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The Spectral West Nile virus IgM STATus™ test is a rapid immunochromatographic lateral flow assay that utilizes recombinant West Nile virus (WNV) antigen (E glycoprotein) for the qualitative detection of IgM antibodies to WNV in human serum or plasma (sodium heparin or sodium citrate). This test is for the presumptive laboratory diagnosis of West Nile virus infection in patients having signs and symptoms of meningoencephalitis. Positive results must be confirmed by the PRNT (Plaque Neutralization Reduction Test), or by using the current CDC guidelines for diagnosis of this disease. The Spectral test is not intended for point of care testing, home use or in screening blood donor samples.

A Simple and Rapid Immunoassay for the Qualitative Detection of West Nile Virus IgM Antibodies in Human Serum or Plasma. The Spectral WNV IgM STATus™ test employs solid-phase immunochromatographic assay technology to qualitatively detect the presence of WNV IgM antibodies in serum or plasma. When the specimen to be tested is dispensed into the sample well of the Spectral device, anti-WNV IgM in the sample will bind to the recombinant WNV antigen (envelop glycoprotein (E) of West Nile virus, NY99 strain) to form a tertiary complex with gold-labeled monoclonal murine antibody against flavivirus family glycoprotein E. This tertiary complex will migrate through reaction strip and be captured by goat anti-human IgM antibodies at the Test area. Excess, unreacted gold complex detector is captured by immobilized anti-mouse IgG antibodies at the Control area. A visible pinkish-purple horizontal band will appear in the Test area within 15 minutes following the addition of a sample if the level of the WNV IgM antibodies in the human serum sample is above the cut-off level. A pinkish-purple band in the Control area indicates that the test is working properly and such a band must always appear, irrespective of the WNV IgM levels, in order for the test to be valid.

Acceptance Criteria and Device Performance Study for Spectral West Nile Virus IgM STATus™ Test

This document outlines the acceptance criteria and the studies that demonstrate the Spectral West Nile Virus IgM STATus™ Test meets these criteria, based on the provided 510(k) summary (K052519).

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria with specific numerical targets in a formal table. However, based on the performance data presented, the implicit acceptance criteria appear to be high agreement (sensitivity and specificity/negative agreement) with a legally marketed predicate device (Focus West Nile Virus IgM Capture ELISA) and reference methods like PRNT, along with robust reproducibility.

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

The test set consisted of several distinct groups of samples tested at different study sites.

• Non-flavivirus IgM samples (for Negative Agreement):
  • Total Sample Size: 346 specimens.
  • Provenance: Prospectively collected from patients with a variety of non-flavivirus ailments (e.g., rash, febrile, bronchitis, diarrhea, drug, neuropathy, acute coronary syndrome) and from endemic normal populations.
  • Country of Origin:
    • Site 1: South-Western State of America (endemic region).
    • Sites 2 & 3: South Eastern Provinces of Canada (endemic regions).
• WNV PRNT Confirmed / CDC WNV IgM ELISA Negative specimens (Study Site 4):
  • Total Sample Size: 90 specimens (40 WNV PRNT confirmed; 50 CDC WNV IgM ELISA negative).
  • Provenance: Randomized retrospective patient serum specimens from a provincial health laboratory, sent with suspected WNV infection.
  • Country of Origin: South Eastern Province of Canada.
• Banked Panel of Clinical Serum Specimens (Study Site 5):
  • Total Sample Size: 79 specimens.
  • Provenance: Banked clinical serum specimens from patients with clinical symptomology consistent with WNV infection (including symptomatic acutely infected, neuro-invasive disease, and asymptomatic for previous exposures).
  • Country of Origin: Prairie Province at Central Canada.
• Reproducibility Panel: 15 clinical specimens.
• Interfering Substances Panel: Positive and negative serum specimens spiked with specific substances.
• IgM Specificity Panel: 14 paired positive samples.
• Cross-Reactivity Panel: Varied number of samples for each potentially cross-reactive agent (e.g., 10 for HSV, 28 for ANA, 33 for Rheumatoid Factor).
  • Provenance: Sera sero-positive to other potentially cross-reactive pathogens.
  • Country of Origin: North Eastern USA (site 1), Mid-West Canada (site 3 for Dengue), in-house (site 2 for ANA/RF), CDC laboratory at Mid-West USA (site 4 for EEE).

