(79 days)
The products encompassed by this request are intended for in vitro diagnostic use only and are intended for use in the calibration of equivalent Roche/AVL 9100 Series Electrolyte Analyzers.
Thermo ALKO Calibration Packs are intended for use on equivalent Roche/AVL 9100 Series Analyzers. Calibration Pack, Product No. A9100-101S, contains Standard A, Standard B, Reference Solution and a waste container. It is intended for calibration of equivalent Roche/AVL 9120 and 9130 Analyzers, Calibration Pack, Product No. A9100-103S, contains Standard B, Standard C, Reference Solution and a waste container. It is intended for calibration of equivalent Roche/AVL 9180 and 9181 Analyzers.
The provided text describes a 510(k) summary for Thermo ALKO Calibration Packs, which are calibration standards for electrolyte analyzers. The study aims to demonstrate that these calibration packs are substantially equivalent to a predicate device (AVL ISE SnapPak™).
Here's an analysis of the acceptance criteria and study details based on the provided information:
Acceptance Criteria and Device Performance
The core acceptance criterion for substantial equivalence in this context is that the Thermo ALKO Calibration Packs perform comparably to the predicate device (AVL ISE SnapPak™) when used with equivalent Roche/AVL Analyzers. This is demonstrated through:
- Precision Study: Showing consistent results with the Thermo ALKO Calibration Pack over time.
- Method Comparison (Correlation) Study: Showing agreement between results obtained using Thermo ALKO Calibration Packs and those obtained using AVL ISE SnapPak™.
Table of Acceptance Criteria (Implied) and Reported Device Performance
Since this is a submission for substantial equivalence of calibrators, explicit numerical "acceptance criteria" are not given in the traditional sense of a performance target. Instead, the implication is that the precision and correlation values should fall within generally accepted analytical performance ranges for these types of assays, and critically, demonstrate equivalence to the predicate. The presented data are the reported device performance.
Thermo ALKO Calibration Pack, Product Number A9100-101S (for AVL 9130 Analyzer)
| Study Type | Analyte | Performance Metric | Reported Device Performance | Implied "Acceptance" (e.g., strong correlation, acceptable precision) |
|---|---|---|---|---|
| Precision | Na+ | Total CV% (Low Level) | 0.54% | Acceptable analytical precision |
| K+ | Total CV% (Low Level) | 2.03% | Acceptable analytical precision | |
| Cl- | Total CV% (Low Level) | 1.20% | Acceptable analytical precision | |
| Na+ | Total CV% (High Level) | 0.73% | Acceptable analytical precision | |
| K+ | Total CV% (High Level) | 1.18% | Acceptable analytical precision | |
| Cl- | Total CV% (High Level) | 1.71% | Acceptable analytical precision | |
| Correlation | Na+ | R Squared (vs. Predicate) | 0.9993 | R-squared close to 1.0 indicates strong correlation |
| Slope (vs. Predicate) | 0.9796 | Slope close to 1.0 indicates good agreement | ||
| K+ | R Squared (vs. Predicate) | 0.9988 | R-squared close to 1.0 indicates strong correlation | |
| Slope (vs. Predicate) | 0.9786 | Slope close to 1.0 indicates good agreement | ||
| Cl- | R Squared (vs. Predicate) | 0.9989 | R-squared close to 1.0 indicates strong correlation | |
| Slope (vs. Predicate) | 0.9818 | Slope close to 1.0 indicates good agreement |
Thermo ALKO Calibration Pack, Product Number A9100-103S (for AVL 9180 Analyzer)
| Study Type | Analyte | Performance Metric | Reported Device Performance | Implied "Acceptance" (e.g., strong correlation, acceptable precision) |
|---|---|---|---|---|
| Precision | Na+ | Total CV% (Low Level) | 0.44% | Acceptable analytical precision |
| K+ | Total CV% (Low Level) | 1.08% | Acceptable analytical precision | |
| Cl- | Total CV% (Low Level) | 0.90% | Acceptable analytical precision | |
| Ca++ | Total CV% (Low Level) | 2.07% | Acceptable analytical precision | |
| Li+ | Total CV% (Low Level) | 2.11% | Acceptable analytical precision | |
| Na+ | Total CV% (High Level) | 0.61% | Acceptable analytical precision | |
| K+ | Total CV% (High Level) | 0.76% | Acceptable analytical precision | |
| Cl- | Total CV% (High Level) | 0.62% | Acceptable analytical precision | |
| Ca++ | Total CV% (High Level) | 2.15% | Acceptable analytical precision | |
