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Assay:

ZEUS IFA™ ANA HEp-2 Test System is an indirect immunofluorescence assay for the qualitative detection and semiquantitative determination of IgG anti-nuclear antibodies in human serum by manual fluorescence microscopy or with ZEUS dlFine®. The presence of anti-nuclear antibodies can be used in conjunction with other serological tests and clinical findings to aid in the diagnosis of systemic lupus erythematosus and other systemic rheumatic diseases. All suggested results obtained with ZEUS dIFine® must be confirmed by a trained operator.

Instrument:

ZEUS dIFine® is an automated instrument consisting of a fluorescent microscope and software that acquires, interprets, stores and displays digital images of stained indirect immunofluorescence slides. ZEUS dlFine can only be used with FDA cleared or approved ZEUS in vitro diagnostic assays that are indicated for use on this instrument. All suggested results obtained with ZEUS dIFine must be confirmed by a trained operator

ZEUS dIFine® is an automated instrument consisting of a fluorescent microscope and software that acquires, interprets, stores and displays digital images of stained indirect immunofluorescence slides.

The provided text is an FDA 510(k) clearance letter for the Zeus IFA ANA HEp-2 Test System and Zeus dIFine. While it states the device is "substantially equivalent" and outlines its indications for use, it does not contain the detailed study information required to answer your specific questions about acceptance criteria and performance data.

The FDA 510(k) summary, often referred to as the 510(k) "Premarket Notification Summary" or "Special 510(k) Notification Summary," would contain the information you are seeking regarding acceptance criteria and performance data. This document is typically publicly available on the FDA's website alongside the 510(k) clearance letter.

Therefore, I cannot provide the requested information based solely on the text you provided. To answer your questions, I would need access to the 510(k) summary document for K201956.

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ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System: The ZEUS ELISA Borrelia VIsE1/pepC10 IgG/IgM Test System is intended for the qualitative detection of IgG and IgM class antibodies to VlsE1 and pepC10 antigens from Borrelia burgdorferi in human serum. The assay is intended for testing serum samples from symptomatic patients or those suspected of having Lyme disease. Positive and equivocal test results with the ZEUS ELISA Borrelia VIsE1/pepC10 IgG/IgM Test System for the presence of Borrelia burgdorferi antibodies must be confirmed through additional testing by one of the following methods: (1) Standard two-tier test methodology (STTT) using IgG or IgM Western blot testing following current interpretation guidelines; or (2) Modified two-tier test methodology (MTTT) using one of the following three ELISA-based assays: - ZEUS ELISA Borrelia burgdorferi IgG/IgM Test System - ZEUS ELISA Borrelia burgdorferi IgM Test System - ZEUS ELISA Borrelia burgdorferi IgG Test System Positive test results by either the STTT or MTTT methodology are supportive evidence for the presence of antibodies and exposure to Borrelia burgdorferi, the cause of Lyme disease. A diagnosis of Lyme disease should be made based on the presence of Borrelia burgdorferi antibodies, history, symptoms, and other laboratory data.

Zeus ELISA Borrelia burgdorferi IgG/IgM Test System: The ZEUS ELISA Borrelia burgdorferi IgG/IgM Test System is an enzyme-linked immunosorbent assay (ELISA) for the qualitative detection of IgG and IgM class antibodies to Borrelia burgdorferi in human serum. The assay is intended for testing serum samples from symptomatic patients or those suspected of Lyme Disease. Positive and equivocal test results with the ZEUS ELISA Borrelia burgdorferi IgG/IgM Test System for the presence of Borrelia burgdorferi antibodies must be confirmed through additional testing by one of the following methods: (1) Standard two-tier test methodology (STTT) using IgG or IgM Western blot testing following current interpretation guidelines; or (2) Modified two-tier test methodology (MTTT) using the ZEUS ELISA Borrelia VIsE1/pepC10 IgG/IgM Test System. Positive test results by either the STTT or MTTT methodology are supportive evidence for the presence of antibodies and exposure to Borrelia burgdorferi, the cause of Lyme disease. A diagnosis of Lyme disease should be made based on the presence of Borrelia burgdorferi antibodies, history, symptoms, and other laboratory data.

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This document is an FDA 510(k) clearance letter for two ELISA Borrelia test systems. While it outlines the intended use and regulatory classifications, it does not contain the detailed study information required to answer your questions about acceptance criteria, device performance, sample sizes, ground truth establishment, or expert involvement in a study.

Therefore, I cannot provide the requested information based solely on the provided text. To answer your questions, I would need access to the actual 510(k) summary or the full submission data, which would typically contain the results of performance studies.

The document primarily focuses on regulatory approval and equivalence to predicate devices, not the detailed scientific performance data from the clinical studies.

