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The RAMP® Influenza A/B Assay is a qualitative immunochromatographic assay used to identify the presence of Influenza A and Influenza B nucleoprotein antigens in nasal wash, nasal aspirate, nasopharyngeal aspirate, and nasopharyngeal swab specimens from symptomatic patients. It is an in vitro diagnostic assay that aids in the rapid differential diagnosis of influenza viral infections in symptomatic patients. A negative test is presumptive and it is recommended these results be confirmed by cell culture. Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other management decisions.

The test performance characteristics for Influenza B were established primarily with retrospective, frozen specimens. Users may wish to further evaluate the sensitivity performance of this test for Influenza B using fresh samples.

The RAMP Influenza A/B Assay is a qualitative immunochromatographic test that utilizes the RAMP 200 instrument for the differential determination of Influenza B in nasal wash/aspirate, nasopharyngeal aspirate, and nasopharyngeal swab samples. A wash/aspirate or swab sample is mixed with Sample buffer and applied into the sample well of the Test Cartidge. The sample migrates along the strip. Fluorescent-dyed latex (test) particles, coated with anti-Influenza A and anti-Influenza B antibodies bind to Influenza A or B antigens, respectively, if present in the sample. As the sample migrates along the strip, Influenza-bound particles are captured at either the Influenza A or the Influenza B detection zone, and additional particles are captured at the internal standard zone.

The instrument then measures the amount of fluorescence emitted by the complexes at the two detection zones (Influenza A and Influenza B) and at the internal standard zone. The instrument calculates a ratio (RAMP Ratio) using the fluorescence reading of each detection zone (A or B) and the internal standard zone. The instrument compares these ratios to pre-defined threshold limits to determine a positive or negative result for Influenza B in the tested sample.

The provided text describes the analytical reactivity study for the RAMP® Influenza A/B Assay, specifically for the K093116 submission, which provides additional analytical reactivity information for the previously cleared K071591 device.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The document focuses on analytical reactivity rather than clinical performance (e.g., sensitivity, specificity in patient samples). The implicit acceptance criterion for analytical reactivity is that the device should consistently detect the target antigen at a certain concentration, and not detect at a lower, non-target concentration.

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

• Test Set Sample Size: For the analytical reactivity study, 5 replicates were tested at each concentration of the Influenza A (Swine NY/02/2009) isolate. This means a total of 25 tests were performed for Influenza A detection (5 concentrations x 5 replicates).
• Data Provenance: The study was conducted using an isolate strain of Influenza A (Swine NY/02/2009) prepared in Copan UTM. This indicates a laboratory-based, analytical study rather than a clinical study with patient samples. The document does not specify a country of origin for the isolate beyond it being "Swine NY/02/2009". It is a prospective study in the sense that the testing was performed specifically for this submission.

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

• Number of Experts: Not applicable. The ground truth for this analytical study was established by the known concentration of the Influenza A isolate (TCID50/mL), which is a quantitative measure determined through laboratory techniques (e.g., cell culture, endpoint dilution assays). It does not involve human expert consensus for qualitative assessment of clinical samples.
• Qualifications of Experts: Not applicable for this type of analytical study.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable. The results are quantitative (TCID50/mL) and instrument-read (RAMP instrument calculates a ratio and determines positive/negative based on predefined thresholds). There is no human adjudication process described.

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:

• MRMC Study: No. This document describes an analytical reactivity study of a diagnostic device (RAMP® Influenza A/B Assay) which is an "immunochromatographic test that utilizes the RAMP 200 instrument". It is not an AI-based device, and therefore, an MRMC comparative effectiveness study involving human readers with/without AI assistance is not relevant or described.

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

• Standalone Performance: Yes, in a way. The RAMP® Influenza A/B Assay with the RAMP 200 instrument determines the result based on measurement of fluorescence and calculation of a ratio against predefined thresholds. This process is automated ("algorithm only") and does not involve real-time human interpretation or human-in-the-loop performance during the test itself. The study confirms the performance of this automated system in detecting the target analyte.

7. The Type of Ground Truth Used:

• Ground Truth: The ground truth for the analytical reactivity study was the known concentration of the viral isolate (Influenza A/Swine NY/02/2009), quantified in Tissue Culture Infectious Dose 50% (TCID50/mL). This is a precise laboratory-derived standard.

8. The Sample Size for the Training Set:

• Training Set Sample Size: Not specified or applicable in the provided text. This document describes a verification study of an already developed device. It is not clear if an explicit "training set" in the context of machine learning was used, as this is primarily a chemical/immunological assay with an automated reader rather than an AI/machine learning algorithm that requires extensive training data. The "pre-defined threshold limits" for the RAMP instrument would have been established during the device's initial development, but the data used for that is not part of this document.

