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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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The Jot Dx™ 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 cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.

The Jot Dx™ ICM DM4500 System consists of the Jot Dx™ ICM Model DM4500 Implantable Device, Implant Tools (Incision tool Model DM3520 and Insertion tool Model DM3510), Confirm Rx ICM Accessory Kit DM3500A, Magnet, Clinician Programmer (Merlin PCS Programmer Model 3650), myMerlin™ Mobile Application (Model APP1000 (Android) and APP1001 (iOS)), and Remote Care/Clinician Portal (Merlin.net MN5000 Report Generator). The ICM is a minimally invasive, implantable diagnostic monitoring device with subcutaneous electrodes, looping memory, and automatic as well as patient-activated EGM storage capability.

This document is a 510(k) premarket notification for the Abbott Jot Dx™ Insertable Cardiac Monitor (ICM) DM4500. The core of this submission is to demonstrate substantial equivalence to an existing predicate device, the Abbott Confirm Rx™ ICM DM3500 (K202888).

Therefore, the study supporting acceptance criteria isn't a traditional clinical study with human readers and ground truth established by experts. Instead, the "study" is a non-clinical test summary demonstrating that the new device is identical to the predicate device in all relevant aspects affecting safety and effectiveness.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Since the submission claims identity to a predicate, the acceptance criteria are effectively that the Jot Dx™ ICM DM4500 must perform identically to the Confirm Rx™ ICM DM3500.

"The fundamental technological characteristics of the candidate Jot Dx™ ICM DM4500 are not changing in comparison to the predicate device, the current Confirm Rx™ ICM DM3500 (510(k) K202888). The candidate Jot Dx™ ICM DM4500 system has the same:

• Intended Use and Indications for Use
• Operating rules
• Device/tool functionality
• Packaging materials and process
• Shelf life
• Device Longevity
• Software"

"The candidate Jot Dx™ ICM DM4500 is identical in design and function and has the same indications and intended use as the predicate Confirm Rx™ ICM DM3500 (K202888)." |
| Safety and Effectiveness: The minor differences (name, model number, laser marking) do not raise new issues of safety and effectiveness. | "The minor differences in name, model number, and laser marking do not raise new issues of safety and effectiveness."

"Completion of all verification and validation activities demonstrated that the candidate Jot Dx™ ICM DM4500 meets its predetermined design and performance specifications and that the product is substantially equivalent to the predicate device (Model DM3500, K202888)."

"The results of the testing show that the candidate Jot Dx ICM DM4500 system performs as intended and is safe for its intended use."

"The candidate Jot Dx™ ICM system is substantially equivalent in terms of safety and technological characteristics to the identified predicate device (Confirm RxTM ICM System; K202888). Product verification and validation testing demonstrate that the candidate Jot Dx ICM system is as safe and as effective and performs as well as the predicate system (K202888)." |
| Risk Assessment: Acceptable risk profile. | "The risk analysis method used to assess the impact of the addition of the candidate Jot Dx™ ICM DM4500 documents the investigation of hazards and mitigation of associated risks and reports the result of the investigation. The risk analysis method used to assess the impact of the modifications was a Failure Mode and Effects Analysis (FMEA/FMECA). It was determined that the overall risk is acceptable." |

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

• Test Set Sample Size: Not applicable in a traditional sense. The "test set" here refers to the engineering verification and validation testing performed on the single design of the Jot Dx™ ICM DM4500 to confirm its identity and performance against the predicate. This isn't a statistical sample of independent clinical cases.
• Data Provenance: Not applicable for a traditional clinical study. The "data" comes from internal engineering verification and validation activities. It's retrospective in the sense that they are comparing it to an already cleared predicate device's specifications and performance. No country of origin is specified for these internal engineering tests, but the company is based in the USA.

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

• Number of Experts: Not applicable. Ground truth, in the context of substantial equivalence for an identical device, is established by its adherence to the design and performance specifications of the predicate device, not through expert human interpretation of clinical data on the new device.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable. There is no ambiguous clinical data requiring 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:

• MRMC Study: No. This submission does not involve an AI component or a comparative effectiveness study with human readers. The device is an insertable cardiac monitor that automatically detects events.

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

• Stand-alone Performance: While the device automatically detects cardiac arrhythmias (an "algorithm" in a broad sense), the submission doesn't present a standalone performance study with metrics like sensitivity and specificity against a clinical ground truth. Instead, it relies on the established performance of the identical predicate device. The document explicitly states the "Automated triggering of EGM storage when tachycardia, bradycardia, or pauses are detected" and "Automated triggering of EGM storage when atrial fibrillation (AF) is detected." The performance of these detection algorithms is considered equivalent to the predicate.

7. The Type of Ground Truth Used:

• Type of Ground Truth: The "ground truth" for this submission is the established design, performance specifications, and safety/effectiveness profile of the legally marketed predicate device (Confirm Rx™ ICM DM3500, K202888). The new device is asserted to be identical in these respects, making the predicate the reference "truth."

8. The Sample Size for the Training Set:

• Training Set Sample Size: Not applicable. There is no machine learning or AI algorithm being trained for this device submission as it is presented as a re-branding/model number change of an existing technology.