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The ZEUS ELISA Borrelia VLSe-1/PepC10 IgG/IgM Test System is intended for the qualitative detection of IgG and IgM class antibodies to VlsE1 and pepC10 antigens from Borrelia burgdorferi in human serum. The assay is intended for testing serum samples from symptomatic patients or those with a history of Lyme Borreliosis. All positive and equivocal specimens should be tested with a second-tier test such as Western Blot, which if positive, is supportive evidence of infection with Borrelia burgdorferi. Diagnosis of Lyme Borreliosis should be made based on the presence of B. burgdorferi antibodies, history, symptoms, and other laboratory data. Negative first or second tier results should not be used to exclude Borreliosis. This kit is for in vitro diagnostic use.

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This FDA 510(k) clearance letter pertains to the ZEUS ELISA Borrelia VlsE-1/pepC10 IgG/IgM Test System. However, the provided document does not contain the detailed study information, acceptance criteria, or performance data that would typically be found in a 510(k) summary (which is a separate document). The letter primarily confirms substantial equivalence to a predicate device and outlines regulatory responsibilities.

Therefore, I cannot fulfill most of your request directly from the provided text. To answer your questions, I would need access to the 510(k) summary for K113397.

Based only on the provided document, here's what can be inferred or stated about what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

• Information in document: Not present.
• Missing: The specific clinical performance acceptance criteria (e.g., sensitivity, specificity thresholds) and the actual performance metrics achieved by the ZEUS ELISA Borrelia VlsE-1/pepC10 IgG/IgM Test System are not provided in this regulatory letter.

2. Sample Size Used for the Test Set and Data Provenance

• Information in document: Not present.
• Missing: The number of samples used in the clinical studies to evaluate the device and details about their origin (e.g., country, retrospective/prospective collection) are not included.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

• Information in document: Not present.
• Missing: This document does not describe the methodology for establishing ground truth, including the number or qualifications of experts involved.

4. Adjudication Method for the Test Set

• Information in document: Not present.
• Missing: Details on how discrepancies in ground truth establishment (if applicable) were resolved are not mentioned.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

• Information in document: Not present.
• Missing: This type of study is more common for imaging devices where human interpretation is a key component. For an ELISA diagnostic kit, a MRMC study involving human readers comparing performance with and without AI assistance is generally not applicable, as the device output is typically quantitative or qualitative (positive/negative) and does not involve human interpretation of complex images or data fields that an AI might augment. Therefore, no effect size of human readers improving with AI vs. without AI assistance would be relevant or found for this type of device.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• Information in document: The device is a "Test System" (ELISA kit), implying it functions as a standalone diagnostic tool.
• Implied: Yes, the performance of an ELISA kit is inherently standalone, as it produces a result based on the chemical reaction, not on human interpretation or an "algorithm" in the AI sense. Its "performance" refers to its analytical and clinical accuracy in detecting antibodies.

7. The Type of Ground Truth Used

• Information in document: The "Indications for Use" section states: "All positive and equivocal specimens should be tested with a second-tier test such as Western Blot, which if positive, is supportive evidence of infection with Borrelia burgdorferi." Also, "Diagnosis of Lyme Borreliosis should be made based on the presence of B. burgdorferi antibodies, history, symptoms, and other laboratory data."
• Inferred based on typical Lyme disease diagnostics: For validating a Lyme disease ELISA, the ground truth for patient samples would typically be established by a combination of:
  • Clinical diagnosis: Based on patient history, symptoms (e.g., erythema migrans), and other clinical findings.
  • Confirmatory laboratory tests: Often a 2-tier testing algorithm as described, where initial screening (like this ELISA) is followed by a Western Blot (which is a more specific confirmatory test) and potentially other specialized tests.
  • Seroprevalence in endemic vs. non-endemic populations: Using panels from confirmed Lyme patients and healthy controls from both endemic and non-endemic areas.
  • Reference standard panels: From organizations like the CDC or NIBSC that provide well-characterized samples.
• Missing: The specific "ground truth" definition used for the clinical study that supported this 510(k) is not detailed.

8. The Sample Size for the Training Set

• Information in document: Not present.
• Missing: ELISA kits do not typically have a "training set" in the same way machine learning algorithms do. However, during the development of the kit, a large number of characterized samples would be used to optimize the assay's cutoff values and ensure robust performance. The size of this internal optimization/development set is not mentioned.

9. How the Ground Truth for the Training Set Was Established

• Information in document: Not present.
• Missing: As explained above, the concept of a "training set" doesn't directly apply in the AI sense. For the samples used in the development and optimization of the ELISA, the ground truth would have been established through a similar combination of clinical diagnosis and confirmatory laboratory testing as described for the test set.

