(532 days)
The Nova StatStrip Lactate Hospital Meter System is intended for in vitro diagnostic use by health care professionals for clinical and for point-of-care usage for the quantitative determination of Lactate (Lac) in fresh venous and arterial whole blood specimens. 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 is indicated for use in a clinical setting by healthcare professionals as an aid to evaluate the acid-base status of patients suspected of having lactic acidosis.
Nova StatStrip Lactate Test Strips are intended for use only with Nova StatStrip Lactate Hospital Meter for quantitative determination of lactate in fresh venous and arterial whole blood specimens. It is not for use on capillary blood specimens. The performance characteristics of the device for lactate measurements on capillary specimens have not been established. Nova StatStrip Lactate Test Strips are for testing outside the body (in vitro diagnostic use only).
Nova StatStrip Lactate Control Solutions are intended for use with the Nova StatStrip Family of Meters and Nova StatStrip Lactate Test Strips as a quality control check to verify the accuracy of blood lactate test results. There are 2 levels of controls. (Level 1 and Level 2).
Nova StatStrip Lactate Linearity Kit solutions are used to check the linearity of the Nova StatStrip Family of Meters. There are 4 levels of lactate linearity solutions: Level 1, Level 2, Level 3, and Level 4.
The Nova StatStrip Lactate Hospital Meter System consists of:
- Nova StatStrip Lactate Hospital Meter
- Nova StatStrip Lactate Test Strips
- Nova StatStrip Lactate Control Solutions (Levels 1 and 2)
- Nova StatStrip Lactate Linearity Solutions (Levels 1,2,3 and 4)
- Meter Docking Station
The provided text does not contain specific acceptance criteria or detailed performance data from a study that would allow for a direct numerical comparison in a table. The document is a 510(k) summary and approval letter, stating that performance studies were conducted and the device was found substantially equivalent to predicate devices. However, it does not provide the raw performance data, acceptance thresholds, or detailed methodology of these studies.
Therefore, many of the requested fields cannot be filled with specific information from the provided document.
Here's an attempt to answer based on the available information, with clear indications where information is not provided:
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Not explicitly stated numerically in document) | Reported Device Performance (Summary statement only, no specific values) |
|---|---|---|
| Accuracy (vs. predicate devices) | (Not explicitly stated numerically, implied to be "substantially equivalent") | "The studies demonstrated that the blood lactate results were substantially equivalent to the current methods for blood lactate measurements." |
| Equivalence (to laboratory methods) | (Not explicitly stated numerically) | "It is intended to provide plasma equivalent results to laboratory methods." |
| Precision/Reproducibility | (Not provided) | (Not provided) |
| Linearity | (Not provided, though linearity solutions are mentioned for checking) | (Not provided) |
| Interference | (Not provided) | (Not provided) |
| Measuring Range | (Not provided) | (Not provided) |
| Time to Result | (Not provided, though "within 13 seconds" is mentioned for both new and predicate device) | "Each utilizes a test strip that is inserted into a meter for results within 13 seconds." |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not provided. The document mentions "Laboratory and clinical testing was performed" but does not specify the number of samples or patients included in these studies.
- Data Provenance: Not provided specific details. The studies were described as "Laboratory and clinical testing," implying data collected for the purpose of this submission. The country of origin is not specified, but the submitter is a U.S. company. It's likely prospective data collected for the purpose of the 510(k) submission, given the nature of performance studies for new devices, but this is an inference.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not provided. The document states "substantially equivalent to the current methods for blood lactate measurements" and "plasma equivalent results to laboratory methods," implying comparison to established methods or gold standards, but the process of establishing ground truth for the specific test set is not detailed.
4. Adjudication method for the test set
- Not provided. Given that the ground truth establishment method is not described, the adjudication method is also not mentioned.
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 is a medical device for quantitative determination of lactate in whole blood, not an imaging or diagnostic AI device that involves human reader interpretation. Therefore, an MRMC study is not relevant to this type of device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The device itself is a standalone system (meter and test strips) that provides a quantitative lactate reading. The performance studies described would inherently be standalone, assessing the device's ability to measure lactate accurately. There isn't a separate "algorithm only" component beyond the device's inherent operation.
7. The type of ground truth used
- The ground truth would implicitly be reference laboratory methods for lactate measurement, as the device aims to provide "plasma equivalent results to laboratory methods" and demonstrate "substantial equivalence to the current methods for blood lactate measurements."
8. The sample size for the training set
- Not applicable/Not provided. This device is a measurement system (meter and test strips), not a machine learning or AI-based diagnostic tool that typically involves a distinct "training set" for model development in the same way. Its performance is based on its electrochemical detection principle and manufacturing precision, not on being "trained" on a dataset. The performance studies mentioned are for validation or verification, not training.
9. How the ground truth for the training set was established
- Not applicable/Not provided, as there isn't a "training set" in the context of this type of device.
§ 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.