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

The document does not specify the number or qualifications of experts used to establish the ground truth for the test set. Instead, it relies on established reference methods and the comparator predicate device.

4. Adjudication Method for the Test Set

The document does not mention an explicit adjudication method for the test set (e.g., 2+1, 3+1). The "ground truth" was established by reference assays or clinical characterization of samples.

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

There is no indication of a multi-reader multi-case (MRMC) comparative effectiveness study or any assessment of human readers improving with AI vs. without AI assistance. This device is a diagnostic assay (rapid immunochromatographic test) designed for laboratory use, not an AI-assisted diagnostic imaging or interpretation tool for human readers.

6. Standalone Performance Study

Yes, a standalone performance study was conducted. The "Method Comparison" section explicitly tests the Spectral device against a comparator device (Focus West Nile Virus IgM Capture ELISA) and other reference methods like PRNT and CDC WNV IgM ELISA. The reported performance metrics (e.g., negative agreement, serological sensitivity) are measures of the algorithm's (device's) performance without human-in-the-loop intervention beyond reading the visible bands.

7. Type of Ground Truth Used

The ground truth for the different test sets was established using a combination of the following:

• Reference Devices/Assays:
  • Comparator device: Focus West Nile Virus IgM Capture ELISA (for negative agreement studies).
  • PRNT (Plaque Neutralization Reduction Test): Considered a gold standard for confirming WNV infection. Used for characterizing positive WNV samples at Study Site 4 and 5.
  • CDC WNV IgM ELISA and IgG ELISA: Used as reference assays for characterizing WNV positive and negative samples at Study Site 4 and 5.
• Clinical Characterization: Samples at Study Site 4 were from patients with "suspected WNV infection based on clinical signs and symptoms." Samples at Study Site 5 were from patients with "clinical symptomology consistent with the West Nile virus infection."
• Pathogen Sero-positivity: For cross-reactivity studies, samples were characterized as sero-positive to other potentially cross-reactive pathogens (e.g., Herpes Simplex Virus, Cytomegalovirus, Syphilis, Epstein Barr Virus, ANA, Rheumatoid Factor, HIV, certain Encephalitis viruses, Dengue Virus, Hepatitis B/C, Legionella, Yellow Fever, E. coli infection).

8. Sample Size for the Training Set

The document does not provide any information regarding a training set or its sample size. This is a rapid diagnostic test, and the reported studies focus on validation and performance characteristics as opposed to machine learning model development which would typically involve distinct training and test sets.

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

Since no information on a training set is provided, the method for establishing its ground truth is also not available in the document.

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For the qualitative determination of CK-MB, myoglobin, and cardiac troponin I in human whole blood, plasma or serum as an aid in the diagnosis of acute myocardial infarction in emergency room, critical care, pointof-care, and hospital settings.

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The provided text is a 510(k) premarket notification letter from the FDA regarding the "Spectral Cardiac STATus™ CK-MB-Myoglobin/Troponin I 3-in-1 test." This document is an approval letter and an "Indications for Use" statement, not a study report or clinical trial summary.

Therefore, it does not contain the acceptance criteria or the study details requested in your prompt. It only states that the device is substantially equivalent to legally marketed predicate devices and outlines its intended use.

To answer your questions, I would need access to the actual 510(k) submission document or a clinical study report for this device, which are not provided in the input text.

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For the qualitative determination of CK-MB in human whole blood, plasma or serum as an aid in the diagnosis of acute myocardial infarction in emergency room, critical care, point-of-care, and hospital settings.

