(62 days)
Per 21 CFR, 682.2160, the AEROSET System is a discrete photometric chemistry Analyzer for clinical use. The device is intended to duplicate manual analytical procedures by performing 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. The AEROSET System also has a solid state Ion-Selective Electrode module, trademarked as Integrated Chip Technology™ (ICT), utilizing potentiometry, for electrolyte determinations (sodium, potassium, and chloride).
The AEROSET System is a fully automated random access clinical chemistry Analyzer which utilizes spectrophotometry (mono and bichromatic modes of measurement). The AEROSET System has a solid state Ion-Selective Electrode module, trademarked as Integrated Chip Technology™ (ICT), utilizing potentiometry, which can perform electrolyte determinations for sodium, potassium, and chloride. The AEROSET System can run up to 100 different assays simultaneously with a maximum throughput approaching 2000 tests per hour (depending on configuration).
Here's an analysis of the provided text, outlining the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes a correlation study comparing the AEROSET™ System to a legally marketed predicate device, the Boehringer Mannheim Diagnostics' Hitachi® 717 Chemistry Analyzer. The acceptance criteria are implicitly based on demonstrating "substantial equivalence," which is shown through high correlation coefficients, and slopes close to 1, and small Y-axis intercepts. Linearity and acceptable precision are also shown.
Because this is a substantial equivalence submission, specific quantitative acceptance criteria (e.g., "correlation coefficient must be >0.95") are not explicitly stated as they would be for a de novo submission. Instead, the performance is presented to demonstrate that it is comparable to the predicate.
| Performance Metric | Acceptance Criteria (Implicit for Substantial Equivalence) | Reported Device Performance (AEROSET™ System vs. Hitachi 717) |
|---|---|---|
| Correlation | High correlation coefficient (close to 1.0) | Total Protein: 0.977 |
| Alkaline Phosphatase: 0.99 | ||
| Creatinine-Serum: 0.995 | ||
| Creatinine-Urine: 0.933 | ||
| Urea Nitrogen: 0.996 | ||
| Sodium-Serum: 0.94 | ||
| Sodium-Urine: 0.998 | ||
| Potassium-Serum: 0.99 | ||
| Potassium-Urine: 0.994 | ||
| Chloride-Serum: 0.96 | ||
| Chloride-Urine: 0.979 | ||
| Slope | Close to 1.0 | Total Protein: 0.931 |
| Alkaline Phosphatase: 0.9 | ||
| Creatinine-Serum: 0.924 | ||
| Creatinine-Urine: 0.9743 | ||
| Urea Nitrogen: 0.95 | ||
| Sodium-Serum: 0.86 | ||
| Sodium-Urine: 0.967 | ||
| Potassium-Serum: 1.08 | ||
| Potassium-Urine: 0.856 | ||
| Chloride-Serum: 0.93 | ||
| Chloride-Urine: 1.02 | ||
| Y-axis intercept | Close to 0 | Total Protein: 0.105 g/dL |
| Alkaline Phosphatase: 3.4 U/L | ||
| Creatinine-Serum: -0.198 mg/dL | ||
| Creatinine-Urine: 2.214 mg/dL | ||
| Urea Nitrogen: -1.114 mg/dL | ||
| Sodium-Serum: 16.14 mmol/L | ||
| Sodium-Urine: 1.227 mmol/L | ||
| Potassium-Serum: -0.49 mmol/L | ||
| Potassium-Urine: 2.273 mmol/L | ||
| Chloride-Serum: 3.9 mmol/L | ||
| Chloride-Urine: 5.38 mmol/L |
Linearity:
| Performance Metric | Acceptance Criteria (Implicit for Acceptable Analytical Range) | Reported Device Performance (AEROSET™ System) |
|---|---|---|
| Linearity | Demonstrated across a clinically relevant range | Total Protein: To 10.90 g/dL |
| Alkaline Phosphatase: To 1484.16 U/L | ||
| Creatinine-Serum: To 23.82 mg/dL | ||
| Creatinine-Urine: To 191.65 mg/dL | ||
| Urea Nitrogen: To 123.51 mg/dL | ||
| Sodium-Serum: To 182.92 mmol/L | ||
| Sodium-Urine: To 398.02 mmol/L | ||
| Potassium-Serum: To 8.74 mmol/L | ||
| Potassium-Urine: To 400.24 mmol/L | ||
| Chloride-Serum: To 148.88 mmol/L | ||
| Chloride-Urine: To 411.00 mmol/L |
Precision:
| Performance Metric | Acceptance Criteria (Implicit for Acceptable Analytical Reproducibility) | Reported Device Performance (AEROSET™ System) |
|---|---|---|
| Total %CV | Acceptable (typically within industry standards for clinical chemistry) | Normal controls: 1.0 to 5.3 |
| Abnormal controls: 0.7 to 4.0 (acceptable) |
2. Sample Size and Data Provenance:
- Sample Size: The document does not specify the exact sample size (number of patient samples) used for the correlation analysis, linearity, or precision studies. It only lists the analytes tested.
- Data Provenance: The document does not provide information on the country of origin of the data or whether the study was retrospective or prospective.
3. Number of Experts and Qualifications:
- Number of Experts: Not applicable. This study involves the performance of a clinical chemistry analyzer, not a diagnostic imaging or classification task requiring expert interpretation. The "ground truth" (or reference method) in this context is the performance of the predicate device (Hitachi 717) and established analytical standards for linearity and precision.
- Qualifications of Experts: Not applicable for this type of analytical device validation.
4. Adjudication Method:
- Adjudication Method: Not applicable. This study compares quantitative analytical measurements between two instruments. There is no subjective human interpretation that would require adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret images or data, and the AI's impact on their performance is being evaluated. The AEROSET System is a standalone clinical chemistry analyzer, not an AI-assisted diagnostic tool for human readers.
6. Standalone Performance Study (Algorithm Only):
- Standalone Study: Yes, the entire performance study (correlation, linearity, precision) represents the standalone performance of the AEROSET™ System. Clinical chemistry analyzers are inherently "standalone" in this context, meaning their performance is evaluated independently of human interpretation in a diagnostic workflow. The "algorithm" here is the underlying analytical methods and hardware of the device. The reported performance metrics directly reflect what the device itself measures.
7. Type of Ground Truth Used:
- Type of Ground Truth:
- For Correlation: The "ground truth" or reference method for the correlation analysis was the Boehringer Mannheim Diagnostics' Hitachi® 717 Chemistry Analyzer. The AEROSET™ System's results were compared against this predicate device's results.
- For Linearity: The ground truth for linearity is established through analytical standards of known concentrations, which are measured by the device to determine if its response is proportional to the analyte concentration across the specified range.
- For Precision: The ground truth for precision is established by running control materials (normal and abnormal) multiple times to assess the reproducibility of the measurements.
8. Sample Size for the Training Set:
- Sample Size: Not applicable. The AEROSET™ System is a traditional clinical chemistry analyzer, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. Its operational parameters and performance characteristics are determined by its physical design, chemical reagents, and established analytical principles, not by learning from a dataset.
9. How Ground Truth for Training Set Was Established:
- Ground Truth Establishment: Not applicable, as there is no training set for this type of device.
§ 862.1170 Chloride test system.
(a)
Identification. A chloride test system is a device intended to measure the level of chloride in plasma, serum, sweat, and urine. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.(b)
Classification. Class II.