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510(k) Data Aggregation
(58 days)
LGC
The Trinity Biotech Captia™ Herpes Group IgG ELISA kit is an Enzyme-Linked Immunosorbent Assay (ELISA) for qualitative determination of IgG antibodies in human serum to Herpes simplex virus. The Herpes Group IgG ELISA kit may be used to determine serologic status in females of child bearing age, and to evaluate paired sera for the presence of a seroconversion of IgG as an aid in the diagnosis of Herpes simplex virus infection. It is not intended for determining the type of Herpes simplex virus.
The Herpes Group IgG ELISA kit is an Enzyme-Linked Immunosorbent Assay (ELISA) for qualitative determination of IgG antibodies in human serum to Herpes simplex virus. The Herpes Group IgG ELISA kit may be used to evaluate paired sera for the presence of seroconversions of IgG as an aid in the diagnosis of Herpes simplex virus infection.
The Herpes Group IgG ELISA test is an enzyme linked immunosorbent assay to detect IgG antibodies to Herpes simplex virus. Purified Herpes Group antigen is attached to a solid phase microtiter well. Diluted test sera are added to each well. If the antibodies are present that recognize the antigen, they will bind to the antigen in the well. After incubation, the wells are washed to remove unbound antibody. An enzyme labeled anti-human IgG is added to each well. After incubation, the wells are washed to remove unbound conjugate. A substrate solution is added to each well. If enzyme is present, the substrate will undergo a color change. After an incubation period the reaction is stopped and the color intensity is measured photometrically, producing and indirect measurement of specific antibody in the patient specimen.
The Trinity Biotech Herpes Group IgG ELISA Test Kit was evaluated for its agreement with predicate devices (Clark HSV 1 and HSV 2 ELISA assays) and for precision, cross-reactivity, and paired serum study performance.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state acceptance criteria in terms of predefined thresholds that the device must meet for approval. Instead, it presents performance characteristics (agreement percentages and precision) observed in comparison to predicate devices and other studies. The approval from the FDA indicates that the device's performance, as demonstrated, was deemed substantially equivalent to existing predicate devices. We can infer that the reported percentages of agreement and precision values were considered acceptable by the regulatory body for demonstrating substantial equivalence.
Based on the cumulative data from the four comparison studies with the predicate device, the key performance metrics are:
| Metric | Acceptance Criteria (Inferred from FDA Approval for Substantial Equivalence) | Reported Device Performance (Cumulative across 4 studies) |
|---|---|---|
| % Agreement Positive | Performance demonstrated substantial equivalence to predicate device | 98.9% (95% CI: 97.9% - 100%) |
| % Agreement Negative | Performance demonstrated substantial equivalence to predicate device | 96.7% (95% CI: 94.2% - 99.1%) |
| % Total Agreement | Performance demonstrated substantial equivalence to predicate device | 98.1% (95% CI: 97.0% - 99.2%) |
| Precision (Intersite CV) |
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(30 days)
LGC
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(126 days)
LGC
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(78 days)
LGC
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(70 days)
LGC
This test system is designed for the manual or automated, qualitative detection of IgM antibodies to Herpes Simplex Virus (HSV) type 1 and type 2 in human serum. The test system is designed to detect IgM antibody to HSV-1 and/or HSV-2. but can not distinquish between the two IgM antibodies. The test system is intended to evaluate serologic evidence of primary or reactivated infection with HSV-1 and/or HSV-2.
Not Found
The provided text is a 510(k) clearance letter from the FDA for a device called "The APTUS (Automated) Application of the HSV 1/2 IgM ELISA". It outlines the regulatory approval process but does not contain any information regarding acceptance criteria or a study proving the device meets those criteria.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as this information is not present in the provided document.