To obtain the specific details requested, you would need to access the 510(k) Summary (K113397) for this device, which the FDA generally makes publicly available. That document typically contains the detailed clinical and analytical study results used to support the substantial equivalence claim.

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The ZEUS ELISA Cardiolipin IgG/IgM/IgA Test System is intended for the in vitro, qualitative measurement of IgG, IgM and/or IgA antibodies directed to cardiolipin in human serum to aid in the diagnosis of primary antiphospholipid syndrome (PAPS) and secondary antiphospholipid syndrome (SAPS) in conjunction with other laboratory and clinical findings.

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I am sorry, but the provided text does not contain the detailed information required to answer your request about the acceptance criteria and the study proving the device meets those criteria. The document is an FDA 510(k) clearance letter for the "ZEUS ELISA Cardiolipin IgG/IgM/IgA Test System," describing its intended use and regulatory classification. It does not include specific study details such as:

• A table of acceptance criteria and reported device performance.
• Sample sizes or data provenance for test sets.
• Number or qualifications of experts for ground truth establishment.
• Adjudication methods.
• Details on Multi-Reader Multi-Case (MRMC) studies or effect sizes.
• Standalone algorithm performance.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

This information would typically be found in a more detailed submission document, such as the 510(k) summary or a clinical study report, which is not provided here.

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The ZEUS ELISA HSV gG-2 IgG Test System is intended for the qualitative detection of type specific IgG class antibodies to Herpes Simplex Virus Type 2 (HSV-2) in human serum. The test is intended for testing sexually active individuals or pregnant women for aiding in the presumptive diagnosis of HSV-2 infection.

The predictive value of positive or negative results depends on the population's prevalence and the pretest likelihood of HSV-2. The test is not intended for donor screening or for self testing.

The performance of this assay has not been established for use in a pediatric population, neonates, or immunocompromised patients.

Not Found

This document describes the FDA's decision to clear the Zeus ELISA HSV gG-2 IgG Test System, not a study report detailing its performance against acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study design, and performance metrics cannot be found in the provided text.

However, I can extract what is implied about the regulatory context and intended use, which informs the type of studies typically required for such devices.

Here's a breakdown of what can be inferred and what cannot:

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

• Cannot be provided as the document is an FDA clearance letter, not a study report. It does not contain specific acceptance criteria values (e.g., sensitivity, specificity thresholds) or the reported performance data from a clinical study.

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

• Cannot be provided. The document does not describe the test set size, its provenance, or whether the study was retrospective or prospective.

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)

• Cannot be provided. The document does not describe how ground truth was established, nor the number or qualifications of experts. Given that this is an in-vitro diagnostic device for serological testing, the "ground truth" would likely be established through a combination of other established testing methods rather than expert consensus on images.

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

• Cannot be provided. The document does not discuss adjudication methods.

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 and cannot be provided. This is an in-vitro diagnostic device (ELISA test) for detecting antibodies, not an imaging device intended for interpretation by human readers, nor does it involve AI assistance for human interpretation.

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

• Implied as 'yes' for the device itself. The device, an ELISA test system, operates as a standalone diagnostic tool to detect antibodies. It's a laboratory test, not an AI algorithm. Its performance is measured directly, not in conjunction with human interpretation for improvement.

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

• Cannot be provided explicitly, but typically for serological tests: Ground truth for serological assays like this often involves a composite reference standard, which can include multiple established laboratory tests (e.g., Western Blot, viral culture, PCR, or other highly sensitive and specific serological assays).

8. The sample size for the training set

• Cannot be provided. The document does not mention a training set, as it's an ELISA assay, not a machine learning algorithm that requires supervised training data.

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

• Cannot be provided. Not applicable as explained above.

Summary based on the provided document:

The provided document is an FDA 510(k) clearance letter for the Zeus ELISA HSV gG-2 IgG Test System. It indicates that the device has been found "substantially equivalent" to legally marketed predicate devices, allowing its commercialization. The letter itself does not contain the detailed clinical study data, including acceptance criteria or performance metrics, that would have been submitted by the manufacturer to the FDA for review.

The primary information available is:

• Device Name: Zeus ELISA HSV gG-2 IgG Test System
• Indications for Use: Qualitative detection of type-specific IgG class antibodies to Herpes Simplex Virus Type 2 (HSV-2) in human serum for aiding in the presumptive diagnosis of HSV-2 infection in sexually active individuals or pregnant women.
• Limitations: Not intended for donor screening or self-testing. Performance not established for pediatric population, neonates, or immunocompromised patients.
• Regulatory Class: Class II
• Product Code: MYF
• Regulatory Pathway: 510(k) (substantial equivalence)

To obtain the specific acceptance criteria and detailed study data, one would typically need to consult the 510(k) summary submitted by Zeus Scientific, Inc. to the FDA, which is usually publicly available on the FDA's website after clearance, or the device's Instructions For Use (IFU)/package insert. These documents would detail the specific studies performed (e.g., sensitivity, specificity, reproducibility, interference studies) and the results that demonstrated substantial equivalence.

