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The IMMAGE Immunochemistry System Antithrombin III (AT3) Reagent, when used in conjunction with Beckman IMMAGE™ Immunochemistry Systems and Beckman Calibrator 2, is intended for the quantitative determination of human Antithrombin III by rate nephelometry.

The IMMAGE Immunochemistry System AT3 Reagent, in conjunction with Beckman Calibrator 2, is intended for use in the quantitative determination of Antithrombin III concentrations on Beckman's IMMAGE Immunochemistry System.

The provided document describes the IMMAGE™ Immunochemistry System Antithrombin III (AT3) Reagent. The acceptance criteria and supporting study details are summarized below.

1. Table of Acceptance Criteria and Reported Device Performance

The document implicitly uses the performance of the predicate device (Array System Antithrombin III (AT3) Reagent) as the acceptance criteria for the IMMAGE System AT3 Reagent. The key performance metrics evaluated are method comparison (correlation with the predicate), stability, and imprecision.

2. Sample Size for the Test Set and Data Provenance

• Sample Size: N = 136 for the method comparison study.
• Data Provenance: The document does not explicitly state the country of origin. It is a retrospective study as it compares the new device's results to an existing, commercially available predicate device using collected samples. The "plasma" sample type is mentioned.

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

This device is an in-vitro diagnostic (IVD) for quantitative determination of Antithrombin III. The "ground truth" for such devices is typically established through direct measurement on samples where the analyte concentration is known or determined by a well-established, often reference, method.

• Number of Experts: Not applicable in the context of expert consensus for image review or clinical diagnosis. The ground truth for the method comparison was established by the predicate device (Array 360 System AT3 Reagent), which itself is a laboratory instrument.
• Qualifications of Experts: Not applicable. The "ground truth" here is the measurement from the predicate device.

4. Adjudication Method for the Test Set

The concept of an adjudication method (e.g., 2+1, 3+1) is typically relevant for studies where human interpretation of medical images or clinical data is involved and discrepancies between readers need to be resolved. For an IVD device like the IMMAGE AT3 Reagent, the "adjudication" is essentially the statistical comparison of the new device's output against the predicate device's output. There is no mention of a human adjudication process for resolving discordant results between the IMMAGE system and the Array system; rather, a statistical correlation (regression analysis) is performed.

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

• Was an MRMC study done? No. This type of study is not applicable for this device. MRMC studies are designed to assess diagnostic performance with and without AI assistance for human readers, typically in image interpretation. The IMMAGE AT3 Reagent is an automated in-vitro diagnostic system that quantifies a biomarker, not an imaging device or an AI assistant for human interpretation.

6. Standalone (i.e. algorithm only without human-in-the-loop performance) Study

• Was a standalone study done? Yes. The performance data presented (method comparison, stability, imprecision) appears to be for the IMMAGE AT3 Reagent operating as a standalone system (algorithm only) without direct human-in-the-loop diagnostic interpretation that would alter its output. The system measures Antithrombin III concentrations, and its accuracy is assessed against a predicate device.

7. Type of Ground Truth Used

• Type of Ground Truth: The ground truth for the performance evaluation (method comparison) was established by the results obtained from a legally marketed predicate device: the Array 360 System AT3 Reagent. This is a form of "reference method" in the context of IVD devices for quantitative analytes.

8. Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of machine learning or AI algorithm development. This device, being an immunochemistry system, likely relies on established biochemical reaction principles and calibration curves rather than machine learning algorithms trained on large datasets. Therefore:

• Sample Size for Training Set: Not applicable or not specified, as the device doesn't appear to be based on an AI/ML model requiring a training set in the conventional sense. Its performance is validated through analytical studies (method comparison, stability, imprecision).

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

As noted above, the concept of a "training set" with ground truth in the AI/ML context doesn't appear to apply directly to this device. The system's operation is based on rate nephelometry and calibrated using a specific calibrator (Beckman Calibrator 2). The establishment of the calibrator values would involve a separate, rigorous process, likely traceable to a reference standard, but this is distinct from establishing ground truth for an AI training set.