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This document is limited in the information it provides regarding the acceptance criteria and the study that proves the device meets them. It is a 510(k) clearance letter for the "Spectral's Cardiac Status™ CK-MB Rapid Test," indicating that it has been determined substantially equivalent to a legally marketed predicate device. This type of clearance generally implies that the new device performs as well as, or is as safe and effective as, an existing device.

However, the letter itself does not contain the detailed study results, acceptance criteria, or performance data. These would typically be found in the 510(k) submission itself, which is not provided here.

Therefore,Based on the provided document, I cannot fully answer your request. The document is a 510(k) clearance letter, confirming that the "Spectral's Cardiac Status™ CK-MB Rapid Test" has been found substantially equivalent to a predicate device. This letter does not contain the detailed study information, acceptance criteria, or performance data that would typically be part of the 510(k) submission.

Here's what can be inferred or stated as missing:

1. A table of acceptance criteria and the reported device performance:
* Not present in this document. The 510(k) clearance letter itself does not include performance data or specific acceptance criteria. These would have been part of the original 510(k) submission.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
* Not present in this document.

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):
* Not present in this document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
* Not present in this 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:
* Not applicable/Not present. This device is an in vitro diagnostic test for CK-MB, not an AI-assisted diagnostic imaging device requiring human reader improvement studies.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
* Yes, implicitly. As an in vitro diagnostic test, the "Spectral's Cardiac Status™ CK-MB Rapid Test" would perform its analysis (qualitative determination of CK-MB) independently, without a human "in-the-loop" once the sample is applied and the test is run. Its performance would be evaluated in a standalone manner. No specific study details are given here, but the nature of the device implies a standalone performance evaluation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
* Not explicitly stated in this document. For an in vitro diagnostic device like this, the ground truth for CK-MB levels would typically be established using a reference laboratory method (e.g., a highly sensitive and specific quantitative CK-MB assay) or clinical diagnosis based on a combination of symptoms, ECG, and other lab markers as part of MI diagnosis.

8. The sample size for the training set:
* Not present in this document. This device, being a rapid diagnostic test, might not use a "training set" in the same way a machine learning algorithm would. It would likely be validated against clinical samples with known concentrations/statuses.

9. How the ground truth for the training set was established:
* Not present in this document.

Summary of what's provided by the document:

• Device Name: Spectral's Cardiac Status™ CK-MB Rapid Test
• Intended Use: For the qualitative determination of CK-MB in human whole blood, plasma or serum as an aid in the diagnosis of acute myocardial infarction in emergency room, critical care, point-of-care, and hospital settings.
• Regulatory Status: Class II device, cleared via 510(k) as substantially equivalent to a predicate device.

To obtain the detailed study information, acceptance criteria, and performance data, one would need to refer to the actual 510(k) submission (K022409) filed with the FDA, rather than just the clearance letter.

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For the qualitative determination of cardiac troponin I (cTnI) and myoglobin in numali whole blood, prasilia of the many of the of-care, and hospital settings.

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Here's an analysis of the provided text, focusing on the acceptance criteria and the study details:

The provided document is an FDA 510(k) clearance letter for the "Spectral's 2 in 1 (TnI-Myo) test." This type of document primarily confirms substantial equivalence to a predicate device and provides regulatory information. It does not typically contain the detailed study results, acceptance criteria, or ground truth establishment methods that would be found in a clinical study report or a 510(k) submission itself.

Therefore, much of the requested information cannot be directly extracted from the provided text. I will explicitly state if the information is "Not available in the provided text."

Acceptance Criteria and Device Performance (Based on available information and typical device regulation)

Since the document is an FDA clearance letter for a diagnostic test, the "acceptance criteria" generally refer to the performance characteristics that render the device substantially equivalent to a legally marketed predicate device. While specific numerical acceptance criteria are not in this document, the overall acceptance standard is "substantial equivalence."

