Search Results

The OSOM® Mono Test is intended for the qualitative detection of infectious monomucleosis heterophile antibodies in serum, plasma or whole blood as an aid in the diagnosis of infectious mononucleosis.

The OSOM Mono Test uses color immunochromatographic dipstick technology with bovine erythrocyte extract coated on the membrane. In the test procedure, serum, plasma or whole blood is mixed with the Diluent. Then the Test Stick is placed in the mixture migrates along the membrane. If the specific IM heterophile antibody is present in the sample, it will form a complex with the bovine erythrocyte extract conjugated color particles. The complex will then be bound by bovine erythrocyte xtract immobilized on the membrane and a visible blue Test Line will appear to indicate a positive result.

The Sekisui Diagnostics OSOM Mono Test is a qualitative diagnostic device for infectious mononucleosis heterophile antibodies. The 510(k) submission [K181436] focuses on a device modification: replacing the prior capillary tube with the Microsafe capillary pipette for whole blood collection.

Here's an analysis of the acceptance criteria and the study performed:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document provides limited detail on sample sizes for the "Compatibility Study". It states "All patients had negative results." The exact number of patients is not specified.

Data provenance: The document does not explicitly state the country of origin or if the data was retrospective or prospective for the non-clinical tests. Given the nature of a device modification focused on a component change, these tests are typically conducted in-house by the manufacturer.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not provided in the document. The studies described are non-clinical, focusing on the functionality of the new pipette, rather than clinical efficacy studies requiring expert interpretation of results.

4. Adjudication Method for the Test Set

This information is not provided in the document. Given that the studies were non-clinical performance tests of a component, an adjudication method typically used for clinical interpretation of diagnostic results would not be applicable.

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 study described is a non-clinical evaluation of a device component modification. The focus was not on human reader performance with or without AI assistance.

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

This is not applicable. The device, OSOM Mono Test, is an immunochromatographic dipstick test for heterophile antibodies, not an AI algorithm. The studies focused on the physical characteristics and compatibility of a new pipette component.

7. The Type of Ground Truth Used

• Volume Capability Study: The ground truth for this study was the actual dispensed volume measured by a calibrated method, compared against the target range of 50µL and 55µL.
• Compatibility Study: The ground truth for this study was the known negative status of the patient samples, allowing the assessment of whether the new pipette introduced false positive reactions or interfered with negative results.

8. The Sample Size for the Training Set

This is not applicable. The OSOM Mono Test is a rapid diagnostic test based on immunochromatographic principles, not a machine learning algorithm that requires a training set. The "device modification" refers to a physical component (pipette), not an algorithmic change.

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

This is not applicable as there is no training set for this type of device and modification.

Ask a specific question about this device

The ACON® Mononucleosis Rapid Test Strip and the ACON® Mononucleosis Rapid Test Device are rapid chromatographic immunoassays for the qualitative detection of heterophile antibodies to infectious Mononucleosis in whole blood, serum or plasma to aid in the diagnosis of infectious Mononucleosis infection in adults at 18 years of age and older. They are intended for health professionals including professionals at point-of-care sites.

The ACON® Mononucleosis Rapid Test Strip and the ACON® Mononucleosis Rapid Test Device are lateral flow immunochromatographic assays for the qualitative detection of heterophile antibodies associated with infectious Mononucleosis in whole blood, serum or plasma. They utilize purified IM heterophilic antigen-coated particles and IM heterophilic antigen-coated on the membrane to selectively detect elevated levels of heterophile antibodies to infectious Mononucleosis. These tests can be performed without the use of an instrument.

Here's a breakdown of the acceptance criteria and study information for the ACON® Mononucleosis Rapid Test Strip and Test Device, based on the provided text:

Acceptance Criteria and Device Performance

Note: The acceptance criteria are implicitly based on the device demonstrating substantial equivalence to the predicate device (Genzyme OSOM® Mono Test). The performance metrics provided (positive agreement, negative agreement, overall agreement) are directly compared against the predicate device. The confidence intervals are provided for each agreement calculation.

