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REMEL's Xpect™ Clostridium difficile Toxin A/B is a rapid in vitro immunochromatographic test for the direct, qualitative detection of Clostridium difficile Toxin A and/or B in human fecal specimens from patients suspected of having Clostridium difficile-associated disease (CDAD). The test is intended for use as an aid in diagnosis of CDAD. The test can also be used for confirmation of toxigenic Clostridium difficile from Brain Heart Infusion (BHI) broth culture.

The Xpect™ Clostridium difficile Toxin A/B test is a qualitative immunochromatographic assay that detects C. difficile Toxin A and Toxin B in stool specimens or cultures of toxigenic C. difficile. In performing the test, a specimen is first diluted with Specimen Diluent to help solubilize the toxins. A portion of the diluted sample is then mixed with a volume of Conjugate 1 containing antibodies to Toxin A and Toxin B coupled to colored microparticles, plus a volume of Conjugate 2 containing biotinylated antibodies to Toxin A and Toxin B. A volume of this mixture is transferred to a test device having immobilized streptavidin as a test line and goat antiimmunoqlobulin antibody a as a control line. Immunocomplexes of toxin and conjugated antibodies form a visible band as they flow across the test line. Excess colored particle conjugates form a visible band at the control line to document that the test is functioning properly.

Here is a summary 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 as distinct numerical targets in the provided text. However, they can be inferred from the reported performance results and the comparison to the predicate device and other commercially available assays. The primary implied acceptance criteria revolve around achieving competitive or superior sensitivity, specificity, and agreement compared to established methods for diagnosing C. difficile-associated disease (CDAD).

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

• Sample Size (Clinical Accuracy): A total of 815 specimens were tested.
• Data Provenance: The study was conducted at four geographically diverse regions of the United States, suggesting a prospective collection or at least a multi-site prospective analysis of collected samples. The text does not explicitly state if the samples were collected retrospectively or prospectively, but the term "evaluated at" suggests prospective evaluation over a period of time.

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

The ground truth for the clinical accuracy study was established using the cytotoxin assay (CTA). This is a laboratory-based assay and does not involve human experts in the same way, for example, a radiologist reads images. Therefore, the concept of "number of experts" and "qualifications of experts" does not directly apply to the primary ground truth method used here. The CTA is considered a gold standard for C. difficile toxin detection.

For discordant results, further investigation involved "toxigenic culture and microwell enzyme immunoassay." Again, these are laboratory methods, not expert human review.

4. Adjudication Method for the Test Set

There was a form of adjudication for discordant results.

• "Discordant results were further investigated by toxigenic culture and microwell enzyme immunoassay that detects both Toxin A and B."
• This suggests that when the Xpect™ test result and the CTA result did not agree, additional, more definitive laboratory tests (toxigenic culture and a different EIA) were used to ascertain the true status of the sample. This acts as an "adjudication" in a laboratory context, where a more definitive test is used to resolve discrepancies between the index test and the primary reference standard.

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 to this device. The Xpect™ Clostridium difficile Toxin A/B test is an in-vitro diagnostic (IVD) assay, not an AI-powered image analysis or diagnostic support tool for human readers. It directly detects bacterial toxins in a specimen. Therefore, there are no "human readers" in the context of interpreting the device's output, nor is there any AI assistance involved.

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

This is not applicable to this device. As an IVD assay, the Xpect™ test inherently operates in a "standalone" fashion in terms of its direct detection mechanism (immunochromatography). It produces a visible line without requiring human interpretation other than observing the presence or absence of the line. The performance data presented (sensitivity, specificity) reflects this standalone performance.

7. The Type of Ground Truth Used

The primary ground truth for the clinical accuracy study was the Cytotoxin Assay (CTA). For discordant results, Toxigenic Culture and Microwell Enzyme Immunoassay (EIA) were used as further confirmatory ground truth methods.

8. The Sample Size for the Training Set

The document does not explicitly mention a distinct "training set" for the clinical accuracy study in the traditional sense of machine learning. For traditional IVD assays, optimization and initial validation (which could be considered analogous to training/development) would occur internally during product development, prior to the formal clinical performance study described. The clinical performance study (n=815) serves as the primary validation of the device's performance against the established ground truth.

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

As no specific "training set" is identified, this question is not directly applicable. However, the ground truth for any internal development or optimization would likely have been established using the same (or similar) gold standard methods as the clinical validation, i.e., Cytotoxin Assay and/or Toxigenic Culture.