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

• Ground Truth for Training Set: Not specified. As mentioned above, the concept of a "training set" as commonly understood in AI/machine learning isn't explicitly addressed here. The "pre-defined threshold limits" for the RAMP instrument (which guide the positive/negative determination) would have been established during the development of the K071591 device (the predicate). This would likely involve testing characterized positive and negative samples at various concentrations to set appropriate cut-offs, but the details of that process are not included in this submission.

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The RAMP RSV Assay is a qualitative immunochromatographic test for the detection of Respiratory Syncytial Virus (RSV) F-protein antigens in nasal wash/aspirate, nasopharyngeal aspirate and nasopharyngeal swab samples. It is an in vitro diagnostic assay that aids in the rapid diagnosis of RSV infections in symptomatic patients 21 years of age and younger. A negative test is presumptive and it is recommended that all negative results be confirmed by cell culture or direct specimen fluorescence assay (DSFA). Negative results do not preclude RSV infection and should not be used as the sole basis for treatment or other management decisions. The test is intended for professional use.

The RAMP RSV Assay is a qualitative immunochromatographic test for the detection of Respiratory Syncytial Virus (RSV) in nasal wash/aspirate, nasopharyngeal aspirate, and nasopharyngeal swab samples from symptomatic patients 21 years of age and younger. A wash/aspirate or swab sample is mixed with Sample buffer and applied into the sample well of the Test Cartridge. The sample migrates along the strip. Fluorescent-dyed latex (test) particles. coated with anti-RSV antibodies bind to RSV antigens, if present in the sample. As the sample migrates along the strip, RSV-bound particles are captured at the RSV detection zone, and additional particles are captured at the internal standard zone.

This document describes the RAMP® RSV Assay, a qualitative immunochromatographic test for detecting Respiratory Syncytial Virus (RSV). The study presented focuses on its analytical and clinical performance.

Here's the breakdown of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

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The RAMP NT-proBNP Assay is a quantitative immunochromatographic test indicated for use as an in vitro diagnostic product used to measure N-terminal pro-brain natriuretic peptide (NT-proBNP) levels in EDTA whole blood. Measurement of NT-proBNP aids in the diagnosis and assessment of severity in individuals suspected of having heart failure and may aid in the risk stratification of patients with heart failure.

The RAMP NT-proBNP Assay is a quantitative immunochromatographic test indicated for use as an in vitro diagnostic product used with a RAMP reader to measure N-terminal pro-brain natriuretic peptide (NT-proBNP) levels in EDTA whole blood. Mixed EDTA whole blood is added to the sample well of the Test Cartridge which houses the immunochromatographic test strip. The red blood cells are retained in the sample pad, and the separated plasma migrates along the strip. Fluorescent-dyed latex particles coated with anti-NT-proBNP antibodies bind to NT-proBNP, if present in the sample. As the sample migrates along the strip. NT-proBNP bound particles are captured at the detection zone, and additional particles are captured at the internal standard zone.

The RAMP reader then measures the amount of fluorescence emitted by the complexes captured at the detection zone and at the internal standard zone. Using a ratio between the two fluorescence values, a quantitative reading is calculated.

Here's a breakdown of the acceptance criteria and study information for the RAMP® NT-proBNP Assay, based on the provided 510(k) summary:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as distinct pass/fail thresholds against which the device performance is measured. Instead, the document presents detailed performance characteristics (precision, linearity, limits, analytical specificity, interference) and then compares the clinical performance (method comparison, sensitivity/specificity, ROC analysis) against a predicate device (Roche Elecsys proBNP Assay) and using established cut-offs.

However, based on the conclusions and the comparative data, we can infer some desired performance characteristics.

Study Details

2. Sample sizes for the test set and data provenance

• Method Comparison Test Set (RAMP vs. Elecsys):
  • Total Patients Enrolled: 699
  • Samples analyzed within reportable range (34 ng/L to 22,000 ng/L): 580
  • HF Diagnosed: 274 (164 males, 110 females)
  • Non-HF Reference Group: 306 (124 males, 182 females)
  • Data Provenance: Not explicitly stated regarding country of origin, but implied to be from clinical sites where patients were enrolled. The use of "individual hospital criteria" suggests multiple sites. The study is prospective in nature, as samples were collected "for each of these subjects" and then analyzed by both devices.
• Clinical Sensitivity and Specificity Test Set:
  • Total Subjects: 858
  • Diagnosed with HF: 299 (using local hospital criteria)
  • Non-HF with potentially confounding co-morbidity: 189
  • Reference Individuals (healthy, no co-morbidities): 370 (includes an additional 159 subjects from an additional clinical site without concomitant testing in the Elecsys system).
  • Data Provenance: Implied to be from clinical sites. The collection of "data collected from 858 subjects" suggests a mix of retrospective and prospective, however the descriptions of "presenting population" and "enrolled" subjects points more towards a prospective data collection. The additional 159 subjects were "added from an additional clinical site".

