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The RUBELLACOL™ TEST is to be used as an aid in the detection of anti-rubella virus antibodies in serum. This test is "For Professional Use Only".

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This document is a 510(k) clearance letter from the FDA for a device called "RUBELLACOL™ Test". It does not contain the information requested regarding acceptance criteria or a study proving device performance on several specific points.

Here's a breakdown of why the requested information cannot be extracted from this document:

• This is a regulatory clearance letter, not a scientific study report. It confirms that the device is "substantially equivalent" to a legally marketed predicate device, allowing it to be marketed. It does not detail the specific performance studies conducted for this equivalence determination.
• The letter refers to a "510(k) premarket notification" which would contain the study details, but that notification document itself is not provided.

Therefore, I cannot provide the requested table or answer most of the specific questions.

However, based on the context of what a 510(k) submission typically entails, I can infer some general information about the type of study that would have been done for a device like this, but this is inferential and not directly stated in the provided text.

Inference about a typical study for a device like this:

For an in vitro diagnostic device like the RUBELLACOL™ Test (a serological reagent for rubella virus antibodies), the acceptance criteria would typically revolve around its agreement with a reference standard, often another legally marketed and validated rubella antibody test. The study would generally assess sensitivity and specificity.

• Test Set Data & Ground Truth: The test set would consist of patient samples (serum) with known rubella antibody status. The ground truth would likely be established using a highly sensitive and specific reference method (e.g., another FDA-cleared rubella ELISA, or potentially a hemagglutination inhibition assay (HAI) if it was the established gold standard at the time).
• Sample Size: The sample size would be chosen to demonstrate statistically significant agreement with the reference method across relevant populations (e.g., pregnant women, those at risk of infection). While not specified, it's typically in the hundreds to low thousands for such assays.
• Adjudication: For serological tests, "adjudication" in the sense of multiple human readers for a single case is usually not applicable. The result is typically an objective measurement (e.g., optical density value) interpreted against a cutoff. Any discrepancies with the reference method would be investigated, perhaps by re-testing.
• No AI Involvement: This device, cleared in 2003, is a laboratory diagnostic kit, not an AI-powered diagnostic. Therefore, there would be no discussion of AI assistance, MRMC studies, or standalone algorithm performance.
• Training Set: While the term "training set" is more common with machine learning, for a traditional IVD, the development and optimization of the assay (e.g., antibody concentrations, incubation times, cutoff values) would be based on internal studies using well-characterized samples. The ground truth for this internal development would be established similarly to the test set, using reference methods.

Specific answers based only on the provided text:

1. A table of acceptance criteria and the reported device performance: Not provided. The document is a clearance letter, not a performance study report.
2. Sample size used for the test set and the data provenance: Not provided. This information would be in the 510(k) submission itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/Not provided. For a serological test, ground truth is typically established by laboratory methods, not by expert consensus on primary data like images.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable/Not provided. This method is typically used for subjective interpretations (e.g., pathology slide reading, radiology image interpretation), not for objective laboratory assays.
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. This device is an in vitro diagnostic test, not an AI-powered image analysis or decision support system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No. This device is a manual or semi-automated laboratory assay, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not explicitly provided. However, for a serological test for antibodies, the ground truth would typically be established by a reference serological method (e.g., another validated rubella antibody test) or sometimes confirmation by culture/PCR in acute cases, though for antibody detection, the reference assay is most common.
8. The sample size for the training set: Not provided.
9. How the ground truth for the training set was established: Not provided. (See inference above for a typical approach).

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The Copalis™ TORC Total Antibody Assay uses Coupled Particle Light Scattering (Copalis™) technology in a microparticle agglutinationbased immunoassay for the qualitative detection of total antibodies (IgG and IgM) to Toxoplasma gondii, rubella and cytomegalovirus (CMV) in human serum using the CopalisTM One Immunoassay System. The presence of antibodies is indicative of current or prior infection with the suspected organism. The results of this assay on a single serum specimen are used to determine the patient's immune status for rubella and to determine the patient's immunological experience for Toxoplasma gondii and CMV. When evaluating properly paired sera, the results of this assay are used to demonstrate seroconversion as evidence of recent infection. Both specimens should be tested simultaneously (see Interpretation of Results). This assay has not been FDA cleared or approved for the screening of blood or plasma donors.