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(290 days)
LGC
The POCkit™ HSV-2 Rapid Test is a single unit, membrane-based immunoassay for the qualitative determination, either in heparinized capillary whole blood taken by fingerstick or in serum, of circulating IgG antibodies specific for herpes simplex virus type 2 (HSV-2), which arise as a result of infection with HSV-2. It is intended for in-vitro diagnostic use by health professionals in Point of Care testing. The presence of antibodies to HSV-2 may be indicative of a previous infection with HSV-2 and may be of value in determination of previous immunological experience and to aid in the diagnosis of HSV associated disease. This assay will not differentiate whether infection is currently in a latent or active state.
The POCkit™ HSV-2 Rapid Test is a qualitative membrane immunoassay for the detection of IgG antibodies to herpes simplex virus type 2 (HSV-2) in human capillary whole blood and serum.
The POCkit™ HSV-2 Rapid Test consists of a lest device that has a solid phase membrane housed in a plastic envelope containing wicking material. The membrane is visible to the user through a test window on the front of the device. The method employs a unique combination of a specific antibody binding protein conjugated to colloidal gold particles and a semi-purified HSV-2 specific antigen (glycoprotein G2, derived from HSV-2 virus). This protein has been bound to the membrane as a TEST spot on the right side of the test window. Human IgG has been bound to the membrane as a CONTROL spot on the left side of the test window.
When a pro-diluted (fingerprick) capillary whole blood sample is allowed to pass through the membrane any anti-HSV-2 antibodies present become bound to the HSV-2 antigen in the TEST spot. Upon addition of the developing reagent, which reacts with human IGG antibodies, a pink/red color develops. The developing reagent also reveals the human IgG immobilized in the CONTROL spot, which demonstrates that the test is functioning property. The test device is designed to absorb the pro-calibrated volume of reagents that are provided in each test kit.
The POCkit™ HSV-2 Rapid Test is a qualitative membrane immunoassay for the detection of IgG antibodies to herpes simplex virus type 2 (HSV-2). The study compared the device's performance to the HSV-2 Western Blot method and also tested it against the CDC serum panel for HSV-2 serology assays.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated as numerical targets in the provided text. However, the study aims to show substantial equivalence to the Western Blot method. Therefore, the "acceptance criteria" can be inferred as achieving high agreement, sensitivity, and specificity in comparison to the Western Blot.
| Metric | Acceptance Criteria (Inferred) | Reported Device Performance (Whole Blood) | Reported Device Performance (Serum) |
|---|---|---|---|
| Performance | High agreement with Western Blot | Evaluated across 1193 samples | Evaluated across 1220 samples |
| Sensitivity | High | Not explicitly quantified in text | Not explicitly quantified in text |
| Specificity | High | Not explicitly quantified in text | Not explicitly quantified in text |
| Comparison Panel | Agreement with CDC serum panel for HSV-2 serology assays | Tested with CDC serum panel | Tested with CDC serum panel |
2. Sample Sizes and Data Provenance
- Test Set Sample Size:
- Whole blood samples: 1193
- Serum samples: 1220
- Data Provenance: Not explicitly stated in terms of country of origin or whether it was retrospective or prospective. However, the "CDC serum panel for HSV-2 serology assays" suggests a US-based dataset for part of the evaluation.
3. Number of Experts and their Qualifications for Establishing Ground Truth
- The document implies that the Western Blot method served as the reference standard (ground truth). The number of experts and their qualifications involved in establishing the ground truth for the Western Blot results are not provided in this document.
- Similarly, for the CDC serum panel, the method of establishing ground truth (e.g., expert consensus, other reference methods) and the number/qualifications of experts are not specified.
4. Adjudication Method for the Test Set
- The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the test set results. The comparison appears to be a direct evaluation against the Western Blot and CDC panel.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC comparative effectiveness study is mentioned. The study focuses on the standalone performance of the device against established methods. There is no information provided regarding human readers or improved performance with AI assistance.
6. Standalone Performance
- Yes, a standalone performance study was conducted. The "Performance Data" section describes the evaluation of the POCkit™ HSV-2 Rapid Test "relative to the HSV-2 Western Blot method" and states that the "CDC serum panel for HSV-2 serology assays was tested with this device." This indicates an assessment of the algorithm's (device's) performance purely on its own.
