The ZEUS Solinas Borrelia VIsE1/pepC10 IgG/IgM Test System uses chemiluminescent immunoassay (CLIA) technology for the qualitative detection of IgGlgM antibodies to Borrelia burgdorferi in human serum. This assay is intended for use on samples from patients with signs and symptoms consistent with or patients suspected of having Lyme disease to assess the presence of IgG/IgM antibodies.

Positive results with the ZEUS Solinas Borrelia VIsE1/pepC10 IgG/IgM Test System should be supplemented with additional testing with a Standard two-tier test (STTT) methodology using an IgG and/or IgM Borrelia burgdorferi immunoblot assay following current guidelines.

Positive supplemental results are supportive evidence of antibodies and exposure to Borrelia burgdorferi and may be used along with patient history, symptoms and other laboratory data to support a clinical diagnosis of Lyme disease.

Negative results by the ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System should not be used to exclude Lyme disease. The test must be performed on the ZEUS Solinas instrument.

The ZEUS Solinas Borrelia VIsE1/pepC10 IgG/IgM Control Kit is intended for use as assayed quality control samples to monitor the performance of the ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System. The performance characteristics of the ZEUS Solinas Borrelia VIsE1/pepC10 IgG/IgM Control Kit have not been established for any other assays or instrument platforms.

Device Description

Not Found

AI/ML Overview

This document is an FDA 510(k) clearance letter for the ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System. It describes a diagnostic test for Lyme disease. The information provided does not contain details about acceptance criteria, study data, sample sizes, expert qualifications, or ground truth establishment typically found in a clinical study report for an AI/ML medical device.

The questions you've asked are most relevant to AI/ML device approval processes, where the device "learns" from data. This document describes a Chemiluminescent Immunoassay (CLIA) technology, which is a laboratory-based diagnostic test, not an AI/ML algorithm. Therefore, the concepts of training sets, test sets, human readers assisting AI, adjudication methods, and expert consensus for AI ground truth do not directly apply to this type of device.

This clearance is based on substantial equivalence to legally marketed predicate devices, meaning it has similar indications for use and technological characteristics to devices already on the market. The performance of such a device is typically assessed through analytical and clinical performance studies, comparing its results to a reference method or clinical diagnosis, rather than through AI-specific metrics like those you've inquired about.

To directly answer your request based on the provided document, I cannot fill in the table or provide the requested details because the document describes a traditional diagnostic assay, not an AI/ML device.

Here's why each of your points cannot be addressed with the provided text:

1. A table of acceptance criteria and the reported device performance: This document is the clearance letter, not the study report. It states the device is substantially equivalent but does not present the raw performance data or acceptance criteria that were met.
2. Sample sizes used for the test set and the data provenance: Not present in this document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable to a CLIA assay in the context typically asked for AI/ML. Ground truth for a diagnostic test usually refers to clinical diagnosis, a gold standard lab test, or patient outcomes, not expert image annotation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable to a CLIA assay.
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, as this is not an AI-assisted device for human interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a laboratory test, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): While not detailed, for a diagnostic test like this, ground truth would typically be established based on a combination of clinical diagnosis, other established laboratory tests, and possibly follow-up outcomes, not expert consensus in the way it's used for AI image interpretation.
8. The sample size for the training set: Not applicable, as this is not an AI/ML device that requires a "training set."
9. How the ground truth for the training set was established: Not applicable for the same reason as above.

In summary, the provided document is an FDA 510(k) clearance letter for a traditional in-vitro diagnostic test, not an AI/ML medical device submission. Therefore, the specific questions related to AI/ML study design and performance metrics cannot be answered from this document.

Summary

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July 13, 2023

ZEUS Scientific Mark Kopnitsky Chief Scientific Officer 200 Evans Way Branchburg, New Jersey 08876

Re: K230863

Trade/Device Name: ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System: ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Control Kit Regulation Number: 21 CFR 866.3830 Regulation Name: Treponema Pallidum Treponemal Test Reagents Regulatory Class: Class II Product Code: LSR, QCH Dated: March 27, 2023 Received: March 29, 2023

Dear Mark Kopnitsky:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Noel J. Gerald -S

Noel J. Gerald, Ph.D. Branch Chief Bacterial Respiratory and Medical Countermeasures Branch Division of Microbiology Devices OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K230863

Device Name

ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Control Kit

Indications for Use (Describe)

Negative results by the ZEUS Solinas Borrelia VlsE1/pepC10 IgG/IgM Test System should not be used to exclude Lyme disease. The test must be performed on the ZEUS Solinas instrument.

Type of Use (Select one or both, as applicable)

	Prescription Use (Part 21 CFR 801 Subpart D)
	Over-The-Counter Use (21 CFR 801 Subpart C)

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Regulation Number and Section

§ 866.3830

Treponema pallidum treponemal test reagents.(a)
Identification. Treponema pallidum treponemal test reagents are devices that consist of the antigens, antisera and all control reagents (standardized reagents with which test results are compared) which are derived from treponemal sources and that are used in the fluorescent treponemal antibody absorption test (FTA-ABS), theTreponema pallidum immobilization test (T.P.I.), and other treponemal tests used to identify antibodies toTreponema pallidum directly from infecting treponemal organisms in serum. The identification aids in the diagnosis of syphilis caused by bacteria belonging to the genusTreponema and provides epidemiological information on syphilis.(b)
Classification. Class II (performance standards).