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The LINQ II ICM is an insertable automatically-activated and patient-activated monitoring system that records subcutaneous ECG and is indicated in adult patients, and in pediatric patients who are at least 2 years old, in the following cases:

· patients with clinical syndromes or situations at increased risk of cardiac arrhythmias

· patients who experience transient symptoms such as dizziness, palpitation, syncope, and chest pain that may suggest a cardiac arrhythmia

The LINQ II Insertable Cardiac Monitor (ICM) Model LNQ22 is a programmable device that continuously monitors a patient's ECG and other physiological parameters. The device records cardiac information in response to automatically detected arrhythmias and patient-initiated activation or markings. The device is designed to automatically record the occurrence of an episode of arrhythmia in a patient. Note: Arrhythmias are classified as tachyarrhythmia, bradyarrhythmia, pause, atrial tachyarrhythmia, or atrial fibrillation. Patients may also manually record symptoms. To manually record symptoms, the patient will also need either the MyCareLink Heart App (patient app on mobile device) or the Patient Assistant Model PA97000. The patient can use the MyCareLink Heart App or the Patient to manually record his or her cardiac rhythm while experiencing or immediately after a symptomatic event.

This document describes post-market changes rather than initial device approval, meaning that the full clinical study details are not provided in the typical format for proving initial efficacy or safety against a specific set of acceptance criteria. Instead, the focus is on demonstrating that a modification to an already approved device does not negatively impact its performance or safety, maintaining substantial equivalence to its predicate.

Therefore, the information regarding acceptance criteria and study details for device performance is limited to information on the modifications and the verification/validation activities assessing those modifications.

Here's a breakdown of the available information based on your requested categories:

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

Based on the provided text, the device itself (LINQ II ICM) is already cleared. The current submission (K240693) describes a modification to the LINQ II ICM. The acceptance criteria and "reported device performance" here refer to the evaluation of this modification.

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

The document does not specify a "test set" sample size in the context of a new clinical study. Instead, it refers to "design verification and validation activities" for the modification. These are typically laboratory-based tests or engineering evaluations, not patient studies with specific sample sizes. Therefore, information on data provenance (country of origin, retrospective/prospective) for a clinical test set is not applicable here.

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

This information is not provided as the submission focuses on design verification and validation of a modification, not a new clinical trial requiring expert consensus for ground truth establishment.

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

This information is not provided as the submission focuses on design verification and validation of a modification, not a new clinical trial that typically employs 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

This type of study is not mentioned as the LINQ II ICM is an insertable cardiac monitor that automatically detects arrhythmias and allows patient-initiated recordings. It's a monitoring device, not an AI-assisted diagnostic tool for human readers.

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

The device is inherently "standalone" in its automatic detection function, as it continuously monitors and records without constant human intervention. The submission focuses on ensuring this existing functionality is maintained after the modification. No specific "standalone performance study" in the context of a new algorithm is detailed. The device's primary function is automatic arrhythmia detection, which is essentially an algorithm-only function.

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

For the original LINQ II ICM, ground truth would likely have been established through clinical correlation with electrophysiologist interpretations or other diagnostic methods. However, for this modification, the "ground truth" for the verification and validation activities would be engineering specifications, established performance standards, and comparison to the predicate device's known characteristics.

8. The sample size for the training set

This information is not provided. The document describes a modification to an existing device, not the development of a new algorithm with a training set.

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

This information is not provided, as a training set for a new algorithm is not discussed in this submission.

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The LINQ II ICM is an insertable automatically-activated and patient activated monitoring system that records subcutaneous ECG and is indicated in adult patients, and in pediatric patients who are at least 2 years old, in the following cases:

• · patients with clinical syndromes or situations at increased risk of cardiac arrhythmias
• patients who experience transient symptoms such as dizziness, palpitation, syncope, and chest pain that may suggest a cardiac arrhythmia