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

The ground truth for Heart Failure (HF) diagnosis was primarily established "based on individual hospital criteria" and "using local hospital criteria." This implies that the diagnosis was made by treating physicians at the respective clinical sites. The document does not specify the number of experts or their specific qualifications (e.g., "radiologist with 10 years of experience").

4. Adjudication method for the test set

The document does not specify an explicit adjudication method (e.g., 2+1, 3+1, none) for the clinical diagnosis of heart failure. The ground truth ("local hospital criteria") suggests that hospital-based clinical judgment was used.

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 involving human readers and AI assistance was not done. This device is a quantitative immunochromatographic test for measuring NT-proBNP levels, not an AI-assisted diagnostic imaging device or a decision support system for human readers. The comparison is between the RAMP device and a predicate laboratory device (Roche Elecsys proBNP Assay) and the device's performance metrics (sensitivity, specificity) in diagnosing HF.

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

Yes, a standalone performance study was clearly done. The entire "Summary of Studies" section details the performance characteristics of the RAMP NT-proBNP Assay when used without human intervention in interpreting the raw data. The RAMP reader provides a quantitative result (ng/L) of NT-proBNP levels. The clinical efficacy (sensitivity, specificity) is calculated based on these quantitative results against a clinical diagnosis (ground truth), demonstrating the algorithm's standalone performance.

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

The primary ground truth used for heart failure diagnosis was clinical diagnosis based on individual hospital criteria. This would typically involve a combination of patient history, physical examination, imaging (e.g., echocardiogram), and other laboratory tests as judged by the treating clinicians. The document does not mention pathology or long-term outcomes data being used as the primary ground truth for the diagnostic studies.

8. The sample size for the training set

The document does not explicitly describe a separate "training set" for the RAMP NT-proBNP Assay algorithm in the context of machine learning. For chemical assays like this, the "training" (or development and optimization) of the assay itself is done during product development using various known concentrations and interfering substances. The performance characteristics studies (precision, linearity, LoD, LoQ, analytical specificity, interference) could be considered part of the internal validation/optimization process which might indirectly involve a "training set" of samples, but these are presented as characterization studies rather than specific training data for a machine learning model. The clinical evaluation samples (699 for method comparison, 858 for sensitivity/specificity) serve as the test sets for demonstrating performance.

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

As there is no explicitly defined "training set" in the machine learning sense, the method for establishing its ground truth is not applicable/not provided. The ground truth for the performance characterization studies (e.g., linearity, LoD) would be established by preparing samples with known, precise concentrations of NT-proBNP (spiked blood or control material where the true concentration is known).

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The RAMP® Influenza A/B Assay is a qualitative immunochromatographic assay used to identify the presence of Influenza A and Influenza B nucleoprotein antigens in nasal wash, nasal aspirate, nasopharyngeal aspirate, and nasopharyngeal swab specimens from symptomatic patients. It is an in vitro diagnostic assay that aids in the rapid differential diagnosis of influenza viral infections in symptomatic patients. A negative test is presumptive and it is recommended these results be confirmed by cell culture. Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other management decisions.

The test performance characteristics for Influenza B were established primarily with retrospective, frozen specimens. Users may wish to further evaluate the sensitivity performance of this test for Influenza B using fresh samples.

The RAMP Influenza A/B Assay is a qualitative immunochromatographic test that utilizes the RAMP 200 for the differential determination of Influenza B in nasal wash, nasal aspirate, nasopharyngeal aspirate, and nasopharyngeal swab samples. A wash/aspirate or swab sample is added to the Sample Buffer. The Sample Buffer is optimized to improve binding of the anti-influenza antibodies to the nucleoprotein antigens and reduce non-specific binding and fluorescent signal background. This sample is then mixed using the Assay Tip containing fluorescent-dyed particles conjugated to specific antibodies and applied into the sample well of the Test Cartridge. The sample migrates along the strip. Fluorescent-dyed particles coated with anti-Influenza A and anti-Influenza B antibodies bind to Influenza A or B antigens, respectively, if present in the sample. As the sample migrates along the strip, Influenza-bound particles are captured at either the Influenza A or the Influenza B detection zone, and excess fluorescent- dyed particles are captured at the internal standard zone.