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not available in the provided text.
• Data Provenance: Not available in the provided text (e.g., country of origin, retrospective or prospective).

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

• Not available in the provided text. This information would typically be in the clinical study section of the 510(k) submission. For a diagnostic cardiac marker test, the "ground truth" (e.g., diagnosis of MI) is often established by a combination of clinical assessment, ECG changes, and serial biomarker measurements using a laboratory reference method, not necessarily by a panel of "experts" in the same way an imaging study might be.

4. Adjudication Method for the Test Set

• Not available in the provided text.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No. An MRMC study is typically for imaging devices where human readers interpret images with and without AI assistance. This device is an in-vitro diagnostic (IVD) test, where a machine or visual reading (depending on the format) produces a result. Human interpretation of the test result occurs, but it's not an MRMC study in the traditional sense of comparing human reader performance on complex cases.

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

• Yes, implicitly. For an IVD device like this, the device itself provides a result (qualitative determination of cTnI and myoglobin). The performance metrics (e.g., sensitivity, specificity, analytical accuracy) would represent the "standalone" performance of the test kit against a reference standard. While the document doesn't provide these specific metrics, they are a fundamental part of the 510(k) submission for IVD devices.

7. The Type of Ground Truth Used

• Not explicitly stated in the provided text. For cardiac biomarker IVDs, the "ground truth" for a positive MI diagnosis in clinical studies usually involves a composite endpoint, which may include:
  • Expert Consensus: A panel of cardiologists reviewing all available clinical data (symptoms, ECG, imaging, clinical course).
  • Outcomes Data: Definitive diagnosis of MI based on all clinical evidence and patient outcomes.
  • Validated Reference Method: Comparison against a highly accurate laboratory-based immunoassay for cTnI and Myoglobin as a primary reference for analytical performance, and then correlated with clinical outcomes for diagnostic performance.

8. The Sample Size for the Training Set

• Not available in the provided text. (IVD devices typically refer to "development" or "validation" sets rather than "training" sets in the context of traditional machine learning, though modern IVDs can incorporate AI/ML).

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

• Not available in the provided text.

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The Spectral's Troponin I test is intended for use as an in vitro diagnostic product for the rapid quantitative determination of cardiac troponin I in human whole blood, serum, and plasma. The test is used as an aid in the diagnosis of myocardial infarction in emergency room, critical care, point of care and hospital settings.

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The provided text is a 510(k) clearance letter from the FDA for "Spectral's Troponin I Test," an in vitro diagnostic device. This document does not contain the detailed information required to answer your prompt regarding acceptance criteria, study design, sample sizes, expert qualifications, or ground truth establishment for an AI/device performance study.

The letter confirms that the device is substantially equivalent to legally marketed predicate devices and can be marketed. It discusses regulatory classifications, general controls, and directs the manufacturer to various FDA offices for further information on labeling, promotion, and other responsibilities.

Therefore, I cannot extract the requested information from the provided text. The document does not describe a study that proves the device meets acceptance criteria in the way you've outlined for an AI/device performance evaluation.

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The CardioQuant™ Troponin I Test is intended for use for as an in vitro diagnostic product to measure by immunochemical techniques the cardiac troponin I in serum and plasma. Measurement of troponin I aids in the rapid diagnosis of heart disease.

The Spectral Diagnostics CardioQuant 1 Troponin 1 Test is an automated latex immunoturbidometric method. The test utilizes monoclonal and polyclonal antibodies each covalently bound to polystyrene supercarboxylated latex particles. When serum or plasma and assay buffer are combined with the latex particles, troponin I in the specimen cross-links adjacent latex beads and produces an increase in the turbidity of the solution. The turbidity, measured at 600mm, is proportional to the concentration of troponin I present in the serum or plasma.

