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The Assert-IQ™ ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms that may be cardiac-related such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias such as bradycardia, and sinus pauses. The Assert-IQ ICM is also indicated for patients who have been previously diagnosed with atrial fibrillation (AF) or who are susceptible to developing AF. The Assert-IQ ICM is intended to be inserted subcutaneously in the left pectoral region, also described as the left anterior chest wall. The Assert-IQ ICM has not been specifically tested for pediatric use.

The Assert-IQ™ ICM system consists of Insertable Cardiac Monitor device models DM5000. DM5300, and DM5500 and is intended to help physicians monitor, diagnose, and document the rhythm in patients who are susceptible to cardiac arrhythmias and unexplained symptoms, as indicated. Specific features include: Patient-initiated triggering of EGM storage using the myMerlin™ mobile application, Automated triggering of EGM storage when tachycardia, bradycardia, or pauses are detected, Automated triggering of EGM storage when atrial fibrillation (AF) is detected, The ability to inhibit EGM storage due to noise and allow for detection and storage of AF and non-AF (pause, bradycardia, and tachycardia) arrhythmias after noise exit, Collection and display of diagnostic trends, including AF burden, PVC burden, and activity trends, Remote monitoring capability, Remote programming capability. The system includes the ICM device, Delivery/Implant Tools, myMerlin™ mobile application, and Merlin.net™ Software.

The provided text is a 510(k) summary for the Abbott Assert-IQ™ Insertable Cardiac Monitor (ICM), seeking substantial equivalence to a predicate device, the Jot Dx™ ICM. The document primarily focuses on demonstrating that the Assert-IQ™ ICM is substantially equivalent to its predicate, rather than providing detailed acceptance criteria and a standalone study proving the device meets those criteria.

Therefore, much of the requested information regarding specific acceptance criteria, detailed device performance metrics, sample sizes for test and training sets, expert qualifications, and adjudication methods for a de novo study is not available in this document. This document acts as a comparison to a previously cleared device.

However, based on the information provided, here's what can be extracted and inferred:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not provide a table of explicit, quantitative acceptance criteria for this device (Assert-IQ™ ICM) and corresponding performance metrics from a dedicated clinical study. Instead, it states that the Assert-IQ™ ICM "leverages the existing market cleared predicate (Jot Dx ICM DM4500 (K212206)) algorithms and functionality, for which the clinical testing is not repeated." This implies that the clinical acceptance criteria and performance were established with the predicate device and are considered met by the Assert-IQ™ ICM due to substantial equivalence.

The document discusses "design verification and system validation activities" and "all necessary device and system verification testing," but these are engineering and functional tests, not clinical performance studies with specific statistical acceptance criteria for diagnostic accuracy.

Key takeaway: The acceptance criteria for clinical performance are implicitly assumed to be met through substantial equivalence to the predicate device, K212206, which already underwent clinical testing for its algorithms.

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

This information is not provided in the document for the Assert-IQ™ ICM. The document explicitly states that "the clinical testing is not repeated" because the Assert-IQ™ ICM leverages the predicate's algorithms and functionality. Therefore, any clinical "test set" and its provenance would pertain to the predicate device, K212206, and details about that are not included here.

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

This information is not provided for the Assert-IQ™ ICM, as clinical testing was not repeated. This detail would have been part of the predicate device's original clearance.

4. Adjudication Method for the Test Set

This information is not provided for the Assert-IQ™ ICM, as clinical testing was not repeated. This detail would have been part of the predicate device's original clearance.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

This information is not provided for the Assert-IQ™ ICM. MRMC studies typically assess human reader performance with and without AI assistance, which is not the focus of this substantial equivalence submission that explicitly states clinical testing was not repeated.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done

This document does not describe a standalone study for the Assert-IQ™ ICM's algorithms. It states that the device "leverages the existing market cleared predicate... algorithms and functionality," implying that any standalone performance validation would have been done for the predicate device, K212206. The current submission focuses on demonstrating that the technological changes (e.g., longevity, size, programming features) do not alter the fundamental functionality or safety/effectiveness of the existing algorithms.

7. The Type of Ground Truth Used

This information is not provided for the Assert-IQ™ ICM, as clinical testing was not repeated. For the predicate device, ground truth for arrhythmias would typically involve electrophysiologist over-read of EGM data, potentially correlated with patient symptoms or other diagnostic tests, but these specifics are not in this document.

8. The Sample Size for the Training Set

This information is not provided for the Assert-IQ™ ICM. Training set details would pertain to the development of the algorithms, which were part of the predicate device.

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

This information is not provided for the Assert-IQ™ ICM. Ground truth establishment for the training set would pertain to the development of the algorithms used in the predicate device.

Summary of what is provided regarding acceptance criteria indirectly:

The document states that the "Assert-IQ™ ICM leverages the existing market cleared predicate (Jot Dx ICM DM4500 (K212206)) algorithms and functionality, for which the clinical testing is not repeated."

The report concludes that the "modifications to the subject device do not alter the previously evaluated clinical acceptance criteria and were verified through design verification and system validation activities."

The document lists various engineering and safety tests that were performed to support substantial equivalence:

• Software/Firmware Verification and System Verification
• Cybersecurity
• Bluetooth / coexistence
• Preclinical Testing (Animal GLP Study)
• Biocompatibility
• Sterilization
• Shelf Life
• Packaging
• Electromagnetic compatibility (EMC)
• Electrical safety
• MRI safety
• Mechanical performance
• System Validation
• Usability testing

It states that "All verification and validation activities were successfully completed and did not raise new safety or performance issues." This indicates that for these listed engineering and safety aspects, the device met its internal design and regulatory requirements, which serve as a form of acceptance criteria for those specific aspects. However, quantitative acceptance criteria and performance metrics for these individual tests are not detailed in this summary.

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