The LINQ II Insertable Cardiac Monitor (ICM) Model LNQ22 is a programmable device that continuously monitors a patient's ECG and other physiological parameters. The device records cardiac information in response to automatically detected arrhythmias and patient-initiated activation or markings. The device is designed to automatically record the occurrence of an episode of arrhythmia in a patient. Note: Arrhythmias are classified as tachyarrhythmia, bradyarrhythmia, pause, atrial tachyarrhythmia, or atrial fibrillation. Patients may also manually record symptoms. In order to manually record symptoms, the patient will also need either the MyCareLink Heart App (patient app on mobile device) or the Patient Assistant Model PA97000. The patient can use the MyCareLink Heart App or the Patient to manually record his or her cardiac rhythm while experiencing or immediately after a symptomatic event. LINO II ICM includes the following accessories: LINQ II Tool Kit Model LNQ22TK, Reveal LINQ™ Mobile Manager Model MSW002, Device Command Library Model 2692, Instrument Command Library Model 2691, and AccuRhythm AI ECG Classification System Models ZA400, ZA410, ZA420 and CareLink SmartSync LINQ II ICM Application Model D00U024. New to the LINQ II ICM system is the CareLink SmartSync LINQ II Platform Application Model D00U027.

I am sorry, but based on the provided text, I cannot extract any information about the acceptance criteria for device performance, a study proving the device meets acceptance criteria, sample sizes used, data provenance, number of experts, adjudication methods, MRMC comparative effectiveness studies, standalone performance, type of ground truth, or training set details.

The document discusses the substantial equivalence of the LINQ II Insertable Cardiac Monitor (ICM) when used with the CareLink SmartSync LINQ II Platform Application to a predicate device. It states that design verification and validation were performed to ensure the application met design requirements and established performance criteria, and that "all test executions resulted in a status of Passed" and "All results met the criteria in the Validation Plan." However, it does not specify what those performance criteria or validation plan criteria were, nor does it provide details about any specific studies conducted to establish device performance in terms of diagnostic accuracy or clinical effectiveness.

The document focuses on regulatory approval based on substantial equivalence to a predicate device, and the testing mentioned appears to be primarily related to software and system design verification and validation, rather than a clinical performance study with specific acceptance criteria that would include the metrics you've asked for (e.g., sensitivity, specificity, accuracy against a ground truth from experts).

Ask a specific question about this device

The LINQ II ICM is an insertable automatically-activated and patient-activated monitoring system that records subcutaneous ECG and is indicated in adult patients, and in pediatric patients who are at least 2 years old, in the following cases:

• · patients with clinical syndromes or situations at increased risk of cardiac arrhythmias
• · patients who experience transient symptoms such as dizziness, palpitation, syncope, and chest pain that may suggest a cardiac arrhythmia

The LINQ II Insertable Cardiac Monitor (ICM) Model LNQ22 is a programmable device that continuously monitors a patient's ECG and other physiological parameters. The device records cardiac information in response to automatically detected arrhythmias and patient-initiated activation or markings. The device is designed to automatically record the occurrence of an episode of arrhythmia in a patient. Note: Arrhythmias are classified as tachyarrhythmia, bradyarrhythmia, pause, atrial tachyarrhythmia, or atrial fibrillation. Patients may also manually record symptoms. To manually record symptoms, the patient will also need either the MyCareLink Heart App (patient app on mobile device) or the Patient Assistant Model PA97000. The patient can use the MyCareLink Heart App or the Patient to manually record his or her cardiac rhythm while experiencing or immediately after a symptomatic event.

The LINQ II Insertable Cardiac Monitor (LNQ22) is intended to monitor subcutaneous ECG and detect cardiac arrhythmias. The provided document, K233320, is a 510(k) premarket notification for a modification to the LINQ II ICM, specifically a new Firmware solution.

Based on the provided text, the document does not contain detailed information about the acceptance criteria and the study that proves the device meets those criteria for the detection of arrhythmias. The submission states that verification and validation testing was performed and met pre-determined acceptance criteria, but it does not describe those criteria or the specifics of the study.

Therefore, many of the requested details cannot be extracted from this document.

Here's what can be inferred or stated based on the provided text:

• 1. A table of acceptance criteria and the reported device performance: This information is not provided in the document. The document states that "The results of verification and validation testing met pre-determined acceptance criteria," but it does not list these criteria or the specific performance metrics achieved.

• 2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): This information is not provided in the document.

• 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): This information is not provided in the document.

• 4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: This information is not provided in the document.

• 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: This is not applicable as the device is an Insertable Cardiac Monitor, which automatically detects arrhythmias. There is no mention of human reader assistance or AI in the context of improving human performance.