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Remel's ProSpecT® Clostridium difficile Toxin A/B Microplate Assay is a qualitative enzyme immunoassay (EIA) for the detection of C. difficile Toxin A and B in human fecal specimens from patients suspected of having Clostridium difficile disease. The test is intended for use as an aid in diagnosis of Clostridium difficile-associated disease (CDAD). For In vitro Diagnostic Use. Prescription Use.

The ProSpecT® Clostridium difficile Toxin A/B test detects the presence of Toxin A and Toxin B in clinical stool specimens through the use of specific antibodies. Microwell strips are coated with mouse monoclonal anti-Toxin A and rabbit anti-Toxin B antibodies. A stool specimen is diluted in Sample Diluent or used directly if pre-diluted in modified Cary-Blair medium. The sample is added to a microwell allowing the toxins, if present, to bind to the immobilized antibodies. After washing to remove unbound components, a conjugate reagent containing goat anti-Toxin A-HRP and rabbit anti-Toxin B-HRP is added to each well. Unbound conjugate is removed by washing and a chromagenic substrate solution is added to detect the presence of bound toxin. A stop reagent is added and the test results are read visually or spectrophotometrically. The presence of a yellow color indicates the presence of toxin.

Here's a summary of the acceptance criteria and study details for the ProSpecT® Clostridium difficile Toxin A/B Microplate Assay:

Acceptance Criteria and Device Performance

Note: The document does not explicitly state numerical acceptance criteria for sensitivity and specificity. However, the performance data presented, particularly the comparison to predicate devices, suggests that the device's performance met the FDA's requirements for substantial equivalence.

Study Details

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

   • Dual Wavelength Test Set: 764 samples (165 positive, 599 negative based on CTA).
   • Visual Interpretation Test Set: 586 samples (100 positive, 486 negative based on CTA).
   • Data Provenance: Retrospective (clinical trial at three sites in the USA).

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

   • The ground truth was established using the cellular cytotoxicity assay (CTA), which is a laboratory-based method. No human experts were involved in establishing the primary ground truth for the clinical samples.

3. Adjudication method for the test set:

   • Not applicable as the ground truth was established by the cellular cytotoxicity assay (CTA), not human reviewers requiring adjudication.

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:

   • No MRMC comparative effectiveness study was performed. This device is a qualitative enzyme immunoassay (EIA) for detecting C. difficile toxins, not an AI-powered diagnostic imaging or interpretation tool for human readers.

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

   • Yes, the performance data provided (sensitivity and specificity for both dual wavelength and visual interpretation) represents the standalone performance of the ProSpecT® Clostridium difficile Toxin A/B Microplate Assay. The "visual interpretation" involves a human reading the color change, but it's the direct output of the assay itself, not an AI interpreting human input.

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

   • The ground truth used was the cellular cytotoxicity assay (CTA), which is considered a gold standard for detecting C. difficile toxins.

7. The sample size for the training set:

   • The document does not explicitly state a separate "training set" size. The reported performance is based on the clinical validation study. For an IVD like this, the development and optimization (which could be analogous to "training") would typically happen internally during the assay development phase, using characterized control samples and potentially a smaller set of clinical samples, but these are not typically referred to as a "training set" in the same way as for AI/ML models.

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

   • Not explicitly described. For the general development of such assays, ground truth for sample characterization would be established using established laboratory methods, including the CTA for C. difficile toxins, and potentially molecular methods or culture.

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REMEL's Xpect™ Giardia kit is an in vitro qualitative immunoassay for the detection of Giardia antigens in preserved and unpreserved fecal specimens. This test is intended as an aid in the laboratory diagnosis of suspected Giardia infections.

The Xpect™ Giardia Lateral Flow Assay is a chromatographic immunoassay that detects the presence of Giardia antigen. The test utilizes sample wicking to capture Giardia antigen on a discrete test line containing antigen-specific antibodies for Giardia. A specimen is added to a dilution tube containing a buffered solution. A conjugate containing colored micro-particles linked to murine monoclonal antibody specific for Giardia is added. The mixture is dispensed into the sample well of the device and wicks along a membrane containing capture antibody stripes. The Giardia immune complex, if present, reacts with anti- Giardia antibody at the test line. Antibody-labeled microparticles not bound at the test line are later captured at the control line containing anti-mouse antibody. A blue line of any intensity (light blue to black) will appear at the Giardia test position if Giardia antigen is present. A complete line at the Control position indicates that the test is working properly.

