(104 days)
The Hema-Screen™ Specific is for the rapid and qualitative determination of Human Blood fecal samples. It is intended for professional and laboratory use only. It is also useful for determining gastrointestinal bleeding due to a number of gastrointestinal (GI) disorders such as diverticulitis, colitis, polyps and colorectal cancer. This test is recommended for use in routine physical examines, hospital monitoring of bleeding in patients, and for screening for colorectal cancer or gastrointestinal (GI) bleeding from any source.
Not Found
This is an FDA 510(k) clearance letter for the hema-screen™ SPECIFIC Immunochemical Fecal Occult Blood Test (FOBT) with DEVEL-A-TAB Sampler. While it confirms the device is substantially equivalent to a predicate device, it does not contain the detailed study information typically found in a clinical study report or a 510(k) summary (which might be a separate document). Therefore, I cannot provide all the requested information.
Based on the provided document, here's what can be extracted and what cannot:
1. Table of acceptance criteria and the reported device performance:
This information is not present in the provided document. The document is a clearance letter, not a performance study report.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
This information is not present in the provided document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not present in the provided document.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not present in the provided document.
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:
This device is an immunochemical fecal occult blood test, which is a diagnostic kit, not an AI-powered image analysis system that would typically involve human readers interpreting results. Therefore, an MRMC study with human readers improving with AI assistance would not be applicable to this type of device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Given this is a diagnostic test kit and not an algorithm, the concept of "standalone algorithm performance" as it applies to AI/software devices is not directly applicable. The performance would be based on the biochemical reaction and detection method of the kit itself. The document does not provide performance data for the kit.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
This information is not present in the provided document. For a fecal occult blood test, ground truth would typically be established through colonoscopy/pathology results to confirm the presence or absence of GI bleeding or specific conditions like colorectal cancer.
8. The sample size for the training set:
This information is not present in the provided document. This device is not an AI/machine learning model that typically requires a "training set."
9. How the ground truth for the training set was established:
This information is not present in the provided document. As mentioned, the concept of a "training set" for an AI/ML model is not applicable here.
Summary of available information from the document:
- Device Name: hema-screen™ SPECIFIC Immunochemical Fecal Occult Blood Test (FOBT) with DEVEL-A-TAB Sampler
- Intended Use: Rapid and qualitative determination of Human Blood in fecal samples. Intended for professional and laboratory use only. Useful for determining gastrointestinal bleeding due to GI disorders (diverticulitis, colitis, polyps, colorectal cancer). Recommended for routine physical exams, hospital monitoring of bleeding, and screening for colorectal cancer or GI bleeding.
- Regulatory Class: Class II
- Predicate Device: The substantial equivalence determination is based on a comparison to legally marketed predicate devices, but specific details of those predicate devices or the comparison are not provided in this letter.
To obtain the detailed study information, one would typically need to review the 510(k) Summary that Immunostics, Inc. submitted to the FDA, which often contains abstracts of the performance studies. This clearance letter only confirms the FDA's decision, not the full dataset or methodology.
§ 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.