7. Type of Ground Truth Used
- The primary ground truth used was the HSV-2 Western Blot method.
- Additionally, a CDC serum panel for HSV-2 serology assays was used as a reference. This panel would typically have known or well-characterized HSV-2 status, serving as another form of ground truth.
8. Sample Size for the Training Set
- The document does not provide any information regarding a distinct training set sample size. This suggests that if machine learning was involved (which is unlikely given the stated nature of the device as a membrane immunoassay), the training details are not disclosed. More likely, the device is a fixed immunoassay, and what is described is its analytical validation against reference methods.
9. How Ground Truth for the Training Set Was Established
- As no training set is described for this device, the method for establishing its ground truth is not applicable/not provided. The device's mechanism is a membrane immunoassay, which does not typically involve a "training" phase in the context of machine learning. The "ground truth" discussed in the context of performance evaluation refers to the reference standard for validating the device's accuracy.
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(203 days)
LGC
The PREMIER™ TYPE SPECIFIC HSV-2 IgG ELISA TEST is to be used in the testing of human serum specimens from individuals for whom the qualitative presence of detectable IgG antibody to herpes simplex virus type 2 is warranted; specifically, when used in conjunction with the Premier™ Type Specific HSV-1 IgG ELISA in the screening of sexually active adults. This test is indicated for individuals at risk for a sexually transmitted HSV infection or disease (STD), For example, this test is to be used to screen samples from patients with or without clinical history of herpes and can clarify when an individual with symptoms suggestive of genital herpes has genital HSV-2 infection.
The PREMIER™ TYPE SPECIFIC HSV-2 IgG ELISA TEST is not recommended for use in a pediatric population. The performance characteristics of this device have not been established for prenatal and neonatal screening, the testing of patients with other HSV associated diseases and immunosuppressed patients, or the detection of early stages of HSV seroconversion.
The Premier™ Type Specific HSV-2 IgG ELISA Test is an in vitro diagnostic medical device is intended for the qualitative detection of IgG antibody to the herpes simplex virus type 2 in human serum by the enzyme-linked immunosorbent assay (ELISA) method.
The Premier™ Type Specific HSV-2 IgG ELISA Test is comprised of the following items:
- Antigen-Coated ELISA Plate: One 96-well plate comprised of twelve 8-well strips with breakaway wells, each well coated with affinity purified HSV-2 glycoprotein G (gG-2).
- IgG Specimen Diluent: One bottle containing 30 ml of a lavender colored dilution buffer with sodium azide.
- Conjugate: One bottle containing 15 ml of a pink colored solution of alkaline phosphatase-labeled antihuman IgG (Caprine) with sodium azide.
- Substrate Buffer: One bottle containing 30 ml of a blue colored buffer solution with sodium azide.
- p-NPP Tablets: One foil pack containing 6 tablets of p-nitrophenyl phosphate (p-NPP).
- Stopping Reagent: One bottle containing 30 ml of a colorless solution of 1.5 N sodium hydroxide (NaOH).
- Positive Control and Negative Control: One vial of each containing 200 ul of serum (human) with sodium azide.
- Reference Serum: One vial containing 400 ul of serum (human) with sodium azide.
- 20X Wash Solution: One bottle containing 60 ml of a green colored solution with detergent and sodium azide.
- ELISA Plate Sealer: One acetate sheet with contact adhesive.
- Resealable Storage Bag: One plastic sealable bag.
- ELISA Worksheet: One worksheet for recording data.
When the Premier™ Type Specific HSV-2 IgG ELISA Test is employed, diluted patient serum is incubated with purified herpes simplex virus type 2 glycoprotein (gG2) bound to the ELISA plate wells. If antibodies to the herpes simplex virus type 2 are present, they bind to the antigen and do not rinse off. Subsequently when enzyme-labeled antihuman IgG is added to the reaction site it binds to the immobilized IgG antibodies. After washing and the addition of a chromogenic substrate and stopping reagent, specimens containing antibodies to the herpes simplex virus type 2 produce a color endpoint reaction which can be read with a standard ELISA plate reader.
