(38 days)
The VALIDATE Chem 8 Calibration Verification Test Set is used by trained personnel for quantitatively verifying calibration, validating reportable ranges, and determining linearity in automated chemistry systems employing direct ion selective technology to measure the following analytes: lithium, sodium, potassium and chloride.
VALIDATE Chem 8 Calibration Verification Test Set contains purified chemicals in an aqueous base. Multiple levels are provided to establish the relationship between theoretical operation and actual performance of each of the included analytes. Each set contains one bottle each of five (5) levels. Each bottle contains 3.0 milliliters.
The provided text describes a 510(k) summary for the "VALIDATE Chem 8 Calibration Verification Test Set". This device is an in-vitro diagnostic (IVD) product used for quantitatively verifying calibration, validating reportable ranges, and determining linearity in automated chemistry systems that measure specific analytes (lithium, sodium, potassium, and chloride).
The study presented is a comparison of this new device to a predicate device, the "DOCUMENT Direct ISE CAL•VER". The primary goal is to demonstrate "substantial equivalence" to the predicate device.
Here's the information requested, based on the provided text:
1. A table of acceptance criteria and the reported device performance
For a calibration verification test set, the acceptance criteria are generally focused on demonstrating linearity and correlation with a reference method or predicate device. The performance is assessed using statistical measures such as correlation coefficients and linear regression equations.
| Acceptance Criteria (Implied) | Reported Device Performance (VALIDATE Chem 8) |
|---|---|
| High Correlation Coefficient (r) with comparison method/predicate device (e.g., close to 1.0) | Lithium (Li): Correlation Coefficient (r) = 1.0, Regression Equation (Y=intercept + slope(X)) = 1.0011x - 0.0102 |
| Sodium (NA): Correlation Coefficient (r) = 1.0, Regression Equation (Y=intercept + slope(X)) = x + 0.0867 | |
| Potassium (K): Correlation Coefficient (r) = 0.9999, Regression Equation (Y=intercept + slope(X)) = 1.0004x - 0.0607 | |
| Chloride (CL): Correlation Coefficient (r) = 0.9998, Regression Equation (Y=intercept + slope(X)) = 1.0047x - 0.0248 | |
| Linear Regression Equation demonstrating functional equivalence (slope near 1, intercept near 0) in comparison to the predicate. | Lithium (Li): Y = 1.0011x - 0.0102 (Predicate: 1.0162x - 0.0685) |
| Sodium (NA): Y = x + 0.0867 (Predicate: 1.0437x + 0.1) | |
| Potassium (K): Y = 1.0004x - 0.0607 (Predicate: 1.1243x - 0.2693) | |
| Chloride (CL): Y = 1.0047x - 0.0248 (Predicate: 0.9601x + 7.5) |
Summary statement explicitly states: "VALIDATE Chem 8 Calibration Verification Test Set has been shown to be functionally equivalent for calibration verification and linearity assessment to DOCUMENT Direct ISE CAL•VER." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: The document states that there are "Multiple levels" provided, and "Each set contains one bottle each of five (5) levels." The study compares the performance "on the AVL 9180 Electrolyte Analyzer, AVL Scientific Corporation, Roswell, GA, for lithium, sodium and potassium and the Beckman Synchron CX, Beckman Coulter, Inc. Fullerton. CA. for chloride as compared to DOCUMENT Direct ISE CAL•VER using pre-production lots of VALIDATE Chem 8 Calibration Verification Test Set."
- This implies a sample size of 5 data points per analyte for the linearity assessment (one for each level).
- Data Provenance:
- Country of Origin: United States (AVL Scientific Corporation, Roswell, GA; Beckman Coulter, Inc. Fullerton, CA; Maine Standards Company, Windham, ME).
- Retrospective or Prospective: Not explicitly stated, but the use of "pre-production lots" and the nature of calibration verification (testing against known values) suggests a prospective experimental setup where the device samples are analyzed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is an in-vitro diagnostic device, not an image analysis or clinical diagnostic device that relies on expert human interpretation for ground truth. The "ground truth" for this device would be the expected analyte concentrations of the calibration verification materials, which are manufactured to specific specifications. Therefore, this question is not applicable in the traditional sense of human experts establishing ground truth. The "ground truth" is derived from the manufacturing and assay of the calibration materials themselves.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This device does not involve human interpretation or subjective assessment that would require an adjudication method. The performance is assessed by quantitative measurements and statistical analysis.
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 calibration verification product, not an AI-assisted diagnostic tool that involves human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to the performance of the calibration verification test set itself as measured by the automated chemistry systems. The study presented is a form of standalone performance evaluation for the device, showing its analytical performance (linearity, correlation) when used in the intended automated systems. The device itself (the VALIDATE Chem 8 set) is a reagent, and its "performance" is how accurately it allows the instruments to verify calibration and linearity.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this study is the theoretical or target concentrations of the analytes within the VALIDATE Chem 8 Calibration Verification Test Set and the predicate device. These are established during the manufacturing process of the calibration materials. The study then compares the measured values from the automated systems against these known ("ground truth") levels and against the performance of the predicate device.
8. The sample size for the training set
Not applicable. This device is not an AI/ML algorithm that requires a training set. It is a physical reagent used for calibration verification.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of medical 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.