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The Hema-Screen TM Specific Gold 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.

hema-screen™ SPECIFIC Gold is a qualitative, sandwich dye conjugate immunoassay that employs a unique combination of monoclonal antibodies to selectively identify the globin component of human hemoglobin in fecal specimens with a high degree of analytical sensitivity. Two samples of feces, collected using the unique DEVEL-A-TAB Sampler, are dispersed in a single tube containing a known volume of buffer. The unique design of the Sampler ensures that a controlled amount of feces is added to the specimen preparation tube. Then, the feces in buffer is transferred to the test cassette detection system using the tube itself as the delivery system. In less than five minutes, unusually elevated concentrations of human hemoglobin in feces can be detected and positive results for abnormal concentrations of hemoglobin can be seen in the test cassette detection system as early as two or three minutes after application of specimen. As the feces in buffer specimen flows up through the absorbent device, the labeled antibody-dye conjugate binds to the globin of hemoglobin in the specimen forming an antibody-antigen complex. This complex binds to anti-globin antibody in the positive test reaction zone and produces a pink-rose color band. In the absence of hemoglobin, there is no line in the test reaction zone. The pink-rose color bands in the control reaction zone demonstrate that the reagents and devices are functioning correctly. In the extremely rare event of operator or test cassette failure, sufficient specimen is available in the tube to repeat the procedure with another test cassette.

The provided text describes a 510(k) submission for a medical device called "hema-screen™ SPECIFIC Gold," which is a Fecal Immunochemical Test (FIT) for detecting human blood in fecal samples. The submission asserts substantial equivalence to a previously cleared predicate device, "hema-screen™ SPECIFIC."

Here's an analysis of the acceptance criteria and study that proves the device meets them, based on the provided text:

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance

• Sample Size: The document does not specify the exact number of patient fecal samples used in the "Summary of Patient Fecal Sample Testing." It only states that "Each of the three lots of hema-screen™ SPECIFIC Gold were 100% agreement with predicate..." This implies that multiple samples were tested across different manufacturing lots, but the specific count is not provided.
• Data Provenance: The document does not explicitly state the country of origin of the data or whether the study was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• This information is not provided in the document. Given that this is a comparison to a predicate device (hema-screen™ SPECIFIC), the "ground truth" for the test set appears to be the results obtained from the predicate device itself, rather than external expert assessment.

4. Adjudication method for the test set

• None specified. The study's focus was a direct comparison between the subject device and the predicate device, not on independent expert re-assessment of results.

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

• Not applicable. This device is a qualitative diagnostic kit (a Fecal Immunochemical Test), not an AI-powered image analysis system or a device that involves human readers interpreting complex data. Therefore, an MRMC study is not relevant to this type of device.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

• Yes, in essence. The "Summary of Patient Fecal Sample Testing" describes the performance of the device itself (hema-screen™ SPECIFIC Gold) compared to the predicate. While the device is a diagnostic kit used by professionals, the performance metrics (agreement, PPA, NPA) reflect the device's inherent ability to detect human hemoglobin in fecal samples. There isn't an "algorithm" in the typical sense of AI, but the device's chemical and physical principles determine its standalone performance.

7. The type of ground truth used

• The ground truth used was comparison to a legally marketed predicate device (hema-screen™ SPECIFIC). The assumption is that the predicate device's results serve as the accurate reference point for comparison.

8. The sample size for the training set

• Not applicable. This device is a diagnostic kit, not a machine learning algorithm that requires a training set. The development of the device would involve chemical formulation and validation, not data-driven training.

9. How the ground truth for the training set was established

• Not applicable. As stated above, there is no "training set" for this type of device.

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