WAKO NEFA LINEARITY SET by WAKO CHEMICALS, USA, INC.

A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test sytem to estimate test precision and to detect systematic analytivcal deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed or unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.

Device Description

Not Found

AI/ML Overview

The provided document is a 510(k) premarket notification letter for a Class I medical device (Wako NEFA Linearity Set), which is a quality control material. This type of device is significantly different from AI/ML-based diagnostic devices, and therefore, the information requested (acceptance criteria, study details, ground truth, expert involvement, MRMC studies, etc.) is not applicable or typically required for this classification.

Here is why most of the requested information cannot be found in this document for this specific device:

Device Type: The Wako NEFA Linearity Set is a "Quality control material (assayed and unassayed)" for clinical chemistry. This means it's a substance used to check the performance of laboratory tests, not a diagnostic algorithm or imaging analysis tool.
Regulatory Class: It's classified as Class I. Class I devices are subject to general controls and typically have a lower risk profile. They usually do not require extensive clinical studies or performance data like higher-class devices (Class II or III), especially not the kind of studies involving AI performance, human readers, or detailed ground truth establishment as defined for diagnostic algorithms.
Document Content: The letter is an FDA 510(k) clearance letter, which states that the device is substantially equivalent to a legally marketed predicate device. It confirms the regulatory status and allows marketing but does not contain a detailed study report or performance data. The "Indications for Use" section further clarifies its purpose as a quality control material.

Therefore, I cannot provide the requested information in the format given because the nature of the device and the provided document do not support it.

To answer your request in general terms of what would be expected for an AI/ML-based diagnostic device, but acknowledging that this specific document and device do not provide it:

For an AI/ML-based diagnostic device, the requested information would typically be detailed in a separate clinical study report submitted as part of a 510(k) or PMA submission. That report would address:

Acceptance Criteria and Reported Device Performance: This would typically involve metrics like sensitivity, specificity, AUC, accuracy, positive predictive value (PPV), negative predictive value (NPV) against a defined ground truth, often with predefined thresholds for success (e.g., "The device must achieve a sensitivity of at least X% and specificity of at least Y%").
Sample Sizes and Data Provenance: Details about the number of cases (e.g., images, patient records) in the test set, the geographical origin of the data, and whether it was collected retrospectively or prospectively.
Number and Qualifications of Experts for Ground Truth: Quantification of how many human experts (e.g., N radiologists, M pathologists) established the ground truth, along with their specialty, years of experience, and board certifications.
Adjudication Method for Test Set: How disagreements among experts were resolved to establish a single ground truth (e.g., 2+1 means two initial readers, with a third expert adjudicating discrepancies).
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: If conducted, this would compare human performance with and without AI assistance, reporting metrics like AUC improvement, reading time reduction, or changes in diagnostic accuracy. The effect size would quantify this improvement.
Standalone Performance: Evaluation of the algorithm's performance without human intervention.
Type of Ground Truth: The gold standard used (e.g., histology/pathology results, clinical outcomes, validated expert consensus, follow-up data).
Sample Size for Training Set: The number of cases used to train the AI model.
Ground Truth for Training Set: How the labels for the training data were established (often similar methods to the test set but might involve less rigorous adjudication for initial labeling).

In summary, the provided document pertains to a quality control material, not an AI/ML diagnostic device, and thus the specific detailed performance and study information for AI requested is not applicable nor present.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES * USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle with three curved lines representing its wings.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

FEB 1 1 2003

Ms. Tonya Mallory Executive Manager Wako Diagnostics 1600 Bellwood Road Richmond, VA 23237

Re: K030065 Trade/Device Name: Wako NEFA Linearity Set Regulation Number: 21 CFR 862.1660 Regulation Name: Ouality control material (assayed and unassayed) Regulatory Class: Class I Product Code: JJX Dated: January 6, 2003 Received: January 7, 2003

Dear Ms. Mallory:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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. Iisting 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 (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807): labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820).

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This letter will allow you to begin marketing your device as described in your Section 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 information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 594-3084. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely vours.

Steven Butman

Steven I. Gutman, M.D., M.B.A. Director Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use:

Proprietary Name: Wako NEFA Linearity Set

Established Registration Number: 1627434

Premarket Notification 510 (k) Number:

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use (Optional Format 1-2-96)

Han Cooper

(Div
Div. Laboratory Devices
510(k) K030065

Regulation Number and Section

§ 862.1660 Quality control material (assayed and unassayed).

(a)
Identification. A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.(b)
Classification. Class I (general controls). Except when intended for use in donor screening tests, quality control materials (assayed and unassayed) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.