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The MESACUP TEST PR-3 is a semi-quantitative, enzyme-linked immunosorbent assay (ELISA) for the detection of IgG anti-proteinase III (PR-3) antibodies in human serum. The MESACUP TEST PR-3 is intended for in vitro diagnostic use as an aid in the diagnosis of certain systemic vasculitides such as Wegener's granulomatosis.

The MESACUP Test PR-3 is an enzyme-linked immunosorbent assay (ELISA), utilizing the 96-microwell plate format, similar to the predicate device. Diluted serum samples, calibrator sera, and controls are incubated in microwells coated with proteinase III antigen. Incubation allows the anti-PR-3 antibodies present in the samples to react with the immobilized antigen. After the removal of unbound serum proteins by washing, antibodies specific for human IgG immunoglobulins, labeled with horseradish peroxidase (HRP), are added forming complexes with the PR-3 bound antibodies. Following another washing step, The bound enzyme-antibody conjugate is assayed by the addition of a single solution containing tetramethylbenzidine (TMB) and hydrogen peroxide (H2O2) as the chromogenic substrate, The intensity of the color generated is proportional to the serum concentration of anti-PR-3 antibodies, Optical density is read spectrophotometrically at 450mm. The total incubation time (at room temperature) of the assay is 150 minutes. The assay makes use of two calibrators to measure the amount of anti-PR-3 antibody in patient samples.

The provided text describes the MESACUP Test PR-3, an ELISA device for detecting IgG anti-proteinase III (PR-3) antibodies. The information focuses on its substantial equivalence to a predicate device and its intended use, rather than explicit acceptance criteria with pre-defined thresholds. However, we can infer performance metrics and the study details based on the provided summary.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Since explicit numerical acceptance criteria (e.g., "Sensitivity must be >= 90%") are not stated, we can infer the implicit acceptance criterion was "performance equivalent to the predicate device."

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

• Test Set Sample Size: Not explicitly stated. The document mentions "a healthy donor serum population" and "a vasculitis population," but no numbers are provided for either group.
• Data Provenance: "In-house studies." The country of origin is not specified, but the applicant's address is in Des Plaines, IL, USA. The studies are retrospective as they are testing existing samples to determine performance characteristics.

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

• Number of Experts: Not mentioned.
• Qualifications of Experts: Not mentioned. The ground truth appears to be based on the clinical diagnosis (healthy vs. vasculitis) and other diagnostic methods (IIF ANCA positive results, cANCA positive IIF patterns), but who made these determinations is not specified.

4. Adjudication Method for the Test Set

• No adjudication method is mentioned for establishing the ground truth. The text implies a pre-existing classification of samples (e.g., "healthy donor serum population," "vasculitis population," "IIF ANCA positive results," "cANCA positive IIF patterns").

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 device is an In Vitro Diagnostic (IVD) assay, not an AI-powered diagnostic imaging device that involves human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not performed.

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

• Yes, this is an ELISA (Enzyme-Linked Immunosorbent Assay), which is a standalone laboratory test. Its performance is measured directly without human interpretation of its output in the same way an imaging algorithm's output would be interpreted. The "algorithm" here refers to the biochemical process of the assay itself, and its result (optical density) is read spectrophotometrically.

7. The Type of Ground Truth Used

• The ground truth appears to be a combination of:
  • Clinical diagnosis: Healthy individuals vs. patients with vasculitis (specifically Wegener's granulomatosis).
  • Reference laboratory tests: Immunofluorescence (IIF) ANCA positive results and cANCA positive IIF patterns.

8. The Sample Size for the Training Set

• The document does not explicitly mention a "training set." This type of IVD typically undergoes development and optimization, but the term "training set" is more commonly associated with machine learning algorithms. The performance data presented is likely from a validation or test set.

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

• As no "training set" is explicitly mentioned for this IVD, the method for establishing its ground truth is not detailed. For typical IVD development, calibration and controls are used, and the assay design itself is based on known biochemical interactions.

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The MESACUP TEST MPO is a semi-quantitative enzyme-linked immunosorbent assay (ELISA) for the detection of IgG anti-myeloperoxidase (MPO) antibodies in human serum. The MESACUP TEST MPO is intended for in vitro diagnostic use as an aid in the diagnosis of certain systemic vasculitides such as microscopic polyarteritis and crescentic glomerulonephritis.