The Premier™ Type Specific HSV-2 IgG ELISA Test is an in vitro diagnostic medical device intended for the qualitative detection of IgG antibody to the herpes simplex virus type 2 in human serum.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state pre-defined acceptance criteria (e.g., "The device must achieve a sensitivity of X% and specificity of Y%"). Instead, it presents performance metrics from various studies and implies that these "acceptable agreement" and "relative sensitivity and relative specificity" values demonstrate substantial equivalence to a predicate device, particularly noting "improved specificity" over the predicate.
Given the lack of explicit acceptance criteria, the table below reports the performance metrics achieved in the primary clinical studies.
| Metric (Study 1: STD Clinics) | Reported Device Performance (95% CI) |
|---|---|
| Relative Agreement | 93.1% (704/756) |
| Relative Sensitivity | 80.5% (182/226) (74.1%-85.7%) |
| Relative Specificity | 98.5% (522/530) (96.9%-99.3%) |
| Predictive Value Positive | 95.8% (182/190) (91.6%-98.0%) |
| Predictive Value Negative | 92.2% (522/566) (89.6%-94.2%) |
| Metric (Study 2: Clinical Laboratory) | Reported Device Performance (95% CI) |
|---|---|
| Relative Agreement | 97.2% (174/179) (93.6%-99.1%) |
| Relative Sensitivity | 98.0% (50/51) (89.5%-99.9%) |
| Relative Specificity | 96.9% (124/128) (92.2%-99.1%) |
| Metric (CDC Panel) | Reported Device Performance |
|---|---|
| Total Agreement with CDC | 95.0% |
| Agreement with anti-HSV-2+ | 86.1% |
| Agreement with anti-HSV-2- | 100.0% |
2. Sample Sizes Used for the Test Set and Data Provenance
- Study 1 (STD Clinics):
- Sample Size: 756 serum samples.
- Data Provenance: Prospectively collected from unduplicated individuals attending two STD Clinics in the Pacific Northwest Region of the US.
- Study 2 (Clinical Laboratory):
- Sample Size: 193 patients (sequential sera), with 179 included in calculations after exclusions.
- Data Provenance: Frozen samples from patients submitted to a clinical laboratory in the Pacific Northwest Region of the US.
- Study 3 (CDC Panel):
- Sample Size: 100 clinical specimens (50 paired sera).
- Data Provenance: Serum panel obtained from the Centers for Disease Control (CDC).
- Study 4 (Culture Documented HSV-2 Infection):
- Sample Size: 335 archived serum samples.
- Data Provenance: Archived serum samples from patients with culture documented HSV-2 infection (retrospective, pre-selected).
- Study 5 (Low Prevalence Populations for Specificity):
- Sample Size:
- 199 pediatric patients (Northeast Region, US).
- 209 individuals (University Student Health Clinic, Pacific Northwest Region, US).
- 100 Blood Bank donors (Northeast Region, US).
- Data Provenance: Prospectively collected (implied by "pediatric patients," "individuals attending," "Blood Bank donors" in specific regions of the US).
- Sample Size:
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The ground truth for most studies was established using the Western Blot Method for type specific IgG antibody to HSV-2.
- For Study 1 (STD Clinics), it states, "Western Blot results were based on initial testing with the exception of specimens with initial atypical results which were reanalyzed."
- For Study 2 (Clinical Laboratory), it states, "Tested for IgG antibodies to HSV-2 using... a Western Blot Method."
- For Study 3 (CDC Panel), the specimens were "characterized previously by CDC EIA and Western Blot testing."
- For Study 5 (Low Prevalence Populations), the ground truth was also "a Western Blot Method for type specific IgG antibody to HSV-2."
The document does not specify the number of experts or their qualifications who interpreted these Western Blot results. However, Western Blot is typically considered a highly reliable, gold-standard method for HSV-2 serology.