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The ZEUS ELISA Treponema pallidum IgG Test System is intended for the qualitative detection of specific IgG class antibodies to T. pallidum in human serum. The test may be used in conjunction with non treponemal testing and clinical findings to provide serological evidence of infection with T. pallidum. This test is for in vitro diagnostic use only.

This test is not intended for screening blood or plasma donors.

The ZEUS ELISA Treponema pallidum IgG Test System is designed to detect IgG class antibodies in human sera to Treponema pallidum. Wells of plastic microwell strips are sensitized by passive absorption with T. pallidum antigen. The test procedure involves three incubation steps:

1. Test sera are diluted with SAVE Diluent. During sample incubation, any antigen specific lgG antibody in the sample will bind to the immobilized antigen. The plate is washed to remove unbound antibody and other serum components.
2. Peroxidase conjugated goat anti-human IgG is added to the wells and the plate is incubated. The conjugate will react with IgG antibody immobilized on the solid phase in step 1. The wells are washed to remove unbound conjugate.
3. The microwells containing immobilized peroxidase conjugate with peroxidase substrate solution. Hydrolysis of the substrate by peroxidase produces a color change. After ten minutes have elapsed, the reaction is stopped and the color intensity of the solution is measured photometrically. The color intensity of the solution depends on upon the antibody concentration in the original test sample.

The Zeus Scientific Inc. ZEUS ELISA Treponema pallidum IgG Test System is intended for the qualitative detection of specific IgG class antibodies to T. pallidum in human serum. The test may be used in conjunction with non-treponemal testing and clinical findings to provide serological evidence of infection with T. pallidum. It is for in vitro diagnostic use only and not intended for screening blood or plasma donors.

Acceptance Criteria and Device Performance

The acceptance criteria for the ZEUS ELISA Treponema pallidum IgG Test System are implicitly demonstrated by the performance against the predicate device and the specified reproducibility metrics. While explicit quantitative acceptance criteria for clinical performance (e.g., specific sensitivity, specificity thresholds) are not individually listed for each study, the submission aims to demonstrate substantial equivalence to the predicate device.

The internal and external reproducibility studies provide quantitative acceptance criteria for precision (Total CV < 15% for reactive samples, < 25% for negative samples for repeatability; < 15% for reactive samples, < 50% for negative samples for reproducibility).

The reported device performance across various clinical studies is summarized below, with performance relative to the predicate device (TPPA) or clinical diagnosis.

Table 1: Device Performance Summary

Study Details

1. Sample Size Used for the Test Set and Data Provenance:

   • Prospective Studies:
     • 500 unselected samples from patients with a syphilis test ordered (US Mid-Atlantic, Northeast, and Zeus laboratories).
     • 500 unselected samples from pregnant women with a syphilis test ordered (US Mid-Atlantic, Northeast, and Zeus laboratories).
     • 1000 unselected samples from hospitalized patients (US: Monmouth, Mainline laboratories, and Zeus).
   • Retrospective Studies:
     • 223 banked known HIV-1 positive samples (New York vendor).
     • 280 RPR/TPPA positive samples (New York vendor).
     • 250 TPPA negative and 27 TPPA positive samples from pregnant women (New York vendor).
   • Reference Panels:
     • 157 samples from the CDC Syphilis Panel (origin unspecified, but typically US-based reference laboratories).
   • Precision/Reproducibility: 15 samples per study (prepared by Zeus Scientific, Inc.).

2. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications: Not applicable. The ground truth for comparative clinical studies was established using a reference assay (TPPA or RPR) or clinical diagnosis, not by individual expert review of each case. For the CDC Syphilis Panel, the ground truth was "Clinical Diagnosis," implying a consensus or established diagnosis from medical records.

3. Adjudication Method for the Test Set: Not applicable. The studies relied on a reference assay (TPPA) for concordance analysis or established clinical diagnoses for the CDC panel. There is no mention of an adjudication process for discordant results between the device and the reference standard, nor for expert consensus in establishing the ground truth.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done: No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The device is an ELISA test system, which provides an objective quantitative (OD value) and qualitative (Positive/Negative/Equivocal) result, not requiring human interpretation in the way an imaging AI algorithm would. Therefore, the concept of "human readers improving with AI vs. without AI assistance" does not apply here.

5. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done: Yes, the studies described are standalone performance evaluations of the ZEUS ELISA Treponema pallidum IgG Test System. The device output (OD value and interpretation) is generated directly by the assay without human interpretation as part of the primary diagnostic step. The results are compared against a reference standard or clinical diagnosis.

6. The Type of Ground Truth Used:

   • Reference Assay: For most clinical performance studies, the ground truth was established by a treponemal reference assay, specifically TPPA (Treponema pallidum Particle Agglutination assay), or in some cases, RPR (Rapid Plasma Reagin) for the retrospective RPR/TPPA positive samples.
   • Clinical Diagnosis: For the CDC Syphilis Panel, the ground truth was based on "Clinical Diagnosis" of syphilis disease.

7. The Sample Size for the Training Set: Not applicable in the context of an ELISA assay. ELISA assays are biochemical tests with fixed reagents and protocols, not machine learning algorithms that require a "training set" in the same sense. The linearity, analytical specificity (interfering substances, cross-reactivity), and detection limits studies are part of the analytical validation, not algorithm training.

8. How the Ground Truth for the Training Set was Established: Not applicable, as there is no "training set" for an ELISA assay as understood for AI/ML algorithms. The assay's performance characteristics are inherent to its biochemical design.

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The Zeus Scientific, Inc. AtheNA Multi-Lyte® ToRCH IgG Plus Test System is intended for the qualitative detection of specific human IgG class antibodies to Toxoplasma gondii (T.gondii), Rubella, Cytomegalovirus (CMV) and HSV 1 & 2 in human serum. The results of this assay are intended to be used as an aid in the assessment of serological status to Toxoplasma gondii, Rubella and CMV. For HSV 1 and HSV 2, the test is indicated for sexually active adults and expectant mothers, as an aid for presumptively diagnosing Herpes Simplex 1 and Herpes Simplex 2.

The test is not intended for use in screening blood or plasma donors.

The performance of this assay has not been established for use in a pediatric population, neonatal screening, immunocompromised or immunosuppressed patients or for use at point of care facilities.

The Zeus Scientific, Inc. AtheNA Multi-Lyte® ToRCH IgG Plus Test System is a multiplex immunoassav intended for the simultaneous qualitative detection and differentiation of specific human IgG class antibodies to Toxoplasma gondii, Rubella, Cytomegalovirus (CMV), Herpes Simplex 1 (HSV-1) and Herpes Simplex 2 (HSV-2) in human serum. The results of this assay are intended to be used as an aid in the assessment of a patient's serological status to infection with Toxoplasma gondii, Rubella, CMV, HSV 1 and HSV 2 and in the determination of immune status of individuals including pregnant women. The test system is comprised of the AtheNA Multi-Lyte test kit, software and the Luminex Corp instrument.

The AtheNA Multi-Lyte ToRCH IgG Plus Test System provides the following components:

Reactive Reagents:

All reactive reagents contain sodium azide as a preservative at a concentration of 0.1% (w/v).

1. Multiplexed bead suspension 1. Ready to use, 5.5 mL bottle. The suspension contains separate distinguishable 5.6 micron polystyrene beads that are conjugated with:
   . Toxo grade 2 antigen
   . Rubella K2S grade antigen
   CMV grade 2
   . HSV-1 type-specific recombinant gG-1 protein antigen
   . HSV-2 gG-2 type-specific recombinant gG-2 protein antigen

The bead mix also contains one bead set designed to detect non-specific antibodies in the patient sample (if present) and four separate bead sets used for assay calibration.

2. Conjugate: Phycoerythrin conjugated goat anti-human IgG (y chain specific). Ready to use, 15 mL amber bottle.
3. Human positive serum control 1. One, 0.2 mL vial.
4. Human positive serum control 2. One, 0.2 mL vial.
5. Human negative serum control. One, 0.2 mL vial.
6. SAVe Diluent®. One 50 mL bottle containing phosphate-buffered-saline. Ready to use. NOTE, the sample diluent will change color in the presence of serum.
7. Wash Buffer Concentrate: dilute 1 part concentrate + 9 parts deionized or distilled water. One bottle containing 10 X concentrate of phosphate buffered saline.