The MESACUP Test MPO is an enzyme-linked immunosorbent assay (ELISA), utilizing the 96-microwell plate format, similar to the predicate device. Diluted serum samples, calibrator sera, and controls are incubated in microwells coated with myeloperoxidase antigen. Incubation allows the anti-MPO antibodies present in the samples to react with the immobilized antigen. After the removal of unbound serum proteins by washing, antibodies specific for human IgG immunoglobulins, labeled with horseradish peroxidase (HRP), are added forming complexes with the MPO bound antibodies. Following another washing step, the bound enzyme-antibody conjugate is assayed by the addition of a single solution containing tetramethlybenzidine (TMB) and hydrogen peroxide (H2O2) as the chromogenic substrate. The intensity of the color generated is proportional to the serum concentration of anti-MPO antibodies. Optical density is read spectrophotometrically at 450nm. The total incubation time (at room temperature) of the assay is 150 minutes. The assay makes use of two callbrators to measure the amount of anti-MPO antibody in patient samples.

Acceptance Criteria and Device Performance Study

The MESACUP Test MPO is an enzyme-linked immunosorbent assay (ELISA) designed for the semi-quantitative detection of IgG anti-MPO antibodies in human serum to aid in the diagnosis of certain systemic vasculitides. The device's performance was compared to a legally marketed predicate device, the Bindazyme Human Anti MPO Enzyme Immunoassay Kit (K981030).

1. Table of Acceptance Criteria and Reported Device Performance

The public summary does not explicitly state pre-defined acceptance criteria with numerical targets. Instead, it focuses on demonstrating equivalence to the predicate device. The primary performance metrics reported are clinical specificity and sensitivity.

Note: The acceptance criteria are "implied" based on the phrasing "Performance indicates that MESACUP Test MPO and the Bindazyme Human Anti MPO Enzyme Immunoassay are equivalent" and the direct comparison of performance metrics.

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

• Test Set Sample Size:
  • Healthy Donor Serum Population: The specific number is not provided, but the document mentions "a healthy donor serum population."
  • Vasculitis Population: The specific number is not provided, but the document mentions "a vasculitis population."
• Data Provenance: The studies were described as "In-house studies." This typically suggests that the studies were conducted by the manufacturer or a contracted research organization. There is no information regarding the country of origin or whether the data was retrospective or prospective.

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

This type of information is generally not applicable to an ELISA device performance study for antibody detection. The "ground truth" for ELISAs is typically established by the clinical diagnosis of the patient from whom the serum sample was taken (e.g., diagnosed with a vasculitis, or considered healthy). The diagnostic status of the patients (e.g., healthy vs. vasculitis) would have been determined by medical professionals (e.g., physicians, specialists) involved in their care, but these individuals are not functioning as "experts" establishing a ground truth for the device's output in the way a radiologist would interpret an image.

4. Adjudication Method for the Test Set

Adjudication methods (e.g., 2+1, 3+1) are typically used in studies involving subjective interpretations, such as image analysis, where multiple readers provide their opinion and discrepancies need to be resolved. This is not applicable to an objective laboratory test like an ELISA, where the result is a numerical optical density reading that is then interpreted against cutoff values.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. MRMC studies are relevant for diagnostic devices that involve human interpretation of results (e.g., imaging devices) to assess reader performance with and without AI assistance. This document describes an in vitro diagnostic (IVD) device that yields a quantitative result, not one where human readers perform a diagnostic interpretation based on the device's direct output in a way that could be "assisted" by AI.

6. Standalone (Algorithm Only) Performance

Yes, the study primarily describes the standalone performance of the MESACUP Test MPO. As an ELISA kit, it is effectively an "algorithm only" device in a laboratory setting, producing a result based on chemical reactions and optical density measurements, without requiring human "in-the-loop" interpretation beyond performing the assay and reading the result. The performance metrics (sensitivity, specificity, relative agreement) directly reflect this standalone performance.

7. Type of Ground Truth Used

The ground truth for the test samples was based on the clinical status of the patients:

• "Healthy donor serum population": These samples represent individuals without the target condition, providing the ground truth for specificity.
• "Vasculitis population": These samples presumably represent individuals clinically diagnosed with vasculitis, providing the ground truth for sensitivity.

Therefore, the ground truth is based on clinical diagnosis/patient case status, not pathology reports (though pathology may contribute to clinical diagnosis) or expert consensus on the device's output.

8. Sample Size for the Training Set

The document does not provide information on a specific "training set" or its sample size. For an ELISA device, the development process typically involves optimizing reagents and protocols, and establishing cutoff values, rather than training an algorithm in the way machine learning models are trained. The samples mentioned (healthy donor and vasculitis populations) are used for "in-house studies" to assess performance and likely to establish or validate cutoff values, which could be considered part of the development/validation process.