The instrument then measures the amount of fluorescence emitted by the complexes at the two detection zones (Influenza A and Influenza B) and at the internal standard zone. The instrument calculates a ratio (RAMP Ratio) using the fluorescence reading of each detection zone (A or B) and the internal standard zone. The instrument compares these ratios to pre-defined threshold limits to determine a positive or negative result for Influenza B in the tested sample.

Here's an analysis 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 document doesn't explicitly state pre-defined acceptance criteria in a dedicated section with target values. However, based on the performance study results, we can infer the observed performance metrics. The primary method of comparison is against cell culture.

2. Sample Size and Data Provenance:

• Test Set (Clinical Performance):

  • Prospective Study: 844 fresh specimens (nasal wash/aspirate, nasopharyngeal aspirate, or nasopharyngeal swab samples). This study was conducted in North America during the 2006-2007 influenza season.
  • Retrospective Study: 75 retrospective frozen clinical nasopharyngeal swab samples and 130 retrospective frozen clinical wash/aspirate samples. These were compared to original cell culture results performed on fresh specimens.

• Training Set: The document does not explicitly mention a training set size or methodology for the device's algorithm. The studies described are for analytical (device characteristics) and clinical performance evaluation, not for training a machine learning model. This is a traditional IVD.

3. Number of Experts and Qualifications for Ground Truth (Test Set):

• The ground truth for the clinical performance studies was established using cell culture. The document does not specify the number or qualifications of experts involved in performing or interpreting the cell culture results. It states that "cell culture testing was performed using fresh specimens" and implies these are standard laboratory procedures.

4. Adjudication Method (Test Set):

• The document describes comparison studies where the RAMP® Influenza A/B Assay results were compared directly against cell culture results. The term "adjudication method" typically applies to resolving discrepancies between multiple readers or between a new device and a reference standard where a third, independent assessment is needed. In this case, cell culture acts as the definitive gold standard, and direct comparison is made. There is no mention of a separate adjudication process beyond the cell culture determination.

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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not done. This device is an in-vitro diagnostic (IVD) assay that produces a direct result, not an AI-assisted diagnostic imaging tool that improves human reader performance. The "readers" here are the laboratory personnel performing the assay.

6. Standalone Performance Study:

• Yes, a standalone performance study was done for the device. The "Clinical Performance" section directly compares the RAMP® Influenza A/B Assay (algorithm only, as it generates the result) against the cell culture gold standard. The sensitivity and specificity results presented in the tables are indicative of the algorithm's standalone performance.

7. Type of Ground Truth Used:

• For the clinical performance studies, the ground truth was viral cell culture. This is explicitly stated: "The performance of the RAMP Influenza A/B Assay was compared to cell culture."

8. Sample Size for the Training Set:

• As mentioned in point 2, the document does not describe the training of a machine learning algorithm. Therefore, there is no explicit training set size provided for this device in the context of AI/ML. The analytical studies describe the development and validation of the assay's operational parameters rather than training a model.

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

• Not applicable, as there is no mention of an AI/ML training set in the document. For the development of the assay (which could be considered analogous to "training" in a traditional IVD context), the process involves determining optimal reagent concentrations, binding efficiencies, and establishing cut-off values. This is based on internal analytical studies (like LoD, precision, reactivity) using characterized viral strains and clinical samples, rather than a separate ground truth establishment for a training set in the AI sense.

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The RAMP CK-MB Assay is a quantitative immunochromatographic test indicated for use as an in vitro diagnostic product used with the RAMP Clinical Reader to measure CK-MB levels in EDTA whole blood. Measurement of CK-MB aids in the rapid diagnosis of acute myocardial infarction (AMI). The RAMP CK-MB Assay is not intended to monitor reperfusion patients. The RAMP CK-MB Assay is intended to be used only to prioritize patient management for those suspected of AMI.

The RAMP CK-MB Assay is a quantitative immunochromatographic test for the determination of CK-MB levels in EDTA whole blood. Diluted EDTA whole blood is added to the sample well of the Test Cartridge which houses the immunochromatographic test strip. The red blood cells are retained in the sample pad, and the separated plasma migrates along the strip. Fluorescent-dyed latex particles coated with anti-CK-MB antibodies bind to CK-MB, if present in the sample. As the sample migrates along the strip, CK-MB bound particles are immobilized at the detection zone, and additional particles are immobilized at the internal control zone. The RAMP Reader then measures the amount of fluorescence emitted by the complexes bound at the detection zone and at the internal control zone. Using a ratio between the two fluorescence values, a quantitative reading is calculated.