9. How the Ground Truth for the Training Set was Established:

• Ground Truth for Training Set: Not applicable, as there is no training set mentioned in this 510(k) application.

Ask a specific question about this device

The Confirm Rx™ ICM is indicated for the monitoring and diagnostic evaluation of patients who experience unexplained symptoms such as the following: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.

The Confirm Rx™ ICM System consists of the following key features and components: Confirm Rx™ ICM Model DM3500 Implantable Device, Implant Tools (Incision tool model DM3520 and Insertion tool model DM3510), Confirm Rx ICM Accessory Kit DM3500A, Magnet, Clinician Programmer (Merlin PCS Programmer Model 3650), myMerlin™ Mobile Application (Model APP1000 (Android) and APP1001 (iOS)), and Remote Care/Clinician Portal (Merlin.net MN5000 Report Generator). The ICM is a minimally invasive, implantable diagnostic monitoring device with subcutaneous electrodes, looping memory, and automatic as well as patient-activated EGM storage capability.

The provided text does not contain information about acceptance criteria for device performance or a study proving that the device meets specific performance criteria. Instead, it details a 510(k) premarket notification for an Abbott (St. Jude Medical) Confirm Rx™ Insertable Cardiac Monitor system (K202876).

This submission is for an Accessory Kit DM3500A and an updated incision tool DM3520 blade design for an already cleared device (predicate K193310). The document asserts substantial equivalence to the predicate device, meaning it argues that the new components do not raise new questions of safety or effectiveness and perform as well as the predicate.

The document states:

• "Completion of all verification and validation activities demonstrated that the Confirm Rx ICM accessory kit meets its predetermined design and performance specifications and that the product is substantially equivalent to the current device (Model DM3500, K193310)." (Page 9)
• "The results of the verification and validation tests and the risk analysis have demonstrated the candidate Confirm Rx ICM system with Accessory Kit DM3500A and updated incision tool DM3520 blade design functions in accordance with product specifications." (Page 9)
• "Product verification and validation testing demonstrate that the candidate Confirm Rx ICM system is as safe and as effective and performs as well as the predicate system (K193310)." (Page 9)

However, it does not provide a table of acceptance criteria and reported device performance for the new components or the system as a whole. It also does not describe a specific study with a test set, training set, expert ground truth, or adjudication methods in the context of device performance metrics (e.g., sensitivity, specificity for arrhythmia detection). The non-clinical test summary mentions a "risk analysis method... a Failure Mode and Effects Analysis (FMEA/FMECA)," but this is for assessing hazards and mitigating risks, not for evaluating performance against clinical acceptance criteria.

Therefore, I cannot fulfill your request for the detailed information as it is not present in the provided FDA document.

Ask a specific question about this device

The Confirm Rx™ 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 cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.

The Confirm RxTM ICM System consists of the following key features and components:

• Confirm RxTM ICM Model DM3500 Implantable Device: The ICM is intended as a minimally invasive, implantable diagnostic monitoring device, with subcutaneous electrodes, looping memory, and automatic as well as patient-activated EGM storage capability, which help physicians monitor, diagnose, and document patients who are susceptible to cardiac arrhythmias.
• Implant Tools: Model DM3520 incision tool and Model DM3510 insertion tool are used to implant the device subcutaneously.
• Magnet: The magnet facilitates faster startup of Bluetooth connection and provides user authentication (required for programmer sessions).
• Clinician Programmer (Merlin PCS Programmer Model 3650): The Merlin PCS Programmer 3650 operates using Merlin PCS Model 3330 software and provides the means for the physician to program device parameters and retrieve diagnostic information from the device, including electrograms, heart rate history, episode duration and trend information.
• myMerlin™ Mobile Application (Model APP1000 (Android) and APP1001 (iOS)): The mobile application provides the means for the patient to activate EGM recording in the Confirm Rx™ device, with data pass-through functionality to enable physician follow-up via the Merlin.net Patient Care Network.
• Remote Care/Clinician Portal (Merlin.net MN5000 Report Generator): The Merlin.net system allows physicians to remotely monitor and diagnose patients' cardiac events.

This document is a 510(k) summary for the Abbott Confirm Rx Insertable Cardiac Monitor (ICM) with updated MR Conditional labeling. It focuses on demonstrating substantial equivalence to a previously cleared version of the device, specifically for MR Conditional labeling for 3T MRI environments. The acceptance criteria and study described primarily relate to this MR Conditional aspect, not the core cardiac monitoring functionality.

Here's the information extracted from the provided text, addressing your specific points:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the testing performed supports additional 3T MR Conditional labeling. It explicitly mentions that the "3T testing meets the same clinical acceptance criteria that was previously evaluated for predicate 1.5T MR Conditional labeling demonstration of safety."

While the specific clinical acceptance criteria for MR Conditional labeling (e.g., maximum temperature rise, induced voltage, artifact size, device malfunction rates) are not detailed within this summary, the outcome is reported as:

The document concludes that: "The results of the MRI verification testing have demonstrated the candidate Confirm Rx™ ICM DM3500 with updated MR Conditional labeling functions in accordance with product specifications." and "The results of the testing show that the candidate Confirm Rx™ ICM performs as intended and is safe for its intended use."