The Copalis TORC Total Antibody Assay is based on the principle of antibodydependent particle aggregation as detected by measurement of changes in light scattering. Due to the unique measuring system, a sample can be tested for antibodies to Toxoplasma gondii, rubella and CMV using a single reagent and obtain results for the individual antibodies. Sized latex microparticles coated with inactivated Toxoplasma gondii, rubella and CMV antigens aggregate in the presence of antibodies to these infectious agents. After 10 minutes of agitation, the levels of aggregation are determined by discrimination of particle sizes and measurement of the number of reacted and unreacted particles as they flow past a detector. Reactivity is assessed by the level of aggregation per particle size relative to a cutoff value. The Copalis TORC Total Antibody Assay detects the presence of both IgM and IgG antibodies. Two levels of controls are used to monitor proficiency.

Here's an analysis of the acceptance criteria and the study proving device performance, based on the provided text for the Copalis™ TORC Total Antibody Assay:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as distinct numerical targets in the provided text. However, the "Performance Data" section outlines the evaluated metrics and their results, which implicitly serve as the achieved performance benchmarks.

Detailed Study Information:

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

   • Clinical Sample Testing: A total of 250 serum samples were tested.
   • POL Proficiency Study: A 14-member blinded proficiency panel was used. Each panel member was tested in triplicate (across three runs) by multiple operators.
   • Data Provenance: The clinical sample testing was conducted at Sienna Biotech laboratory. The POL Proficiency Study was conducted at 3 POL sites. The text does not specify the country of origin but implies a US context given the FDA submission. Both studies appear to be prospective as they were conducted to evaluate the performance of the new device.

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

   • Clinical Sample Testing: The ground truth for this study was established by comparing the Copalis TORC Total Antibody Assay to the corresponding Abbott IMx assays. These predicate devices are established assays, implying their results serve as the reference standard. The text does not specify the number or qualifications of experts involved in running the Abbott IMx assays or in interpreting their results for ground truth determination.
   • POL Proficiency Study: The "expected" results for the 14-member blinded proficiency panel were established by in-house testing on a comparator assay. Similar to the clinical sample testing, the text does not detail the number or qualifications of experts involved in establishing these "expected" results.

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

   • The provided text does not describe an explicit adjudication method for resolving discordant results in either the clinical sample testing or the POL proficiency study. The ground truth was primarily established by comparator assays.

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 document describes an immunoassay device, not an AI-powered diagnostic system. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable to this device. The POL study did involve multiple operators (human users) to assess reproducibility and proficiency, but it was not framed as an AI-assist study.

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

   • The Copalis TORC Total Antibody Assay is a laboratory-based immunoassay system, not an algorithm that operates independently. Its performance data (sensitivity, specificity, reproducibility) are inherently "standalone" in the sense that they represent the device's analytical performance on samples, rather than human interpretation of device output. The "human-in-the-loop" aspect comes from laboratory personnel operating the system, not interpreting images or complex data in a way that AI would assist.

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

   • The ground truth for both the clinical sample testing and the POL proficiency study was established by results from comparator assays (Abbott IMx assays for clinical, and an unspecified "comparator assay" for the POL study's "expected" results). This falls under the category of reference standard testing using established diagnostic methods.

7. The sample size for the training set:

   • The provided document does not mention a training set. This is expected as the Copalis TORC Total Antibody Assay is an immunoassay, not a machine learning model that requires explicit training data. Its development would involve chemical and biological optimization, not algorithmic training.

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

   • Since there is no mention of a training set or machine learning components, the concept of establishing ground truth for a training set is not applicable to this device.

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The Copalis™ TORC, Toxo, Rubella, and CMV Total Antibody Assays use Coupled Particle Light Scattering (Copalis) technology in microparticle agglutination-based immunoassays for the qualitative detection of total antibodies (IgG and IgM) to Toxoplasma gondii, rubella and/or cytomegalovirus (CMV) in human serum using the Copalis™ I Immunoassay System. The presence of antibodies is indicative of current or prior infection with the suspected organism. The results of these assays on a single serum specimen are used to determine the patient's immune status for rubella and to determine the patient's immunological experience for Toxoplasma gondii and CMV. When evaluating properly paired sera, the results of these assays are used to demonstrate seroconversion as evidence of recent infection. Both specimens should be tested simultaneously (see Interpretation of Results).

These assays has not been FDA cleared or approved for the screening of blood or plasma donors.

The assay will also be offered as separate microparticle immunoassays for the qualitative detection of total antibodies (IgG and IgM) to Toxoplasma gondii, rubella and cytomegalovirus (CMV) in human serum using the Copalis™ One Immunoassay System. The intended use of the individual assays will be specific to the individual antibodies detected but, other than that, will remain the same as the combination assay.

Coupled Particle Light Scattering (Copalis) technology provides a rapid method for the measurement of antibodies to specific viral or protozoal pathogens.

