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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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The Cardiac STATus™ CK-MB/Myoglobin Rapid One Step Test is intended for use as an in vitro diagnostic product for the rapid qualitative determination of CK-MB and myoglobin in serum, human whole blood, or plasma as an aid in the diagnosis of myocardial infarction in emergency room, critical care, point of care or hospital settings.

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This looks like a medical device approval letter. I will do my best to extract the information you requested, but please note that due to the specialized nature of the document, some of the requested information might not be present or explicitly stated.

Based on the provided text, here's an analysis of the acceptance criteria and study information for the "Cardiac STATus CK-MB/Myoglobin Rapid One-Step Test":

No explicit acceptance criteria or detailed study results are provided in this document. This document is a 510(k) clearance letter from the FDA, indicating that the device has been found substantially equivalent to a legally marketed predicate device. It does not typically contain the detailed performance study results or specific acceptance criteria that would have been submitted by the manufacturer.

However, I can infer some aspects based on the nature of a 510(k) submission for an in vitro diagnostic device:

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

   • No specific acceptance criteria or reported device performance metrics (e.g., sensitivity, specificity, accuracy against a gold standard) are explicitly stated in this document. Such information would be detailed in the manufacturer's 510(k) submission, not typically in the FDA clearance letter itself.
   • Inferred based on the indication for use: As an "in vitro diagnostic product for the rapid qualitative determination of CK-MB and myoglobin... as an aid in the diagnosis of myocardial infarction," the device would have been evaluated for its ability to accurately detect the presence or absence of CK-MB and myoglobin, implying performance metrics like sensitivity, specificity, and potentially concordance with a reference method.

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

   • Not specified in this document.

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

   • Not specified in this document. For a diagnostic test like this, the "ground truth" for myocardial infarction would likely be established by clinical diagnosis, potentially involving multiple clinical factors and other diagnostic tests, rather than solely by a panel of experts reviewing the device's output.

4. Adjudication method for the test set:

   • Not specified 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. This device is an in vitro diagnostic test kit (a rapid one-step test for biochemical markers), not an AI-assisted diagnostic tool that humans would use to interpret images or other data. Therefore, an MRMC study comparing human readers with and without AI assistance would not be relevant.

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

   • Yes, implicitly. As an in vitro diagnostic assay, its performance is evaluated as a standalone product. The "test" itself generates the result. While a healthcare professional interprets the result in the context of a patient's overall clinical picture, the assay's performance characteristics (e.g., how accurately it detects the markers) are determined independently of human interpretation of its internal workings. The product is described as a "Rapid One-Step Test," suggesting it provides a direct qualitative result (e.g., positive/negative line on a strip).

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

   • Not explicitly stated in this document. For a device "as an aid in the diagnosis of myocardial infarction," the ground truth for the clinical studies would typically involve:
     • Clinical diagnosis of MI: Based on a combination of clinical symptoms, ECG changes, and serial cardiac marker measurements (often using a laboratory-based, well-established reference method).
     • Reference method comparison: The device's CK-MB and Myoglobin results would be compared against established laboratory methods for these markers.

8. The sample size for the training set:

   • Not specified in this document. (Training sets are relevant for developing the assay, but the 510(k) primarily focuses on clinical validation.)

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

   • Not specified in this document. Similar to the test set, it would likely involve clinical diagnosis and comparison to reference laboratory methods during the development phase.

In summary, this FDA 510(k) clearance letter provides high-level information about the regulatory approval of the "Cardiac STATus CK-MB/Myoglobin Rapid One-Step Test" but does not contain the detailed study specifics (acceptance criteria, sample sizes, expert qualifications, ground truth methods, or performance metrics) typically found in the clinical study report itself. These details would have been part of the original 510(k) submission.

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