| Li+ | Total CV% (High Level) | 1.58% | Acceptable analytical precision | |
| Correlation | Na+ | R Squared (vs. Predicate) | 0.9998 | R-squared close to 1.0 indicates strong correlation |
| Slope (vs. Predicate) | 0.9991 | Slope close to 1.0 indicates good agreement | ||
| K+ | R Squared (vs. Predicate) | 0.9993 | R-squared close to 1.0 indicates strong correlation | |
| Slope (vs. Predicate) | 1.0069 | Slope close to 1.0 indicates good agreement | ||
| Cl- | R Squared (vs. Predicate) | 0.9999 | R-squared close to 1.0 indicates strong correlation | |
| Slope (vs. Predicate) | 1.0032 | Slope close to 1.0 indicates good agreement | ||
| Ca++ | R Squared (vs. Predicate) | 0.9994 | R-squared close to 1.0 indicates strong correlation | |
| Slope (vs. Predicate) | 1.0073 | Slope close to 1.0 indicates good agreement | ||
| Li+ | R Squared (vs. Predicate) | 0.9994 | R-squared close to 1.0 indicates strong correlation | |
| Slope (vs. Predicate) | 0.9930 | Slope close to 1.0 indicates good agreement |
Study Details:
-
Sample sizes used for the test set and data provenance:
- Precision Study (A9100-101S on AVL 9130): Two levels of human serum-based materials, analyzed in duplicate per run, over 23 days (25 total runs reported).
- Correlation Study (A9100-101S on AVL 9130): 47 human serum samples and control materials (N=56 for Na+ and K+, N=52 for Cl- in the table).
- Precision Study (A9100-103S on AVL 9180): Two levels of human serum-based materials, analyzed in duplicate per run, over 24 days (22 total runs reported).
- Correlation Study (A9100-103S on AVL 9180): 48 human serum samples and control materials (N=57 for Na+ and K+, N=50 for Cl-, N=55 for Ca++, N=46 for Li+ in the table).
- Data Provenance: The samples are described as "human serum samples and control materials." The country of origin is not specified, nor is whether the data is retrospective or prospective. Given the nature of a 510(k) for a calibrator, it's typically prospective testing performed during development.
-
Number of experts used to establish the ground truth for the test set and qualifications of those experts:
- This is an analytical performance study for a medical device calibrator, not an diagnostic imaging or AI study requiring human expert interpretation or ground truth in the traditional sense of clinical outcomes or pathology.
- The "ground truth" for the correlation study is implicitly the results obtained using the predicate device (AVL ISE SnapPak™) on the same analyzers. The human serum samples and control materials are measured by both the new device (calibrated with Thermo ALKO packs) and the predicate device (calibrated with AVL ISE SnapPak™), and these results are compared.
-
Adjudication method for the test set:
- Not applicable. This is not a study requiring adjudication of diagnostic findings. The comparison is quantitative between two analytical methods.
-
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 analytical performance study for a calibrator, not a diagnostic imaging or AI study involving human readers.
-
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is an analytical performance study for a calibrator, not an AI algorithm. The performance of the calibrator is assessed alone (precision study) and in comparison to a predicate calibrator (correlation study). There is no "human-in-the-loop" concept in the way it applies to AI-assisted diagnostic devices.
-
The type of ground truth used:
- For the precision study, there isn't a "ground truth" in the diagnostic sense. The study assesses the repeatability and reproducibility of the device itself (when calibrated with the Thermo ALKO packs).
- For the correlation study, the "ground truth" or reference method is the predicate device (AVL ISE SnapPak™). The performance of the Thermo ALKO packs is measured against the established performance of the legally marketed predicate device.
-
The sample size for the training set:
- Not applicable. This device is a calibrator, not a machine learning or AI algorithm, so there is no "training set."
-
How the ground truth for the training set was established:
- Not applicable, as there is no training set for this type of device.
§ 862.1150 Calibrator.
(a)
Identification. A 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. (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.