LACTEST I by JWT, INC. | FDA 510(k) Summary

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.

Device Description

LacTest™I is a lactic acid test system

AI/ML Overview

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.

Summary

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DEC 17 1997

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

James B. Johnston, Ph.D. . Executive Vice President JWT, Inc. 115 Research Drive Bethlehem, Pennsylvania 18015-3715

Re : K971944 LacTest™ I Brand Lactic Acid Test System Regulatory Class: II Product Code: KHP Dated: October 23, 1997 Received: October 27, 1997

Dear Dr. Johnston:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਸੇ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that. through periodic QS inspections, the Food and Druq Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88), this device may require a CLIA complexity categorization. To determine if it does, you should contact the Centers for Disease Control and Prevention (CDC) at (770) 488-7655.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4588. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,
Steven Ditman

Steven I. Gutman, M.D., M.B.A. Director Division of Clinical Laboratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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VI. STATEMENT OF INDICATIONS FOR USE:

510(k) Number (if known): K97 1944

Device Name: LacTest™I

Indications for use:

100 200

Sign-Off)
of Clinical Laboratory Devices
Number 97/944

Regulation Number and Section

§ 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.