Study Information

1. Sample sizes used for the test set and the data provenance:

   • Total Test Set Sample Size (Clinical Evaluation): 611 clinical specimens (whole blood, serum, and plasma combined).
   • Breakdown by specimen type:
     • Whole Blood: 131 specimens (51 positive, 80 negative)
     • Plasma: 240 specimens (60 positive, 180 negative)
     • Serum: 240 specimens (73 positive, 167 negative)
   • POL Study Sample Size:
     • Plasma: 180 coded, blinded, and randomized specimens
     • Whole Blood: 180 coded, blinded, and randomized specimens
     • Comparison to trained lab technician: 120 specimens (presumably a subset read by both)
   • Data Provenance: The document does not specify the country of origin of the data, nor whether it was retrospective or prospective. It only mentions "clinical specimens."

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • The document does not explicitly state the number of experts or their qualifications used to establish the "ground truth" (or reference standard) for the clinical specimens against which the ACON test and predicate test were compared.
   • For the POL study, the comparison was made against "expected results" and "those obtained by a trained lab technician," implying an expert or reference method defined the true positive/negative status, but details are not provided.

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

   • The document does not describe an adjudication method for reconciling discrepancies in results. The study compared the ACON device directly against the Genzyme OSOM® Mono Test. Discrepancies between the two tests would contribute to the calculated agreement percentages, but no specific adjudication process for these discrepancies is mentioned.

4. 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 was not a multi-reader, multi-case (MRMC) comparative effectiveness study with AI assistance. This study evaluates the performance of a rapid diagnostic test (ACON Mononucleosis Rapid Test) against a predicate rapid diagnostic test (Genzyme OSOM® Mono Test). There is no mention of AI or human readers improving with AI assistance.
   • However, a "POL Study Summary" describes evaluating the device's performance when used by personnel at "three distinct sites" (doctors' offices) and compares their results to "expected results" and "those obtained by a trained lab technician." This segment might be considered a form of multi-reader study, but it's not in the context of AI assistance. The "effect size" of improvement is not quantified, but the study showed 98.9% agreement for plasma and 100% agreement for whole blood by POL users compared to expected results, and 100% agreement compared to a trained lab technician (120/120), indicating high accuracy by non-specialized personnel.

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

   • This is a standalone diagnostic test (a lateral flow immunoassay) intended for human interpretation of colored lines. There is no algorithm involved in the test's result generation or interpretation in the way AI would be. The test itself is the "standalone" diagnostic.

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

   • The "ground truth" for the main accuracy study was effectively the results from the Predicate Device, Genzyme OSOM® Mono Test. This is a common approach for demonstrating substantial equivalence for rapid diagnostic tests.
   • For the POL study, the ground truth was referred to as "expected results" and comparisons were made to "those obtained by a trained lab technician." This implies a reference method or expert-derived result was used to determine the true positive/negative status.

7. The sample size for the training set:

   • The document does not mention a training set. This is a traditional immunoassay device, not a machine learning or AI-based device, so the concept of a "training set" for model development does not apply. The clinical evaluation and POL studies are performance validation studies.

8. How the ground truth for the training set was established:

   • As there is no training set for this type of device, this question is not applicable.

Ask a specific question about this device

biorapid Mononucleosis is a one-step immunoassay for the qualitative detection of infectious mononucleosis heterophile antibodies in whole blood, serum, and plasma samples. The test aids in the diagnosis of infectious mononucleosis.

biorapid Mononucleosis is a one-step immunoassay for the qualitative detection of infectious mononucleosis heterophile antibodies in whole blood, serum, and plasma samples. The test aids in the diagnosis of infectious mononucleosis. biorapid Mononucleosis uses the same methodology (immunochromatography test) as the predicate OSOM Mono Test.

The provided text describes the performance of the biorapid Mononucleosis device. There are no explicit "acceptance criteria" presented as specific numerical thresholds that the device must meet in relation to a given ground truth. Instead, the study compares the device's performance against a legally marketed predicate device (OSOM Mono Test) to demonstrate substantial equivalence.