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

The document does not specify the sample size for the test set used for the MR Conditional testing. It generically refers to "all necessary device and system verification testing."

The provenance of the data (e.g., country of origin, retrospective/prospective) is not mentioned. Given the nature of MR Conditional testing, it would typically be conducted in a controlled lab environment.

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

This information is not provided in the document. For MR Conditional testing, ground truth typically relates to engineering measurements against pre-defined safety limits (e.g., temperature probes, E-field/H-field sensors, functional checks), rather than expert medical interpretation of diagnostic outputs.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method. For MR Conditional testing, results are typically objective measurements against engineering standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

An MRMC study was not done as this submission focuses on updated MR Conditional labeling for a device, not the interpretation of its diagnostic output by human readers. Therefore, there is no effect size of human readers improving with AI vs. without AI assistance.

6. Standalone Performance Study

The document implies a standalone (algorithm only) performance study related to MR Conditional labeling, as it focuses on the device itself and its interaction with MRI fields. The "results of the MRI verification testing" demonstrate the device's functional integrity and safety. This testing is conducted on the device without human interpretation of its outputs during the test itself, only checking if the device continues to function correctly after the MRI exposure.

7. Type of Ground Truth Used

The ground truth used for the MR Conditional testing is based on engineering standards and design specifications for safe performance in an MRI environment. This includes, but is not limited to, parameters like temperature rise, induced voltage, and device functionality post-exposure, which are objectively measurable and compared against established safety thresholds.

8. Sample Size for the Training Set

The document describes pre-market notification for an updated label for an existing device. It does not mention any "training set" in the context of an AI/ML algorithm. This device is an implantable cardiac monitor, and the current submission is for an updated MR Conditional label, not for a new or updated AI algorithm.

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

As there is no mention of a training set related to an AI/ML algorithm in this document, this information is not applicable.

Ask a specific question about this device

The Confirm Rx™ 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 cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.

The Abbott Confirm RxTM (ICM) System consists of the following key features and components:

• Confirm Rx™ ICM Model DM3500 Implantable Device: The ICM is intended as a minimally invasive, implantable diagnostic monitoring device, with subcutaneous electrodes, looping memory, and automatic as well as patient-activated EGM storage capability, which help physicians monitor, diagnose, and document patients who are susceptible to cardiac arrhythmias.
• Implant Tools: Model DM3520 incision tool and Model DM3510 insertion tool to implant the device subcutaneously.
• Model 3111 Magnet: SJM donut magnet, facilitates faster startup of Bluetooth connection and provides user authentication (required for programmer sessions).
• Clinician Programmer (Merlin PCS Programmer Model 3650): The Merlin PCS Programmer 3650 operates using Merlin PCS Model 3330 software and provides the means for the physician to program device parameters and retrieve diagnostic information from the device, including electrograms, heart rate history, episode duration and trend information.
• myMerlin™ Patient App (Model APP1000 (Android) and APP1001 (iOS)): The mobile application provides the means for the patient to activate EGM recording in the Confirm RxTM device, with data pass-through functionality to enable physician follow-up via the Merlin.net Patient Care Network.
• Remote Care/Clinician Portal (Merlin.net MN5000 Report Generator): The Merlin.net MN5000 system allows physicians to remotely monitor and diagnose patients' cardiac events.

The provided text describes a 510(k) premarket notification for the "myMerlin Mobile Application (Android)" and "myMerlin Mobile Application (iOS)" by Abbott (St. Jude Medical). This application is part of the Confirm Rx™ Insertable Cardiac Monitor System. The submission claims substantial equivalence to a previously cleared predicate device (K192593, Confirm Rx™ Insertable Cardiac Monitor System).

The submission focuses on updates to the myMerlin™ mobile application, primarily related to scheduled background workflows and telemetry connectivity improvements, as well as the ability to transfer a patient's remote monitoring support profile on Merlin.net.

The document states that the fundamental technological characteristics, intended use, indications for use, operating rules, cybersecurity, and usability testing remain the same as the predicate device. Therefore, the testing performed was to demonstrate that the updated mobile application maintains its safety and effectiveness for its intended use, rather than proving performance against new acceptance criteria for a novel functionality.

Given this context, the acceptance criteria and study details are presented as follows:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample size of a "test set" in terms of patient data or scenarios used. The testing described is primarily focused on software verification, system verification, design validation, and Bluetooth Low Energy proxy software verification. This implies testing involved the software application itself and its interaction with the ICM device, rather than a clinical study with a patient cohort.

• Data Provenance: Not applicable in the context of a clinical test set. The provenance of the software updates is from the manufacturer, Abbott. The nature of the changes (software updates) suggests internal testing and technical verification.

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

This information is not provided. Given the nature of the submission (updates to a mobile application interacting with an already cleared device), the "ground truth" would likely be established by engineering and software performance standards, rather than expert clinical consensus on patient data.

4. Adjudication Method for the Test Set

This information is not provided. As noted in point 3, the testing appears to be technical in nature rather than clinical, so a traditional clinical adjudication method would not be expected.

