Search Results

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, tachycardia, 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 is intended to help physicians monitor, diagnose, and document the rhythm in patients who are susceptible to cardiac arrhythmias and unexplained symptoms, as indicated. The Assert-IQ™ Insertable Cardiac Monitor (ICM) family of Insertable Cardiac Monitor devices includes cleared models DM5000, DM5300, and DM5500. A fourth model is being included as the subject device within this 510(k)—the Assert-IQ™ 4 ICM, model DM5100.

Overview of Technological features relative to predicate (K251221) Assert-IQ™ ICM devices:

• Patient-initiated triggering of EGM storage using the myMerlin™ mobile application. This includes capability for the patient to identify symptoms, which are stored with the EGM for physician review which is identical in Assert-IQ™ ICM models DM5500 and DM5000.

• Automated triggering of EGM storage when tachycardia, bradycardia, or pauses are detected; with physician-programmable values for pause duration, bradycardia rate, tachycardia rate, and number of tachycardia intervals, which is identical in Assert-IQ™ ICM models DM5500 and DM5000.

• Automated triggering of EGM storage when atrial fibrillation (AF) is detected, with physician programmable values for AF duration. 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, which is identical Assert-IQ™ ICM models DM5500 and DM5000.

• Collection and display of diagnostic trends, including AF burden, which is identical in Assert-IQ™ ICM models DM5500 and DM5000 and PVC burden, available in the subject device DM5100 and in model DM5500

• Remote monitoring capability, which is identical in Assert-IQ™ ICM models DM5500 and DM5000

• Remote Programming capability, which is available in the subject device DM5100 and in model DM5500.

• The subject device model DM5100 has a 4-year battery longevity, positioned between the longevity of) model DM5500 (6 years) and model DM5000 (3 years). This design change does not raise new or different questions of safety or effectiveness.

• Accelerometer in subject device model DM5100 is 1D configuration which is identical to that in model DM5000 and differs from model DM5500 (3D configuration). This configuration does not raise new or different questions of safety or effectiveness.

The provided FDA 510(k) Clearance Letter for the Assert-IQ™ Insertable Cardiac Monitor System (K253516) does not contain the detailed information necessary to fully answer all aspects of your request.

The clearance is for a Special 510(k), which indicates that the changes made to the device (model DM5100) are minor and do not introduce new indications for use or alter the fundamental scientific technology compared to a previously cleared predicate device (K251221). As such, the submission primarily leverages testing and validation from the predicate device and focuses on demonstrating that the new model performs equivalently and does not raise new questions of safety or effectiveness.

Therefore, much of the information you requested regarding new acceptance criteria, performance studies, sample sizes, ground truth establishment, or MRMC studies for this specific submission (K253516) is not present. The document explicitly states "No new clinical functionality, user needs, or intended use introduced," and "Existing validation activities from predicate (K251221) models (e.g., usability, algorithm performance, cybersecurity, compliance) remain applicable and sufficient."

However, I can extract the available information and highlight what is missing based on your prompts.

Acceptance Criteria and Device Performance (Based on available information)

The document refers to verification activities to confirm the DM5100 meets design specifications and performs equivalently to predicate models. It also mentions "algorithm performance" being leveraged from the predicate. Without access to the predicate device's 510(k) submission (K251221), specific performance criteria for the AI algorithms are not explicitly stated in this document.

Study Details (Based on available information)

This 510(k) submission is a Special 510(k), and therefore, a primary performance study on the AI algorithm was not conducted for this specific submission (K253516). The document explicitly states that "Existing validation activities from predicate (K251221) models (e.g., usability, algorithm performance, cybersecurity, compliance) remain applicable and sufficient."

To get answers to many of the following questions, one would need to review the original 510(k) submission for the predicate device (K251221).

1. Sample size used for the test set for AI algorithm performance: Not provided in this document. It leverages previous validation from K251221.

   • Data provenance (e.g., country of origin of the data, retrospective or prospective): Not provided in this document.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided in this document. It leverages previous validation from K251221.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not provided in this document. It leverages previous validation from K251221.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not provided in this document. It is unlikely for a Special 510(k) which primarily relies on equivalence to a predicate. The document implies the AI is for automated detection and presumably works in conjunction with a physician review, but doesn't detail reader studies.

   • If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not provided in this document.

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The document mentions "Automated triggering of EGM storage when tachycardia, bradycardia, or pauses are detected," and "Automated triggering of EGM storage when atrial fibrillation (AF) is detected." This implies a standalone algorithm for detection. However, specific standalone performance metrics (e.g., sensitivity, specificity, PPV for these detections) are not provided in this document for this specific K253516 submission, as they are leveraged from the predicate K251221.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not provided in this document. It leverages previous validation from K251221.

7. The sample size for the training set: Not provided in this document. It leverages previous validation from K251221.

8. How the ground truth for the training set was established: Not provided in this document. It leverages previous validation from K251221.

Ask a specific question about this device