Here's an breakdown based on the provided information, addressing your points where possible:

1. Table of Acceptance Criteria and Reported Device Performance

As noted, explicit "acceptance criteria" (e.g., "The device must achieve >95% sensitivity") are not stated. The performance is reported relative to the predicate device.

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

• Sample Size: A total of 622 specimens.
  • 296 serum samples
  • 261 plasma samples
  • 65 whole blood samples
• Data Provenance: The document does not explicitly state the country of origin or if the data was retrospective or prospective. It only mentions that the specimens "were evaluated internally and in an external study."

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

This information is not provided. The study uses the OSOM Mono Test (predicate device) as the comparator, implying that the "ground truth" for the performance comparison is the result obtained by the predicate device, not an independent expert consensus or clinical outcome.

4. Adjudication Method for the Test Set

This information is not provided. Given that the comparison is device-to-device rather than device-to-expert ground truth, a formal adjudication method as typically used with human readers is not applicable in the context described.

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 explicitly described in the provided text in the context of human readers improving with or without AI assistance. The study focuses on comparing the new device's performance to a predicate device, not on human reader performance.

6. If a Standalone Study Was Done (Algorithm only without human-in-the-loop performance)

Yes, the performance reported is a standalone evaluation of the biorapid Mononucleosis device compared to the predicate device. The results (positive agreement, negative agreement, overall agreement) reflect the device's intrinsic performance. The reproducibility study also evaluates the device's standalone performance under different user conditions.

7. The Type of Ground Truth Used

The "ground truth" for the primary performance evaluation (agreement study) was the results obtained from the predicate device (OSOM Mono Test). This is a common approach in 510(k) submissions for in vitro diagnostics where substantial equivalence is demonstrated by comparing performance to a legally marketed device.

For the reproducibility study, the "expected results" were used as the ground truth for the three positive and three negative samples. This implies that these samples had a predetermined positive or negative status.

8. The Sample Size for the Training Set

This information is not provided. The document focuses on the performance evaluation of the final device and does not detail any development or training phases. For an immunoassay, the concept of a "training set" in the context of machine learning (AI) is not typically applicable in the same way.

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

This information is not provided, as details about a training set or its ground truth establishment are not mentioned in the context of this immunoassay.

Ask a specific question about this device

Simple color-enhanced slide test for the qualitative and semiquantitative detection of infectious mononucleosis heterophile antibodies in serum or EDTA plasma. The test aids in the diagnosis of infectious mononucleosis.

Simple color-enhanced slide test for the qualitative and semiquantitative detection of infectious mononucleosis heterophile antibodies in serum or EDTA plasma.

This document describes the acceptance criteria and study proving the performance of the Color-Monogen device.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Sizes and Data Provenance

• Test Set Sample Sizes:
  • Sensitivity: 48 samples (presumptively positive for IM heterophile antibodies)
  • Specificity: 200 samples (randomly selected serum patient samples presumptively negative for IM heterophile antibodies)
  • Reproducibility: An in-house IM heterophile antibody calibrator diluted from 1/1 to 1/32, plus Color-Monogen kit controls (negative and positive). The exact number of individual "samples" for reproducibility testing beyond the calibrator dilutions and controls isn't specified, but it was tested by three operators on five consecutive days.
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). The document only mentions "samples" and "serum patient samples."

3. Number of Experts and Qualifications for Ground Truth

• The study design does not indicate the use of experts to establish ground truth for the test set. Instead, it uses a commercially available horse red cell slide test as the reference method for comparison to determine sensitivity and specificity.

4. Adjudication Method

• No adjudication method (e.g., 2+1, 3+1, none) for the test set is described, as the ground truth was established by comparison to a predicate device, not by expert consensus.

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

• A MRMC comparative effectiveness study was not conducted. The study focuses on the device's performance against a predicate device, not on human reader performance with or without AI assistance.
• For reproducibility, three different operators tested the samples for 5 consecutive days, but this was to assess the device's consistency, not to compare human reader performance with or without AI.

6. Standalone Performance Study

• Yes, a standalone performance study was done. The reported sensitivity, specificity, and reproducibility figures represent the Color-Monogen device's performance directly, independent of human interpretation or assistance beyond following the test procedure.

