A homocysteine test system is an in vitro device intended to measure total homocysteine quantitatively in serum or plasma. Homocysteine measurements are used in the diagnosis and treatment of hyperhomocysteinemia.

Device Description

Homogeneous Enzymic Homocysteine Reagent

AI/ML Overview

The provided text is a 510(k) clearance letter from the FDA for a diagnostic reagent, not a device that relies on a test set, ground truth, or expert review in the way a typical AI/ML-powered medical device would. Therefore, most of the requested information regarding acceptance criteria, study data, ground truth establishment, expert involvement, and sample sizes is not applicable in this context.

However, I can extract the relevant information from the document to address the spirit of your request where possible, focusing on what this type of regulatory document typically provides for a diagnostic reagent.

1. A table of acceptance criteria and the reported device performance

For a diagnostic reagent like this, the "acceptance criteria" are generally established through validation studies showing that the reagent performs as intended (e.g., accuracy, precision, linearity, interference studies) and is substantially equivalent to a legally marketed predicate device. The 510(k) letter itself does not contain a table of acceptance criteria or performance metrics directly, but rather states that the device has been reviewed and found substantially equivalent.

Acceptance Criteria (Inferred from 510(k) process for diagnostic reagents): The device (Homogeneous Enzymic Homocysteine Reagent) performs comparably to a legally marketed predicate device for quantitative measurement of total homocysteine in serum or plasma, demonstrating appropriate accuracy, precision, linearity, and freedom from significant interferences.
Reported Device Performance: The document states that the FDA "reviewed your Section 510(k) notification... and we have determined the device is substantially equivalent to devices marketed in interstate commerce prior to May 28, 1976..." This implicitly means the performance data submitted by Intersect Systems, Inc. met the FDA's requirements for substantial equivalence to a predicate device.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the FDA 510(k) clearance letter. For a diagnostic reagent, validation studies would typically involve testing samples from various patient populations (prospective or retrospective) to assess performance characteristics. The specific details of these studies, including sample size and provenance, are part of the 510(k) submission, but not summarized in the public clearance letter.

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)

This concept of "ground truth" and "experts" as in imaging or clinical decision support AI is not directly applicable to a chemical diagnostic reagent. The "ground truth" for a reagent's performance is typically established by comparing its measurements to a recognized reference method or a legally marketed predicate device, often using clinical samples where the homocysteine levels are known or confirmed by other means.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. Adjudication methods are relevant for subjective interpretations, especially in imaging or expert review panels. A chemical reagent's performance relies on quantitative measurements, not subjective adjudication of results.

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. MRMC studies and "human readers with/without AI assistance" are relevant for AI-powered assistive diagnostic devices, particularly in imaging. This device is a chemical reagent, not an AI system that assists human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable. This is a chemical reagent. Its performance is inherent to its biochemical reaction and the instrument it is used on, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For a diagnostic reagent, the "ground truth" for validation would typically be established by:

Reference Methods: Comparison to established, highly accurate analytical methods for measuring homocysteine.
Predicate Device Comparison: Direct comparison of results with a legally marketed, substantially equivalent homocysteine reagent.
Clinical Samples: Testing samples from patients with known disease states or from healthy individuals, where homocysteine levels were confirmed by other clinical means.

The specific type of ground truth used by Intersect Systems, Inc. for their submission is not detailed in this 510(k) clearance letter.

8. The sample size for the training set

Not Applicable. Chemical reagents do not have "training sets" in the context of machine learning. Their formulation and performance characteristics are determined through chemical and biochemical development, optimization, and rigorous validation studies.

9. How the ground truth for the training set was established

Not Applicable. As there is no "training set" for a chemical reagent in the AI/ML sense, there is no ground truth established for it.

Summary

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Image /page/0/Picture/1 description: The image is a seal for the Department of Health & Human Services (USA). The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" around the top half of the circle. In the center of the seal is a stylized image of an eagle with its wings spread.

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

JUL 2 5 2001

Ms. Joan Cathey Ouality Systems Director Intersect Systems, Inc. PO Box 2219 Longview, WA 98632

Re: 510(k) Number: K011692 Trade/Device Name: Homogeneous Enzymic Homocysteine Reagent Regulation Number: 862.1377 Regulatory Class: II Product Code: LPS Dated: May 25, 2001 Received: May 31, 2001

Dear Ms. Cathey:

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 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 Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. 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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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 notification. The FDA mining of baction 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 il you desire specific advice for your actic devices), please contact the Office of Compliance at additionally 807.10 for mirrido diaglestions on the promotion and advertising of your device, (301) 594-4568. Additionally, 18. quee at (301) 594-4639. Also, please note the regulation please contact the Orneo or Compilance (21CFR 807.97). Other general entitled, TMIsoranding of reference to perched to persons of our the Division of Small
information on your responsibilities under the Act may 1001 - 1001 - 100 - 1607 miormation on your responsibilities areas and in (800) 638-2041 or (301) 443-6597 or at its Maindractdrors 115615x4200ww.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Steven Sutman

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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Indication for Use

Trade Name of the Device:

Homogeneous Enzymic Homocysteine Reagent

510(k) Number: KOII 692

Classification Name; Number:

Urinary Homocystine (Nonquantitative) Test System; 21 CFR §862.1377

Indications for Use

Good Luck

vision Sign-Off) (Bivision of Clinical Laboratory Devices K011692 $10(k) Number.

Regulation Number and Section

§ 862.1377 Urinary homocystine (nonquantitative) test system.

(a)
Identification. A urinary homocystine (nonquantitative) test system is a device intended to identify homocystine (an analogue of the amino acid cystine) in urine. The identification of urinary homocystine is used in the diagnosis and treatment of homocystinuria (homosystine in urine), a heritable metabolic disorder which may cause mental retardation.(b)
Classification. Class II.