(68 days)
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.
Not Found
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.
§ 862.1215 Creatine phosphokinase/creatine kinase or isoenzymes test system.
(a)
Identification. A creatine phosphokinase/creatine kinase or isoenzymes test system is a device intended to measure the activity of the enzyme creatine phosphokinase or its isoenzymes (a group of enzymes with similar biological activity) in plasma and serum. Measurements of creatine phosphokinase and its isoenzymes are used in the diagnosis and treatment of myocardial infarction and muscle diseases such as progressive, Duchenne-type muscular dystrophy.(b)
Classification. Class II.