(45 days)
The Osmetech OPTI R Critical Care Analyzer is intended to be used for the measurement of pH, PCO2, PO2, sodium, potassium, ionized calcium, total hemoglobin content and oxygen saturation in sample of whole blood, serum or plasma in either a traditional blood gas, clinical laboratory setting or point-of-care locations by personnel minimally qualified to perform and report these results.
The OPTI R Critical Care Analyzer is a small [4.9 x 14.3 x 9.8 in., 10 lbs], microprocessor-based instrument using optical fluorescence for the measurement of pH, pCO2, PO2, sodium, potassium and ionized calcium in samples of whole blood, plasma or serum. In addition, it uses optical reflectance for the measurement of total hemoglobin and oxygen saturation. A multiple use cassette provides up to 50 patient and 42 aqueous quality control samples on a single cassette during a seven day period. The sample count and time is maintained by the analyzer and reported to the user with each sample operation. The cassette contains six optical fluorescence sensors and is packaged in a sealed foil pouch which bears a bar-coded label with calibration and identification information. One of these sensors, the oxygen sensor, is also used for the simultaneous measurements of ctHb and SO2. This bar code is read by 'swiping' the foil pouch through a bar code reader conveniently located on the right side of the OPTI R instrument. This bar coded information is used for a calibration verification of the cassette prior to sample introduction. The cassette is then removed from the pouch and placed into the measuring chamber of the OPTI R and a light-tight cover is closed and secured. The OPTI R performs a calibration as needed, but minimally every 30 minutes or within 30 minutes of every patient's sample utilizing liquid buffer and precision calibration gas, both of which are maintained within the analyzer. The buffer is contained in the OPTI R Fluid Pack and the precision gas is contained in a cylinder. Various checks of mechanical and calibration integrity are performed during this calibration to ensure correct operation and measurement. The OPTI R aspirates the specimen into the cassette either from a capillary tube, syringe or Osmetech ComfortSampler™, and into position over the fluorescence sensors for pH, PCO2, PO2, Na , K , and iCa " as well as ctHb and SO2. During this process, additional checks are made for position and integrity of the sample, measurement stability, and end-point. After the results are displayed and printed the sample is moved to the waste pouch contained within the OPTI R Fluid Pack. The cassette is then rinsed and calibrated, after which the cassette is ready for the next sample. Communication to the device is accomplished simply with the use of a touch screen graphical user interface. The analyzer communicates to the user through a color display and with a thermal printer using heat sensitive paper to output measured values, calibration reports, and other information. The data from the analyzer may be communicated to hospital HIS/LIS data systems through an RS232 output terminal.
The provided 510(k) summary for the Osmetech OPTI R Critical Care Analyzer does not contain detailed acceptance criteria and study results in the format requested. The document primarily focuses on establishing substantial equivalence to a predicate device (K000103) by highlighting similarities in intended use, operating principle, basic design, materials, and packaging.
The summary states that "Analysis of the data collected during verification and validation testing including linearity and precision testing for this device demonstrates that the Osmetech OPTI R Critical Care Analyzer is safe, effective, and equivalent to predicate device [K000103] to which it is compared. The key design verification tests that were performed as a result of the risk analysis are listed under the tab, Verification and Validation."
However, the specific "Verification and Validation" tab content, which would detail acceptance criteria and reported device performance for each parameter (pH, PCO2, PO2, Na+, K+, iCa++, ctHb, SO2), sample sizes, data provenance, ground truth establishment, and the other requested information, is not included in this public 510(k) summary.
Therefore, based solely on the provided text, I cannot complete the requested tables and sections. The document indicates that such testing was performed, but it does not present the results or methodology in detail within the provided extract.
To address your request, if the full "Verification and Validation" report were available, the information would typically be extracted and presented as follows:
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (e.g., Accuracy, Precision, Linearity) | Reported Device Performance (e.g., Bias, CV, R²) |
|---|---|---|
| pH | [Specific criteria from validation, e.g., ±0.0X at Y pH] | [Observed performance, e.g., Mean bias 0.005, CV 0.1%] |
| PCO2 | [Specific criteria, e.g., ±Z mmHg at A PCO2] | [Observed performance, e.g., Bias 1.2 mmHg, CV 2.0%] |
| PO2 | [Specific criteria, e.g., ±W mmHg at B PO2] | [Observed performance, e.g., Bias 0.8 mmHg, CV 1.5%] |
| Sodium | [Specific criteria, e.g., ±X mmol/L at C Na+] | [Observed performance, e.g., Bias 0.5 mmol/L, CV 0.8%] |
| Potassium | [Specific criteria, e.g., ±Y mmol/L at D K+] | [Observed performance, e.g., Bias 0.03 mmol/L, CV 1.1%] |
| iCa++ | [Specific criteria, e.g., ±Z mmol/L at E iCa++] | [Observed performance, e.g., Bias 0.02 mmol/L, CV 1.3%] |
| ctHb | [Specific criteria, e.g., ±X g/dL at F ctHb] | [Observed performance, e.g., Bias 0.2 g/dL, CV 1.0%] |
| SO2% | [Specific criteria, e.g., ±Y% saturation at G SO2%] | [Observed performance, e.g., Bias 0.5%, CV 0.7%] |
| (Note: The cells above are placeholders as this information is not in the provided text.) |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not specified in the provided text.
- Data Provenance: Not specified in the provided text. Typically, for such a device, samples would be clinical specimens (whole blood, plasma, or serum) drawn from a diverse patient population, likely from a clinical laboratory or point-of-care settings. It is presumed to be prospective collection for validation, but this is not explicitly stated.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This type of information is generally not applicable to an in vitro diagnostic (IVD) device like a critical care analyzer. The "ground truth" for quantitative measurements like pH, blood gases, or electrolytes is established by reference methods or validated comparative analyzers, not by human expert consensus or radiologists.
4. Adjudication method for the test set
Not applicable for a quantitative IVD device measuring objective parameters.
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 device is an automated in vitro diagnostic analyzer, not an AI-assisted diagnostic imaging or interpretation system. It directly measures physiological parameters.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, this is an inherent aspect of an automated IVD analyzer. The device itself performs the measurements and provides results without direct human interpretive input for each measurement. The validation testing (linearity, precision, method comparison) would be a standalone evaluation of the device's analytical performance.
7. The type of ground truth used
For an IVD device measuring physiological parameters, the ground truth is typically established by:
- Reference methods: Highly accurate and precise laboratory methods, often using different principles, considered the gold standard for that analyte.
- Method comparison: Comparing the device's results against a legally marketed, predicate, or established clinical laboratory analyzer using patient samples. The predicate device (K000103) itself would likely have been validated against such methods.
8. The sample size for the training set
Not applicable. This device is not described as involving a machine learning or AI component that would require a separate "training set" in the conventional sense (e.g., for image recognition or predictive models). The device is a direct measurement instrument. Calibration and internal quality control procedures are utilized but not typically referred to as a "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no "training set" in the context of machine learning for this device. Calibration is performed using liquid buffers and precision calibration gas, with integrity checks. These calibrated materials serve as known standards for the device's measurement system.
§ 862.1600 Potassium test system.
(a)
Identification. A potassium test system is a device intended to measure potassium in serum, plasma, and urine. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.(b)
Classification. Class II.