Here's an analysis of the acceptance criteria and study proving device performance for the Response Biomedical Corp. RAMP CK-MB Premarket Notification (K033747) based on the provided text:

Important Note: The provided text is a 510(k) summary, which is a regulatory document. It describes the studies performed to demonstrate substantial equivalence to a predicate device, not necessarily pre-defined "acceptance criteria" in the rigorous sense of a clinical trial primary endpoint. Therefore, I will interpret "acceptance criteria" as the performance characteristics and comparative metrics targeted to establish substantial equivalence.

Acceptance Criteria and Reported Device Performance

• 7.7% at 7.19 ng/mL
• 7.8% at 14.29 ng/mL
• 4.8% at 25.06 ng/mL
  Total Precision (%CV):
• 8.6% at 7.19 ng/mL
• 8.5% at 14.29 ng/mL
• 6.9% at 25.06 ng/mL |
  | Linearity (R-value & Slope) | R = 0.999 for actual vs. expected CK-MB concentration
  Slope = 1.05
  Offset = 0.098 |
  | Percent Recovery | Ranged from 99% to 111% (average 106%) for spiked CK-MB antigen (at 2.5, 5.0, 10.0, 20.0, 40.0, and 60.0 ng/mL concentrations) |
  | Hook Effect | No high dose hook effect up to 1000 ng/mL CK-MB |
  | Analytical Sensitivity (Lower Limit of Detection - LLD) | LLD = 0.32 ng/mL CK-MB |
  | Analytical Specificity (Cross-reactivity) | CK-MM and CK-BB: No significant cross-reactivity
  HAMA, HAGA, HARA, RhF: Limited cross-reactivity |
  | Interference | No evidence of cross-reactivity or interference observed for hemoglobin (up to 2000 mg/dL), triglyceride (up to 3000 mg/dL), bilirubin (up to 80 mg/dL), cholesterol, or heparin (up to 104 IU/mL). No trend observed with increasing interferent concentration. |
  | Normal Range | 0.00 to 3.74 ng/mL in a study of 180 healthy individuals (5th to 95th percentile).
  (Compared favorably to Triage: 0.80-4.94 ng/mL and Dimension: 0.10-3.11 ng/mL, and their package inserts). |
  | Precision (Replicate Correlation) | Combined Populations: R=0.993, R²=0.988 (n=183)
  Suspect AMI Patients: R=0.993, R²=0.986 (n=128)
  Normal Individuals: R=0.959, R²=0.920 (n=55) |
  | Method Comparison (Correlation with Predicate Device - Dimension CK-MB Assay) | RAMP CK-MB vs. Dimension:
• Combined Normal and Suspect AMI: R=0.986, R²=0.972 (n=363)
• Suspect AMI: R=0.984, R²=0.967 (n=183)
• Normal: R=0.882, R²=0.779 (n=180) |
  | Method Comparison (Correlation with Predicate Device - Triage CK-MB Assay) | Triage CK-MB vs. Dimension (for context/comparison):
• Combined Populations: R=0.981, R²=0.962 (n=363)
• Suspect AMI: R=0.981, R²=0.963 (n=183)
• Normal: R=0.457, R²=0.209 (n=180) |

Study Details:

1. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

   • Precision Study: 184 subjects (55 normal, 129 suspected AMI). Data provenance is from "individual hospital criteria," suggesting it might be from sites within Canada or the US, but the specific country is not explicitly stated. The samples were taken and stored refrigerated for up to one day between analyses, implying a prospective or recently collected retrospective setup.
   • Method Comparison Study: 365 subjects (180 normal, 185 suspected AMI). Data provenance similar to the precision study, from "individual hospital criteria." Normal subjects were consented, and waste samples were used for suspected AMI subjects. Samples were processed for rapid tests (RAMP and Triage) within one day, and heparin samples were frozen and sent to a reference lab for Dimension testing. This suggests a mixed prospective/retrospective approach.
   • Expected Values (Normal Range Study): 180 healthy individuals (84 males, 96 females). Data provenance is not specified beyond "normal population studied."