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

No MRMC comparative effectiveness study was mentioned. The myMerlin™ mobile application is primarily a patient interface for activating EGM recording and data pass-through. It is not an AI-assisted diagnostic tool for "human readers," so this type of study would not be relevant.

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

The submission describes the myMerlin™ mobile application (APP1000/APP1001) as a component of the Confirm Rx™ ICM System. The application enables patients to activate EGM recording and facilitates data pass-through to the Merlin.net Patient Care Network for physician review. The focus is on the functional performance of the application and its connectivity, not on a standalone algorithm for diagnosis without human input. Therefore, a standalone algorithm performance study as typically understood for diagnostic AI was not done or described. The "standalone" performance here refers to the application's ability to fulfill its intended technical functions.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the specific updates to the myMerlin™ mobile application, the "ground truth" for verification and validation would be defined by predetermined design and performance specifications or product specifications. This means the software was tested against its expected behavior and technical requirements, rather than against clinical outcomes, pathology, or expert consensus on a clinical dataset. The objective was to confirm that the updated software performed as intended and did not negatively impact the already cleared system's functionality.

8. The Sample Size for the Training Set

This information is not applicable. The myMerlin™ mobile application is not described as involving a machine learning or AI algorithm that would require a "training set" in the conventional sense (i.e., for learning to identify patterns in data). The changes are described as software updates to workflows and connectivity.

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

This information is not applicable, as no training set for a machine learning algorithm is mentioned or implied.

Ask a specific question about this device

The Confirm RxIM 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 cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atial fibrillation or who are susceptible to developing atrial fibrillation.

The Confirm Rx™ ICM Model DM3500 Implantable Device is intended as a minimally invasive, implantable diagnostic monitoring device, with subcutaneous electrodes, looping memory, and automatic as well as patient-activated EGM storage capability, which help physicians monitor, diagnose, and document patients who are susceptible to cardiac arrhythmias. It has a two-year longevity, MR conditional labeling, sensing and detection algorithms, and Bluetooth communication. Specific features include: Patient-initiated triggering of EGM storage using the myMerlin™ Patient App for mobile devices, 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 identify EGM anomalies as a consequence of noise or vigorous activity and inhibit EGM storage as applicable, Remote care monitoring. The system also includes Implant Tools (incision and insertion tools), a Magnet, a Clinician Programmer (Merlin PCS Programmer Model 3650) with Merlin PCS Model 3330 software, myMerlin™ Patient App (Model APP1000 Android), and Remote Care/Clinician Portal (Merlin.net MN5000 Report Generator).

This document is a 510(k) premarket notification for a minor design change to an existing device, the Confirm Rx Insertable Cardiac Monitor (ICM) Model DM3500. Therefore, the "study" referred to is primarily verification and validation testing to ensure the modified device still meets its specifications and is substantially equivalent to the predicate device, rather than a clinical effectiveness study.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't provide a direct table of specific acceptance criteria or quantitative performance metrics in the format requested, as it's a submission for a minor design change (adding a "peel and stick moisture getter"). Instead, it focuses on demonstrating that the modified device continues to meet the established design and performance specifications of the predicate device.

The study referenced is the Non-Clinical Test Summary, which involved:

• Risk Analysis (FMEA/FMECA): To assess the impact of the minor design change on hazards and associated risks.
• Verification and Validation Activities: To demonstrate that the device with the new moisture getter material meets its predetermined design and performance specifications.

The reported performance is that the device (with the modification) "functions in accordance with product specifications" and "is as safe and as effective and performs as well as the predicate device."

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

The document does not specify a distinct "test set" sample size for evaluating the algorithm's performance or device efficacy in a clinical sense. Given this is a 510(k) for a minor design change, the "test set" likely refers to engineering units used for verification and validation tests. The text indicates that these were non-clinical tests.

• Sample Size: Not specified quantitatively for testing the "peel and stick moisture getter." This would typically involve a specific number of devices or components undergoing various environmental, mechanical, and functional tests.
• Data Provenance: Non-clinical (laboratory/engineering tests). No country of origin is explicitly stated for these specific tests, but the company is based in the USA (Sylmar, CA). The tests are described as part of the "verification and validation activities" for the design change.

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

Not applicable in the context of this submission. The "ground truth" for non-clinical verification and validation tests is typically established by engineering specifications, regulatory standards, and comparison to the predicate device's performance, not by expert medical review of patient data in this specific context.

4. Adjudication Method for the Test Set

Not applicable. This is not a study involving human interpretation of medical data (like ECGs for arrhythmia detection) where adjudication methods (e.g., 2+1, 3+1) would be relevant. The verification and validation activities are engineering-focused.

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

No, an MRMC comparative effectiveness study was not done. This submission is for a minor design change to an existing device and does not involve assessing the impact of AI on human readers. The clinical effectiveness of the Confirm Rx ICM itself would have been established in previous 510(k) or PMA submissions (e.g., K190295 for the predicate device).

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

The document states that the fundamental technological characteristics and operating rules of the Confirm Rx ICM (which includes sensing and detection algorithms for arrhythmias) are not changing. Therefore, standalone performance of the algorithms was established with the predicate device (K190295) and is considered unchanged. This submission does not describe a new standalone performance study for the algorithms.