For Study 4 (Culture Documented HSV-2 Infection), the ground truth was prior culture documentation of HSV-2 infection. This does not require expert interpretation of a secondary diagnostic test.
4. Adjudication Method for the Test Set
The document details the following adjudication methods:
- Study 1 (STD Clinics) and Study 5 (Low Prevalence Populations):
- Western Blot: Initial atypical results were reanalyzed. Patients not returning for repeat testing were presumed negative.
- Premier™ Type Specific HSV-2 IgG ELISA Test: Specimens initially reported as equivocal were retested, and the second test result was used.
- Study 2 (Clinical Laboratory): "There were ten specimens which demonstrated either equivocal ELISA results or atypical Western Blot results and four specimens that could not be typed by Western Blot which were not included in the above calculations." This implies exclusion rather than a specific re-adjudication protocol for these excluded cases.
- Study 4 (Culture Documented HSV-2 Infection): "Based on repeat testing of equivocal samples."
No explicit "2+1" or "3+1" expert adjudication scheme is mentioned, but rather a protocol for handling equivocal or atypical results with repeat testing or re-analysis.
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 is an in vitro diagnostic (IVD) device, specifically an ELISA test, which is read by an automated ELISA plate reader to produce a color endpoint reaction that is then quantitatively measured. It is not an AI-assisted diagnostic imaging or interpretation device that would involve human readers or AI assistance in the way typically discussed in MRMC studies. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance was not applicable and not performed.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
Yes, the studies presented are standalone performance studies for the Premier™ Type Specific HSV-2 IgG ELISA Test. The device provides a quantitative result (color endpoint) which is then interpreted qualitatively (positive/negative/equivocal) based on pre-defined cut-offs without human interpretive "readings" in the sense of image analysis. The performance metrics (sensitivity, specificity, agreement) directly reflect the algorithm's (the ELISA test's) ability to correctly classify samples against the ground truth.
7. The Type of Ground Truth Used
The primary type of ground truth used across most studies was:
- Expertly Interpreted Gold Standard Test: The Western Blot Method for type specific IgG antibody to HSV-2. This is considered the reference standard for HSV type-specific serology.
- Outcomes Data/Validated Diagnosis: For one study (Study 4), culture documented HSV-2 infection was used as the ground truth.
8. The Sample Size for the Training Set
The document does not explicitly mention a separate "training set" for the Premier™ Type Specific HSV-2 IgG ELISA Test. The studies described are performance evaluations of the completed device. For IVDs like ELISA tests, the "training" analogous to machine learning often involves optimizing reagent concentrations, incubation times, and optical density cut-offs during product development, typically using characterized clinical samples (development panels), but this is not typically referred to as a "training set" in the same way as for AI/ML models. No sample size for such a set is provided.
9. How the Ground Truth for the Training Set Was Established
Since no explicit training set is mentioned, this information is not provided. If the question implies how the inherent parameters (like cut-offs) of the ELISA test were established during development, it would have been based on characterized samples, likely against a gold standard like Western Blot or culture results, but the document does not detail this process or the ground truth establishment for such a developmental phase.
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(150 days)
LGC
The Zeus Scientific, Inc. Herpes Simples Virus (HSV) -1 and/or HSV-2 IgM ELISA Test System is intended for the qualitative detection of IgM antibodies to Herpes Simplex Virus type 1 and 2 in human serum. The test system is designed to detect IgM antibody to HSV-1 or HSV-2, but can not disginguish between the two IgM antibodies. The test system is intended to be used to evaluate serologic evidence of primary or reactivated infection with HSV-1 and/or HSV-2.
Not Found
This document is a 510(k) clearance letter from the FDA for a diagnostic device, not a study report. As such, it does not contain the detailed information requested regarding acceptance criteria, study design, sample sizes, expert qualifications, or ground truth establishment.
A 510(k) clearance primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing a detailed clinical study demonstrating new performance characteristics against explicitly defined acceptance criteria in the way a pivotal clinical trial report would.