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

   • This device is an in vitro diagnostic (IVD) for measuring a biomarker (CK-MB). The ground truth for such devices is typically the quantitative value obtained from a reference method or predicate device, not expert interpretation of images or clinical diagnoses based on subjective input.
   • For the "Method Comparison Study," the Dimension® RxL Mass Creatine Kinase MB Isoenzyme Flex® assay was used as the reference method (predicate device) against which both RAMP CK-MB and Triage CK-MB were compared. The "ground truth" (or reference standard) in this context is the quantitative CK-MB concentration determined by the Dimension assay.
   • No human experts were used to establish the "ground truth" in the way one might for an imaging AI device; instead, an established laboratory method served as the reference. Clinical criteria for "suspected AMI" were mentioned as selection criteria for patients but not as the ground truth for an individual CK-MB value.

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

   • No adjudication method, as typically described for subjective assessments like clinical diagnoses or imaging interpretations, was mentioned. The comparison was statistical (correlation, slope, intercept) between quantitative measurements from different assays.
   • Outliers were removed from the dataset: "one outlier was removed from the population with suspect AMI" in the Precision Study, and "two outliers were removed from the suspect AMI samples from both the RAMP and Triage analyses" in the Method Comparison Study. This isn't an "adjudication" in the traditional sense but rather a data cleaning step.

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 or human reader study was mentioned. This device is an in vitro diagnostic assay, not an AI for image interpretation or a decision support tool for human readers. Its performance is measured directly against predicate assays and analytical specifications.

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

   • Yes, the performance characteristics (precision, linearity, sensitivity, specificity, interference) and the method comparison studies represent the standalone performance of the RAMP CK-MB Assay and RAMP Reader system. It's essentially an "algorithm only" in the sense that the device outputs a quantitative value automatically, though it's an assay system rather than an AI algorithm as typically understood for imaging.

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

   • Analytical Performance (Precision, Linearity, etc.): Ground truth was established by controlled laboratory experiments using known concentrations of CK-MB and analysis of samples without known interferents.
   • Clinical Performance (Normal Range, Method Comparison): The "ground truth" or reference was the Dimension® RxL Mass Creatine Kinase MB Isoenzyme Flex® assay. For the normal range study, the normality of individuals was likely based on clinical screening (healthy individuals).

7. The sample size for the training set

   • The document does not explicitly describe a "training set" in the context of machine learning or AI. This is a traditional IVD device (immunochromatographic assay). The development of such an assay involves extensive laboratory work to optimize reagents, antibodies, and detection protocols. This optimization phase isn't typically referred to as "training" in the same way an AI model is trained.

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

   • As there's no explicitly defined "training set" for an AI model, this question is not directly applicable. The development process would have involved establishing the ground truth for various analytical parameters through experiments with known samples and concentrations, guiding the assay's design and calibration.

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The RAMP Troponin I Assay is a quantitative immunochromatographic test indicated for use as an in vitro diagnostic product used with the RAMP Clinical Reader to measure cardiac troponin I levels in EDTA whole blood. Measurement of cardiac troponin I aids in the rapid diagnosis of acute myocardial infarction (AMI). The RAMP Troponin I Assay is intended to be used only to prioritize patient management for those suspected of AMI.

The RAMP Troponin I Assay is a quantitative immunochromatographic test for the rnic Tric Troponia T-Thous) Do A whole blood. Diluted EDTA whole blood is added to the sample well of the Test Cartridge which houses the immunochromatographic test strip our pro real blood cells are retained in the sample pad, and the separated plasma migrates along the strip. Fluorescent-dyed latex particles coated with anti-Tril antibodies hightion and in the sample. As the sample migrates along the strip, Tnl bound particles are immobilized at the detection zone, and additional particles are immobilized at the internal control zone. The RAMP Reader then measures the amount of fluorescence emitted by the complexes bound at the detection zone and at the internal control zone. Using a ratio between the two fluorescence values, a quantitative reading is calculated.

This document describes the RAMP Troponin I Assay, a quantitative immunochromatographic test for measuring cardiac troponin I levels in EDTA whole blood, intended to aid in the rapid diagnosis of acute myocardial infarction (AMI).

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

The document does not explicitly state pre-defined acceptance criteria for performance metrics such as precision, linearity, or analytical sensitivity. Instead, it provides performance characteristics and then concludes that the device is "substantially equivalent" to predicate devices. For a regulatory submission like a 510(k), substantial equivalence implies that the device performs as well as or better than existing legally marketed devices.