7. Type of Ground Truth Used

For the specific tests related to the "peel and stick moisture getter" modification:

• Ground Truth: Engineering specifications, performance criteria established for the predicate device, and regulatory standards. The goal was to demonstrate that these were still met after the modification.

For the underlying Confirm Rx™ ICM's arrhythmia detection algorithms, the "ground truth" for previous clearances would have likely involved:

• Expert Consensus: Cardiologists or electrophysiologists manually reviewing ECGs/EGMs to identify and classify arrhythmias.
• Clinical Outcomes: Correlating device detections with actual patient events or diagnoses.

However, these details are not provided in this specific document because the algorithms themselves are not being changed or re-evaluated for efficacy here.

8. Sample Size for the Training Set

Not applicable. The document describes a non-clinical modification to a hardware component (moisture getter) and explicitly states that the device's operating rules and functionality (which would include its algorithms) remain the same. This submission does not involve training new algorithms or a training set of data.

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

Not applicable, as there is no mention of a training set or new algorithm development/training in this submission.

Ask a specific question about this device

The Confirm Rx™ 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 cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.

The Confirm RxTM ICM has not been specifically tested for pediatric use.

The Confirm Rx™ Insertable Cardiac Monitor (ICM) Model DM3500 is intended as a minimally invasive, implantable diagnostic monitoring device, with subcutaneous electrodes, looping memory, and automatic as well as patient-activated EGM storage capability, which help physicians monitor, diagnose, and document patients who are susceptible to cardiac arrhythmias. It has a two-year longevity, MR conditional labeling, sensing and detection algorithms, and Bluetooth communication. Specific features include:

• Patient-initiated triggering of EGM storage using the myMerlin™™ Patient App for mobile devices. This includes capability for the patient to identify symptoms, which are stored with the EGM for physician review.
• 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.
• Automated triggering of EGM storage when atrial fibrillation (AF) is detected, with physician programmable values for AF duration.
• The ability to identify EGM anomalies as a consequence of noise or vigorous activity and inhibit EGM storage as applicable.
• Remote care monitoring.

The provided document is a 510(k) premarket notification for the Abbott Confirm Rx™ Insertable Cardiac Monitor (ICM) System, Model DM3500, with updated firmware. The purpose of this submission is to demonstrate substantial equivalence to a predicate device (K182981).

The document details the device description, technological characteristics, and the testing conducted to support the substantial equivalence claim. However, it does NOT contain a detailed study proving the device meets specific acceptance criteria for AI/algorithm performance as would be typically found for new AI-driven diagnostic devices. Instead, the focus is on demonstrating that the updated firmware, particularly its detection algorithms, functions as intended without raising new issues of safety and effectiveness compared to the predicate device.

Specifically, the acceptance criteria and performance data are described in terms of verification and validation activities showing the device meets its "predetermined design and performance specifications" and "functions in accordance with product specifications." The changes in the firmware relate to "detection algorithms for the diagnosis of bradycardia, asystole (pause), and atrial fibrillation (AF)," including "second pass undersensing discriminators" and a "P-wave detection discriminator."

Given the information provided, it's not possible to present a table of acceptance criteria and reported device performance in the context of an AI study as you described.

However, I can extract the relevant information regarding the firmware update validation and
address the closest approximations to your questions for this type of medical device submission.

Analysis of the Provided Document Regarding Acceptance Criteria and Study:

The document describes an update to the firmware of an existing, already cleared device. The "study" here is the validation of the firmware update to ensure it doesn't negatively impact safety or effectiveness and that the new algorithms perform as intended.

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

The document states that the "Completion of all verification and validation activities demonstrated that the device with updated firmware meets its predetermined design and performance specifications and that the product is substantially equivalent to the predicate Confirm Rx™ ICM device (K182981)." It also states, "The results of the testing show that the candidate Confirm RxTM ICM performs as intended and is safe for its intended use."

The updated firmware includes changes to detection algorithms for bradycardia, asystole (pause), and atrial fibrillation (AF). The acceptance criteria would inherently be related to the accuracy and reliability of these detections compared to established benchmarks or the predicate device, although specific numerical performance metrics (e.g., sensitivity, specificity, accuracy percentages) are not detailed in this summary.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document does not specify the sample size (number of patients, number of EGM recordings) used for the verification and validation (V&V) testing. It also does not specify the data provenance (country of origin, retrospective/prospective). This type of detail is typically found in the full testing report, not usually summarized in this section of a 510(k) summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

The document does not specify the number or qualifications of experts used to establish ground truth. For embedded device algorithm testing, ground truth might often be established through simulated signals, pre-recorded clinical data with confirmed diagnoses, or expert review of EGMs, but this detail is not provided.

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

The document does not specify any adjudication method for ground truth establishment.

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

No, an MRMC comparative effectiveness study was not conducted or described. This is a device firmware update, not a new AI-assisted diagnostic tool where human reader performance would be compared. The focus is on the device's internal algorithm performance.