Therefore, I cannot populate the requested table and answer the questions based solely on the provided text. The document confirms that a study was conducted to support the 510(k) submission, but it does not describe the specifics of that study.
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(140 days)
LGC
The HSV 1+2 IgG ELISA TEST is to be used manually or in conjunction with the Duet™ instrument in the testing of human serum specimens from individuals in whom the qualitative presence or absence of detectable IgG antibody to herpes simplex virus type 1 and type 2 is warranted in the determination of immunological experience pertaining to infection with herpes simplex virus type 1 and type 2 and as an aid in the diagnosis of herpes simplex virus associated disease.
The HSV 1+2 IgG ELISA Test is an in vitro diagnostic medical device intended for the qualitative detection of IgG antibody to the herpes simplex virus (HSV) in human serum by the enzyme-linked immunosorbent assay (ELISA) method. The HSV 1+2 IgG ELISA Test is comprised of the following items: Antigen-Coated ELISA Plate, IgG Specimen Diluent, Conjugate, Substrate Buffer, p-NPP Tablets, Stopping Reagent, Positive Control and Negative Control, Reference Serum, 20X Wash Solution, ELISA Plate Sealer, Resealable Storage Bag, and ELISA Worksheet. When the HSV 1+2 IgG ELISA Test is employed, diluted patient serum is incubated with partially purified HSV antigen bound to the ELISA plate wells. If antibodies to herpes simplex virus are present, they bind to the antigen and do not rinse off. Subsequently when enzyme-labeled antihuman IgG is added to the reaction site it binds to the immobilized IgG antibodies. After washing and the addition of a chromogenic substrate and stopping reagent, specimens containing antibodies to herpes simplex virus produce a color endpoint reaction which can be read with a standard ELISA plate reader.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Implicit) | Reported Device Performance (Comparative Study) | Reported Device Performance (CDC Panel Study - Site 1 & 2) | Reported Device Performance (CDC Panel Study - Site 3/Gull Labs) |
|---|---|---|---|---|
| Relative Agreement with Predicate | High agreement | 96.7% (95% CI: 92.5% to 98.9%) | N/A | N/A |
| Relative Sensitivity with Predicate | High sensitivity | 99.1% (95% CI: 95.2% to 100.0%) | N/A | N/A |
| Relative Specificity with Predicate | High specificity | 90.0% (95% CI: 75.3% to 97.2%) | N/A | N/A |
| Total Agreement with CDC Ground Truth | High agreement | N/A | 96.0% (96/100) | 95.0% (95/100) |
| Agreement for Positive Specimens (CDC Ground Truth) | High agreement (positive predictive value) | N/A | 100% (72/72) | 100% (72/72) |
| Agreement for Negative Specimens (CDC Ground Truth) | High agreement (negative predictive value) | N/A | 85.7% (24/28) | 82.1% (23/28) |
Note on Acceptance Criteria: The document primarily focuses on demonstrating "substantial equivalence" rather than explicit, pre-defined numerical acceptance criteria for absolute performance. The implied acceptance criteria are a high level of agreement, sensitivity, and specificity when compared to a legally marketed predicate device (HERPELISA II Test Kit) and a characterized serum panel from the CDC.
2. Sample Size Used for the Test Set and Data Provenance
-
Comparative Study (vs. Predicate Device):
- Sample Size: 154 donors
- Data Provenance: The study was conducted at Gull Laboratories, Inc. The country of origin for the samples is not explicitly stated but is implied to be within the US, given the company's location. The study is prospective in the sense that the new device was evaluated against existing samples, but the samples themselves could be either prospectively collected for this study or retrospectively gathered from a bank. The text "Blood samples from 154 donors were evaluated" suggests a specific collection for this comparison.