Non-Reactive Reagents

1. One, 96-well filtration plate for rinsing the microspheres
2. Data Labels: One label is adhered to the inside lid of the kit box and a second label is inside the kit box.
3. Package Insert providing instructions for use
4. Calibration CD: a compact disc that includes all lot-specific kit calibration values required for specimen analysis and assay quality control

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Device: AtheNA Multi-Lyte® ToRCH IgG Plus Test System
Submission Purpose: Simultaneous qualitative detection and differentiation of specific human IgG class antibodies to Toxoplasma gondii (Toxo), Rubella, Cytomegalovirus (CMV), and Herpes Simplex 1 (HSV-1) and Herpes Simplex 2 (HSV-2). The results aid in assessing serological status for Toxo, Rubella, and CMV, and for presumptively diagnosing HSV-1 and HSV-2 in sexually active adults and expectant mothers.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state "acceptance criteria" as a single, consolidated list with numerical targets for each performance metric (e.g., "Sensitivity must be >95%"). Instead, it presents the results of comparative studies against predicate devices and CDC panels. The implicit acceptance criterion is that the device demonstrates performance substantially equivalent to or in agreement with these established methods.

The table below summarizes the reported device performance from the clinical studies for various analytes and populations, indicating successful agreement or high percentage agreement where applicable. For Toxoplasma, Rubella, and CMV in the "Individuals Undergoing ToRCH Antibody Assessment," the columns refer to "Positive Percent Agreement (PPA)" which represents sensitivity and "Negative Percent Agreement (NPA)" which represents specificity. For HSV-1 and HSV-2 in "Sexually Active Adults", it uses "Sensitivity" and "Specificity." For the CDC panels, it also uses "PPA" and "NPA" against the CDC results.

2. Sample Size Used for the Test Set and Data Provenance

The evaluation of the AtheNA Multi-Lyte ToRCH IgG Plus Test System involved several studies:

• Comparative testing of Intended Use Populations (651 samples):
  • Sample Size: 651 unselected samples.
  • Data Provenance:
    • 300 samples from a hospital laboratory in the Mid-Atlantic region (United States).
    • 351 samples from a hospital laboratory in the Northeast (United States).
    • The samples were "prospectively collected" individuals undergoing ToRCH antibody assessment. They were described as "frozen remnant serum samples" which suggests they might have been collected over a period and then accessed retrospectively for this study. The phrasing "prospectively collected frozen remnant serum samples" can be ambiguous, but generally, "prospectively collected" refers to data collected specifically for the study. However, using "remnant" suggests they were left over from routine testing.
    • Data was gathered concurrently with the AtheNA Multi-Lyte test system and predicate assays.
• Pregnant Women Population (200 samples):
  • Sample Size: 200 samples.
  • Data Provenance: From expectant mothers, sourced from two serum vendors. The samples were "prospectively collected" and were "frozen remnant serum samples". Tested internally at the manufacturer's lab.
• CDC Reference Panels:
  • Sample Size:
    • Toxo: 100 samples (70 positive, 30 negative)
    • Rubella: 100 samples (80 positive, 20 negative)
    • CMV: 100 samples (54 positive, 46 negative)
    • HSV-1: 100 samples (50 positive, 50 negative)
    • HSV-2: 100 samples (48 positive, 52 negative)
  • Data Provenance: Masked, well-characterized serum panels from the CDC (Centers for Disease Control and Prevention), a US government agency.
• HSV-1 & HSV-2 Low Prevalence Population:
  • Sample Size: 67 samples.
  • Data Provenance: Serum samples from 18 and 19-year-old subjects previously tested for non-sexual infections. Assessed internally at Zeus. Retrospective.
• Rubella Retrospective Negative Sample Study:
  • Sample Size: 100 samples.
  • Data Provenance: Pre-selected banked samples of sera previously tested negative for Rubella antibody by the predicate device. Assessed internally at Zeus. Retrospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

The document does not explicitly mention the number or qualifications of experts used to establish the ground truth for the test sets. Instead, the "ground truth" was established by:

• Predicate assays: The results of FDA-cleared predicate ELISA test systems (Toxo IgG ELISA, Rubella IgG ELISA, CMV IgG ELISA, HerpeSelect 1 and 2 Immunoblot IgG for HSV-1/2) were used as the reference standard for the clinical performance studies in general populations and pregnant women. These predicate devices are themselves validated diagnostic tools.
• CDC Reference Panels: These are "well-characterized" serum panels which implicitly means their status (positive/negative) for the target analytes has been rigorously established, likely through expert consensus and/or a battery of highly sensitive and specific reference methods, although the details are not provided here.

4. Adjudication Method for the Test Set

The document does not describe any explicit adjudication method (like 2+1 or 3+1) for resolving discrepancies between the AtheNA Multi-Lyte system and the predicate devices or CDC panels.

