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The Albumin Cobalt Binding Test (ACB®) Assay Verification Set (AVS) is intended for use in verifying the accuracy of the ACB Test on the Roche INTEGRA 700/800, the Roche/Hitachi 917 and the Roche MODULAR P. It is recommended as part of assay installation. For In Vitro Diagnostic Use

The Assay Verification Set consists of twenty (20) single vial 0.5 mL aliquots of frozen serum based samples with assigned IMA values over the physiological range.

The Inverness Medical Innovations, Inc. Albumin Cobalt Binding Test (ACB®) Assay Verification Set (AVS) is a quality control material intended for verifying the accuracy of the ACB Test on specific Roche clinical analyzers (INTEGRA 700/800, Roche/Hitachi 917, and Roche MODULAR P). The provided documentation describes its intended use and a general statement about its performance, but lacks specific details on the acceptance criteria and the comprehensive study design, results, and ground truth establishment typically associated with a detailed device validation study.

Here's an attempt to extract and infer information based on the provided text, while also highlighting what is not explicitly stated in the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information: The specific numerical acceptance criteria (e.g., target ranges, allowable percentage deviation from assigned values, precision requirements) are not detailed in the provided text. The statement "using revised acceptance criteria" further implies that such criteria exist but are not disclosed.

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

• Sample Size: The Assay Verification Set consists of "twenty (20) single vial 0.5 mL aliquots of frozen serum based samples." This represents the test set (the verification set itself).
• Data Provenance: The testing was conducted "internally and at multiple clinical sites." The country of origin for the data is not specified. The study appears to be prospective in nature, as it's described as an evaluation for range setting values and performance verification.

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

• Not explicitly stated. The document mentions the samples have "assigned IMA values over the physiological range." The method and number of experts/assigners for these values are not detailed.
• Qualifications of Experts: Not explicitly stated.

4. Adjudication Method for the Test Set

• Not explicitly stated. The document refers to "assigned IMA values," implying that a definitive value exists for each sample. How these values were agreed upon if multiple assessments were involved (e.g., 2+1, 3+1 consensus) is not described.

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

• No, an MRMC study was NOT done. This device is a quality control material, not an AI-powered diagnostic tool requiring human-in-the-loop performance evaluation. The study focuses on the device's ability to verify the accuracy of an assay on an analyzer.

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

• Yes, effectively a "standalone" evaluation of the AVS was done. The study evaluated how the AVS performed on various clinical analyzers to verify the accuracy of the ACB Test. This is an assessment of the AVS's performance as a material without direct human interaction interpreted for diagnostic purposes. It's about the material's consistency and its ability to challenge the analytical system.

7. The Type of Ground Truth Used

• The ground truth for the AVS samples is the "assigned IMA values." These are likely reference values established through a highly accurate and precise analytical method, often using calibrated reference materials or methods with known traceability. This would be a form of expert consensus/reference method data for the chemical properties of the control material.

8. The Sample Size for the Training Set

• Not applicable. This device is a quality control material, not a machine learning model or algorithm that requires a "training set" in the conventional sense. The "test set" described (the 20 vials) serves as the entirety of the AVS product itself that is being validated.

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

• Not applicable, as there is no training set for this type of device. The "assigned IMA values" for the AVS samples (which serve as the ground truth for performance verification) would have been established through a rigorous process of analytical measurement, often involving multiple runs on a reference instrument and statistical analysis, possibly with certified reference materials. The exact method is not detailed.

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The Ischemia Albumin Cobalt Binding Test (ACB®) is a quantitative in vitro diagnostic test used on human serum that detects Ischemia Modified Albumin (IMA™) by measuring the cobalt binding capacity of albumin in human serum. IMA is intended for use in conjunction with ECG and cardiac troponin as an aid to the short term risk stratification of patients presenting with chest pain suggestive of cardiac origin.

Thus, in patients with chest pain or equivalent symptoms suggestive of cardiac origin, with non-diagnostic ECG and normal troponin, a negative IMA can be used as an aid to rule out Acute Coronary Syndrome (ACS) in low risk patients.

The safety and effectiveness of this device for use in patients with potential Acute Coronary Syndrome (ACS) with negative ECG; or positive ECG; or positive ECG combined with negative, low, or normal troponin levels; or positive troponin levels also has not been established. IMA results do not correlate with blood flow and in the event of a positive IMA, ECG, or troponin test result, could be misleading as either ruling in or ruling out ACS.

The Ischemia ACB® Test measures the cobalt binding capacity of albumin in a serum specimen. Cobalt is added to serum and allowed to react. Dithiothreitol (DTT), a colorimetric indicator, is added to the reacted specimen and the degree of color formation is detected spectrophotometrically on clinical chemistry analyzers.

In normal patients, cobalt binds at the N-terminus of albumin leaving little cobalt to react with DTT and form a colored product. In serum of patients with ischemia, cobalt does not bind to the metal binding sites leaving more free cobalt to react with DTT and form a darker color.

Here's a breakdown of the acceptance criteria and study information for the Ischemia Albumin Cobalt Binding Test (ACB® Test), based on the provided documents:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state acceptance criteria in terms of specific performance metrics (e.g., sensitivity, specificity, accuracy thresholds). Instead, it lists the types of verification/validation testing performed. The "reported device performance" would be the results obtained from these tests, which are not detailed in this submission.

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

The document does not provide details on the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only mentions "patients presenting with chest pain suggestive of cardiac origin" for the intended use.

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

This information is not available in the provided document.

4. Adjudication Method for the Test Set

This information is not available in the provided document.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This device is an in-vitro diagnostic test for a biomarker, not an imaging or diagnostic device requiring human reader interpretation in the same way. The intended use is "in conjunction with ECG and cardiac troponin as an aid to the short-term risk stratification of patients."

6. Standalone (Algorithm Only) Performance Study

The Ischemia Albumin Cobalt Binding Test (ACB® Test) is an in-vitro diagnostic test that measures the cobalt binding capacity of albumin. While it's a quantitative test and can be run on clinical chemistry analyzers, it's not an "algorithm only" device in the sense of AI-driven image analysis or decision support. Its performance is inherent to the chemical reaction and measurement, not a separate algorithm. The "standalone performance" is implicitly covered by the "Typical Calibration Curve, Linearity, Sensitivity, Precision, Test Method Comparison, On Board Component Stability, Specificity, and Interfering Substances" testing.

7. Type of Ground Truth Used

For diagnostic tests like this, the "ground truth" would typically refer to the clinical diagnosis of Acute Coronary Syndrome (ACS) established by a combination of clinical assessment, ECG, cardiac troponin levels, and potentially other diagnostic procedures (e.g., angiography, outcomes data). The document itself does not specify how the ground truth was established for the study cohort, but mentions its use "in conjunction with ECG and cardiac troponin as an aid to the short-term risk stratification of patients presenting with chest pain suggestive of cardiac origin." The negative IMA result is used to "rule out Acute Coronary Syndrome (ACS) in low risk patients" with non-diagnostic ECG and normal troponin.

8. Sample Size for the Training Set

The document does not explicitly mention a "training set" in the context of machine learning or AI. For an in-vitro diagnostic device, this would typically refer to the samples used during development and optimization of the assay. This information is not provided.

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

As there is no explicit mention of a "training set" in the AI/ML context, this information is not applicable and not provided in the document. The development processes for chemical assays involve different methodologies for optimizing performance and establishing reference ranges.

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