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K Number
K023505
Device Name
VBL SERUM TROPONIN I TEST, MODEL 1001
Manufacturer
VANCOUVER BIOTECH LTD.
Date Cleared
2003-03-31

(164 days)

Product Code
MMI
Regulation Number
862.1215
Type
Traditional
Panel
CH
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The VBL Serum Troponin I Test is intended for the qualitative determination of cardiac troponin I in human serum. Measurement of troponin I values are useful in the evaluation of acute myocardial infarction (AMI).

Device Description

Not Found

AI/ML Overview

The provided text is a 510(k) clearance letter from the FDA for a device called "Vancouver Biotech, Ltd. Rapid Human Cardiac Troponin I Test" or "Vancouver Biotech, Ltd. Serum Troponin I Test." This letter primarily discusses the regulatory approval process and acknowledges substantial equivalence to a predicate device.

Unfortunately, the provided document does not contain the detailed information required to answer your specific questions regarding acceptance criteria, study design, sample sizes, ground truth establishment, or expert qualifications. These details are typically found in the supporting technical sections of a 510(k) submission, which are not included in this FDA clearance letter.

Therefore, I cannot populate the table or provide answers to most of your questions based only on the provided text.

Here's what I can extract, and what is missing:

Information Extracted from the Document:

  • Device Name: Vancouver Biotech, Ltd. Rapid Human Cardiac Troponin I Test or Vancouver Biotech, Ltd. Serum Troponin I Test
  • Intended Use: "The VBL Serum Troponin I Test is intended for the qualitative determination of cardiac troponin I in human serum. Measurement of troponin I values are useful in the evaluation of acute myocardial infarction (AMI)."
  • Regulatory Class: Class II
  • Product Code: MMI
  • Type of Ground Truth (implied): The test is for the qualitative determination of cardiac troponin I in human serum. This implies the ground truth for performance evaluation would likely be a reference method for troponin I measurement, or clinical diagnosis of AMI confirmed by other means.

Missing Information (Not Available in the Provided Text):

  1. A table of acceptance criteria and the reported device performance: This document confirms regulatory clearance but does not present the specific performance metrics (e.g., sensitivity, specificity, accuracy) or the acceptance thresholds that were used in the testing.
  2. Sample size used for the test set and the data provenance: Not mentioned.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for this type of in vitro diagnostic test, as ground truth is typically established by laboratory reference methods or clinical diagnosis, not expert consensus on images.
  4. Adjudication method for the test set: Not applicable for this type of in vitro diagnostic test.
  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 in vitro diagnostic device, not an AI-assisted diagnostic imaging device.
  6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device is a "test system" for qualitative determination, implying a standalone performance evaluation against a reference. However, the details of such a study (its results, design, and outcome) are not in this document.
  7. The type of ground truth used: While it's implied to be related to clinical diagnosis of AMI and/or a reference method for troponin I, the specific method used for the study is not detailed.
  8. The sample size for the training set: Not applicable, as this is an in vitro diagnostic test, not typically "trained" in the way an AI algorithm is.
  9. How the ground truth for the training set was established: Not applicable.

§ 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.