Here's a breakdown of the acceptance criteria and study information for the Xpect™ Giardia Lateral Flow Assay, based on the provided 510(k) notification:

Acceptance Criteria and Reported Device Performance

Study Information

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

   • Clinical Performance Study (compared to microscopy):
     • Total samples with Giardia present by microscopy: 97
     • Total samples with Giardia absent by microscopy: 478
     • Total samples in this comparison: 575 (97 positive + 478 negative)
     • Data Provenance: The study was evaluated at "six geographically diverse laboratories," indicating a multi-center, likely prospective collection of clinical samples. The country of origin is not explicitly stated but can be inferred to be within the US given the submission to the FDA.
   • Comparison to Predicate Device:
     • Total samples: 147 (26 positive by predicate, 121 negative by predicate).

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

   • The primary ground truth for the clinical performance study was microscopy. The document does not specify the number of experts (e.g., medical technologists, parasitologists) involved, nor their specific qualifications (e.g., years of experience). It simply states the comparison was "compared to microscopy."

3. Adjudication Method for the Test Set:

   • The document does not explicitly state an adjudication method (like 2+1, 3+1). It implies that the microscopy results served as the definitive ground truth for the comparison.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No, an MRMC comparative effectiveness study involving human readers with and without AI assistance was not done. This device is a rapid diagnostic test (lateral flow immunoassay), not an AI-powered diagnostic imaging or interpretation tool designed to assist human readers.

5. Standalone (Algorithm Only) Performance:

   • Yes, the performance presented in the "Sensitivity/Specificity" table is the standalone performance of the Xpect™ Giardia Lateral Flow Assay, as it directly compares the device's results to the microscopy ground truth. It operates independently of human interpretation beyond reading the positive/negative line.

6. Type of Ground Truth Used:

   • The primary ground truth used for the clinical performance evaluation was microscopy, which involves expert examination of fecal specimens for the presence of Giardia parasites.

7. Sample Size for the Training Set:

   • The document does not specify a separate "training set" or its size. As this is a lateral flow immunoassay, the development process would involve analytical studies and optimization rather than machine learning training on a distinct dataset. The studies described are performance validation studies.

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

   • Since a separate training set, in the context of machine learning, is not applicable or described for this device, the method for establishing its ground truth is not provided. The ground truth for the validation test set was established by microscopy.

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REMEL's Xpect™ Cryptosporidium kit is an in vitro qualitative immunoassay for the detection of Cryptosporidium antigens in preserved and unpreserved fecal specimens. This test is intended as an aid in the laboratory diagnosis of suspected Cryptosporidium infections.

The Xpect™ Cryptosporidium Lateral Flow Assay is a chromatographic immunoassay that detects the presence of Cryptosporidium antigen. The test utilizes sample wicking to capture Cryptosporidium antigen on a test line containing antigen-specific antibody. A specimen is added to a dilution tube containing a buffered solution. A conjugate containing colored micro-particles linked to murine monoclonal antibody specific for Cryptosporidium is added. The mixture is dispensed into the sample well of the device and wicks along a membrane containing capture antibody stripes. The Cryptosporidium immune complex, if present, reacts with anti-Cryptosporidium antibody at the test line. Conjugate not bound at the test line is later captured at the control line containing anti-mouse antibody. A red line of any intensity will appear at the Cryptosporidium test position if Cryptosporidium antigen is present. A line in the Control position indicates that the test is working properly.

Here's a summary of the acceptance criteria and study details for the Xpect™ Cryptosporidium Lateral Flow Assay, based on the provided 510(k) notification:

Acceptance Criteria and Device Performance

Study Details

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

   • Sensitivity/Specificity Study:
     • Total Samples: 578 (112 positive for Cryptosporidium by microscopy, 466 negative by microscopy).
     • Provenance: Not explicitly stated regarding country of origin; the study was conducted at "six geographically diverse laboratories" (implying multiple sites within a country or potentially internationally), and data was retrospective (compared to microscopy, which would have been performed on collected samples).
   • Percent Agreement Study (Comparison with Predicate):
     • Total Samples: 146 (30 positive for Cryptosporidium by microscopy, 116 negative by microscopy).
     • Provenance: Not explicitly stated regarding country of origin or retrospective/prospective nature.

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

   • The ground truth for the test set was established by microscopy. The document does not specify the number of experts (e.g., microscopists) involved in reading these slides or their qualifications. It's common in diagnostic studies for the comparator method (like microscopy) to be performed by qualified laboratory personnel, but this detail is not provided.

3. Adjudication method for the test set:

   • The document does not specify any formal adjudication method for the microscopy results that served as the ground truth. It simply states the comparison was "to microscopy."

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:

   • No, an MRMC comparative effectiveness study was not done. This device is a standalone in vitro diagnostic (IVD) lateral flow assay, not an AI or imaging device designed to assist human readers.

