(21 days)
The IMMAGE Immunochemistry System Valproic Acid (VPA) Reagent, when used in coniunction with Beckman IMMAGE™ Immunochemistry Systems and Beckman Drug Calibrator 1, is intended for the quantitative determination of valproic acid in human serum or plasma by rate nephelometric inhibition immunoassay.
The IMMAGE Immunochemistry System VPA Reagent in conjunction with Beckman Drug Calibrator 1, is intended for use in the quantitative determination of valproic acid in human serum or plasma on Beckman Coulter's IMMAGE Immunochemistry Systems.
The provided text describes the IMMAGE® Immunochemistry System Valproic Acid (VPA) Reagent and outlines the performance data used to demonstrate its safety and effectiveness. However, it does not explicitly state "acceptance criteria" in a quantitative manner or provide a detailed study report that proves the device meets specific, pre-defined acceptance criteria with quantifiable results.
The document primarily focuses on demonstrating "substantial equivalence" to a predicate device through method comparison, stability, and imprecision experiments, as required for a 510(k) submission. While performance data is presented, it's not structured as a direct comparison against a set of stated acceptance criteria.
Therefore, the following response will extract the available performance data and highlight the limitations in directly answering all parts of your request based on the provided text.
Here's the analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" against which the device's performance is measured. Instead, it presents performance data (Method Comparison and Imprecision) that are implicitly compared against the performance of the predicate device (Abbott TDx Valproic Acid Reagent) to demonstrate substantial equivalence.
Table: Available Performance Data (No Explicit Acceptance Criteria)
| Performance Metric | Reported Device Performance (IMMAGE VPA Reagent) |
|---|---|
| Method Comparison | Data for "Method Comparison Study Results IMMAGE Valproic Acid (VPA) Reagent" is present but the formatting and content in the provided text is unreadable/corrupt (e.g., "American Car Call (11) Lampulanes...", "P. RAKERAE . Illust . Pres . busaneses ."). Therefore, specific values cannot be extracted. It states "Equivalence is demonstrated through method comparison..." implying favorable results against the predicate. |
| Imprecision | Data for "Estimated Imprecision" is present but the formatting and content in the provided text is unreadable/corrupt (e.g., "IN ANDRIGAL COLLER I SULLER BE...", "TEELLISELVIDE"). Values are noted under "Control . NE Automore and" and "evel". For example, "evel 3" shows "1 . 1 . 11 . 1 . 1 . 1 . 1 . 1". Therefore, specific values cannot be extracted. |
| Stability | "Equivalence is demonstrated through... stability... experiments." No specific data or acceptance criteria are provided in the extract. |
| Intended Use | Quantitative determination of valproic acid in human serum or plasma by rate nephelometric inhibition immunoassay. |
2. Sample Size Used for the Test Set and Data Provenance
Due to the unreadable nature of the "Method Comparison Study Results" and "Estimated Imprecision" sections, specific sample sizes for these test sets cannot be determined from the provided text.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). The studies are implied to be internal validation studies conducted by Beckman Coulter, Inc.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. For an immunochemistry system that quantifies a substance in blood, the "ground truth" would typically be established by a reference method or a highly accurate gold standard assay, not by human expert interpretation.
4. Adjudication Method for the Test Set
This information is not applicable as the ground truth for this type of device is established by quantitative laboratory methods, not by expert consensus requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve With AI vs Without AI Assistance
This information is not applicable. The device is an immunochemistry system for quantitative determination of valproic acid, not an AI-assisted diagnostic imaging or interpretation tool involving human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device is described as an "Immunochemistry System Valproic Acid (VPA) Reagent" for use on the "IMMAGE® Immunochemistry Systems." This implies a standalone diagnostic test performed by the instrument. There is no mention of human interpretation being part of the primary assay result generation process. Therefore, the standalone performance is what is being reported (though specific values for method comparison and imprecision are unreadable).
7. The Type of Ground Truth Used
The ground truth for this type of quantitative assay would typically be established by:
- Reference Method: Comparison against a widely accepted and highly accurate reference method (e.g., Gas Chromatography-Mass Spectrometry (GC-MS) or Liquid Chromatography-Mass Spectrometry (LC-MS) for drug levels).
- Predicate Device Comparison: As stated in the document, "Equivalence is demonstrated through method comparison, stability, and imprecision experiments," implicitly using the TDx® Valproic Acid (VPA) from Abbott Laboratories as a comparative "gold standard" or predicate for performance evaluation.
The document explicitly mentions a "Method Comparison Study" against the predicate device, suggesting the predicate device's results served as the comparative 'truth' in the context of demonstrating substantial equivalence.
8. The Sample Size for the Training Set
This information is not provided in the document. For a traditional immunoassay system, there isn't a "training set" in the machine learning sense. The assay is developed and validated through laboratory experiments, calibration, and QC procedures.
9. How the Ground Truth for the Training Set Was Established
As there is no "training set" in the machine learning context for this device, this question is not applicable. The 'ground truth' for the development and validation of such a system would involve precise preparation of known concentration samples and characterization of reagents and system performance through a rigorous analytical chemistry process. Calibration is performed using "Beckman Drug Calibrator 1," which would have its concentrations established by a trusted reference method.
§ 862.3200 Clinical toxicology calibrator.
(a)
Identification. A clinical toxicology calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. A clinical toxicology calibrator can be a mixture of drugs or a specific material for a particular drug (e.g., ethanol, lidocaine, etc.). (See also § 862.2 in this part.)(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.