(69 days)
The Stat Profile® Prime Plus Analyzer System is indicated for use by healthcare professionals in clinical laboratory settings and for point-of-care usage for quantitative determination of Hematocrit, Oxygen Saturation, Total Hemoglobin, Oxyhemoglobin, Carboxyhemoglobin, Methemoglobin, and Deoxyhemoglobin in heparinized arterial and venous whole blood.
The Stat Profile Prime Plus Analyzer System is a low cost, low maintenance analyzer for hospital laboratory and point-of-care settings. It consists of the analyzer, sensor cartridges, and thermal paper for an onboard printer. Optionally, it provides for reading of barcode labels (such as operator badges and data sheets).
The Stat Profile Prime Plus Analyzer has slots to accommodate two sensor cartridges (Primary and Auxiliary). The analyzer will determine the configuration of the system by detecting which sensor cards are installed.
As with the predicate, the Stat Profile Prime Plus Analyzer is a blood gas, co-oximetry, electrolyte, chemistry, and hematology analyzer with an enhanced test menu and multiple quality control options. Both traditional internal and external quality control is available, as well as an on-board Quality Management System (QMS), and an electronic monitoring approach that insures the analyzer is working properly at all times.
The Stat Profile Prime Plus Analyzer accepts samples from syringes and open tubes. The minimum sample size for analysis is 135 µL.
Sample collection, preparation and application to the analyzer are the same as for the previously cleared predicate. The end user can select which analytes are to be tested in the panel.
The provided text describes the performance validation of the Stat Profile® Prime Plus Analyzer System, specifically focusing on its point-of-care (POC) capabilities and comparability to a predicate device. This is a medical device, not an AI/ML software. Therefore, many of the requested categories related to AI/ML software development (e.g., number of experts for ground truth, adjudication method, MRMC studies, training set details) are not applicable to this document.
However, I can extract information related to the device's acceptance criteria and how its performance was proven.
Here's the breakdown of the available information:
Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by demonstrating "substantial equivalence" to the predicate device and by meeting established criteria for method comparison and imprecision, based on CLSI guidelines. The performance data is presented as method comparison statistics (slope, intercept, r-value) and total imprecision (SD, %CV).
Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state quantitative acceptance criteria thresholds for each parameter prior to the results. Instead, it presents the quantitative results from the study and concludes that these results "confirmed that the performance of the Stat Profile Prime Plus Analyzer System is substantially equivalent to that of the Nova Stat Profile pHOx Ultra Analyzer System (predicate device)."
Therefore, I will present the reported device performance, and the implicit acceptance can be inferred as meeting industry standards for substantial equivalence in medical devices of this type.
| Analyte | N (samples) | Range (tested) | Slope | Intercept | r (correlation coefficient) | MDL (Min. Detection Limit) | 95% Confidence Interval of Bias (Lower-Upper) | Total Imprecision (Representative Data) |
|---|---|---|---|---|---|---|---|---|
| Hct | 417 | 18 - 69 | 0.9997 | 0.1315 | 0.9929 | 20-56 | 20-20 | Level 1: Mean 61, Total %CV 0.9 |
| Level 2: Mean 38, Total %CV 0.8 | ||||||||
| Level 3: Mean 27, Total %CV 1.6 | ||||||||
| SO2 | 398 | 30 - 100 | 1.0084 | -0.9664 | 0.9982 | 80-90 | 80-80 | Level 1: Mean 47.5, Total %CV 1.4 |
| Level 2: Mean 78.0, Total %CV 0.5 | ||||||||
| Level 3: Mean 91.0, Total %CV 0.0 | ||||||||
| tHb | 416 | 5.0 - 24.2 | 1.0042 | -0.0058 | 0.9923 | 7-22 | 6.9-7.1 | Level 1: Mean 19.8, Total %CV 1.0 |
| Level 2: Mean 13.3, Total %CV 2.2 | ||||||||
| Level 3: Mean 6.6, Total %CV 2.2 | ||||||||
| O2Hb | 422 | 7.1 - 98.4 | 1.0072 | -0.8636 | 0.9983 | 85-90 | 84.6-85.1 | Level 1: Mean 20.5, Total %CV 1.7 |
| Level 2: Mean 47.1, Total %CV 0.9 | ||||||||
| Level 3: Mean 80.1, Total %CV 0.2 | ||||||||
| COHb | 425 | 0.3 - 50.5 | 1.0024 | -0.0013 | 0.9986 | 3-10 | 3.0-3.0 | Level 1: Mean 29.2, Total %CV 0.7 |
| Level 2: Mean 21.2, Total %CV 1.4 | ||||||||
| Level 3: Mean 6.2, Total %CV 1.5 | ||||||||
| MetHb | 437 | 0.3 - 56.7 | 1.0040 | 0.0006 | 0.9993 | 5-10 | 5.0-5.0 | Level 1: Mean 27.7, Total %CV 0.4 |
| Level 2: Mean 18.4, Total %CV 1.2 | ||||||||
| Level 3: Mean 5.8, Total %CV 2.3 | ||||||||
| HHb | 322 | 0.4 - 39.7 | 1.0123 | 0.0882 | 0.9962 | 6-15 | 6.0-6.3 | Level 1: Mean 22.7, Total %CV 0.6 |
| Level 2: Mean 13.2, Total %CV 1.2 | ||||||||
| Level 3: Mean 7.9, Total %CV 1.7 |
2. Sample Size and Data Provenance
- Test Set Sample Size:
- Method Comparison (POC vs. Lab):
- Hct: 417 samples
- SO2: 398 samples
- tHb: 416 samples
- O2Hb: 422 samples
- COHb: 425 samples
- MetHb: 437 samples
- HHb: 322 samples
- Total Imprecision Performance: 20 runs performed on 3 analyzers, using 3 levels of quality control/linearity materials.