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

As noted above, the concept of a "training set" in the context of an ELISA kit is different from that of an AI algorithm. If the "in-house studies" that defined the cutoff values are considered part of a "training" or optimization phase, the ground truth would have been established by the clinical status of the patients (healthy vs. vasculitis diagnosis), similar to the test set. However, the document does not explicitly detail a separate training phase with distinct ground truth methods.

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The MESACUP-2 Test CENP-B is a semi-quantitative enzyme-linked immunosorbent assay (ELISA) for the detection of anti-CENP-B antibodies in human serum. The MESACUP-2 Test CENP-B is intended for in vitro diagnostic use as an aid in the diagnosis of CREST syndrome and related connective tissue diseases.

The MESACUP-2 Test CENP-B is an enzyme-linked immunosorbent assay (ELISA), utilizing the 96microwell plate format, similar to the predicate device. Diluted serum samples, calibrator sera, and controls are incubated in microwells coated with CENP-B antigen. Incubation allows the anti-CENP-B antibodies present in the samples to react with the immobilized antigen. After the removal of unbound serum proteins by washing, antibodies specific for human immunoglobulins (IgG, IgM and IgA), labeled with horseradish peroxidase (HRP), are added forming complexes with the CENP-B bound antibodies. Following another washing step, the bound enzyme-antibody conjugate is assayed by the addition of a single solution containing tetramethlybenzidine (TMB) and hydrogen peroxide (H2O2) as the chromogenic substrate. The intensity of the color generated is proportional to the serum concentration of anti-Jo-1 antibodies. Optical density is read spectrophotometrically at 450nm. The total incubation time (at room temperature) of the assay is 150 minutes. The assay makes use of two calibrators to measure the amount of anti-CENP-B antibody in patient samples.

The MESACUP-2 Test CENP-B is an in vitro diagnostic device intended to detect anti-CENP-B antibodies in human serum.

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

1. Acceptance Criteria and Reported Device Performance

Note: The document implies that the performance of the MESACUP-2 Test CENP-B is considered equivalent to the predicate device, thereby meeting the acceptance criteria for market clearance. The specific numerical thresholds for "acceptance" beyond establishing equivalence are not explicitly stated as strict cut-offs, but rather demonstrated through comparable performance.

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

The document states that in-house studies were conducted.

• Healthy Donor Population: The sample size for healthy donors is not specified.
• CREST Syndrome Population: The sample size for the CREST Syndrome population is not specified.
• Data Provenance: The studies were "in-house," suggesting the data was collected and analyzed by the manufacturer. The country of origin is not specified, but the submission is to the U.S. FDA, implying relevance to a U.S. context. The studies appear to be retrospective as they are described as "in-house studies" and "additional studies" rather than a prospective clinical trial.

3. Number of Experts and Qualifications for Ground Truth

The document does not provide information on the number of experts used or their qualifications for establishing the ground truth for the test sets.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method used for the test set.

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

No MRMC comparative effectiveness study was mentioned. The device is an ELISA assay; therefore, a human-in-the-loop scenario, as typically seen in image interpretation or diagnostic aid, does not apply in the same way. The comparison is between two analytical methods (the MESACUP-2 Test and the predicate device).

6. Standalone Performance Study

Yes, a standalone performance study was conducted. The "in-house studies" and "additional studies" of the MESACUP-2 Test CENP-B's specificity and sensitivity directly report the algorithm's (or device's) performance without human intervention in the interpretation of the output. The MESACUP-2 Test CENP-B is a laboratory assay that produces a quantitative result (optical density) which is then interpreted against established cut-offs by the device's design, not by a human reader's subjective assessment.

7. Type of Ground Truth Used

• For Specificity (Healthy Donor Population): The ground truth was based on a "healthy donor serum population," implying that these individuals were confirmed not to have anti-CENP-B antibodies or the associated conditions.
• For Sensitivity (CREST Syndrome Population): The ground truth was established using a "CREST Syndrome population on both assay respectively for anti-CENP-B antibodies previously also found positive by double immunodiffusion (DID)." This indicates that Double Immunodiffusion (DID) was used as the reference standard (ground truth) to independently confirm the presence of anti-CENP-B antibodies in the CREST Syndrome patients.