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CAL 2 (Calibrator 2), when used in conjunction with Beckman alpha,-antitrypsin (AAT), ceruloplasmin (CER), properdin factor B (PFB), beta-2-microglobulin (B2M), alphamacroglobulin (AMG) and antithrombin III (AT3) reagents, is intended for used on Array®, Array® 360, and IMMAGE™ Systems for the calibration of these reagents.

Beckman Calibrator 2 is derived from fresh frozen human plasma that has been defibrinated and processed. Assay of CAL 2 provides a response value that is utilized for the adjustment of pre-programmed calibration curves from which AAT, CER, PFB, B2M, AMG, and AT3 concentration values are determined for test specimens.

The provided document is a 510(k) summary for the Beckman Calibrator 2 (CAL2), a device used for calibrating diagnostic instruments. It describes the device's intended use and compares it to predicate devices. However, this document does not contain the detailed study results, acceptance criteria, or performance data typically associated with studies proving a device meets specific acceptance criteria for diagnostic accuracy metrics (e.g., sensitivity, specificity, AUC) or human reader performance with AI assistance.

The document states: "The data in the Premarket Notification on safety and effectiveness supports a finding of substantial equivalence to chemistry test systems already in commercial distribution. The value assignment process for each analyte is correlated to a known standard via the anchor method. The Beckman Calibrator 2 value assignment and verification processes yield acceptable calibrator assigned values for calibration on the Array® and IMMAGE™ Systems."

This indicates that internal testing was conducted to ensure the calibrator's values were acceptable and correlated to known standards, consistent with establishing substantial equivalence to existing predicate devices. However, it does not provide the specific numerical acceptance criteria or the raw performance data from such a study.

Therefore, much of the requested information cannot be extracted from this specific document.

Here's an attempt to answer the questions based only on the provided text, highlighting what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

• "The Beckman Calibrator 2 value assignment and verification processes yield acceptable calibrator assigned values for calibration on the Array® and IMMAGE™ Systems."
• The device was found substantially equivalent to predicate devices (K771603, K780913, K791339, K791340, K901977, K940353). |

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

• Sample Size for Test Set: Not specified in the document.
• Data Provenance: Not specified in the document (e.g., country of origin, retrospective or prospective). The document only mentions "The data in the Premarket Notification."

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

• Not applicable/Not specified. This device is a calibrator for in-vitro diagnostic tests, not an interpretive AI device for medical images or clinical decision support that would typically involve expert ground truth establishment for a test set in the same way. The ground truth for a calibrator would be an established reference standard or a method traceable to an international standard.

4. Adjudication Method for the Test Set

• Not applicable/Not specified. Adjudication methods like 2+1 or 3+1 are typically used for expert consensus on image interpretation or clinical diagnosis, which is not the primary function of a calibrator.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

• No, an MRMC comparative effectiveness study was not done. This type of study involves human readers interpreting cases, often with and without AI assistance, to measure performance improvement. The Beckman Calibrator 2 is a diagnostic calibrator, not an AI-powered diagnostic tool used by human readers for interpretation.

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

• Yes, in spirit. The testing described (though lacking detail) focuses on the performance of the calibrator itself in assigning values and its compatibility with the instruments. This is analogous to a "standalone" performance evaluation of the calibrator's function, independent of human operators, beyond its intended use in calibrating the instrument. The "value assignment and verification processes" would be an assessment of the calibrator's intrinsic performance.

7. The Type of Ground Truth Used

• Known Standard / Anchor Method: The document states, "The value assignment process for each analyte is correlated to a known standard via the anchor method." This implies that the ground truth for the calibrator's values is established by comparing them to pre-defined, validated reference materials or methods.

8. The Sample Size for the Training Set

• Not applicable/Not specified. This is a calibrator, not an AI algorithm that undergoes "training" in the machine learning sense. Its values are assigned using a chemical process and verified against standards.

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

• Not applicable/Not specified, as this device does not have a "training set" in the context of AI. The "ground truth" for the calibrator's values is established through correlation to "known standards via the anchor method."

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