-
CDC Serum Panel Study:
- Sample Size: 100 frozen clinical specimens (50 paired sera)
- Data Provenance: The serum panel was obtained from the Centers for Disease Control (CDC). These were "characterized" specimens, indicating their properties were already known. The testing was conducted at three sites in the U.S.: a hospital in the Northeastern region, a clinical laboratory in the Northwestern region, and Gull Laboratories, Inc. This is a retrospective evaluation using a pre-characterized panel. The country of origin for the data is the USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
-
Comparative Study (vs. Predicate Device):
- The ground truth was established by the HERPELISA II Test Kit, which is a legally marketed predicate device. This isn't based on human expert consensus for this specific study, but rather on the established performance of the predicate device.
-
CDC Serum Panel Study:
- The serum panel was "characterized at the CDC using both an enzyme immunoassay (EIA) and an in-house Western Blot method for HSV type specific antibody detection." While not explicitly stated as "experts," the CDC's characterization methods imply the involvement of highly qualified personnel with expertise in virology and serological testing. The number of individuals involved in the CDC's ground truth establishment is not specified.
4. Adjudication Method for the Test Set
-
Comparative Study (vs. Predicate Device): Not applicable. The comparison was directly between the new device and the predicate device. Equivocal results were excluded from calculations, implying a binary (positive/negative) comparison.
-
CDC Serum Panel Study:
- The "ground truth" was already established by the CDC using EIA and Western Blot. The results from the three testing sites were then compared to this pre-established truth.
- For the device's own internal consistency: "All three sites produced the same qualitative results for all but one sample which gave negative results at the hospital... and the clinical laboratory... but equivocal results at Gull Laboratories, Inc." This indicates a comparison across sites, but no formal adjudication process to resolve discrepancies other than noting the difference.
5. 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 in vitro diagnostic (IVD) ELISA test, which is an automated or semi-automated laboratory assay, not an imaging device or AI algorithm requiring human reader interpretation in the same way. Therefore, the concept of "human readers improve with AI vs without AI assistance" does not apply here.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Yes, the performance studies described are essentially standalone evaluations of the device (the HSV 1+2 IgG ELISA Test). While human technicians perform the assay, the "performance" metrics (agreement, sensitivity, specificity) reflect the device's ability to correctly classify samples based on its biochemical reactions, independent of human interpretive influence on the result itself (beyond correct assay execution).
7. The Type of Ground Truth Used
- Comparative Study (vs. Predicate Device): The ground truth was the results from a legally marketed predicate device (HERPELISA II Test Kit). This is a form of "reference standard" from another diagnostic test.
- CDC Serum Panel Study: The ground truth was established by expert-characterized reference methods (EIA and in-house Western Blot) from the CDC. This leans towards a form of "expert consensus/reference method" ground truth.
8. The Sample Size for the Training Set
The document does not mention a training set. This is a characteristic of traditional IVD devices like ELISAs, which are developed based on biochemical principles and validation rather than machine learning algorithms that require explicit training data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set is mentioned for this type of device.
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(172 days)
LGC
The Diamedix Is-HSV 1 & 2 IgG is an indirect Enzyme Immunoassay (EIA) for the qualitative and semi-quantitative determination of IgG antibodies to herpes simplex virus (HSV) type 1 and/ or type 2 in human serum. This test is useful for indicating a past infection with HSV in a single specimen, including females of child-bearing age. The evaluation of acute and convalescent specimens, by demonstrating seroconversion or a significant increase in antibody level, can aid in the diagnosis of primary infection with HSV. These reagents can be used either manually or in conjunction with the MAGO® Plus Automated EIA Processor.
The Is-HSV 1 & 2 IgG Test System is an enzyme-linked immunosorbent assay (ELISA) for the detection and semi-quantitation of IgG to HSV 1 and/or HSV 2 antigens in human serum
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated in a quantitative manner (e.g., "sensitivity must be > X%"). Instead, the study aims to demonstrate "substantial equivalence" to a legally marketed predicate device (Incstar HSV I/II IgG "fast" ELISA Kit). The performance data presented shows the agreement, sensitivity, and specificity of the new device relative to this predicate device across multiple sites. The implicit acceptance criterion is that the new device performs comparably to the predicate.