7. Type of Ground Truth Used

• The ground truth for sensitivity and specificity was established by comparing the Color-Monogen device's results to a commercially available horse red cell slide test. For reproducibility, an in-house IM heterophile antibody calibrator and Color-Monogen kit controls served as the reference.

8. Sample Size for the Training Set

• No information is provided about a training set. This device is a diagnostic test kit (direct hemagglutination) and likely does not involve machine learning or an algorithm that requires a separate training set.

9. How Ground Truth for Training Set Was Established

• Not applicable, as no training set is mentioned or implied for this type of device.

Ask a specific question about this device

Acute infectious mononucleoisis is a self-limiting clinical syndrome that most commonly occurs in teenagers and young adults in developed nations. In developing, IM can occur much earlier in life. This assay is intended for use as an aid in the rapid diagnosis of IM.

The Dryspot IM Test is a simple two minute latex agglutination test for the detection of the specific heterophile antibody associated with IM in serum and plasma. The purified specific heterophile antigen from bovine red cell membranes is used to coat latex particles. When a drop of serum or plasma containing the heterophile antibody associated with IM is mixed with a drop of latex, visible agglutination of the latex occurs within 2 minutes. Agglutination will not occur when such an antibody is absent.

The provided document is an FDA 510(k) clearance letter for the DRYSPOT® Infectious Mononucleosis Kit and its Indications for Use. This type of document, particularly for an in vitro diagnostic (IVD) kit like this one, does not typically contain the detailed information necessary to answer all parts of your request about acceptance criteria and a study proving device performance in the context of, for example, an AI medical device.

The information you've requested pertains more to performance evaluation studies for complex medical devices, especially those utilizing AI, which involves measuring diagnostic accuracy against a ground truth established by experts.

However, I can extract what is implicitly present or can be inferred, and clearly state what is missing based on the provided text.

Here's an attempt to answer your questions based only on the provided document:

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

The document does not explicitly state quantitative acceptance criteria or detailed reported device performance in the format you've requested. For IVD devices like this one cleared via 510(k), performance is typically demonstrated against a predicate device and/or clinical samples, but the specific metrics are not in this letter.

The "Indications for Use" section describes the device's mechanism:

• "When a drop of serum or plasma containing the heterophile antibody associated with IM is mixed with a drop of latex, visible agglutination of the latex occurs within 2 minutes." (Positive result)
• "Agglutination will not occur when such an antibody is absent." (Negative result)

Implicit Performance Criteria (Inferential, not explicit in the document):

• Sensitivity: Should be high enough to detect the heterophile antibody when present (i.e., agglutination occurs).
• Specificity: Should be high enough to not show agglutination when the antibody is absent.
• Time to Result: Agglutination should occur within 2 minutes.

Reported Device Performance:
The document does not provide specific performance metrics such as sensitivity, specificity, accuracy, positive predictive value (PPV), or negative predictive value (NPV) for the DRYSPOT® Infectious Mononucleosis Kit. It only describes the mechanism of action.

2. Sample size used for the test set and the data provenance

The document does not mention the sample size used for any test set or the provenance of any data. This information would typically be in a detailed study report submitted with the 510(k), but it is not part of this clearance letter or the "Indications for Use" statement.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not present in the provided text. For an IVD like this, ground truth would typically be established by clinical diagnosis, potentially supported by other laboratory assays, but the specifics of how it was established for the study are not detailed here. The concept of "experts" in the context of adjudicating AI output (e.g., radiologists) is not applicable here as this is a chemical/latex agglutination test, not an image-based AI device.

4. Adjudication method for the test set

This information is not present in the provided text. Adjudication methods like "2+1" or "3+1" are characteristic of studies involving human interpretation (e.g., reading medical images) where multiple readers might disagree, and a tie-breaker or consensus is needed. For a latex agglutination test, the result (agglutination or no agglutination) is generally intended to be objectively observable, though inter-reader variability could still exist but is not typically addressed with a formal adjudication process described in this manner.