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

Yes, the testing described appears to be a standalone validation of the algorithm's performance within the device, given the context of "Software/Firmware Verification and System Verification" and "Design Validation." The purpose is to confirm the algorithm's internal logic and detection capabilities. The document states:

• "Second pass undersensing discriminators added to the Asystole and Bradycardia detection algorithms to reject false Pause and Bradycardia detections."
• "Second pass P-wave detection discriminator to reject false AF detections."

This implies that the algorithm itself was tested for its ability to correctly identify and reject false detections, which is a standalone performance metric.

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

The type of ground truth is not explicitly stated. For cardiac rhythm detection algorithms, ground truth typically involves a highly accurate reference ECG/EGM interpretation, which could be established via:

• Expert Consensus: Review by multiple cardiologists or electrophysiologists.
• Manual Annotation: Beat-by-beat or episode-by-episode annotation of EGM data by trained personnel, often adhering to specific criteria.
• Validation against high-fidelity recordings: Comparing device output to a gold-standard recording from a different, validated system.

Given the focus on "reject[ing] false detections," it implies that there was a reference against which the algorithm's detection (true positive/false positive) was measured.

8. The sample size for the training set

The document does not provide any information about a training set size. This indicates that this submission is about validating a firmware update for an already cleared device, not seeking de novo clearance for a new machine learning algorithm that typically requires a distinct training phase. While the algorithms were likely "trained" or designed using data at some point in their development, that information is not part of this 510(k) summary for a firmware update.

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

Since there is no mention of a training set in this document, there is no information on how its ground truth was established.

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The Confirm RxIM ICM is indicated for the monitoring and diagnostic evaluation of patients who experience wersplained symptoms such as: dizziness, palpitations, chest pain, syncope, and shortness of breath, as well as patients who are at risk for cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.

The Confirm RxIM ICM has not been specifically tested for pediatric use.

The ICM is intended as a minimally invasive, implantable diagnostic monitoring device, with subcutaneous electrodes, looping memory, and automatic as well as patient-activated EGM storage capability, which help physicians monitor, diagnose, and document patients who are susceptible to cardiac arrhythmias. It has a two-year longevity, MR conditional labeling, sensing and detection algorithms, and Bluetooth communication. Specific features include:

• Patient-initiated triggering of EGM storage using the myMerlin™™ Patient App for o mobile devices. This includes capability for the patient to identify symptoms, which are stored with the EGM for physician review.
• Automated triggering of EGM storage when tachycardia, bradycardia, or pauses are o detected; with physician-programmable values for pause duration, bradycardia rate, tachycardia rate, and number of tachycardia intervals.
• Automated triggering of EGM storage when atrial fibrillation (AF) is detected, with O physician programmable values for AF duration.
• The ability to identify EGM anomalies as a consequence of noise or vigorous activity o and inhibit EGM storage as applicable.
• Remote care monitoring. o

Here's an analysis of the provided text regarding the Abbott Confirm Rx Insertable Cardiac Monitor (ICM) System, Model DM3500, focusing on acceptance criteria and the supporting study:

Important Note: The provided document is a 510(k) clearance letter and related submission materials. It primarily focuses on demonstrating "substantial equivalence" to a predicate device rather than presenting a detailed standalone performance study with comprehensive acceptance criteria and results for the new device. Therefore, some of the requested information (like specific performance metrics and their ranges) is not explicitly listed as "acceptance criteria" and "reported device performance" in the way one might expect for a de novo device clearance. The document emphasizes that the fundamental technological characteristics are not changing, and the focus is on minor firmware updates and a manufacturing material change.

1. Table of Acceptance Criteria and Reported Device Performance

As mentioned, the document doesn't explicitly define a table of new acceptance criteria with numerical performance targets and reported results for the DM3500 in the way a clinical study report would. Instead, it states that the device "meets its predetermined design and performance specifications" and "performs as intended and is safe for its intended use."

The "acceptance criteria" are implied by the verification and validation activities conducted to ensure the device with the minor changes:

• Functions in accordance with product specifications.
• Performs as intended.
• Is safe for its intended use.
• Is substantially equivalent to the predicate (K163407).

The reported device performance is therefore that these criteria were met, specifically through:

• Firmware Verification and System Validation: This would ensure the updated firmware functions correctly and that the overall system operates as specified.
• Mechanical Performance Testing: This would verify the mechanical integrity and function of the device with the new UV Cure material.

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

The document does not specify a "test set" sample size in terms of patient data or clinical cases. The testing conducted was primarily bench testing and system validation for the firmware and mechanical changes. No clinical study on human subjects is mentioned for this particular 510(k) submission.

• Sample Size: Not applicable in the context of human clinical data. For engineering verification and validation, it would refer to the number of devices or test units, which is not stated.
• Data Provenance: Not applicable for clinical data. The testing described is internal engineering and validation testing.

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

Not applicable. This submission is for a device modification (firmware update and material change) and relies on engineering verification and validation, not on expert adjudication of diagnostic performance on a test set of clinical cases. The "ground truth" here would be the predefined functional and performance specifications of the device.

