(204 days)
LacTest™I is a lactic acid test system intended for use by healthy athletes for the determination of their lactate threshold. Lactate threshold is an important physiological parameter that reflects an individual's capacity for sustained exercise. It has been used by coaches and trainers of elite athletes in a wide range of sports that involve aerobic exercise, to optimize the conditioning of the athlete.
LacTest™I is a lactic acid test system
While the provided text indicates that the device, LacTest™I, has been deemed substantially equivalent by the FDA, it does not contain the detailed information necessary to answer all aspects of your request regarding acceptance criteria and the specific study proving the device meets those criteria. The document is a 510(k) clearance letter, confirming regulatory approval, but it doesn't provide the underlying study data or methodology.
Here's what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
- Acceptance Criteria: Not explicitly stated in this document. The FDA letter indicates the device is "substantially equivalent" to predicate devices, implying it met certain equivalency standards, but the specific numerical acceptance criteria (e.g., accuracy, precision thresholds) are not provided.
- Reported Device Performance: Not explicitly stated. The letter acknowledges that the manufacturer provided information to demonstrate substantial equivalence, but the actual performance metrics are not included in this FDA communication.
2. Sample size used for the test set and the data provenance
- Sample Size: Not mentioned in the provided text.
- Data Provenance: Not mentioned in the provided text.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not mentioned in the provided text, as this information would typically be in the study report itself, not the FDA clearance letter.
4. Adjudication method for the test set
- Not mentioned in the provided text.
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
- This question is not applicable to the device described. The LacTest™I is a "lactic acid test system," which sounds like an in vitro diagnostic (IVD) device for measuring a biochemical marker, not an imaging device that would involve human readers interpreting images with or without AI assistance. Therefore, an MRMC study as typically understood for AI in medical imaging would not be performed for this type of device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This question is likely applicable to the device, but the answer is not in the provided text. For an IVD device, "standalone performance" refers to the device's analytical performance (e.g., accuracy, precision, linearity, limits of detection) without human interpretation affecting the result. Such studies are certainly done for these types of devices, but the details are not in this letter.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For a lactic acid test system, the "ground truth" would likely be established through comparison with a reference method (e.g., a highly accurate laboratory assay for lactate) or clinical outcomes where lactate levels are a known indicator. The exact nature of the ground truth is not specified in the document.
8. The sample size for the training set
- Not mentioned in the provided text. The concept of a "training set" is generally more relevant for machine learning algorithms. For a traditional IVD device, there would be validation studies but perhaps not a distinct "training set" in the AI sense.
9. How the ground truth for the training set was established
- Not mentioned in the provided text.
In summary:
The provided document is an FDA 510(k) clearance letter for the LacTest™I, a lactic acid test system. It confirms the device's regulatory approval based on its substantial equivalence to a predicate device. However, it does not contain the detailed clinical study data, acceptance criteria, sample sizes, expert qualifications, or ground truth establishment methods that would typically be found in the manufacturer's 510(k) submission summary or a peer-reviewed publication of the validation study. To answer your questions fully, the actual submission document (summary or full application) would be required.
§ 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.