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Dimension Vista™ TRF Flex® reagent cartridge: The TRF method is an in vitro diagnostic test for the quantitative determination of transferrin in human serum, heparinized plasma or EDTA plasma on the Dimension Vista® System. Measurements of transferrin aid in the diagnosis of malnutrition, acute inflammation, infection, and iron deficiency anemia.

Dimension Vista " Protein 1 Calibrator: PROT1 CAL is an in vitro diagnostic product for the calibration of the C3 complement (C3), C4 complement (C4), Immunoglobulin A (IGA), Immunoglobulin G (IGG), Immunoglobulin M (IGM), Prealbumin (PREALB) and Transferrin (TRF) methods on the Dimension Vista® System.

Dimension Vista™ Protein 1 Control L, M and H: PROT1 CON L, M and H are assayed intralaboratory quality controls for assessment of precision and analytical bias in the determination of C3 Complement (C3), C4 Complement (C4), immunoglobulin A (IGA), immunoglobulin G (IGG), immunoglobulin M (IGM), prealbumin (PREALB) and transferrin (TRF) on the Dimension Vista "System.

Dimension Vista™ TRF Flex® reagent cartridge: Proteins contained in human body fluids form immune complexes in an immunochemical reaction with specific antibodies. These complexes scatter a beam of light passed through the sample. The intensity of the scattered light is proportional to the concentration of the respective protein in the sample. The result is evaluated by comparison with a standard of known concentration.

Dimension Vista" Protein 1 Calibrator: Protein 1 Calibrator is a multi-analyte, liquid, human serum based product containing C3 complement, C4 complement, immunoglobulin A (IGA), immunoglobulin G (IGG), immunoglobulin M (IGM), prealbumin (PREALB) and Transferrin.

Dimension Vista™ Protein 1 Control L, M and H: Protein 1 Control L, M and H are multi-analyte, liquid, human serum based products containing C3 complement, C4 complement, immunoglobulin A (IGA), immunoglobulin G (IGG), immunoglobulin M (IGM), prealbumin (PREALB) and transferrin.

This document describes the Dimension Vista™ TRF Flex® reagent cartridge, Dimension Vista™ Protein 1 Calibrator, and Dimension Vista™ Protein 1 Control L, M, and H, which are in vitro diagnostic medical devices. The core of your request focuses on the Dimension Vista™ TRF Flex® reagent cartridge for the quantitative determination of transferrin.

Here's an analysis of the provided information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the traditional sense of pre-defined thresholds. Instead, it presents a method comparison study comparing the new device (Dimension Vista™ TRF assay) with a legally marketed predicate device (Dade Behring N Antisera to Human Transferrin assay on the BN ProSpec® System). The reported device performance from this study serves as the evidence of equivalence to the predicate.

Note: The document states, "These studies demonstrate correlation and equivalent performance between the Dade Behring N Antisera to Human Transferrin assay and the Dimension Vista™ TRF assay." This implies that the observed correlation, slope, and intercept values were considered acceptable by the manufacturer for demonstrating substantial equivalence.

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

• Sample Size for Test Set: 180 samples (n = 180)
• Data Provenance: The document does not explicitly state the country of origin. It also does not explicitly state if the data was retrospective or prospective. However, given that it's a method comparison study for an in vitro diagnostic device, it is typically conducted on clinical samples, which are generally considered prospective or retrospective clinical samples collected for research purposes. No specific information on the demographics or collection methods is provided.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This type of in vitro diagnostic device (immunoassay for transferrin) does not typically involve human experts for establishing "ground truth" in the same way an imaging or pathology device would. The "ground truth" for method comparison studies like this is the measurement obtained from the predicate device (Dade Behring N Antisera to Human Transferrin assay on the BN ProSpec® System), which is itself an established laboratory method. Therefore, no human experts were involved in establishing the ground truth for this test set; rather, it relied on the analytical performance of a reference method.

4. Adjudication Method for the Test Set

Not applicable. As explained above, the "ground truth" for this method comparison study is the measurement obtained from the predicate device, not an interpretation requiring expert adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. This is an in vitro diagnostic assay, not an imaging or interpretive device that would involve multiple human readers. Therefore, an MRMC comparative effectiveness study is not relevant here.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, in a sense. The study directly compares the analytical performance of the new automated Dimension Vista™ TRF assay (device only) against the predicate automated assay (device only). This is an evaluation of the algorithm/device's performance in generating quantitative results without human interpretive input affecting the result itself. The device is designed to provide a quantitative measurement.

7. Type of Ground Truth Used

The "ground truth" for the performance comparison was the measurements obtained from the legally marketed predicate device, the Dade Behring N Antisera to Human Transferrin assay on the BN ProSpec® System. This is a common approach for demonstrating substantial equivalence for new in vitro diagnostic assays.

8. Sample Size for the Training Set

The document does not provide information about a separate "training set." For in vitro diagnostic assays, especially those based on established immunochemical principles, the development often relies on well-understood chemical reactions and calibration procedures rather than a large, continuously-trained machine learning model in the typical sense. Data used for initial assay development and optimization would precede this validation study, but specifics are not mentioned.

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

As with point 8, the document does not detail a "training set" or its ground truth establishment. Development of such assays generally involves using characterized reference materials and calibrators, often with values traceable to international standards or established reference methods, to ensure accuracy during the assay's development and optimization phases.

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The ATEC® Breast Biopsy System is indicated to provide breast tissue samples for diagnostic sampling of breast abnormalities. The ATEC® Breast Biopsy System is intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality. The extent of histologic abnormality cannot be reliably determined from its mammographic appearance. Therefore, the extent of removal of the imaged evidence of an abnormality does not predict the extent of removal of histologic abnormality, e.g., malignancy. When the sampled abnormality is not histologically benign, it is essential that the tissue margins be examined for completeness of removal using standard surgical procedure.

Not Found

The provided document is a 510(k) clearance letter from the FDA for a medical device (Vacuum Assisted Core Biopsy Device, Trade/Device Name: SUROS Surgical Systems, Inc. - ATEC® Breast Biopsy System). This type of document primarily confirms substantial equivalence to a predicate device for market clearance. It does not contain the details of a study with acceptance criteria and reported device performance in the format requested.

The document states:

• Device Name: SUROS Surgical Systems, Inc. - ATEC® Breast Biopsy System
• Indications For Use: To provide breast tissue samples for diagnostic sampling of breast abnormalities, and intended to provide breast tissue for histologic examination with partial or complete removal of the imaged abnormality.

To answer your request, a detailed study report (e.g., a clinical trial report or a performance validation study report) would be needed, which is not part of this 510(k) clearance letter. The FDA clearance confirms that SUROS demonstrated substantial equivalence to a legally marketed predicate device, implying that its performance is comparable to the predicate. However, specific acceptance criteria and performance metrics from a dedicated study are not detailed in this document.

Therefore, I cannot populate the table or provide the specific study details you requested based solely on the information provided in this 510(k) clearance letter. This document is a regulatory approval notice, not a study report.

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