4. Adjudication Method for the Test Set

Not applicable. As no clinical test set requiring human adjudication is described, there is no adjudication method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study was done and none is described. This device is an insertable cardiac monitor, and its capabilities are assessed through its detection algorithms and hardware performance, not through human interpretation of its outputs in a comparative effectiveness study involving reader performance improvement with AI.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The device's core function is automatic detection of cardiac events (tachycardia, bradycardia, pauses, AF). The document states:

• "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 identify EGM anomalies as a consequence of noise or vigorous activity and inhibit EGM storage as applicable."

The "Firmware Verification and System Validation" would have evaluated the performance of these algorithms in a standalone manner (without human intervention) against known inputs. However, no specific metrics (e.g., sensitivity, specificity for AF detection) from such a study are provided in this regulatory document. The statement implies that the existing algorithms (from the predicate) have been verified with the updated firmware.

7. Type of Ground Truth Used

For the Firmware Verification and System Validation, the ground truth would be:

• Predefined system specifications: The expected behavior and output of the device's firmware and algorithms under various conditions.
• Known input signals: Simulated or recorded ECG/EGM data with precisely defined events (e.g., specific heart rates, AF episodes, pauses) to test the detection algorithms.
• Mechanical engineering standards: For the mechanical performance testing.

8. Sample Size for the Training Set

Not applicable. The document does not describe the development of new AI algorithms that require a "training set." The firmware updates are described as "minor changes" to an existing ERI detection algorithm and magnet response, implying fine-tuning or bug fixes rather than a re-training of a predictive model.

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

Not applicable, as no training set for new AI algorithms is described.

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The Confirm Rx™ 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 cardiac arthythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.

The myMerlin™ mobile application Model APP1001 is an application for patients who are implanted with the Confirm Rx™ Insertable Cardiac Monitor (ICM) Model DM3500 (K163407). The mobile application is used by patients to initiate recording of the heart's electrical activity by the Confirm Rx™ ICM device, read the information about the heart's activity from the Confirm Rx™ ICM device, and send this information to a clinician for remote monitoring. The myMerlin™ mobile application Model APP1001 is to be installed on a patient's mobile device with the iOS operating system which meets the specified minimum criteria for compatibility with the myMerlin™ mobile application.

This is a response to the question regarding the acceptance criteria and study proving the device meets the criteria. Based on the provided FDA 510(k) summary for the myMerlin™ Mobile Application, Model APP1001, here's an analysis of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) or detailed performance metrics for the myMerlin™ Mobile Application, Model APP1001. Instead, the document focuses on demonstrating substantial equivalence to a predicate device (myMerlin™ Mobile Application Model APP1000).

The "performance" is implicitly defined by the device fulfilling its intended functions, which are:

• Initiating recording of the heart's electrical activity by the Confirm Rx™ ICM device.
• Reading information about the heart's activity from the Confirm Rx™ ICM device.
• Sending this information to a clinician for remote monitoring.

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

The document does not explicitly state a "test set" in the context of clinical data or patient samples. The evaluation appears to be based on non-clinical testing, specifically verification and validation (V&V) activities and risk analysis (FMEA/FMECA) related to software functionality and safety. Therefore, information about data provenance (e.g., country of origin, retrospective/prospective) for a test set of patient data is not provided as it doesn't appear to be a clinical study.

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

Since the document describes non-clinical software V&V and risk analysis, there is no mention of "experts" establishing ground truth in the context of medical image interpretation or diagnosis. The "ground truth" for V&V would be the predefined functional and performance specifications.

4. Adjudication Method for the Test Set

Not applicable, as there is no mention of a "test set" requiring adjudication in a clinical context.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not performed or described in this 510(k) summary. The device is a mobile application for data transmission and initiation of recording, not a diagnostic algorithm requiring human interpretation of its output.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The evaluation described is essentially a standalone assessment of the software's functionality and safety (V&V, FMEA). However, it's not an "algorithm-only" performance in the sense of a diagnostic algorithm because its primary function is data acquisition and transmission, not independent diagnosis. Its performance is validated against its specifications for these functions.

7. Type of Ground Truth Used

For the non-clinical testing (verification and validation), the "ground truth" would be the predefined design specifications and functional requirements of the software, as well as established software engineering best practices and regulatory standards for medical device software. For the risk analysis (FMEA/FMECA), the ground truth is the identification of potential failure modes and their associated risks, evaluated against acceptable risk levels.

8. Sample Size for the Training Set

Not applicable. This device is a mobile application for data management and transmission, not an AI/ML algorithm that requires a "training set" of data for learning or pattern recognition.

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

Not applicable, as there is no training set mentioned for this device.

Ask a specific question about this device

The Confirm Rx™ 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 cardiac arrhythmias. It is also indicated for patients who have been previously diagnosed with atrial fibrillation or who are susceptible to developing atrial fibrillation.

