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The Daxor BVA-100 is a software package designed to calculate human blood volume, using the method of tracer dilution, utilizing tagged scrum albumin (a commonly used tag is I-131, resulting in "I-HSA"). Data inputs to the software come from the measured characteristics of patient blood samples (hematocrit and tracer concentration) and traccr calibration standards. The package also calculates the patient expected (or ideal) blood volume from physical parameters. Hyper- or hypovolemia, and associated red ccll volumes, are reported, with statistics showing the quality of the results.

The patient blood samples and the calibration standards are measured in a gamma counter, whose output is automatically, or manually, input to this calculation program.

The Daxor BVA-100 is a software package designed to calculate human blood volume, using the method of tracer dilution, utilizing tagged scrum albumin (a commonly used tag is I-131, resulting in "I-HSA"). Data inputs to the software come from the measured characteristics of patient blood samples (hematocrit and tracer concentration) and traccr calibration standards. The package also calculates the patient expected (or ideal) blood volume from physical parameters. Hyper- or hypovolemia, and associated red ccll volumes, are reported, with statistics showing the quality of the results.

The patient blood samples and the calibration standards are measured in a gamma counter, whose output is automatically, or manually, input to this calculation program.

I am sorry, but the provided text does not contain the detailed information necessary to answer your request about acceptance criteria and a study proving device performance. The document is an FDA 510(k) clearance letter for the Daxor BVA-100 Blood Volume Analyzer, indicating that it has been found substantially equivalent to a predicate device.

While it mentions the device's indications for use and general regulatory information, it does not include any specifics about:

1. Acceptance criteria or reported device performance.
2. Sample sizes, data provenance, or details about test sets.
3. Number or qualifications of experts for ground truth.
4. Adjudication methods.
5. Multi-reader multi-case (MRMC) comparative effectiveness studies.
6. Standalone algorithm performance.
7. Type of ground truth used (expert consensus, pathology, outcomes data).
8. Sample size for the training set.
9. How ground truth for the training set was established.

To obtain this information, you would typically need to consult a comprehensive study report, a specific clinical trial publication, or the full 510(k) submission document (which often contains more detailed performance data than the clearance letter itself).

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