(185 days)
The Lactate Pro™ System is intended for the determination of Lactate in whole blood. The system is designed for the determination of blood Lactate by individuals with biochemical indicator of Lactic Acidosis. And evaluate physical performance or to establish a proper intensity of exercise for athletes. The system can be used in the clinical setting.
The Lactate Pro™ System consists of Lactate Pro™ Blood Lactate Test Meter, Lactate ProTM Test Strip.
The provided text does not contain a study that proves the device meets specific acceptance criteria. Instead, it is a 510(k) premarket notification letter from the FDA, granting clearance for the Lactate Pro™ System based on substantial equivalence to predicate devices. It discusses the device's indications for use and classification but does not include detailed performance data or acceptance criteria that a clinical study would typically provide.
Therefore, for items 1-9, the answer will largely be "Not applicable" or "Information not provided in the document."
Here's a breakdown based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in this document. | Not specified in this document. |
The document is a marketing clearance letter, not a performance study report. It does not detail specific acceptance criteria for accuracy, precision, or other performance metrics, nor does it present the results of such testing for the Lactate Pro™ System. The FDA's clearance is based on a determination of substantial equivalence to predicate devices.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Information not provided in the document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Information not provided in the document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Information not provided in the document.
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 a blood lactate test system, not an AI-powered diagnostic imaging device that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Information not provided in the document. As a blood lactate test system, its standalone performance would typically refer to its accuracy and precision against a reference method, not an algorithm's performance. The document does not contain this data.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Information not provided in the document. For a blood lactate meter, ground truth would typically be established by a laboratory reference method (e.g., a laboratory analyzer). The document does not specify this.
8. The sample size for the training set
Not applicable. This device is a measurement system, not a machine learning algorithm that requires a training set in the conventional sense. Any internal calibration data or development data are not discussed.
9. How the ground truth for the training set was established
Not applicable. See reasoning for point 8.
§ 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.