The Copalis™ TORC, Toxo, Rubella, and CMV Total Antibody Assays are based on the principle of antibody-dependent particle aggregation as detected by measurement of changes in light scattering. Due to the unique measuring system, a sample can be tested for antibodies to Toxoplasma gondii, rubella and CMV using a single TORC reagent and obtain results for the individual antibodies. Sized latex microparticles coated with inactivated Toxoplasma gondii, rubella and CMV antigens aggregate in the presence of antibodies to these infectious agents. After 10 minutes of agitation, the levels of aggregation are determined by discrimination of particle sizes (for the TORC assay) and measurement of the number of reacted and unreacted particles as they flow past a detector. Reactivity is assessed by the level of aggregation per particle size relative to a cutoff value. The Copalis TORC and individual Total Antibody Assays detect the presence of both IgM and IgG antibodies. Two levels of controls are used to monitor system performance.

Here's a breakdown of the acceptance criteria and study information for the Copalis TORC Total Antibody Assay, based on the provided text:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the results presented in the clinical trials, specifically the "Relative Sensitivity" and "Relative Specificity" (which are effectively measures of accuracy against comparator devices). The reproducibility data also indicates levels of acceptable variation.

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

• Test Set Sample Size: A total of 769 serum samples were tested.
• Data Provenance: The samples were collected as part of clinical trials conducted at 3 sites (2 clinical laboratories and Sienna Biotech laboratory). The text states "20% of which were fresh samples," implying the remaining 80% were retrospective or banked samples. The country of origin is not explicitly stated, but given "Sienna Biotech, Inc." in Columbia, MD, it is likely the US. The nature of the samples being "patient specimens" suggests they were from individual patients.

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

The ground truth was established by comparison to predicate devices: the BioWhittaker ToxoStat, Becton Dickinson And Co. Rubascan, and CMVscan assays. Therefore, the "experts" were the established predicate assays themselves, which are assumed to have undergone prior rigorous validation. The qualifications of a human expert are not relevant here, as the comparison is device-to-device.

4. Adjudication Method for the Test Set

The adjudication method is described as "Agreement Following Resolution of Discordants." This indicates that samples where the Copalis assay results disagreed with the predicate assay results were further investigated or adjudicated to determine the true status, likely using a "tie-breaker" or a more definitive method. The exact method of resolution is not detailed (e.g., if a third, more definitive test was used, or if human review was involved).

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. This study is an in vitro diagnostic (IVD) device, and its performance is evaluated objectively against established methods (predicate devices) on biological samples. There is no human reader "improving with AI vs. without AI assistance" in this context.

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

Yes, the performance reported is inherently standalone. The Copalis™ Immunoassay System is described as using "Coupled Particle Light Scattering (Copalis) technology" and "measurement of changes in light scattering" to detect aggregation and discrimination of particle sizes. The results are "assessed by the level of aggregation per particle size relative to a cutoff value." This indicates an automated system producing qualitative (positive/negative) results directly, without human interpretation of raw data for diagnosis.

7. The Type of Ground Truth Used

The primary type of ground truth used was the results from established, commercially available predicate devices (BioWhittaker ToxoStat, Becton Dickinson And Co. Rubascan, CMVscan assays). For the CDC serum panels, the ground truth was the known, characterized status of the samples as determined by the CDC. For reproducibility and reference standard testing, the ground truth was related to expected values and consistency, rather than a diagnostic 'truth' for patient samples.

8. The Sample Size for the Training Set

The text does not provide information on a specific training set size. As an immunoassay system, it likely relies on a pre-defined algorithm and cutoff values established during previous assay development and validation, rather than a "training set" in the machine learning sense. The clinical trials described here are for validation and performance assessment rather than training.

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

Since there is no explicit mention of a "training set" in the context of machine learning, the question of how its ground truth was established is not directly applicable. For a traditional immunoassay, the "training" (or development) phase involves establishing optimal reagent concentrations, reaction conditions, and cutoff values using a characterized set of positive and negative samples, which would have their true status determined by well-established diagnostic methods (e.g., other validated assays, clinical diagnosis, or a combination).

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The Murex Rub-ex test is a rapid latex agglutination test for the qualitative and semi-quantitative determination of rubella antibodies in serum.

The Murex Rub-ex test is a rapid latex agglutination test for the qualitative and semi-quantitative determination of rubella antibodies in serum. The rubella virus used to sensitize the Latex Reagent is inactivated and disrupted before use. Sera used in the preparation of controls are tested with FDA approved tests for hepatitis B virus surface antigen (Hosag) and antibodies to HIV and hepatitis C virus (HCV). Only units that are non-reactive for Hbsag and antibodies to HIV and HCV are selected.