| Acceptance Criteria (Implied: Substantial Equivalence to Predicate Device) | Reported Device Performance (Relative to Predicate/Other Legally Marketed Devices) |
|---|---|
| Relative Sensitivity (High agreement with positive cases of predicate) | Site 1: 100.0% (97.7-100.0%) |
| Site 2: 99.2% (95.4-100.0%) | |
| Site 3 (manual): 100.0% (98.3-100.0%) | |
| Site 3 (automated): 99.5% (97.4-100.0%) | |
| Relative Specificity (High agreement with negative cases of predicate) | Site 1: 92.7% (80.1-98.5%) |
| Site 2: 94.7% (85.4-98.9%) | |
| Site 3 (manual): 100.0% (93.4-100.0%) | |
| Site 3 (automated): 97.8% (88.5-99.9%) | |
| Overall Agreement | Site 1: 98.5% (95.6-99.7%) |
| Site 2: 97.7% (94.3-99.4%) | |
| Site 3 (manual): 100.0% (98.6-100.0%) | |
| Site 3 (automated): 99.2% (97.2-99.9%) | |
| Precision (Intra-assay CV) | 1.4 to 18.7% for positive samples |
| Precision (Inter-assay CV) | 3.5 to 15.5% for positive samples |
| Linearity (for semi-quantitative aspect) | Demonstrated linear relationship between EU/ml values and log of serum dilution for strongly positive samples. |
| No detectable cross-reactivity | No detectable cross-reactivity to VZV, CMV, EBV, measles, rubella, or Toxoplasma. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: A total of 645 different patient sera were evaluated across 3 test sites.
- Data Provenance: Not explicitly stated regarding country of origin. The study was a "Performance Data" evaluation, implying it was a prospective or retrospective collection of patient sera for the purpose of testing the device. It was tested at "3 different test sites," suggesting real-world clinical samples, but whether they were newly collected (prospective) or previously banked (retrospective) is not specified. The CDC serum panel for HSV serology assays was also tested, which suggests a well-characterized, potentially external, reference set.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication Method for the Test Set
- The text states the Is-HSV 1 & 2 IgG Test System was "evaluated relative to the predicate device and to other legally marketed devices". This implies the predicate device and other legally marketed devices served as the reference standard (ground truth). It is not specified if there was a separate expert adjudication process to establish the ground truth for the 645 patient sera. Equivocal samples were excluded from calculations, but the method for resolving discrepancies or establishing initial truth is not detailed beyond comparison to existing devices.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, a MRMC comparative effectiveness study was not done. This study is focused on an in-vitro diagnostic (IVD) ELISA test, not an imaging device requiring human interpretation, so the concept of "human readers" and "AI assistance" in the traditional sense of an MRMC study does not apply.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Yes, this was a standalone performance study. The device itself is an ELISA test system designed to detect antibodies. Its performance (sensitivity, specificity, agreement) was evaluated directly, both manually and with an automated processor (MAGO Plus), without a human-in-the-loop scenario where a physician interprets the results with or without the device's output. The device is the "algorithm" in this context, providing a direct measurement.
7. The Type of Ground Truth Used
- Comparison to legally marketed devices (predicate and others). The performance of the Is-HSV 1 & 2 IgG Test System was evaluated "relative to the predicate device and to other legally marketed devices." This means the results from these established, cleared tests served as the reference or "ground truth" against which the new device was compared. Additionally, the CDC serum panel for HSV serology assays was used, which represents a highly characterized reference standard.
8. The Sample Size for the Training Set
- Not applicable / Not specified. ELISA assay development does not typically involve a "training set" in the same way machine learning algorithms do. The development involves optimizing reagents, conditions, and cutoff values through laboratory studies, but not a distinct "training set" of patient samples for algorithm learning.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As noted above, the concept of a training set and its ground truth establishment in the machine learning sense does not apply to this type of IVD device development. The performance characteristics of the assay (e.g., linearity, cross-reactivity, precision) would be established through laboratory experiments and optimization during development.
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