(55 days)
The Audit® MicroCV™ Beta-Hydroxybutyric Acid Linearity Set is an assayed quality control material consisting of five levels of human based serum. Each level contains Beta- Hydroxybutyric Acid. These five levels demonstrate a linear relationship to each other for Beta-Hydroxybutyric Acid. It is intended to simulate human patient serum samples for purpose of determining linearity, calibration verification and verification of reportable range for Beta- Hydroxybutyric Acid.
The product is intended for use with quantitative assays on the indicated analyzer provided in the labeling and may be used as quality control material for Beta-Hydroxybutyric Acid. When used for quality control purposes, it is recommended that each laboratory establish its own means and acceptable ranges and use the values provided only as guides. The Audit® MicroCV™ Beta- Hydroxybutyric Acid Linearity Set should not be used for calibration or standardization of the Beta- Hydroxybutyric Acid assay. The Audit® MicroCV™ Beta- Hydroxybutyric Acid Linearity Set is "For In Vitro Diagnostic Use Only".
The Audit® MicroCV™ Beta-Hydroxybutyric Acid Linearity Set is an assayed quality control material consisting of five levels of human based serum, with each level containing Beta-Hydroxybutyric Acid. It is used to confirm the proper calibration, linear operating range, and reportable range of Beta-Hydroxybutyric Acid. Level A is near the lower limit level and Level E has concentrations near the upper limit of instruments. Levels B - D are related by linear dilution of Level A and Level E.
The provided document is a 510(k) Summary for a medical device (Audit® MicroCV™ Beta-Hydroxybutyric Acid Linearity Set), which describes the device's intended use, performance data, and comparison to a predicate device. It is a regulatory submission, not a study report that details the methodology and results of a device's performance against specific acceptance criteria in the manner requested.
Therefore, many of the specific details for acceptance criteria and the study that proves the device meets them, especially those pertaining to clinical performance with human readers, ground truth establishment for AI models, and comparative effectiveness studies, cannot be extracted directly from this document. This document is focused on the analytical performance of a quality control material rather than the clinical performance of a diagnostic device.
However, I can extract the information relevant to the analytical performance as described in the document.
Here's an analysis based on the provided text:
Device: Audit® MicroCV™ Beta-Hydroxybutyric Acid Linearity Set
Device Type: Assayed quality control material for Beta-Hydroxybutyric Acid.
Purpose: To confirm proper calibration, linear operating range, and reportable range of Beta-Hydroxybutyric Acid assays.
1. Table of Acceptance Criteria and Reported Device Performance
The document provides "Product claims" based on stability studies and expected values. These claims serve as the performance characteristics. Explicit "acceptance criteria" for linearity or other analytical parameters are not detailed in this summary, but the "Target Range" for expected values implicitly reflects acceptable performance for value assignment.
| Performance Characteristic | Acceptance Criteria (Implicit from "Product Claims") | Reported Device Performance |
|---|---|---|
| Open Vial Stability | Stable for 40 days when stored tightly capped at 2 - 8° C | Stable for 40 days at 2 - 8° C |
| Shelf Life | Two years, when stored unopened at 2 - 8° C | Two years, when stored unopened at 2 - 8° C (Note: Real time studies ongoing) |
| Expected Values (B-HB, mmol/L) | Within specified Target Ranges for each level | |
| Level A (Target Value) | 0.0 (Target Range) | 0.0 |
| Level B (Target Value) | 1.2 (Target Range: 1.0-1.4) | 1.2 |
| Level C (Target Value) | 2.3 (Target Range: 2.0-2.6) | 2.3 |
| Level D (Target Value) | 3.4 (Target Range: 2.9-3.9) | 3.4 |
| Level E (Target Value) | 4.4 (Target Range: 3.8-5.1) | 4.4 |
Note: The document states, "When used for quality control purposes, it is recommended that each laboratory establish its own means and acceptable ranges and use the values provided only as guides." This indicates that the "Target Range" is a guide for expected values, and laboratories would define their specific acceptance criteria based on their analytical system.
Regarding the study that proves the device meets acceptance criteria:
The document refers to "Stability studies" and "Value assignment" studies. These are analytical studies, not clinical studies.
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not explicitly stated. The document mentions "five levels of human based serum" for the linearity set. For stability studies, the number of samples or experimental replicates is not provided.
- Data Provenance: Not explicitly stated for the test data (e.g., country of origin). The material itself is "human based serum." The studies were performed by Aalto Scientific, Ltd. in Carlsbad, CA, US, suggesting the data originates there.
- Retrospective/Prospective: Not specified, but stability studies typically involve prospective real-time testing, while value assignment could be either.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This is not applicable as the device is a quality control material for analytical assays, not a diagnostic device requiring expert interpretation of clinical data. The "ground truth" here is the assigned analytical value of Beta-Hydroxybutyric Acid.
4. Adjudication method for the test set
- Not applicable for this type of analytical device. Ground truth for value assignment is established through laboratory methods, not expert 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
- Not applicable. This device is a linearity set for an analytical instrument, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is not an algorithm or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The ground truth for the expected values of Beta-Hydroxybutyric Acid in the linearity set samples is established through analytical testing/value assignment using quantitative assays on an indicated analyzer (e.g., "P-Modular Instrument, Roche Reagent" is mentioned for the values). This involves precise laboratory measurements.
8. The sample size for the training set
- Not applicable as this is not an algorithm/AI model that requires training data. The "training" for this product would be the manufacturing and quality control processes to ensure consistency.
9. How the ground truth for the training set was established
- Not applicable as this is not an algorithm/AI model. The "ground truth" for the manufactured product's components and values would be established through standard analytical chemistry and manufacturing quality control procedures.
Summary of Limitations Based on Document Content:
The provided 510(k) summary focuses on the analytical performance and stability of a quality control material. It does not contain information about clinical studies, diagnostic accuracy, human reader performance, AI algorithms, or "ground truth" established by clinical experts, which are typical expectations for the detailed questions provided. The data presented is intended to demonstrate the material's suitability for its stated purpose in verifying the performance of Beta-Hydroxybutyric Acid assays.
§ 862.1660 Quality control material (assayed and unassayed).
(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.