The provided text describes the Spectral Diagnostics Inc. CardioQuant™ Troponin I Test 510(k) Notification. This submission does not pertain to an AI/ML device but rather to an in vitro diagnostic (IVD) test. Therefore, many of the requested categories related to AI/ML device studies (e.g., sample size for training set, number of experts for ground truth, MRMC study, AI vs. human improvement) are not applicable.

Here's an analysis based on the information provided for this IVD device:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: N = 281
• Data Provenance: Serum samples. The document does not specify the country of origin or whether the data was retrospective or prospective.

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

• Not applicable as this is an IVD device measuring a biochemical marker, not an AI/ML device requiring expert interpretation of complex data for ground truth. The "ground truth" implicitly refers to the measurement by the predicate device.

4. Adjudication method for the test set

• Not applicable for this type of IVD device. The comparison is a quantitative measurement against a predicate device.

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 IVD device, not an AI-assisted diagnostic tool for human readers.

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

• Not applicable. This is a laboratory diagnostic test that produces a quantitative result; it's inherently "standalone" in its measurement function, but there's no "algorithm" in the sense of AI/ML.

7. The type of ground truth used

• The "ground truth" in this context is the measurement obtained from the Dade-Behring Stratus® Troponin I Fluorometric Assay, which is the predicate device. This is a form of comparative measurement against an established method.

8. The sample size for the training set

• Not applicable. This is an IVD chemical assay, not an AI/ML model that requires a "training set."

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

• Not applicable, as there is no training set for this type of device.

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CardioQuant™ Cardiac Assessment Controls are intended for use as assayed quality control materials in quality assurance programs to monitor the performance of clinical diagnostic test methods for troponin I, CK-MB and myoglobin. These external controls compliment the monitoring of the test performance by the kit specific controls provided by each test device manufacturer.

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This is a New 510(k) K991447 for a Class I device, CardioQuant™ Cardiac Assessment Controls. As such, there is no discussion of acceptance criteria, device performance, or study design. There would have been no requirement for clinical studies to prove substantial equivalence. All the information that can be extracted is described below.

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

Not applicable for this device and 510(k) submission.

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

Not applicable for this device and 510(k) submission.

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)

Not applicable for this device and 510(k) submission.

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

Not applicable for this device and 510(k) submission.

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 for this device and 510(k) submission.

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

Not applicable for this device and 510(k) submission.

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

Not applicable for this device and 510(k) submission.

8. The sample size for the training set

Not applicable for this device and 510(k) submission.

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

Not applicable for this device and 510(k) submission.

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The Multiquant® Quantitative Myoglobin Test is intended for use for as an in vitro diagnostic product to measure by immunochemical techniques the myoglobin ( an oxygen storage protein found in muscle) in serum and plasma. Measurement of myoglobin aids in the rapid diagnosis of heart disease.

The Spectral Diagnostics Multiquant® Quantitative Myoglobin Test is an automated latex immunoturbidometric method. The test utilizes a monoclonal antibody and a polyclonal antibody each covalently bound to polystyrenesupercarboxylated latex particles. When serum or plasma and assay buffer are combined with the latex particles, myoglobin in the specimen crosslinks adjacent latex beads and produces an increase in the turbidity of the solution. The turbidity, measured at 600nm, is proportional to the concentration of myoglobin present in the serum or plasma.

Here's an analysis of the acceptance criteria and study detailed in the provided document for the Spectral Diagnostics Multiquant® Quantitative Myoglobin Test:

Acceptance Criteria and Device Performance for Spectral Diagnostics Multiquant® Quantitative Myoglobin Test

1. Table of Acceptance Criteria and Reported Device Performance:

Rationale for Acceptance Criteria: The primary acceptance criterion for substantial equivalence was method correlation with a legally marketed predicate device (Dade-Behring Stratus® Myoglobin Fluorometric Assay). A correlation coefficient of 0.99, indicating a very strong linear relationship, along with a regression equation close to y=x (or a slope near 1 and y-intercept near 0), demonstrates that the new device performs comparably to the predicate. Precision data supports the reliability and reproducibility of the device.