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

   • Yes, this was a standalone performance study. The Xpect™ Cryptosporidium Lateral Flow Assay is an "algorithm-only" in the sense that it provides a direct qualitative result (presence/absence of a line) without human interpretation beyond reading the line. The presented sensitivity and specificity values represent the performance of the device itself.

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

   • The primary ground truth used was microscopy (specifically, for detection of Cryptosporidium).

7. The sample size for the training set:

   • The document does not provide information regarding a separate training set for algorithm development. As this is a lateral flow immunoassay, not an AI or machine learning model, a distinct "training set" in the context of data-driven algorithm development is typically not applicable. The assay's performance characteristics are inherent to its design and manufacturing.

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

   • As there's no explicit mention of a training set in the context of algorithm development, this information is not applicable to this device. Early development and optimization of the assay would involve various characterized positive and negative samples, but these are not typically referred to as a "training set" in the same way as for AI.

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REMEL's Xpect™ Giardia/Cryptosporidium kit is an in vitro qualitative immunoassay for the detection of Giardia and Cryptosporidium antigens in preserved and unpreserved fecal specimens. This test is intended as an aid in the laboratory diagnosis of suspected Giardia and Cryptosporidium infections.

The Xpect™ Giardia/Cryptosporidium Lateral Flow Assay is a chromatographic immunoassay that detects the presence of Giardia and Cryptosporidium antigens. The test utilizes sample wicking to capture Giardia and Cryptosporidium antigens on discrete test lines containing antigen-specific antibodies for each organism. A specimen is added to a dilution tube containing a buffered solution. A conjugate containing colored micro-particles linked to monoclonal antibodies specific for Giardia and Cryptosporidium is added. The mixture is dispensed into the sample well of the device and wicks across a membrane containing capture antibody stripes. The Giardia/Cryptosporidium immune complexes if present react with anti-Giardia antibody and/or anti-Cryptosporidium antibody at the test line. Conjugates not bound at the test lines are later captured at the control line containing anti-mouse antibody. A blue line will appear at the Giardia test position if Giardia antigen is present and a pink line will appear at the Cryptosporidium test position if Cryptosporidium antigen is present. A line in the Control position indicates that the test is working properly.

Here's a breakdown of the acceptance criteria and study details for the Remel Xpect™ Giardia/Cryptosporidium Lateral Flow Assay, based on the provided text:

Acceptance Criteria and Reported Device Performance

Study Information

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

• Giardia Test Set Sample Size:
  • Sensitivity/Specificity vs. Microscopy: 577 total specimens (96 positive, 481 negative by microscopy).
  • Percent Agreement vs. Microscopy: 146 specimens (21 positive, 125 negative by microscopy).
• Cryptosporidium Test Set Sample Size:
  • Sensitivity/Specificity vs. Microscopy: 577 total specimens (112 positive, 465 negative by microscopy).
  • Percent Agreement vs. Microscopy: 146 specimens (30 positive, 116 negative by microscopy).
• Data Provenance: The studies were conducted at "six geographically diverse laboratories" for the primary sensitivity/specificity comparison and in a side-by-side comparison with a predicate device. The text does not specify the country of origin but implies a multi-site clinical evaluation. The studies appear to be retrospective as they involve analyzing collected fecal specimens.

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

• The ground truth for the test set was established by microscopy. The document does not specify the number of experts or their qualifications (e.g., years of experience for the microscopists).

4. Adjudication method for the test set:

• The document does not specify an adjudication method for disagreements in establishing the ground truth via microscopy. It is simply stated that performance was "compared to microscopy on a single specimen."

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a lateral flow immunoassay not an AI-assisted diagnostic.

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

• Yes, this device is a standalone test. The Xpect™ Giardia/Cryptosporidium Lateral Flow Assay is a qualitative immunoassay designed to provide a direct result (presence or absence of colored lines) without human interpretation beyond reading the lines.

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

• The ground truth used was microscopy for the detection of Giardia and Cryptosporidium.

8. The sample size for the training set:

• The document does not explicitly mention a training set sample size. As a lateral flow immunoassay, the device itself is not "trained" in the same way an AI algorithm would be. The development and optimization of such assays involve laboratory work and validation, but not a distinct "training set" in the context of machine learning. The studies described are performance evaluations.

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

• As noted above, there is no explicit "training set" for an AI algorithm. The development of the immunoassay would have involved internal validation and optimization to ensure the antibodies and detection system worked as intended. The ground truth for such development would likely rely on known positive and negative control samples, potentially confirmed by gold standard methods like microscopy or PCR, to select optimal reagents and assay conditions. However, the provided text does not detail these developmental activities or their ground truth establishment.

