(45 days)
The VALIDATE Chem 3 Calibration Test Set is intended for in vitro diagnostic use in quantitatively verifying calibration, validating reportable ranges, and determining linearity in automated, semi-automated and manual chemistry systems for the following analytes: total protein, albumin, cholesterol and iron.
The VALIDATE Chem 3 Calibration Verification Test Set is used by trained laboratory professionals for quantitatively verifying calibration, validating reportable ranges, and determining linearity in automated, semi-automated and manual chemistry systems for the following analytes: total protein, albumin, cholesterol, and iron.
VALIDATE Chem 3 Calibration Verification Test Set is a liquid, human serum based calibration verification test set containing multiple levels used establish the relationship between theoretical operation and actual performance of each of the included analytes Each set contains one bottle each of six (6) ievels, including zero. Each bottle contains 5 milliliters.
The provided document describes the VALIDATE Chem 3 Calibration Verification Test Set and its substantial equivalence to predicate devices. Here's an analysis of the requested information based on the text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" for the VALIDATE Chem 3 Calibration Verification Test Set in terms of pre-defined thresholds for correlation coefficients or regression equations. Instead, it demonstrates substantial equivalence to predicate devices by comparing their performance.
The implicit acceptance criterion for this 510(k) submission is that the performance of the VALIDATE Chem 3 device on a specific instrument system (Roche Diagnostics Hitachi 911) should show strong correlation and similar regression characteristics to the predicate devices.
| Analyte | Acceptance Criteria (Implicit - Strong Correlation to Predicate) | Reported VALIDATE Chem 3 Performance (Correlation Coefficient r) | Reported VALIDATE Chem 3 Performance (Regression Equation Y=intercept + slope(X)) |
|---|---|---|---|
| TP | Strong correlation to predicate TP (DOCUMENT Total Protein / Albumin / Cholesterol CAL•VER) | 0.99984 | .109 + .969 |
| ALB | Strong correlation to predicate ALB (DOCUMENT Total Protein / Albumin / Cholesterol CAL•VER) | 0.99920 | .022 + 1.025 |
| CHOL | Strong correlation to predicate CHOL (DOCUMENT Total Protein / Albumin / Cholesterol CAL•VER) | 0.99998 | 2.117 + .988 |
| FE | Strong correlation to predicate FE (DOCUMENT Iron / Magnesium / Triglyceride CAL•VER) | 0.99950 | -7.942 + .996 |
Study Proving Device Meets Acceptance Criteria:
A "Linear Regression Statistical Comparison" study was conducted to demonstrate the substantial equivalence of the VALIDATE Chem 3 Calibration Verification Test Set to the predicate devices.
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: The document states that "Each analyte was tested in triplicate." For each analyte (Total Protein, Albumin, Cholesterol, Iron), the VALIDATE Chem 3 test set contains six levels (including zero). Therefore, the total number of measurements for each analyte from the VALIDATE Chem 3 device would be 6 levels * 3 replicates = 18 data points. Similar testing was presumably done for the predicate devices to generate the comparison data.
- Data Provenance: The study was conducted using "pre-production lots" of the VALIDATE Chem 3 Calibration Verification Test Set. The country of origin of the data is not explicitly stated, but the company (Maine Standards Company, LLC) is based in the USA, suggesting the study was likely conducted domestically. The study is prospective in the sense that it used pre-production lots to generate new data for comparison.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This type of study (calibration verification/linearity assessment) does not typically involve human experts establishing ground truth in the same way an image analysis study would. The ground truth here is the performance of the predicate devices and the expectation that a new device designed for the same purpose on the same instrument should yield highly correlated results. The "ground truth" for the linearity and calibration verification aspects are the known, expected values for each level of the calibrator and the inherent accuracy and precision of the instrument system itself.
4. Adjudication method for the test set
Not applicable for this type of in vitro diagnostic device study. The comparison is statistical (linear regression) rather than 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 is an in vitro diagnostic device, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This study evaluates the performance of the device (calibration verification test set) on an automated instrument system (Roche Diagnostics Hitachi 911). So, in essence, it is an "algorithm only" or "device-only" performance evaluation as it assesses the chemical performance and linearity of the calibrator solutions on the instrument. There is no human-in-the-loop performance being evaluated in this context, other than the initial setup and reading of the instrument.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth for this study is essentially the established performance and linearity of the predicate devices on the specified instrument system, as well as the theoretical true values of the analytes in robust calibrator materials. The study aims to show that the new device's measurements align with these established "truths" through strong statistical correlation.
8. The sample size for the training set
This document does not describe a machine learning algorithm or a "training set" in that context. The device is a chemical calibrator.
9. How the ground truth for the training set was established
Not applicable, as there is no training set mentioned or implied for this type of device.
§ 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.