The results are presented as direct comparisons, and for discrepant cases in the Rubella category, a note mentions qualitative differences (e.g., "4/4 discrepant Rubella samples which tested positive by ELISA had low positive values for AtheNA and high negative values for ELISA, 4/4 discrepant Rubella samples which tested positive by AtheNA and equivocal by ELISA had low positive values for ELISA"). This suggests discrepancy analysis was performed but no formal adjudication by an independent panel of experts is explicitly mentioned for overriding results.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This device is an automated in vitro diagnostic assay (multiplex microparticle immunoassay) that generates quantitative/qualitative results, not an imaging AI algorithm requiring human interpretation. Therefore, the concept of "human readers improve with AI vs without AI assistance" does not apply in this context.

6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, the studies reported are essentially standalone performance studies. The AtheNA Multi-Lyte® ToRCH IgG Plus Test System is an automated immunoassay system (test kit, software, and Luminex Corp instrument) which provides qualitative detection of antibodies. Its performance is evaluated directly against predicate devices or reference panels without human interpretation influencing the device's output. The results presented (PPA, NPA, Sensitivity, Specificity) are inherent to the device's diagnostic capability.

7. The Type of Ground Truth Used

The ground truth used for the test sets was primarily based on:

• Predicate devices: Established and FDA-cleared immunoassay systems for each analyte (ELISA for Toxo, Rubella, CMV; Immunoblot IgG for HSV-1/2).
• CDC Reference Panels: Well-characterized serum panels with known positive or negative status.
• Previously tested results: For the low prevalence HSV study and retrospective Rubella study, pre-selected banked samples with known results from predicate devices were used.

These are considered established diagnostic results from reference methods or highly characterized samples, rather than pathology or direct outcomes data from patients.

8. The Sample Size for the Training Set

The document does not explicitly mention a "training set" or its sample size for the AtheNA Multi-Lyte® ToRCH IgG Plus Test System. As an immunoassay, the device itself is developed and optimized through laboratory procedures, reagent formulation, and analytical validation rather than machine learning training on a dataset. The studies described are performance evaluation studies, akin to a test set, to demonstrate substantial equivalence and establish performance characteristics.

9. How the Ground Truth for the Training Set Was Established

Since a "training set" in the context of machine learning is not applicable here, the method of establishing ground truth for a training set is not provided. The development of an immunoassay involves optimizing reagents and reaction conditions, typically through analytical experiments rather than data-driven machine learning training.

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The Zeus Scientific, Inc AtheNA Multi-Lyte Borrelia VISE-1/ pepC10 Plus Test System is a multiplexed sandwich immunoassay for the qualitative detection of IgG class antibody to recombinant VISE-1 and the IgM class of antibody to synthetic pepC10 in human serum. The AtheNA Multi-lyte Borrelia VISE-1/pepC10 Plus Test System is intended for use with the Luminex® 200 IS and the AtheNA Multi-Lyte data management package in testing serum samples from symptomatic patients or those with a history of Lyme Borreliosis. All positive specimens should be tested with a second-tier test such as Western Blot which if positive, is supportive evidence of infection with B.burgdorferi. Diagnosis of Borreliosis should be made based on the presence of 8.burgdorferi antibodies, history, symptoms and other laboratory data. Negative first or second tier results should not be used to exclude Borreliosis.

The AtheNA Multi-Lyte Borrelia VlsE-1/pepC10 Plus Test System is a micro particle immunoassay intended for the qualitative detection of distinct IgG class antibody to VlsE-1 and distinct IgM antibody to pepC10. The assay is a multiplexed immunoassay designed to simultaneously detect, distinguish and identify IgG reactivity to recombinant VISE-1 antigen and IgM reactivity to synthetic pepC10 antigen. The test system is comprised of the AtheNA Multi-Lyte test kit and the Luminex Corp instrument model number Luminex™ 200 IS and software version 3.

Here's an analysis of the acceptance criteria and the studies performed for the Zeus Scientific Inc. AtheNA Multi-Lyte Borrelia VlsE-1/pepC10 Plus Test System, based on the provided text:

Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device. It does not explicitly state "acceptance criteria" in the format of a predefined performance target, but rather presents the results of various validation studies, which imply what would be considered acceptable performance for a diagnostic device in its class. For the purpose of this analysis, I will infer relevant performance metrics from the study results.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Sizes Used for the Test Set and Data Provenance

The document describes multiple studies with different test sets:

• Characterized Samples (Study 1): 229 human serum samples.
  • Provenance: Northeastern state Department of Health Laboratory. Implies a mix of acute, convalescent, and culture-proven Lyme disease patients, likely collected prospectively or retrospectively for diagnostic purposes.
• Prospective Population (Study 2): 756 unselected samples from patients with an order for a Lyme antibody test.
  • Provenance: Samples collected from four sites in the US: a hospital laboratory in the Mid-Atlantic (103 samples), a hospital laboratory in upper Connecticut (100 samples), a hospital laboratory in lower Connecticut (107 samples), and a state Department of Health Lab in the northeast (446 samples). All samples were submitted for Lyme antibody testing and were sequentially numbered, de-identified and archived.
• Retrospective Samples (Study 3): 242 samples (124 from Connecticut, 118 from Pennsylvania).
  • Provenance: Believed to have screened positive for Borrelia burgdorferi antibodies, tested at a hospital facility in Connecticut and a Pennsylvania hospital laboratory.
• CDC Characterized Lyme Panel (Study 4): 40 samples (5 normal blood donors, 35 Borreliosis patients).
  • Provenance: Acquired from the CDC.
• Analytical Specificity / Endemic & Non-Endemic Controls (Study 5): 700 samples (300 endemic from New England, 400 non-endemic from New Mexico).
  • Provenance: Blood donors from New England (endemic) and blood donors/individuals undergoing routine non-infectious testing from New Mexico (non-endemic).
• Reproducibility: 5 internal samples (levels: negative, near cut-off, low positive, moderate and high positive).*
• Repeatability: 6 internal samples (levels: negative, high negative, near cut-off, low positive, moderate and high positive).*

*For reproducibility and repeatability, reference samples are typically prepared internally or sourced commercially with known characteristics, not representative of general patient populations for diagnostic accuracy evaluation.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

The document does not explicitly state the "number of experts" or their specific "qualifications" for establishing ground truth. However, implicitly:

• Clinical Diagnosis: For the "Characterized Samples" (Study 1) and "CDC Characterized Lyme Panel" (Study 4): The ground truth is based on "clinical diagnosis," "history of Borreliosis," "culture proven, early acute Lyme disease," or "patients diagnosed with Borreliosis." This implies a consensus among medical professionals (physicians, infectious disease specialists) using clinical criteria, possibly supported by existing laboratory results.
• Western Blot: For discrepant results in prospective and retrospective studies, Western Blot methodology was used to confirm reactivity. Western Blot interpretation is a specialized skill typically performed and verified by laboratory professionals experienced in serology.
• Predicate Device: For comparative studies, the predicate ELISA test system was used as a reference assay. The "ground truth" here is the result of the predicate device, which itself would have been FDA cleared based on its own validation by medical laboratory experts.

4. Adjudication Method for the Test Set

The document describes adjudication for discrepancies:

• Prospective Samples (Study 2): "If available, western blot testing was performed on the discrepant results."
• Retrospective Samples (Study 3): "Western blot testing was done on discrepant results."

This indicates a form of discrepancy resolution using a higher-tier test (Western Blot), which acts as a secondary adjudication method. The document does not specify if multiple readers were involved in the Western Blot interpretation or what consensus rule was applied (e.g., 2+1).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly conducted or described in the provided text for evaluating human reader performance with and without AI assistance. This device is an in vitro diagnostic test system (an assay), not an AI-powered image analysis tool that assists human interpretation of images. The comparison is between the new assay system and a predicate ELISA assay, not human readers.

6. Standalone Performance

Yes, standalone performance was done. The entire document describes the performance of the "AtheNA Multi-Lyte Borrelia VlsE-1/pepC10 Plus Test System" as a standalone algorithm (a fully automated assay, without human-in-the-loop performance in terms of interpretative decision-making). The results presented are directly from the device's output. Clinical studies compare its performance against clinical diagnoses, recognized reference standards (Western Blot), and a predicate device.

7. Type of Ground Truth Used

The ground truth for the various studies includes:

• Clinical Diagnosis: For characterized samples (e.g., acute, convalescent patients with history of Borreliosis, culture-proven early acute Lyme disease, patients diagnosed with Borreliosis).
• Predicate ELISA: For comparison studies (Prospective, Retrospective) where samples were categorized as "reference assay positive" or "reference assay negative" based on the predicate ELISA.
• Western Blot: Used as a confirmatory test for discrepant results between the investigational device and the predicate device. For the "Characterized Samples" table, Western Blot results are presented as another comparator for agreement with clinical diagnosis.
• CDC Characterized Lyme Panel: Samples from the CDC with established reactivity profiles.
• Normal Blood Donors/Non-infectious Individuals: Used to assess specificity/low prevalence.

8. Sample Size for the Training Set

The document does not explicitly describe a "training set" in the context of machine learning or AI algorithm development. This is an immunoassay, not typically developed using machine learning with distinct training and test sets in the same way an AI diagnostic algorithm would be. The studies described are validation studies for the device's performance, not for training stages.

9. How the Ground Truth for the Training Set Was Established

Since no explicit "training set" for an AI algorithm is mentioned (as the device is an immunoassay), the method for establishing ground truth for a training set is not applicable here. The focus is on the validation of the assay's performance using established methods of clinical and analytical evaluation.

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