8. Sample Size for the Training Set

The document does not provide information about a separate training set or its sample size. For an ELISA assay, the "training" equivalent might involve optimizing assay parameters and cut-offs using a set of known samples, but this is not explicitly detailed.

9. How Ground Truth for the Training Set Was Established

As no specific training set is mentioned, information on how its ground truth was established is not available in the provided text.

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The MESACUP-2 TEST Jo-1 is a semi-quantitative enzyme-linked immunosorbent assay (ELISA) for the detection of anti-Jo-1 antibodies in human serum as an aid in the diagnosis of polymyositis and/or dermatomyositis, or other related connective tissue diseases.

The MESACUP-2 Test Jo-1 is an enzyme-linked immunosorbent assay (ELISA), utilizing the 96-microwell plate format, similar to the predicate device. Diluted serum samples, calibrator sera, and controls are incubated in microwells coated with Jo-1 (histidyl-tRNA synthetase) antigen. Incubation allows the anti-Jo-1 antibodies present in the samples to react with the immobilized antigen. After the removal of unbound serum proteins by washing, antibodies specific for human immunoglobulins (IgG, IgM and IgA), labeled with horseradish peroxidase (HRP), are added forming complexes with the Jo-1 bound antibodies. Following another washing step, the bound enzyme-antibody conjugate is assayed by the addition of a single solution containing tetramethlybenzidine (TMB) and hydrogen peroxide (H2O2) as the chromogenic substrate. The intensity of the color generated is proportional to the serum concentration of anti-Jo-1 antibodics. Optical density is read spectrophotometrically at 450mm. The total incubation time (at room temperature) of the assay is 150 minutes. The assay makes use of two calibrators to measure the amount of anti-Jo-1 antibodies in patient samples.

Here's a breakdown of the acceptance criteria and study information for the MESACUP-2 Test Jo-1, based on the provided text:

Acceptance Criteria and Device Performance

Study Information

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

• Test Set Sample Size:
  • Healthy donor serum population: Not explicitly stated, but "in-house studies" are mentioned for specificity.
  • Polymyositis/dermatomyositis population: Not explicitly stated, but "additional studies" are mentioned for sensitivity.
• Data Provenance: Retrospective ("in-house studies" and "additional studies"). Country of origin is not specified, but the submission is from a US company (Corgenix Inc.).

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

Not specified. The ground truth for the sensitivity study was based on antibodies "previously also found positive by double immunodiffusion (DID)," which implies a prior established diagnosis, but the expert involvement in that initial diagnosis is not detailed.

4. Adjudication Method for the Test Set:

Not applicable. This is an ELISA assay detecting antibodies, not a diagnostic imaging or clinical assessment where adjudication between readers would typically occur.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:

Not applicable. This is an in-vitro diagnostic (IVD) device, specifically an ELISA. It does not involve human readers interpreting images or data with or without AI assistance.

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

Yes. The performance data (specificity and sensitivity) are for the device itself, the MESACUP-2 Test Jo-1, as a standalone diagnostic tool. The "human-in-the-loop" component in an ELISA is a laboratory technician performing the assay and reading the spectrophotometer, but the output (optical density and subsequent antibody concentration) is determined by the assay itself, not human interpretation in the sense of an AI-assisted diagnostic.

7. The Type of Ground Truth Used:

• For Specificity: Healthy donor serum population (absence of disease/antibodies).
• For Sensitivity: Polymyositis/dermatomyositis population with antibodies "previously also found positive by double immunodiffusion (DID)." This indicates a reference method (DID) was used to confirm the presence of anti-Jo-1 antibodies, serving as the ground truth for that cohort.

8. The Sample Size for the Training Set:

Not applicable. ELISA assays are not typically "trained" in the machine learning sense. Their performance is determined by their chemical and biological design, optimization, and validation against known samples.

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

Not applicable, as there isn't a training set in the machine learning context for this type of device. The ground truth for the validation/test sets was established as described in point 7.

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The MESACUP-2 TEST Mitochondria M2 is semi-quantitative enzyme-linked immunosorbent assay (ELISA) for the detection of anti-Mitochondrial antibodies in human serum as an aid in the diagnosis of primary biliary cirrhosis.

