(215 days)
The Sirrus® Clinical Chemistry Analyzer is a discrete photometric chemistry analyzer for clinical use. The device is intended to duplicate manual analytical procedures by performing automatically various steps such as pipetting, heating, and measuring color intensity. This device is intended for use in conjunction with certain materials to measure a variety of analytes to include Glucose, Cholesterol, and Triglycerides.
The Sirrus® Clinical Chemistry Analyzer is an automated system for quantitative analysis of clinical chemistries. The analyzer is intended for clinical use in conjunction with certain materials to measure a variety of analytes.
Here's an analysis of the provided 510(k) summary regarding the acceptance criteria and study proving the device meets those criteria:
Device: Sirrus® Clinical Chemistry Analyzer
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for substantial equivalence are presented through correlation and precision studies, comparing the Sirrus® Clinical Chemistry Analyzer to the predicate device, Roche Cobas Mira®. The summary outlines the performance criteria for correlation via correlation coefficient, slope, and y-intercept, and for precision via Standard Deviation and %CV.
| Study Type | Analyte | Acceptance Criteria (Predicate Performance) | Reported Device Performance (Sirrus) |
|---|---|---|---|
| Correlation | Glucose | Not explicitly stated as "acceptance criteria" but implied via comparison to predicate. The predicate (Roche Cobas Mira®) is assumed to have acceptable correlation values, and the Sirrus aims to demonstrate similar performance. | Correlation Coefficient: 0.9971, Slope: 0.887, Y-axis intercept: 16.17 mg/dL |
| Cholesterol | (Same as above) | Correlation Coefficient: 0.9894, Slope: 1.126, Y-axis intercept: -24.90 mg/dL | |
| Triglycerides | (Same as above) | Correlation Coefficient: 0.9978, Slope: 0.972, Y-axis intercept: -5.03 mg/dL | |
| Precision | |||
| Within Run | Cholesterol (Sam #1) | Not explicitly stated, but typically a low %CV is desired for good precision. | Mean: 143 mg/dL, SD: 1.50, % CV: 1.05 % |
| Cholesterol (Sam #2) | Not explicitly stated | Mean: 242 mg/dL, SD: 2.68, % CV: 1.11 % | |
| Triglycerides (Sam #1) | Not explicitly stated | Mean: 78 mg/dL, SD: 1.35, % CV: 1.73 % | |
| Triglycerides (Sam #2) | Not explicitly stated | Mean: 183 mg/dL, SD: 1.79, % CV: 0.98 % | |
| Between Run | Glucose (Sam #1) | Not explicitly stated | Mean: 100 mg/dL, SD: 2.23, % CV: 2.22% |
| Glucose (Sam #2) | Not explicitly stated | Mean: 302 mg/dL, SD: 4.86, % CV: 1.61% | |
| Cholesterol (Sam #1) | Not explicitly stated | Mean: 154 mg/dL, SD: 6.15, % CV: 3.99% | |
| Cholesterol (Sam #2) | Not explicitly stated | Mean: 263 mg/dL, SD: 4.17, % CV: 1.58% | |
| Triglycerides (Sam #1) | Not explicitly stated | Mean: 86 mg/dL, SD: 2.86, % CV: 3.30% | |
| Triglycerides (Sam #2) | Not explicitly stated | Mean: 208 mg/dL, SD: 5.56, % CV: 2.67% |
Note on Acceptance Criteria: For this type of device (clinical chemistry analyzer), the "acceptance criteria" are implicitly met by demonstrating performance (correlation and precision) that is comparable to a legally marketed predicate device (Roche Cobas Mira®). The summary doesn't explicitly state numerical acceptance thresholds for these metrics beyond the reported predicate performance, but rather presents the Sirrus's performance against the predicate's expected performance through various trials. The FDA's substantial equivalence determination implies that these results were found acceptable.
2. Sample Size for the Test Set and Data Provenance
- Sample Size: The document does not explicitly state the sample size (number of patient samples) used for the correlation and precision studies. It refers to "Sam #1" and "Sam #2" for precision, implying multiple samples or control levels were tested, but not the total number of individual runs or replicates.
- Data Provenance: The document does not specify the country of origin of the data. The studies appear to be laboratory-based evaluations for performance characteristics. There is no information to indicate if the data is retrospective or prospective patient data, it's more likely referring to control samples or spiked samples in a laboratory setting typical for instrument validation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This type of device (a clinical chemistry analyzer) does not typically involve human experts establishing "ground truth" in the way a diagnostic imaging AI might. The "ground truth" for the test set is established by the reference values obtained from the predicate device (Roche Cobas Mira®) for correlation studies, and through the inherent accuracy and precision of the analytical methods themselves for precision studies, often using certified reference materials or control solutions with known values. Therefore, this section is not applicable in the traditional sense.
4. Adjudication Method for the Test Set
Not applicable. As described in point 3, the "ground truth" for a clinical chemistry analyzer's performance (correlation and precision) is determined by comparison to a predicate device and established analytical methods, not by expert adjudication of individual cases.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. An MRMC study is not applicable for a standalone clinical chemistry analyzer like the Sirrus®. This type of study is relevant for diagnostic imaging AI devices where human readers interpret results with and without AI assistance.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done
Yes, the performance data presented (correlation and precision) represents the standalone performance of the Sirrus® Clinical Chemistry Analyzer. It's an automated system intended to duplicate manual analytical procedures, meaning its performance is evaluated based on its own output against established reference methods or predicate devices, without human intervention in the result generation process.
7. The Type of Ground Truth Used
- Correlation Study: The ground truth for the correlation study is implicitly the results obtained from the predicate device (Roche Cobas Mira®). The Sirrus® device's measurements are compared against these predicate values to establish correlation.
- Precision Study: The ground truth for the precision study involves known concentrations of analytes in control samples ("Sam #1," "Sam #2"). The consistency of the Sirrus® device's measurements around these known means or its own calculated mean demonstrates its precision.
8. The Sample Size for the Training Set
Not applicable. The Sirrus® Clinical Chemistry Analyzer is a hardware device that performs chemical assays based on established photometric principles, not a machine learning or AI algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device.
§ 862.2160 Discrete photometric chemistry analyzer for clinical use.
(a)
Identification. A discrete photometric chemistry analyzer for clinical use is a device intended to duplicate manual analytical procedures by performing automatically various steps such as pipetting, preparing filtrates, heating, and measuring color intensity. This device is intended for use in conjunction with certain materials to measure a variety of analytes. Different models of the device incorporate various instrumentation such as micro analysis apparatus, double beam, single, or dual channel photometers, and bichromatic 2-wavelength photometers. Some models of the device may include reagent-containing components that may also serve as reaction units.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.