(93 days)
The Nova StatStrip Lactate Hospital Meter System is intended for in vitro diagnostic use by healthcare professionals for multiple patient use in a professional healthcare setting for clinical and for point-of-care usage for the quantitative determination of Lactate (Lac) in fresh venous and arterial whole blood specimens as an aid to evaluate the acid-base status of patients suspected of having lactic acidosis. It is not for use on capillary blood specimens. It Is intended to provide plasma equivalent results to laboratory methods.
The Nova StatStrip Lactate Hospital Meter System has the same fundamental scientific technology and intended use as the currently marketed Nova StatStrip Lactate Hospital Meter System (K100602). Both the Nova StatStrip Lactate Hospital Meter System and the proposed Nova StatStrip Lactate Hospital Meter System are hand held devices with similar intended use to quantitatively measure the lactate levels in whole blood. The principle of operation is the same for the proposed and predicate device. Each utilizes a test strip that is inserted into a meter for results within 13 seconds.
The provided document describes the Nova StatStrip Lactate Hospital Meter System. Here's an analysis of its acceptance criteria and the study that proves whether the device meets these criteria:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated as numerical targets in the provided document. Instead, the primary acceptance criterion is substantial equivalence to the predicate device (K100602 - Nova StatStrip Lactate Hospital Meter System) in terms of intended use, technological characteristics, and performance.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial Equivalence: | Conclusion: "Results of laboratory and clinical testing demonstrate that the performance of the Nova StatStrip Lactate Hospital Meter System has the same intended uses, with similar technological characteristics and and can produce results that are substantially equivalent to results obtained on the predicate device. The system performs as intended and raises no new safety or effectiveness issues." |
Specific Performance Characteristics Compared to Predicate (K100602):
- Measuring Range: Proposed: 0.3 - 20.0 mmol/L (Predicate: 0.7 - 20.0 mmol/L). The proposed device has a wider lower detection limit, implying an improvement rather than just equivalence. This suggests the proposed device meets or exceeds the predicate's range.
- Operating Principle: Electromechanical Biosensor, Lactate oxidase (LOD) - "Same"
- Intended Use: "Same"
- Sample Type: Whole Blood - "Same"
- Sample Size: 0.6 uL - "Same"
- Sample Application: Capillary Draw - "Same"
- Handheld Meter? Yes - "Same"
- Meter Calibration: Automatic - "Same"
- Data Storage: 1000 Patient Tests, 200 QC Tests, 4000 Operators - "Same"
- Test Time: 13 Seconds - "Same"
- Weight: 360 grams - "Same"
Overall: The performance studies confirmed that the blood lactate results from the proposed system were "substantially equivalent to the current methods for blood lactate measurements" and to the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not explicitly state the specific sample size (i.e., number of patient samples or data points) used for the definitive performance testing. It generally refers to "laboratory and clinical testing."
- Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. It just mentions "Laboratory testing was performed" and "clinical testing."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the given text. For a lactate monitor, the ground truth would typically be established by a reference laboratory method, not necessarily by "experts" in the sense of human readers interpreting images or data.
4. Adjudication Method for the Test Set
This information is not applicable as the device is an in vitro diagnostic test determining lactate levels, not an AI system interpreting complex data that requires expert adjudication. The "ground truth" would be the result from a reference laboratory method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC study was not done. This type of study (comparing human readers with and without AI assistance) is relevant for diagnostic imaging or interpretation tasks, not for continuous measurement devices like a lactate meter.
6. If a Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, effectively. The performance studies described are inherently "standalone" in the context of an automated measuring device. The device itself performs the measurement, and its results are compared against reference methods. While a human operates the device, the core performance being evaluated is the device's accuracy in measuring lactate independent of human interpretation bias. The statement "The laboratory studies demonstrated that the blood lactate results from the Nova StatStrip Lactate Hospital Meter System were substantially equivalent to the current methods for blood lactate measurements" supports this.
7. The Type of Ground Truth Used
The ground truth used for evaluating the Nova StatStrip Lactate Hospital Meter System was based on "current methods for blood lactate measurements," implying reference laboratory methods. The intended use explicitly states, "It Is intended to provide plasma equivalent results to laboratory methods."
8. The Sample Size for the Training Set
This information is not provided in the document. For an in vitro diagnostic device like this, there isn't typically a "training set" in the machine learning sense. The device's calibration and analytical performance are established through development and validation, not through learning from a specific training data set by the end-user.
9. How the Ground Truth for the Training Set Was Established
Since a "training set" in the machine learning context is not applicable, the concept of establishing ground truth for it is also not relevant here. Device development and calibration would involve comparing the device's measurements against established reference methods, but this is part of the engineering and verification process for the device itself, not a separate "training set" of data.
§ 862.1450 Lactic acid test system.
(a)
Identification. A lactic acid test system is a device intended to measure lactic acid in whole blood and plasma. Lactic acid measurements that evaluate the acid-base status are used in the diagnosis and treatment of lactic acidosis (abnormally high acidity of the blood).(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.