The MESACUP-2 Test Mitochondria M2 is an enzyme-linked immunosorbent assay (ELISA), utilizing the 96-microwell plate format, similar to the predicate device. Diluted serum samples, calibrator sera, and controls are incubated in microwells coated with mitochondria M2 antigens. Incubation allows the antimitochondria M2 antibodies present in the samples to react with the immobilized antigen. After the removal of unbound serum proteins by washing, antibodies specific for human immunoglobulins (IgG, IgM and IgA), labeled with horseradish peroxidase (HRP), are added forming complexes with the mitochondria M2 bound antibodies. Following another washing step, the bound enzyme-antibody conjugate is assayed by the addition of a single solution containing tetramethlybenzidine (TMB) and hydrogen peroxide (H3O2) as the chromogenic substrate. The intensity of the color generated is proportional to the serum concentration of anti-mitochondria M2 antibodies. Optical density is read spectrophotometrically at 450mm. The total incubation time (at room temperature) of the assay is 150 minutes. The assay makes use of two calibrators to measure the amount of anti-mitochondria M2 antibodies in patient samples.

Here's a breakdown of the acceptance criteria and study information for the MESACUP-2 Test Mitochondria M2 device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a tabular format, but rather compares the performance of the MESACUP-2 Test to a legally marketed predicate device (Quanta Lite Mitochondria M2 ELISA) and implies that comparable performance is the measure of acceptance. The key performance metrics are clinical specificity and sensitivity.

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

• Sample Size: Not explicitly stated as a numerical value for each group. The text mentions "a healthy donor serum population" and "a primary biliary cirrhosis population."
• Data Provenance: The studies were "In-house studies," suggesting they were conducted by RhiGene, Inc. The country of origin of the data is not specified but implied to be the US given the submission to the FDA. The studies were likely retrospective as they involve patient populations already categorized.

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

This information is not provided in the document. The text does not elaborate on how the classification of "healthy donor serum population" or "primary biliary cirrhosis population" was established.

4. Adjudication Method for the Test Set:

This information is not provided in the document.

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 not applicable. The device is an ELISA assay for detecting antibodies, not an AI-assisted diagnostic imaging or interpretation tool that involves human readers.

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

The device itself is a standalone in vitro diagnostic (IVD) test. It's an "algorithm only" in the sense that it provides a semi-quantitative result based on a chemical reaction and optical density reading, without direct human interpretation of complex patterns in the way an imaging AI would. The performance metrics (specificity and sensitivity) are derived from the device's output.

7. The Type of Ground Truth Used:

The ground truth used was clinical diagnosis/status. The populations were defined as "healthy donor serum population" and "primary biliary cirrhosis population." It's assumed that this classification was based on established clinical diagnostic criteria (e.g., patient history, physical examination, other laboratory tests, biopsies if applicable for PBC).

8. The Sample Size for the Training Set:

This information is not provided. The document describes a comparison study, implying that the MESACUP-2 Test has already been developed. There is no mention of a separate "training set" for the device itself, as it's a biochemical assay rather than a machine learning algorithm that requires explicit training data in the modern sense.

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

This information is not provided and is largely not applicable in the context of a traditional ELISA assay development, which focuses on chemical and biological validation rather than algorithmic training with ground truth labels in the same way an AI model would be.

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The RhiGene MESACUP-2 TEST RNP is a semi-quantitative enzyme-linked immunosorbent assay for the detection of antibodies to RNP in human serum. The RhiGene MESACUP-2 TEST RNP is intended for in vitro diagnostic use as an aid in the determination of certain autoimmune diseases.

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I am sorry, but the provided text does not contain the detailed information necessary to complete all sections of your request. The document discusses regulatory approval for a medical device (RhiGene MESACUP-2 Test RNP) and its intended use, but it does not include specifics about the acceptance criteria, the study design, sample sizes, or expert qualifications for performance evaluation.

Therefore, many of the requested fields cannot be filled based on the given text.

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The RhiGene MESACUP ANA TEST is a semi-quantitative enzyme-linked immunosorbent assay for the detection of disease specific antinuclear antibodies in human serum. The RhiGene MESACUP ANA TEST is intended for in vitro diagnostic use as an aid in the determination of certain autoimmune diseases.

Not Found

The provided text describes a 510(k) premarket notification for the "RhiGene MESACUP ANA TEST" and confirms its substantial equivalence to a legally marketed predicate device. However, the document does not contain the specific information required to complete the table and answer the questions about acceptance criteria, study details, ground truth establishment, or sample sizes.

The document is primarily an FDA clearance letter for a medical device (an in-vitro diagnostic test), and as such, it focuses on the regulatory determination of substantial equivalence rather than providing detailed study protocols or results.

To fulfill the request, one would typically need access to the full 510(k) submission, which would include the performance data and the study's design.

Therefore, I cannot provide the requested information based solely on the text provided.

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