However, we can infer some criteria and list the reported performance:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Precision Study Test Set:
  • Sample Size: 184 subjects (55 normal individuals, 129 patients suspected of AMI).
  • Provenance: Samples were selected from those obtained during the Method Comparison Study. The document does not explicitly state the country of origin but implies a clinical setting via "individual hospital criteria." It indicates the samples were retrospective for the precision study, as they were "stored refrigerated for up to one day between analyses" and subsequently analyzed in duplicates "over 10 days."
• Method Comparison Study Test Set:
  • Sample Size: 365 subjects (180 normal individuals, 185 patients suspected of AMI).
  • Provenance: The samples were obtained from subjects where "EDTA and heparin whole blood samples were obtained for each of these subjects." "All normal subjects were consented. Waste samples were used for the subjects suspected of AMI." This suggests a prospective collection for this specific study for the normal subjects, and potentially retrospective or waste samples for the AMI subjects. Country of origin is not specified but the submission is to the FDA, implying US or internationally recognized standards.
• Expected Values (Normal Range) Study Test Set:
  • Sample Size: 180 healthy individuals.
  • Provenance: "Whole blood samples from 180 healthy individuals... were assayed". This implies a prospective collection from a healthy population.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

The studies described are for an in-vitro diagnostic device measuring a biomarker (Troponin I). The "ground truth" here is the actual concentration of Troponin I in the samples. This is typically established by reference methods or comparison to legally marketed predicate devices, not by human expert consensus or radiologists.

• For the Method Comparison Study, the Dimension® RxL Cardiac Troponin-I Flex® assay (a predicate device, K973650) served as a reference for comparison, implying its results were considered a form of "ground truth" or a highly reliable comparator. The data was also compared to the Triage Cardiac Panel®, another predicate device.
• For analytical performance (precision, linearity, LLD), the ground truth is established by preparing known concentrations of the analyte (Tnl antigen) in a controlled laboratory setting.

Therefore, the concept of "experts" establishing ground truth in the way described (e.g., radiologists) is not applicable to this type of device and study.

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

Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation (e.g., radiology reads) where discrepancies between readers need to be resolved. This document describes studies for an automated in-vitro diagnostic device measuring a biomarker. Therefore, no adjudication method of this type was used or is relevant. The device output is a quantitative measurement.

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 type of study focuses on the impact of a device (often AI-based) on human reader performance, which is not applicable to an automated quantitative immunoassay like the RAMP Troponin I Assay. The device provides a direct numerical measurement of a biomarker, not an interpretation that human readers would "improve with."

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

Yes, the studies described are inherently standalone algorithm performance studies. The RAMP Troponin I Assay, in conjunction with the RAMP Reader, is an automated system that provides quantitative measurements. The performance characteristics (precision, linearity, analytical sensitivity, hook effect, cross-reactivity, interference, and method comparison) are all evaluating the device's ability to accurately measure Troponin I concentrations directly, without human interpretation of the assay's output influencing the direct measurement itself. The "human-in-the-loop" aspect for this device would be the clinician's interpretation of the numerical result in the context of patient symptoms, not the interpretation of the assay output itself.

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

The primary "ground truth" used for this quantitative assay comprises:

• Known concentrations of analyte: For analytical sensitivity, linearity, and recovery studies, known concentrations of Tnl antigen were prepared and used as the reference.
• Results from legally marketed predicate devices: For the method comparison study, the Dimension® RxL Cardiac Troponin-I Flex® Assay and Triage Cardiac Panel® Troponin I Assay were used as comparators, providing a "ground truth" for clinical sample concentrations.

This is distinct from ground truth based on expert consensus, pathology, or outcomes data, which are more common for diagnostic imaging or clinical prediction models.

8. The sample size for the training set

The document does not explicitly describe a "training set" in the context of machine learning or AI models, as this is a chemical immunoassay, not a software algorithm that learns from data.

However, if we consider "training" in a broader sense related to assay development and optimization (e.g., determining assay parameters, reagent concentrations), that information is not provided as part of this 510(k) summary. The summary focuses on the final performance validation of the developed assay.

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

As there is no "training set" described in the machine learning sense, this question is not fully applicable. For the development and establishment of the assay itself (analogous to "training" certain parameters), the ground truth would have been established through controlled laboratory experiments using purified Troponin I antigens at known concentrations and characterization against reference materials. However, details of this developmental phase are not included in the 510(k) "Summary of Studies," which focuses on performance verification.

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The RAMP Reader is a general use fluorometer that analyzes results produced by immunoassays that use a fluorophore having an excitation wavelength at 560 nm and an emission wavelength of 610 nm.

The RAMP™ Myoglobin Assay is an immunochromatographic test for the quantitative determination of myoglobin in human EDTA whole blood, using the RAMP Reader.