The St. Jude Medical Confirm Rx™ system consists of the following key features and components:

• Confirm RxTM ICM Model DM3500 Implantable Device: The ICM is intended as a minimally invasive, implantable diagnostic monitoring device, with subcutaneous electrodes, looping memory, and automatic as well as patient-activated EGM storage capability, which help physicians monitor, diagnose, and document patients who are susceptible to cardiac arrhythmias. It is predicated on SJM Confirm™ DM2102 with a two-year longevity, MR conditional labeling, and identical sensing and detection algorithms as SJM Confirm™ DM2102, but with downsized hardware and Bluetooth communication.
• Implant Tools: Model DM3520 incision tool and Model DM3510 insertion tool to implant the device subcutaneously.
• Model 3111 Magnet (existing SJM donut magnet) facilitates faster startup of Bluetooth connection and provides user authentication (required for programmer sessions).
• Clinician Programmer (Merlin PCS Programmer Model 3650): The Merlin PCS Programmer 3650 operates using Merlin PCS Model 3330 software and provides the means for the physician to program device parameters and retrieve diagnostic information from the device, including electrograms, heart rate history, episode duration and trend information.
• myMerlin™ Patient App (Model APP1000 Android): The Patient App provides the means for the patient to activate EGM recording in the Confirm Rx™ device, with data pass-through functionality to enable physician follow-up via the Merlin.net Patient Care Network.
• Remote Care/Clinician Portal (Merlin.net MN5000 Report Generator): The Merlin.net MN5000 system allows physicians to remotely monitor and diagnose patients' cardiac events.

The provided text describes the Confirm Rx™ Insertable Cardiac Monitor (ICM) System, Model DM3500.

Here's an analysis of the acceptance criteria and the studies mentioned:

1. Table of Acceptance Criteria and Reported Device Performance:

The document mentions that the Confirm Rx™ ICM leverages the existing market-cleared SJM Confirm™ (DM2102) algorithms and functionality. Therefore, the "acceptance criteria" for the detection algorithms are implicitly inherited from the predicate device. While specific numerical targets for metrics like sensitivity or specificity are not explicitly stated as acceptance criteria for the Confirm Rx™ ICM in this summary, the key performance aspects verified through testing are:

Important Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices. It typically does not contain the detailed clinical study reports or comprehensive performance metrics that would be found in a full PMA application or a detailed peer-reviewed publication. The "acceptance criteria" here are therefore inferred from the context of substantial equivalence to a previously cleared device.

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

• Test Set Sample Size: The document does not explicitly state a specific sample size for a clinical test set used to evaluate the Confirm Rx™ ICM's diagnostic performance for arrhythmia detection. It states: "R-wave detection and device migration were verified via bench and animal testing for the Confirm Rx™ ICM DM3500." and "The Confirm Rx™ ICM leverages the existing market cleared SJM Confirm™ (DM2102) algorithms and functionality for which the clinical testing, performed on the SJM Confirm™ (DM2102) device per St. Jude Medical IDE G080090, is applicable and was not repeated."
• Data Provenance: The document does not specify the country of origin for the data, but it refers to an IDE (Investigational Device Exemption) study (G080090) conducted for the predicate device, SJM Confirm™ (DM2102). IDE studies are typically prospective clinical trials.

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

• This information is not provided in the 510(k) summary for the Confirm Rx™ ICM. Since the clinical performance data is leveraged from the predicate device, the details about ground truth establishment would reside in the original IDE G080090 submission for the SJM Confirm™ (DM2102).

4. Adjudication Method for the Test Set:

• This information is not provided in the 510(k) summary. Details on adjudication methods would typically be found in the full clinical study report for the predicate device (IDE G080090).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs. without AI assistance:

• No MRMC comparative effectiveness study is mentioned. The Confirm Rx™ ICM is an insertable cardiac monitor that automatically detects and records cardiac events. It is not an AI-assisted diagnostic tool designed to improve human reader performance in interpreting medical images or complex waveforms. Its primary function is automated detection and recording, with physician review of the recorded electrograms (EGMs).

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

• Yes, the document implies standalone performance evaluation of the detection algorithms. It states that the Confirm Rx™ ICM utilizes "identical sensing and detection algorithms as SJM Confirm™ DM2102." These algorithms are designed for automated triggering of EGM storage based on detected events like tachycardia, pauses, and atrial fibrillation. The verification of R-wave detection (a fundamental aspect of these algorithms) was performed via bench and animal testing, suggesting an evaluation of the algorithm's performance independent of a human in the loop for the core detection task. Physicians later review the automatically captured EGMs.

7. The Type of Ground Truth Used:

• For the R-wave detection and device migration verification in the Confirm Rx™ ICM, the ground truth would likely be based on direct physiological measurements from bench testing and animal studies (e.g., direct electrical signals or physical tracking of device position).
• For the leveraged clinical performance of the detection algorithms (from SJM Confirm™ DM2102 IDE G080090), the ground truth for arrhythmia detection would typically involve expert consensus of ECG/EGM interpretation by cardiologists or electrophysiologists, potentially corroborated with other clinical data or findings.

8. The Sample Size for the Training Set:

• The document does not specify a training set sample size. Given that the device leverages "identical sensing and detection algorithms" from a predicate device, the algorithms were likely developed and "trained" (or more accurately, designed and optimized) at an earlier stage with data that is not detailed in this 510(k) summary. This summary focuses on verifying the new device's implementation of those existing algorithms, not on new algorithm development.

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

• This information is not provided in the 510(k) summary. As mentioned, the algorithms are inherited from a predicate. Details on their initial development and the establishment of ground truth for any underlying "training" or optimization data would be found in the documentation for the predicate device (SJM Confirm™ DM2102).

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