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REMEL's Xpect™ Flu A/B is a rapid in vitro immunochromatographic test for the direct, qualitative detection of influenza A and influenza B viral antigen (nucleoprotein) from nasal wash, nasal swab, and throat swab specimens from symptomatic patients. The test is intended as an aid in the rapid diagnosis of influenza A and influenza B viral infections. Negative tests should be confirmed by cell culture.

The Xpect™ Flu A/B is a chromatographic immunoassay for the qualitative detection of influenza A and influenza B viral antigens. The test device incorporates separate membrane strips for influenza A and for influenza B. To perform the test, the patient specimen is diluted and added to the sample well of the device. The mixture moves along the membranes by capillary action. If present, influenza A or B viral antigens in the patient sample bind anti-influenza A or B conjugated antibodies. A visible line forms as a complex of antibody-antigen-antibody coated colored particles is captured in the test region (T). Antibody coated colored particles not bound at the test line are later captured in the control region (C) containing goat anti-mouse antibody. A visible line will always appear in the control region indicating that the test is working properly. The presence of a control line combined with the absence of a visible test line is interpreted as a negative test result.

Acceptance Criteria and Device Performance Study for Xpect™ Flu A/B Device

This document describes the acceptance criteria and the study that demonstrates the performance of the Xpect™ Flu A/B device.

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state pre-defined acceptance criteria (e.g., "Sensitivity must be > 90%"). Instead, it presents observed performance metrics. However, based on the clinical accuracy results, we can infer the implied acceptance criteria were met by the observed performance.

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

• Overall Clinical Accuracy:
  • Total Samples for Flu A: 77 positive by culture, 314 negative by culture (Total = 391)
  • Total Samples for Flu B: 46 positive by culture, 345 negative by culture (Total = 391)
• Stratified by Specimen Type:
  • Nasal Wash: n=239 (40 Flu A positive, 199 Flu A negative; 36 Flu B positive, 203 Flu B negative)
  • Throat Swabs: n=30 (10 Flu A positive, 20 Flu A negative; 4 Flu B positive, 26 Flu B negative)
  • Nasal Swab: n=122 (27 Flu A positive, 95 Flu A negative; 6 Flu B positive, 116 Flu B negative)
• Data Provenance: The clinical trials were conducted at three sites in the United States (north, south, and east regions). The sites included a children's hospital (pediatric population), a university hospital (primarily adult population), and a reference laboratory (60% adult, 40% pediatric population). The data appears to be prospective clinical data collected specifically for this evaluation.

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

The text does not specify the number or qualifications of experts used to establish the ground truth. It states that the ground truth for clinical accuracy was established by cell culture. While cell culture is a definitive method, the interpretation and execution of these cultures would be performed by trained laboratory personnel, but they are not explicitly referred to as "experts" in the context of adjudication or consensus.

4. Adjudication method for the test set:

The primary ground truth was established by cell culture. For discrepant results (samples that were culture positive but Xpect™ Flu A/B negative), RT-PCR was performed on some of the available samples. This indicates a secondary, confirmatory method was used for discrepant analysis, but not a formal expert adjudication panel. Specifically:

• For Influenza A, 4 out of 5 available discrepant samples were positive by RT-PCR.
• For Influenza A in Nasal Wash, 2 out of 3 discrepant samples were positive by RT-PCR.
• For Influenza A and B in Nasal Swab, 2 out of 4 discrepant specimens (1 Flu A, 1 Flu B) that were available were positive by PCR.

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 is a rapid in vitro diagnostic test for antigen detection. It is not an imaging device or an AI-driven diagnostic system that involves human readers interpreting results with or without AI assistance. Therefore, an MRMC comparative effectiveness study is not applicable and was not conducted.

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

Yes, the performance data presented (sensitivity, specificity) reflects the standalone performance of the Xpect™ Flu A/B device. The device provides a qualitative result (positive or negative) based on the presence of visible bands, without human interpretation for the result itself, beyond observing the bands as per the instructions.

7. The type of ground truth used:

The ground truth used for clinical accuracy evaluation was cell culture. For some discrepant results, RT-PCR was used as a confirmatory method.

8. The sample size for the training set:

The document does not provide information about a separate "training set" in the context of machine learning or AI. This device is a rapid immunochromatographic test, not an AI/ML-based algorithm. The described studies are performance evaluations of the final device.

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

As this is not an AI/ML-based device, there is no "training set" in that context described. The studies outlined are for the validation of the device's performance against established diagnostic methods (cell culture).

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