(155 days)
The TECO Diagnostics URS-1B (Blood Test) is intended for "Professional Use." The test is used, by professional people, for a qualitative determination of blood in human urine. Urinary blood measurements are used in the diagnosis and treatment of hematuria and glomerulonephritis.
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The provided text is a 510(k) summary from the FDA for a medical device called URS-1B (Blood Test) by Teco Diagnostics. It states that the device is substantially equivalent to a predicate device for the qualitative determination of blood in human urine for professional use.
However, the provided document does not contain the detailed information required to answer your request about acceptance criteria, study details, sample sizes, ground truth establishment, or multi-reader multi-case studies. This document is primarily an FDA clearance letter, confirming substantial equivalence to a predicate device, and includes the indications for use. It does not elaborate on the specific performance studies that led to this clearance.
Therefore, most of the information requested cannot be extracted from the given text.
Here is what can be inferred or stated based on the provided text, with the understanding that much of the request cannot be fulfilled:
1. A table of acceptance criteria and the reported device performance:
- Cannot be provided. The document does not specify quantified acceptance criteria or detailed performance metrics from a study (e.g., sensitivity, specificity, accuracy). It only states that the device is "substantially equivalent" to a legally marketed predicate device.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Cannot be provided. This information is not present in the FDA clearance letter.
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):
- Cannot be provided. This document does not detail how ground truth was established for any studies, nor does it mention experts or their qualifications.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Cannot be provided. This information is not present in the FDA clearance letter.
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:
- Cannot be provided. This device is a "Blood Test" (likely an in-vitro diagnostic strip or similar), not an AI-assisted imaging device. Therefore, an MRMC study with human readers and AI assistance is not applicable and not mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Cannot be provided directly. While the device itself would have a standalone performance, the specific study details (if one was done in this context) are not described in this document. Given it's a qualitative test for "Professional Use," it implies the professional interprets the result, so a true "algorithm only without human-in-the-loop" study in the AI sense is unlikely.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Cannot be provided. The document does not specify the method for establishing ground truth for any studies. For a qualitative blood test for hematuria, ground truth would typically be established by a more definitive laboratory method or clinical diagnosis, but this is not detailed here.
8. The sample size for the training set:
- Cannot be provided. This document is silent on any training sets or their sizes.
9. How the ground truth for the training set was established:
- Cannot be provided. This document is silent on any training sets or their ground truth establishment.
§ 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.