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

• Sample Size: 172 serum samples (N = 172).
• Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given the nature of a 510(k) submission for an in vitro diagnostic product, it is most likely that the samples were collected in a clinical setting (e.g., hospital laboratory) and were retrospective (pre-existing samples) or collected via a prospective study for the purpose of this validation. No specific country of origin is mentioned, but the manufacturer is Canadian (Spectral Diagnostics Inc. 135-2 The West Mall Toronto, Ontario Canada M9C 1C2) and the regulatory body is the US FDA, so the study could have been conducted in either country or internationally.

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

• This information is not applicable to this type of device and study. For in vitro diagnostic assays like the Multiquant® Quantitative Myoglobin Test, the "ground truth" for the test set is established by testing the samples with a predicate device (the Dade-Behring Stratus® Myoglobin Fluorometric Assay). The performance of the new device is then compared against the results generated by this established predicate method. No human experts are used to interpret the results and establish a "ground truth" in the way they would for image-based diagnostic aids.

4. Adjudication Method for the Test Set:

• Not applicable. As described above, the ground truth is established by the predicate device's measurement. There is no subjective human interpretation requiring adjudication.

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

• No. An MRMC study is not applicable to this type of in vitro diagnostic device. MRMC studies are typically used to assess human reader performance, often in the context of imaging diagnostics where radiologists interpret images. This device measures a biomarker concentration, which is an objective numerical result, not subject to human interpretation in the same way. Therefore, there is no "human reader" component to improve.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

• Yes. The study described (method correlation and precision) represents the standalone performance of the Spectral Diagnostics Multiquant® Quantitative Myoglobin Test. It evaluates the device's ability to accurately and precisely measure myoglobin concentrations in serum/plasma samples, independently of human interpretation. The output is a quantitative value, not a diagnosis requiring human augmentation.

7. Type of Ground Truth Used:

• Predicate Device Results (Comparative Ground Truth): The "ground truth" for the performance evaluation of the Multiquant® test was the results obtained from the Dade-Behring Stratus® Myoglobin Fluorometric Assay. The study aimed to demonstrate substantial equivalence by showing that the new device's measurements correlated highly with those of an already legally marketed and accepted device.

8. Sample Size for the Training Set:

• Not explicitly stated/Likely not applicable in the classical sense. For an immunoassay like this, there isn't a "training set" in the machine learning sense that would be used to develop an algorithm. The "training" of such a device primarily involves optimizing the chemical reagents, reaction conditions, and calibration curve during the product development phase. This optimization process would typically involve numerous experiments and testing of different concentrations of myoglobin, but not a distinct "training set" of patient samples in the way that an AI algorithm has a training dataset. The 172 validation samples would be its primary performance assessment.

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

• Not explicitly stated/Likely not applicable as described above. Since there isn't a classical training set for a machine learning algorithm, the concept of establishing "ground truth" for it is not directly applicable. The "ground truth" for calibration and optimization during development would originate from known concentrations of myoglobin standards.

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Cardiac STATus™ Controls (CK-MB/Myoglobin/Troponin I) are intended for use as assayed quality control materials in quality assurance programs to monitor the performance of the Spectral Diagnostics Inc. Cardiac STATus™ CK-MB, Myoglobin, and Troponin I Rapid Tests. These external controls compliment the monitoring of the test performance by the internal control provided in each test device.

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This document is an FDA 510(k) clearance letter for an in vitro diagnostic device, specifically quality control materials for cardiac markers. It does not contain information about a study that assesses a device's performance against detailed acceptance criteria in the way described in the prompt.

Therefore, I cannot extract the requested information (acceptance criteria, device performance, sample sizes, ground truth details, expert qualifications, adjudication methods, MRMC studies, or standalone performance) from this document. This letter primarily confirms that the device is substantially equivalent to a previously marketed device and outlines regulatory obligations.

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