POLY-CHEM 90 DIRECT HDL CHOLESTEROL, POLY-CHEM 90 DIRECT LDL CHOLESTEROL, POLY-CHEM 90 CHOLESTEROL, POLY-CHEM 90 TRIGLYC by POLYMEDCO, INC.

The Poly-Chem 90 Direct HDL-Cholesterol test system is an in vitro diagnostic procedure intended to measure high density lipoproteins quantitatively in human serum on the Poly-Chem 90 analyzer. HDL Cholesterol results are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis and various other liver and renal diseases, and for the assessment for the risk of developing cardiovascular disease.

The Poly-Chem 90 Direct LDL-Cholesterol test system is an in vitro diagnostic procedure intended to measure low density lipoprotens quantitatively in human serum on the Poly-Chem 90 analyzer. LDL Cholesterol results are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis and various other liver and renal diseases, and for the assessment for the risk of developing cardiovascular disease.

The Poly-Chem 90 Cholesterol test system is an in vitro diagnostic procedure intended to measure cholesterol quantitatively in human serum on the Poly-Chem 90 analyzer. Cholesterol measurements are used in the diagnosis and treatment of lipid disorders, lipoprotein metabolism disorders and atherosclerosis.

The Poly-Chem 90 Triglycerides test system is an in vitro diagnostic procedure intended to measure triglyceride quantitatively in human serum on the Poly-Chem 90 analyzer. Triglycerides measurements are used in the diagnosis and treatment of disease involving lipid metabolism and various endocrine disorders e.g. diabetes mellitus, nephrosis and liver obstruction.

Device Description

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AI/ML Overview

This document is a 510(k) premarket notification from the FDA for an in vitro diagnostic device (IVD) called "Poly-Chem 90 Direct HDL-Cholesterol, Direct LDL-Cholesterol, Cholesterol and Triglycerides tests."

It is important to note that a 510(k) notification primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device. This typically involves performance data, but it does not usually include the level of detail regarding acceptance criteria, study design, and ground truth establishment that would be found in a full efficacy study for a novel device or a clinical trial for an AI/ML-based device.

The document does not contain the detailed study information required to fully answer the request, particularly regarding acceptance criteria and the specifics of a study proving the device meets them in the context of an AI/ML device. The device described here is a chemical assay kit, not an AI/ML-based diagnostic.

Therefore, many of the requested fields cannot be populated from the provided text.

Here's an attempt to answer based on the available information, with clear indications of what is not present:

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

This information is not present in the provided document. The 510(k) summary (which is not provided here, only the decision letter and indications for use) would typically contain performance characteristics like precision, accuracy, linearity, and interference studies compared to a predicate device. Acceptance criteria for these metrics would have been established by the manufacturer and accepted by the FDA for the substantial equivalence determination.

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 present in the provided document. For an IVD, the sample size would typically refer to the number of patient samples tested. The provenance and study type are also not mentioned.

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 information is not applicable/relevant for this type of chemical IVD and is not present in the document. Ground truth for chemical assays like cholesterol levels is established through reference methods (e.g., gas chromatography-mass spectrometry, ultracentrifugation) or comparison to well-established, previously validated commercial assays, not typically by expert adjudication of images or clinical cases.

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

This information is not applicable/relevant for this type of chemical IVD and is not present in the document. Adjudication methods like 2+1 are used for interpreting qualitative or subjective data, often in imaging or pathology.

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 information is not applicable/relevant for this type of chemical IVD and is not present in the document. MRMC studies are used for evaluating diagnostic performance of systems involving human interpretation, often with AI assistance, which is not the case here.

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

This information is not applicable/relevant for this type of chemical IVD and is not present in the document. This concept applies to AI/ML algorithms, not to a chemical assay. The Poly-Chem 90 operates as a standalone analyzer for measuring these analytes.

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

For this type of chemical IVD, the ground truth would typically be established through:

Reference methods: Highly accurate and precise laboratory methods (e.g., GC-MS for cholesterol, ultracentrifugation for lipoproteins) used to assign true values to samples.
Comparison to a legally marketed predicate device: The submitted 510(k) is based on demonstrating substantial equivalence to existing devices. Therefore, the predicate device's performance would serve as a de facto "ground truth" for comparison, provided the predicate itself was rigorously validated.

The specific ground truth method used is not detailed in this document.

8. The sample size for the training set

This information is not applicable/relevant as this is not an AI/ML device with a training set in the typical sense. For a chemical IVD, "training" might refer to calibration procedures, which involve a very small set of known standards. This information is not present in the document.

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

This information is not applicable/relevant for the reasons stated above (not an AI/ML device). If considering "training" as calibration, the "ground truth" for calibration samples would be established by preparing precise concentrations of the analyte using primary reference materials. This information is not present in the document.

Summary of what the document DOES tell us:

The document is an FDA 510(k) clearance letter for the "Poly-Chem 90 Direct HDL-Cholesterol, Direct LDL-Cholesterol, Cholesterol and Triglycerides tests." This device is an in vitro diagnostic procedure intended to quantitatively measure these lipids in human serum on the Poly-Chem 90 analyzer.

Indications for Use: The document clearly outlines the specific medical conditions for which each test's results are used (e.g., diagnosis and treatment of lipid disorders, assessment of cardiovascular disease risk).
Regulatory Classification: Class I, falling under specific regulations for lipoprotein test systems.
Device Type: This is a chemical assay kit designed to measure specific biomolecules in a laboratory setting, not an AI/ML-based diagnostic.

Therefore, the detailed questions about AI-specific study methodologies (MRMC, standalone AI performance, expert adjudication, training/test sets for algorithms, etc.) are fundamentally misaligned with the nature of the device described in the provided text.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight.

Public Health Service

Polymedco, Inc. c/o Ms. Helen Landicho Vice President, Regulatory Affairs 510 Furnace Dock Rd. Cortland Manor, NY 10567

Food & Drug Administration 10903 New Hampshire Avenue Building 66 Silver Spring, MD 20993

K100550 Re:

Trade Name: Poly-Chem 90 Direct HDL-Cholesterol. Direct LDL-Cholesterol. Cholesterol and Triglycerides tests Regulation Number: 21 CFR §862.1475 Regulation Name: Lipoprotein test system Regulatory Class: Class I, meets limitations per 21 CFR 862.9(c)(4) Product Codes: LBS, MRR, CHH, CDT Dated: September 14, 2010 Received: September 15, 2010

SEP 2 8 2010

Dear Ms. Landicho:

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, 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 (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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820).

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If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

C.C.

Courtney Harper, Ph.D. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

SEP 2 8 2010

510(k) Number (if known):

Device Name: Poly-Chem 90 Direct HDL-Cholesterol, Direct LDL-Cholesterol, and Triglycerides tests

Indications For Use:

. :

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Carol Benam

Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety

510(k)/550

Page 1 of 1

Regulation Number and Section

§ 862.1475 Lipoprotein test system.

(a)
Identification. A lipoprotein test system is a device intended to measure lipoprotein in serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.(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.