets.
- Data provenance or details about ground truth establishment.
- Information about expert involvement or adjudication methods.
- Details on MRMC studies or standalone algorithm performance.
Therefore, I cannot populate the requested table and answer the subsequent questions.
§ 872.6855 Manual toothbrush.
(a)
Identification. A manual toothbrush is a device composed of a shaft with either natural or synthetic bristles at one end intended to remove adherent plaque and food debris from the teeth to reduce tooth decay.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. If the device is not labeled or otherwise represented as sterile, it is exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.