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

• No, an MRMC comparative effectiveness study was not done, nor is it applicable. The DRYSPOT® Infectious Mononucleosis Kit is an in vitro diagnostic device that directly detects an antibody in blood samples. It is not an AI-powered device, nor is it designed to assist human readers in interpreting complex data (like medical images). Therefore, the concept of "human readers improving with AI assistance" does not apply to this device.

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

• This question is not applicable. The DRYSPOT® Infectious Mononucleosis Kit is a physical diagnostic test kit, not an algorithm. Its performance is inherent to the chemical and biological interaction designed, not an algorithmic output.

7. The type of ground truth used

The document does not explicitly state the type of ground truth used for performance evaluation. However, given it's an assay for "specific heterophile antibody associated with IM," the ground truth would most likely be established through:

• Clinical diagnosis of Infectious Mononucleosis (IM): Integrating patient symptoms, physical examination findings, and potentially other confirmatory lab tests (e.g., complete blood count with atypical lymphocytes, Epstein-Barr virus (EBV) serology if the etiology is being confirmed).
• Other laboratory assays: More definitive or reference IM tests (e.g., various EBV antibody tests, or established predicate IM tests) could have been used to define true positive/negative samples for the study.

8. The sample size for the training set

The document does not mention any training set or its sample size. This concept is most relevant for machine learning/AI devices, which this IVD kit is not.

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

• Not applicable. As the device is not an AI algorithm, there is no "training set" in the machine learning sense, and thus no ground truth established for such a set.

Ask a specific question about this device

Clearview IM is an immunoassay for the qualitative detection of Infectious Mononucleosis lgM heterophile antibodies in human serum or plasma specimens as an aid in the diagnosis of infectious mononucleosis.

Not Found

The provided text is a 510(k) clearance letter from the FDA for a device called "Clearview™ IM". This document confirms that the device is substantially equivalent to legally marketed predicate devices. However, this letter does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert evaluations.

The letter is a regulatory approval document and not a scientific study report. It states that the device is "an immunoassay for the qualitative detection of Infectious Mononucleosis IgM heterophile antibodies in human serum or plasma specimens as an aid in the diagnosis of infectious mononucleosis."

Therefore, I cannot provide the requested information based on the text provided. To answer your questions, I would need a different type of document, such as a clinical study report, a scientific publication, or the device's 510(k) submission summary which often includes performance data.

Ask a specific question about this device

The MONOCOL/LEX-IM TEST is a rapid color enhanced latex slide agglutination test for the qualitative and semiquantitative detection of heterophile antibodies in serum or plasma associated with infectious mononucleosis and is to be used as an aid in the diagnosis of infectious mononucleosis. This test is "For Professional Use Only".

Not Found

The provided text is an FDA 510(k) clearance letter for the MONOCOL/LEX-IM Test. While it grants market clearance, it does not contain the acceptance criteria or detailed study information required to answer your request.

Specifically, the letter states:

• "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976..."

This indicates that the device was cleared based on substantial equivalence to a predicate device, not necessarily on a de novo study proving it met specific performance criteria detailed in this document. The letter itself is a regulatory approval, not a scientific report of the validation study.

Therefore, I cannot extract the following information from the provided text:

1. A table of acceptance criteria and the reported device performance: This information is not present in the clearance letter.
2. Sample size used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and their qualifications: Not mentioned.
4. Adjudication method for the test set: Not mentioned.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not mentioned. This type of study is more common for imaging AI devices, and the MONOCOL/LEX-IM Test is a latex slide agglutination test.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a diagnostic test, not an AI algorithm.
7. The type of ground truth used: Not mentioned.
8. The sample size for the training set: Not applicable, as this is a chemistry/immunology test, not an AI model.
9. How the ground truth for the training set was established: Not applicable.

To obtain this information, you would need to access the full 510(k) submission document for K972457, which often contains the clinical and analytical validation studies performed by the manufacturer. The clearance letter only confirms that the FDA reviewed these materials and found the device substantially equivalent.