This 510(k) summary for the Murex Rub-ex Test provides very limited information regarding detailed performance studies for establishing acceptance criteria. Based on the provided text, it's clear that the device is a rapid latex agglutination test for rubella antibodies, and its safety and effectiveness are primarily supported by comparative studies with other existing, presumably FDA-approved, rubella tests.

Here's an attempt to extract and infer information based on the given text, acknowledging significant limitations due to the brevity of the summary:

1. Table of Acceptance Criteria and Reported Device Performance

Unfortunately, the summary does not explicitly state specific acceptance criteria (e.g., sensitivity, specificity, agreement percentages) or precise quantitative performance metrics for the Murex Rub-ex test itself. Instead, it refers to "equivalent performance" in comparative studies.

Inferred Acceptance Criteria (based on comparison to existing devices):
For the Murex Rub-ex Test to be considered safe and effective, it must demonstrate comparable performance to established, FDA-approved rubella antibody tests (specifically mentioned: Rubascan by Becton Dickinson and Rubalex by Orion Diagnostics). This likely implies that its diagnostic accuracy (sensitivity, specificity, positive predictive value, negative predictive value) should be within a pre-defined, clinically acceptable margin of these predicate devices. The summary does not quantify this margin.

Reported Device Performance:
The summary states: "The Murex Rub-ex test showed an equivalent performance in comparative studies with test kits distributed by Becton Dickinson and Orion Diagnostics." It further asserts: "Any differences between the Murex Rub-ex test and either Rubascan or Rubalex do not compromise the safety and efficacy of the product nor do they represent a potential unreasonable risk of illness or injury."

Without specific numbers, we cannot populate a detailed table.

2. Sample Size for the Test Set and Data Provenance

• Sample Size: The summary does not specify the sample size used for the comparative studies.
• Data Provenance: The summary does not specify the country of origin of the data or whether the studies were retrospective or prospective. It just mentions "comparative studies."

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

The summary describes a laboratory test, not an imaging or interpretive device requiring expert human readers to establish ground truth from patient data. The "ground truth" for evaluating this type of diagnostic test would typically be established by concordance with a reference method or a combination of methods, not by expert interpretation of the test's output. Therefore, information on "number of experts" or their qualifications is not applicable in the traditional sense for this type of device.

4. Adjudication Method for the Test Set

Since the device performs a biochemical assay resulting in a qualitative or semi-quantitative result, and not an interpretive task requiring human review, an "adjudication method" as typically described for AI/CAD systems (e.g., 2+1, 3+1) is not applicable. The results would likely be determined by the assay readout. Discrepancies between the Murex test and predicate devices would be analyzed for agreement and clinical significance, but not "adjudicated" by experts in the same way.

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

• No, a MRMC study was not done. MRMC studies are typically performed for interpretive tasks (like reading medical images) to assess how human performance changes with or without AI assistance. This device is a diagnostic assay, not an AI-assisted diagnostic tool for human readers.

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

• Yes, in essence, this is a standalone device. The Murex Rub-ex test performs its function (detecting and semi-quantifying rubella antibodies) as an algorithm/assay without human interpretive input in the direct act of determining the result. A technician would perform the test and read the result, but the diagnostic output itself is generated by the chemical reaction and agglutination, not a human interpretation of raw data. The "performance" being evaluated is of the assay itself.

7. The Type of Ground Truth Used

Given this is a diagnostic assay, the ground truth would most likely be established by:

• Concordance with a "reference standard" method: This could be an independently validated, highly accurate laboratory test for rubella antibodies, potentially a more complex or time-consuming method.
• Agreement with predicate devices: The summary explicitly states comparisons with Rubascan and Rubalex, implying these predicate devices served as a de-facto "ground truth" or at least a benchmark for "equivalent performance."
• Clinical serology panels: Use of well-characterized serum samples from individuals with known rubella infection status (e.g., confirmed recent infection, past infection, unvaccinated, immune) would be a more robust form of ground truth, though not explicitly mentioned.

The summary points primarily to comparison with other existing diagnostic tests as the basis for establishing "equivalent performance," which implies those tests served as the practical ground truth for the comparison.

8. The Sample Size for the Training Set

• Not applicable / Information not provided. This device is a latex agglutination assay, not a machine learning or AI-driven algorithm that requires a "training set" in the computational sense. The "training" of such a device is in its chemical formulation and manufacturing process.

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

• Not applicable / Information not provided. As this is not an AI/ML device, the concept of a "training set" and establishing ground truth for it is irrelevant. The "performance" of the assay is inherent in its design and validated through testing.

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