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The SJM Confirm " ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for other cardiac arrhythmias.

The SJM Confirm ICM, Model DM2102, is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.

The SJM Confirm ICM is a cardiovascular monitoring device used to record and play back. physiological signals.

The provided text for SJM Confirm (DM2102) ICM 5 10(k) Premarket Notification (K133481) indicates that clinical performance testing was performed to demonstrate the device meets the required performance criteria. However, the document does not provide specific acceptance criteria or detailed results of this clinical study. It primarily focuses on asserting substantial equivalence to predicate devices based on technological characteristics and general performance.

Therefore, much of the requested information cannot be extracted from the provided text.

Here is what can be inferred and what is missing:

1. A table of acceptance criteria and the reported device performance

• Acceptance Criteria: Not explicitly stated in the provided text. The document broadly states the device "meets the required performance criteria" and "performs as intended."
• Reported Device Performance: Not explicitly stated in terms of quantitative metrics. The document concludes that "the SJM Confirm ICM functions to its specifications, performs as intended, and exhibits the appropriate characteristics of an implantable cardiovascular monitoring device."

2. Sample size used for the test set and the data provenance

• Sample Size for Test Set: Not specified. The document mentions "clinical performance testing" but does not provide details about the number of patients or cases.
• Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not specified. There is no mention of expert review or ground truth establishment in the context of the clinical study described.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

• Not specified.

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

• The document implies that the SJM Confirm is a standalone cardiac monitoring device rather than an AI-assisted interpretation tool for human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device's function as described. No such study is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• The document states "clinical performance testing were performed to demonstrate the SJM Confirm ICM meets the required performance criteria." While it doesn't explicitly use the term "standalone performance," given that it's an "Implantable Cardiac Monitor," its primary function would be continuous, automated monitoring and recording of physiological signals. This suggests the evaluation would focus on the device's ability to accurately detect and record these signals on its own. However, specific metrics are not provided.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not specified.

8. The sample size for the training set

• Not applicable as this seems to be a hardware device with embedded firmware/software rather than a machine learning algorithm that requires a separate training set. The relevant testing is "Software Verification and System Validation" and "Clinical Study."

9. How the ground truth for the training set was established

• Not applicable.

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