Ask a specific question about this device

The OSOM™ Mono Test is intended for the qualitative determination of infectious mononucleosis heterophile antibodies in serum, plasma or whole blood as an aids in the diagnosis of infectious mononucleosis .

OSOM Mono Test uses color immunochromatographic technology with bovine erythrocyte extract coated on the membrane. If the specific IM heterophile antibody is present in the sample, a visible blue test line will appear to indicate a positive result.

The provided text is a 510(k) summary for the OSOM™ Mono Test, an in vitro diagnostic device. It does not contain the detailed study information or acceptance criteria requested in the prompt.

Specifically, the document focuses on:

• Device Identification: Proprietary name, common name, classification.
• Intended Use: Qualitative determination of infectious mononucleosis heterophile antibodies.
• Description: Color immunochromatographic technology.
• Substantial Equivalence Claim: Comparing it to two predicate devices (Meridian's MonoSpot Latex Test and Pacific Biotech's CARDS OS Mono Test) based on similar intended use and technology.
• Regulatory Communication: An FDA letter granting substantial equivalence.

Therefore, I cannot provide a table of acceptance criteria, reported device performance, sample sizes, ground truth information, or details about MRMC or standalone studies because this information is not present in the provided text.

The document implies that the device meets criteria for substantial equivalence to predicates, but it does not specify what those criteria are or present the data from a study to demonstrate performance against such criteria. The letter from the FDA confirms that the device is substantially equivalent to legally marketed predicate devices, which means its performance is considered comparable enough, but the specific data supporting that comparison is not in this extract.

Ask a specific question about this device

The qualitative detection of human IgM antibodies to heterophile antigen in serum, plasma or whole blood as an aid in the diagnosis of acute infectious mononucleosis for use in the physician's office laboratory and the clinical laboratory.

Rapid membrane based immunoassay for the qualitative detection of human IgM antibodies to heterophile antigen using mouse monoclonal anti-IgM antibodies and heterophile antigen from bovine red blood cells.

Here's an analysis of the provided text regarding the Genzyme Diagnostics Contrast® Mono test, structured according to your request:

1. Acceptance Criteria and Reported Device Performance

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

• Sample Size: 480 specimens (serum, plasma, and whole blood)
• Data Provenance: Retrospective (specimens submitted for infectious mononucleosis testing) and prospective (students presenting with symptoms) from a multicenter clinical study. The study was conducted in three physician's office laboratories (POLs), including two university student health centers and one clinical laboratory. The country of origin is not explicitly stated.

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

The text states that the Genzyme device was compared to the "reference method" and the legally marketed "Quidel Concise® Plus™ Mono Test." The predicate device likely served as the de facto "ground truth" or a strong proxy for it. There is no information provided about the number of experts or their qualifications used to establish this reference method or to adjudicate the results of the Quidel test itself for the purpose of this study.

4. Adjudication Method for the Test Set

The document does not describe an explicit adjudication method (e.g., 2+1, 3+1). The "reference method" or the predicate device's results were used for comparison. It's implied that the results of these reference methods were taken as authoritative.

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 reported. The study focused on the agreement of the novel device with a predicate device, not on how human readers' performance improved with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, this was a standalone performance study. The Genzyme Diagnostics Contrast® Mono Test is a rapid immunoassay kit. Its performance was evaluated by comparing its direct results to those of a reference method/predicate device. There is no "human-in-the-loop" aspect to the device's output itself.

7. The Type of Ground Truth Used

The ground truth was established by comparing the test device's results to a legally marketed predicate device (Quidel Concise® Plus™ Mono Test) and a "reference method." While the nature of the "reference method" isn't explicitly detailed, in the context of IVD devices like this, it typically refers to a well-established and accepted diagnostic procedure for the disease.

8. The Sample Size for the Training Set

This information is not provided. The document describes a clinical study to evaluate the device's performance, but it does not detail any separate training set or process for developing the immunoassay itself.

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

This information is not provided, as details about a specific "training set" for the device's development are absent from the document. The immunoassay itself would have been developed based on scientific principles and internal validation, but the documentation focuses on the external clinical validation study.

Ask a specific question about this device

Ask a specific question about this device