Search Results

The Daxor BVA-200 is an automated system that is used to measure/calculate the red cell mass (mL), plasma volume (mL) and total blood volume (mL), along with the related deviations from ideal values by amount (mL) and percentage (%) in adults. In addition, the Normalized Hematocrit (%) and Albumin Transudation Rate (%/min) are calculated. It is an in vitro medical device composed of a microprocessor, software, touchscreen, and gamma counter and accessory convenience kit.

The Daxor BVA-200 is intended to calculate human blood volumes by the method of tracer diffusion (Indicator dilution technique) with I-131 as the tracer after injection of I-131 Human Serum Albumin. The Daxor BVA-200 provides a Quantitative Assessment of total blood and plasma volumes using an automated system.

Data inputs to the software come from the measured characteristics of patient venous whole blood samples collected in K3EDTA vacutainer tubes (hematocrit and tracer concentration) and tracer calibration standards. The patient blood samples and the calibration standards are measured in a gamma counter, whose output is automatically input to this calculation program. The package also calculates the patient expected (or ideal) blood volume from physical parameters. Hyper- or hypovolemia, and associated red cell volumes are reported, with statistics showing the quality of the results.

For in vitro diagnostic use in a Clinical Laboratory setting and operated by laboratory technicians.

Rx use only.

The Daxor BVA-200 is an automated system that is used to calculate the red cell mass, plasma volume and total blood volume. It is an in vitro medical device composed of a microprocessor, software, touchscreen, and gamma counter. The accessory convenience kit includes single-use whole blood cartridges and protective sleeves.

The Daxor BVA-200 is designed to calculate human blood volume, using the method of tracer dilution, utilizing tagged serum albumin (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 tracer calibration standards. The package also calculates the patient expected (or ideal) blood volume from physical parameters. Hyper- or hypovolemia, and associated red cell 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 input to this calculation program.

The BVA-200 has a touchscreen for operator interaction, and provides clear instructions and prompts for the steps necessary for performing the test.

Here's a breakdown of the acceptance criteria and study information for the Daxor Blood Volume Analyzer (200), based on the provided FDA 510(k) clearance letter.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a tabulated format. However, it provides performance metrics from a clinical comparison study and precision, linearity, carryover, and stability studies. The implicit acceptance criteria are that the device performance should be substantially equivalent to the predicate device and demonstrate acceptable precision and linearity.

Implicit Acceptance Criteria and Reported Device Performance for BVA-200 (vs. BVA-100)

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: 319 unique, independent, comparable measurements.
• Data Provenance:
  • Blood derived from patients undergoing blood volume measurement with the BVA-100 (predicate device) as part of their clinical treatment or as part of a research study.
  • The document implies the data is retrospective for the clinical comparison, as it used blood derived from patients undergoing measurement with the predicate device.
  • For precision, linearity, sample stability, handling, and interference studies, contrived samples and venous whole blood samples from male and female volunteers were used. No specific country of origin is mentioned.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document does not mention the use of experts to establish ground truth for the test set in the context of a reader study or image interpretation. The ground truth for the clinical comparison study was established by the predicate device (Daxor BVA-100) measurements.

4. Adjudication Method for the Test Set

Not applicable. The ground truth for the clinical comparison was based on measurements from the predicate device, not expert adjudication of subjective assessments.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This device is a quantitative measurement system, not an AI software intended for interpretation by human readers. The clinical study focused on comparing the performance of the new device (BVA-200) to its predicate (BVA-100) on quantitative measurements.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, the studies performed focused on the standalone performance of the BVA-200. The device is an automated system that measures and calculates blood volumes. The performance data presented (clinical comparison, precision, linearity, stability, etc.) represents the device's output independently, without human interpretation as part of a "human-in-the-loop" workflow being evaluated.

7. The Type of Ground Truth Used

The ground truth for the primary clinical comparison study was the measurements obtained from the predicate device, the Daxor BVA-100. For other studies (precision, linearity, stability, etc.), the ground truth was based on known properties of contrived samples or established physical/biological principles (e.g., known decay rate of I-131).

8. The Sample Size for the Training Set

The document does not provide information on a training set sample size. This suggests that the BVA-200, similar to its predicate BVA-100, is likely based on established physiological and radiological principles (indicator dilution technique, I-131 decay) rather than a machine learning model that requires a distinct "training set." The software performs calculations based on these principles and measured inputs, not through a learned model from a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as a "training set" in the context of machine learning is not implied or described in the document for this device.

Ask a specific question about this device

This device is intended for use by health care professionals for fluid injection, where it is important to ensure that the quantity of the injected fluid bolus is known exactly.

This device will be used to inject into IV ports (not directly into the patient or into arterial lines).

Not Found

The provided text is a 510(k) premarket notification letter from the FDA regarding the Daxor Max100 Syringe. It confirms substantial equivalence but does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement. Therefore, I cannot fulfill the request to describe these details.

The document only states the device's indications for use: "This device is intended for use by health care professionals for fluid injection, where it is important to ensure that the quantity of the injected fluid bolus is known exactly. This device will be used to inject into IV ports (not directly into the patient or into arterial lines)."

Ask a specific question about this device

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).

Ask a specific question about this device