(111 days)
COLON ALERT is a rapid, convenient and non-offensive aid in the diagnosis of asymptomatic gastrointestinal conditions that may manifest themselves by the asyniptomatic "gastronitestinal" ocharities" than may of the COUNTER USE". presence of occult blood in the stool. "This test is "FOR OVER-THE COUNTER USE".
Not Found
This appears to be a 510(k) clearance letter from the FDA for the "Colon Alert Test" and an "Indications for Use" statement. It does not contain the acceptance criteria or a study proving the device meets the criteria. The document explicitly states it is a "510(k) Number (if known): K992759", which is a premarket notification for a device that is substantially equivalent to a legally marketed predicate device. This type of submission generally does not require new clinical studies demonstrating device performance against specific acceptance criteria in the same way a PMA submission might.
Therefore, many of the requested details cannot be extracted from this document. However, I can provide the information that is present and indicate what is missing:
Missing Information:
- A table of acceptance criteria and the reported device performance
- Sample size used for the test set
- Data provenance for the test set
- Number of experts used to establish ground truth for the test set
- Qualifications of experts for ground truth
- Adjudication method for the test set
- Multi-reader multi-case (MRMC) comparative effectiveness study information
- Standalone (algorithm only) performance information
- Type of ground truth used
- Sample size for the training set
- How ground truth for the training set was established
Based on the provided text, the following information can be inferred or stated:
- Study showing device meets acceptance criteria: There is no study detailed in this document that explicitly proves the device meets specific acceptance criteria in the sense of a clinical trial. The FDA letter is a notification of substantial equivalence to a predicate device. This means the device's performance, safety, and effectiveness are considered comparable to an existing, legally marketed device.
Let me know if you have another document that describes the actual performance study!
§ 864.6550 Occult blood test.
(a)
Identification. An occult blood test is a device used to detect occult blood in urine or feces. (Occult blood is blood present in such small quantities that it can be detected only by chemical tests of suspected material, or by microscopic or spectroscopic examination.)(b)
Classification. Class II (special controls). A control intended for use with an occult blood test is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.