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

The SJM Confirm® Implantable Cardiac Monitor is a minimally invasive, implantable diagnostic monitoring device with subcutaneous electrodes that are used for sensing and a looping memory for storage of electrograms (EGM). The device is comprised of three main components: the implantable cardiac monitor (Model DM2100) and the external patient activator (Model DM2100A). The third component is the programmer the physician uses to communicate to the cardiac monitor and associated programmer software. The programmer is the legally marketed SJM Merlin PCS programmer Model 3650 (with Software Model 3330).

This 510(k) premarket notification (K122090) from St. Jude Medical, CRMD, for the SJM Confirm® Implantable Cardiac Monitor (Model DM2100) describes a change to an existing device, specifically the use of an alternate collector cell battery. The submission uses substantial equivalence to a legally marketed predicate device (SJM Confirm® Implantable Cardiac Monitor System, K081365).

The provided text does not include acceptance criteria for the device's performance in detecting or diagnosing arrhythmias, nor does it detail a study proving such performance specific to this 510(k) submission. Instead, the core of this submission focuses on demonstrating that the new battery component does not negatively impact the device's existing performance, which was presumably established in the predicate device's original clearance.

Therefore, many of the requested sections (e.g., sample size, expert qualifications, MRMC studies, standalone performance, training set details) are not applicable or cannot be extracted directly from this document.

Here's a breakdown of the information that can be extracted or inferred based on the nature of this 510(k) submission:

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: This 510(k) is about a component change. The acceptance criteria are implicitly that the device, with the new battery, performs identically to the predicate device in all relevant aspects (electrical performance, safety, sterilization, etc.). The reported performance is a summary statement that this equivalence has been confirmed through testing.

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

• Sample Size for Test Set: The document mentions "Device testing (documented in 60041954, Attachment 3) and component level testing (documented in QTR40008803, Attachment 4)." However, it does not specify the sample size of devices or components used for these tests. The testing would have been conducted on a representative sample of devices containing the new battery.
• Data Provenance: The testing was conducted by St. Jude Medical, CRMD. Given it's a premarket submission, the testing would be considered prospective in the context of validating the new battery component. The country of origin of the data is not specified but is inferred to be from St. Jude Medical's internal testing.

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

• Not Applicable / Not Provided: This submission focuses on engineering and component-level performance validation post-battery change, not on diagnostic accuracy against a clinical ground truth. Therefore, there's no mention of experts establishing a ground truth for clinical performance.

4. Adjudication method for the test set

• Not Applicable / Not Provided: As explained above, this submission does not involve clinical performance assessment requiring ground truth adjudication.

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 device is an implantable cardiac monitor with diagnostic capabilities (detecting arrhythmias), but the submission focuses on a battery change, not on an AI algorithm or human reader interaction. Therefore, no MRMC study, AI component, or effect size is discussed.

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

• Not Applicable: This submission relates to the hardware component change of an existing implantable cardiac monitor, not a standalone algorithm. The device itself performs sensing and EGM storage as part of its diagnostic function, but the approval here is for the battery, not a new or modified detection algorithm.

7. The type of ground truth used

• Engineering Specifications and Existing Device Performance: For this 510(k), the "ground truth" for the battery change is that the device with the new battery must meet the established engineering specifications for the original device and exhibit performance equivalent to the device with the original battery. This would involve electrical performance metrics, mechanical integrity, and other product and system specifications established for the predicate device. There is no clinical "ground truth" (like pathology or outcomes data) established in this document for the purpose of demonstrating diagnostic accuracy.

8. The sample size for the training set

• Not Applicable / Not Provided: As this submission is about a hardware component change, there is no "training set" in the context of an algorithm.

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

• Not Applicable / Not Provided: As there is no training set for an algorithm in this submission, this question is not applicable.

Summary of Device Performance Study:

The study described is an internal engineering and component-level validation. It involved:

• Device testing: Documented in St. Jude Medical record 60041954, Attachment 3.
• Component level testing: Documented in St. Jude Medical record QTR40008803, Attachment 4.

The conclusion of these tests was that the alternate collector cell battery "has no effects on the device performance." No further details on methodologies, specific results, or quantitative metrics are provided in this summary. The focus is on demonstrating equivalence to the predicate device, not on re-proving the predicate device's efficacy.

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