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CareStart™ Cardiac 3-in-1 Troponin I/CK-MB/Myoglobin Test is intended for the qualitative detection of cardiac troponin I, CK-MB and myoglobin in human blood, serum qualitative detection of cardiac troponin I, CK-MB and myoglobin aids in rapid diagnosis of acute myocardial infarction. The performance characteristics of the test have not been evaluated in a point-of-care (POC) setting.

CareStart™ Cardiac 2-in-1 Troponin I/Myoglobin Test is intended for the qualitative detection of cardiac troponin I, and myoglobin in human blood, serum or plasma. detooking of cardiae troponin I, and myoglobin aids in rapid diagnosis of acute myocardial infarction. The performance characteristics of the test have not been evaluated in a point-of-care (POC) setting.

CareStart™ Cardiac CKMB Test is intended for the qualitative detection of CK-MB in human blood, serum or plasma. Measurement of CK-MB aids in rapid diagnosis of numan blood, corant of on. The performance characteristics of the test have not been evaluated in a point-of-care (POC) setting.

CareStart™ Cardiac Troponin I Test is intended for the qualitative detection of cardiac oarcotar troponiir in haman broomyocardial infarction. The performance characteristics of the test have not been evaluated in a point-of-care (POC) setting.

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This document is a 510(k) premarket notification for the CareStart Cardiac 3-in-1 Troponin I/CK-MB/Myoglobin Test, CareStart Cardiac 2-in-1 Troponin I/Myoglobin Test, CareStart Cardiac Troponin I, and CareStart Cardiac CK-MB devices.

Per the provided document, the FDA has determined that the device is substantially equivalent to legally marketed predicate devices. This type of submission relies on demonstrating substantial equivalence to a predicate device, rather than providing extensive clinical trial data with predefined acceptance criteria and performance metrics.

Therefore, the document does not contain the detailed information requested regarding specific acceptance criteria and a study proving the device meets them in the format typically seen for novel devices requiring extensive clinical validation. The approval is based on the device's similarity to existing devices already on the market.

However, I can extract the information that is present concerning the intended use and performance in a general sense:

1. A table of acceptance criteria and the reported device performance:
   The document does not provide a table of acceptance criteria nor reported device performance metrics (e.g., sensitivity, specificity, accuracy, PPV, NPV) from a dedicated study. The FDA's substantial equivalence determination implies that the device performs comparably to the predicate devices, which would have established performance characteristics.

2. Sample size used for the test set and the data provenance:
   This information is not provided in the document. The filing is a 510(k) and does not detail a specific performance study with a test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   This information is not provided in the document.

4. Adjudication method for the test set:
   This information is not provided in the 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:
   This is not applicable. These are in-vitro diagnostic tests for qualitative detection of biomarkers, not AI-assisted imaging or diagnostic devices where human reader performance would be a factor in an MRMC study.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
   This is not applicable. These are diagnostic test kits, not algorithms. Their performance is inherent to the kit itself.

7. The type of ground truth used:
   This information is not explicitly stated in the document. For in-vitro diagnostic tests like these, ground truth for performance studies would typically be established by laboratory reference methods or clinical diagnosis supported by multiple lines of evidence for the target condition (acute myocardial infarction).

8. The sample size for the training set:
   This information is not provided in the document. (Not typically relevant for 510(k) submissions of IVD kits that are based on chemical reactions rather than machine learning algorithms.)

9. How the ground truth for the training set was established:
   This information is not provided in the document. (Not typically relevant for 510(k) submissions of IVD kits.)

Summary of what can be inferred from the document:

• Device Intended Use: The devices are intended for the qualitative detection of cardiac biomarkers (Troponin I, CK-MB, Myoglobin) in human blood, serum, or plasma to aid in the rapid diagnosis of acute myocardial infarction.
• Regulatory Class: Class II
• Prescription Use: All listed devices are for prescription use.
• Point-of-Care (POC) Setting: The performance characteristics have not been evaluated in a point-of-care (POC) setting, meaning their use is intended for laboratory or clinical settings where trained personnel can perform the test.
• Basis for Approval: Substantial equivalence to legally marketed predicate devices, meaning the FDA believes these devices are as safe and effective as existing devices for their stated indications. This does not involve independent clinical trials detailed within this specific 510(k) submission.

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