The RAMP Myoglobin Assay is an immunochromatographic test for the quantitative determination of myoglobin in human EDTA whole blood, using the RAMP Reader.

Diluted EDTA whole blood is applied into the sample well of the Test Cartridge. The red blood cells are retained in the sample pad, and the separated plasma migrates along a strip, through a contact zone where it interacts with fluorescent latex particles. Latex (test) particles, coated with mouse monoclonal anti-myoglobin antibodies bind to myoglobin in the sample.

The sample moves by capillary action towards the end of the strip. As the sample migrates to the detection zone, myoglobin anti-myoglobin particles are immobilized at the detection zone. and additional particles are immobilized at the internal control zone.

The RAMP Reader then measures the amount of fluorescence emitted by the complexes bound at the detection zone and at the internal control zone. Using a ratio between the two fluorescence values, a quantitative reading is calculated.

This document describes the regulatory submission for the RAMP™ Myoglobin Assay and RAMP Reader.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated in terms of pass/fail thresholds for clinical performance but are implied by demonstrating substantial equivalence to predicate devices through correlation. The reported device performance is presented as correlation coefficients (r), slopes, and intercepts from method comparison studies, and precision data.

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

• Method Comparison Study (vs. Beckman ACCESS Myoglobin Assay):
  • Test Set Size: 415 subjects (196 normal individuals, 219 patients suspected of AMI).
  • Data Provenance: Not explicitly stated but inferred to be from a clinical setting where samples for patients suspected of AMI were collected and compared with the predicate device. The samples were "EDTA whole blood samples obtained for each of these subjects." The study was likely prospective to obtain samples for direct comparison.
• Precision Study (duplicate testing):
  • Test Set Size: 179 subjects (77 normal individuals, 102 patients suspected of AMI).
  • Data Provenance: Samples were "selected randomly from those obtained during the Method Comparison Study." These samples were stored refrigerated for up to five days between analyses. This suggests retrospective analysis of samples collected during the method comparison, or a subset of freshly collected samples used specifically for this precision arm.
• Expected Values (Normal Range Study):
  • Test Set Size: 196 healthy individuals.
  • Data Provenance: Not explicitly stated, but "Whole blood samples from 196 healthy individuals" implies prospective collection from a healthy population.

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

There were no experts used to establish ground truth in the traditional sense. The device's performance was evaluated by comparing its quantitative myoglobin measurements to those obtained from an already marketed, legally predicate device (Beckman ACCESS Myoglobin Assay). The "ground truth" here is the measurement provided by the predicate device at the time of the study rather than a consensus of human experts interpreting diagnostic images or clinical scenarios.

4. Adjudication Method for the Test Set

No adjudication method was used, as this was a quantitative measurement comparison study against a predicate device. The comparison involved direct numerical measurements, not subjective interpretations requiring adjudication.

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 MRMC comparative effectiveness study was done. This device is an in vitro diagnostic (IVD) assay for quantitative measurement, not an AI-assisted diagnostic imaging or interpretation tool. It does not involve human readers interpreting cases with or without AI assistance.

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

Yes, the studies presented are standalone performance studies. The RAMP Myoglobin Assay, when used with the RAMP Reader, directly generates a quantitative myoglobin result. The performance data (precision, linearity, analytical sensitivity, and method comparison) evaluate the device's ability to produce accurate and reproducible measurements independently. Human input is limited to sample collection, loading, and reading the final numerical result from the RAMP Reader.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The "ground truth" for the method comparison studies was the quantitative myoglobin concentration determined by the predicate device, the Beckman ACCESS Myoglobin Assay. For analytical performance, the "ground truth" was established by known concentrations of myoglobin antigen (e.g., for linearity and analytical sensitivity).

8. The Sample Size for the Training Set

The document does not provide details about a specific "training set" for the RAMP™ Myoglobin Assay in the context of machine learning or AI models. This device is an immunochromatographic assay; its "training" or calibration would typically involve laboratory procedures to establish standard curves and internal controls during manufacturing and quality control, rather than a data-driven training set in the AI sense.

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

As noted in point 8, the concept of a "training set" and its "ground truth" in the AI sense does not apply directly to this particular device. Calibration and quality control for an immunoassay involve:

• Known Calibrators: Using substances with precisely known concentrations of myoglobin to establish a standard curve for the RAMP Reader to accurately convert fluorescence signals into myoglobin concentrations.
• Controls: Running samples with known myoglobin concentrations (quality controls) to ensure the assay is performing within established limits over time.

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