- Within-Run Whole Blood Precision: Minimum of 2 operators per site across 3 POC sites (total 9 operators). Each precision run consisted of 10 replicate measurements using 7 different whole blood samples (5 native, 2 altered).
- Method Comparison (POC vs. Lab):
- Data Provenance: The study was conducted in the United States, across three Point-of-Care (POC) sites: a Cardiothoracic Intensive Care Unit (CTICU), an Emergency Department (ED), and a Respiratory Therapy Lab (RT). The data utilized a mix of quality control materials and discarded blood gas specimens. This suggests prospective collection of real-world samples within a clinical setting.
3. Number of Experts and Qualifications for Ground Truth
- This device is a medical diagnostic instrument, not an AI/ML algorithm. Ground truth for the method comparison study was established by laboratory measurements (presumably using the established predicate device or a gold standard lab method) which the new device's results were compared against.
- The study involved "trained Healthcare Professionals" and "POC personnel". These personnel performed the tests on the new device. Their qualifications are described as "trained, qualified staff found in typical POC sites where blood gas analyzers are utilized," including Respiratory Care, Nursing, and Exercise Physiology personnel. No "experts" in the sense of adjudicating image interpretations are mentioned, as this is not an imaging AI.
4. Adjudication Method for the Test Set
- Not applicable. This is a quantitative measurement device, not an interpretive one requiring expert adjudication. The comparison was quantitative against a reference method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Not applicable. This is a quantitative measurement device, not an AI-assisted diagnostic tool that would be evaluated for human reader improvement. The study compares the new device's performance to a predicate device and laboratory methods.
6. Standalone Performance
- Yes, effectively. The "Stat Profile® Prime Plus Analyzer System" provides quantitative measurements. The performance data presented (Method Comparison, Total Imprecision, Within-Run Whole Blood Precision) represents the standalone performance of the device in generating these measurements, compared against established laboratory methods or statistical precision targets. There is no "human-in-the-loop" performance as the human simply operates the device to obtain the measurement.
7. Type of Ground Truth Used
- Comparative ("Reference") Method: For the method comparison study, the ground truth was the results obtained from analyses performed by "Lab" (laboratory reference methods, presumably the predicate device or another validated laboratory analyzer). This is a comparative ground truth against an established standard.
- Statistical Targets: For precision studies, the ground truth is implicitly defined by the acceptable statistical variance and bias from the mean of repeated measurements, often against known control material values.
8. Sample Size for the Training Set
- Not applicable. This is a physical, chemical, and optical measurement device, not a machine learning model that requires a "training set" in the computational sense. The device's measurement algorithms are fixed based on spectrophotometric and impedance principles.
9. How the Ground Truth for the Training Set was Established
- Not applicable, as there is no "training set" for an AI/ML model for this device. The principles of measurement are based on established scientific methods (e.g., spectrophotometry and impedance) and not trained on data in the AI/ML sense.
§ 864.7500 Whole blood hemoglobin assays.
(a)
Identification. A whole blood hemoglobin assay is a device consisting or reagents, calibrators, controls, or photometric or spectrophotometric instrumentation used to measure the hemoglobin content of whole blood for the detection of anemia. This generic device category does not include automated hemoglobin systems.(b)
Classification. Class II (special controls). An acid hematin intended for use with whole blood hemoglobin assays is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 864.9.