• 6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: The device description states it "automatically detects arrhythmias" and "continuously monitors a patient's ECG, and analyze the timing of ventricular events to detect possible episodes of arrhythmia." This implies a standalone algorithm performance is key, but the specifics of how this was evaluated (e.g., in a standalone study) are not detailed. The document focuses on the firmware update and its impact on the existing system.

• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): This information is not provided in the document.

• 8. The sample size for the training set: This information is not provided in the document.

• 9. How the ground truth for the training set was established: This information is not provided in the document.

In summary, the provided submission focuses on establishing substantial equivalence for a firmware update to an already cleared device. It asserts that verification and validation testing confirmed the device continues to meet pre-determined acceptance criteria but does not provide the details of those criteria or the studies that established them for the original device's performance regarding arrhythmia detection. To get this specific information, one would need to review the original 510(k) submission (K221962) for the predicate device.

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The LUX-Dx Insertable Cardiac Monitor (ICM) is intended to monitor and record subcutaneous electrocardiogram (S-ECG). The recorded S-ECG is used for the clinical evaluation and diagnosis of cardiac arrhythmias. The LUX-Dx is indicated for use in patients that have a known heart condition and are at risk of developing an abnormal heart rhythm, or have symptoms that may suggest a cardiac arrhythmia such as dizziness, palpitations, syncope, chest pain, and/or shortness of breath. The LUX-Dx has not been tested specifically for pediatric use.

The LUX-Dx II (M302) and LUX-Dx II+ (M312) ICM devices evaluate S-ECG waveform data for indications of cardiac arrhythmias and "marks" the S-ECG signal for clinical presentation and evaluation when the algorithm criteria are met. The ICM device is inserted into the subcutaneous layer of the fourth intercostal space of the left chest wall. The ICM device is powered by an integrated battery. The electrodes used for detecting the S-ECG signal are located on each end of the ICM device, in the header and at the base of the battery. The LUX-Dx system includes the following main components:

• ICM Device - a subcutaneously-implanted cardiac monitor device for cardiac arrhythmia event data collection and transmission. In addition, symptom events are collected and transmitted from the device.
• . Mobile Monitor (MM) - mobile applications (myLUX™ Patient app and LUX-Dx™ Clinic Assistant app) running on an OTS mobile device that communicates with the ICM device (using Bluetooth Low Energy (BLE)) and the LATITUDE Clarity™ server (using cellular/Wi-Fi) for collection and transmission of event, patient, and device data.
• . LATITUDE Clarity™ server - a server that communicates with the Mobile Monitor for bidirectional data transmission and provides web access for clinicians to perform remote monitoring activities and manage general patient and system parameters and workflow activities.
• . System Accessories- for insertion of the ICM device, an insertion tool and incision tool are provided. In addition, a magnet is provided to initiate ICM/MM app communication.

The provided text describes the LUX-Dx II (M302) and LUX-Dx II+ (M312) Insertable Cardiac Monitors (ICM) and their substantial equivalence to a predicate device. However, the text does not contain detailed acceptance criteria or the specific results of a study demonstrating the device meets those criteria, nor does it provide information about the test set, experts, adjudication, or training set as requested in points 2-9 of your prompt.

The document primarily focuses on establishing substantial equivalence to a predicate device (LUX-Dx ICM M301, K193473) for FDA 510(k) clearance. It mentions "algorithm validation" as part of design validation testing but does not elaborate on the specifics of this validation study to the extent requested.

Here's a breakdown of what can be extracted from the provided text, and what is missing:

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

What is provided: The document states that the new device models (M302, M312) include "new and enhanced detection algorithms, bring-your-own-device (BYOD) capability, and additional changes for sustaining/maintenance and continuous improvement." Specifically, they feature a PVC detection algorithm and enhancements to the Pause algorithm (M302, M312) and AF algorithm (M312 only) to reduce false positives.

What is missing: The text does not provide specific quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy targets) for these algorithms, nor does it present the reported performance against such criteria. The "Summary of Performance Testing" section broadly mentions "algorithm validation" but gives no results.

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

Missing. The text mentions "algorithm validation" but does not provide any details about the test set used for this validation, including its size or provenance.

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)

Missing. There is no information in the document regarding experts or their qualifications for establishing ground truth.

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

Missing. The document does not describe any adjudication methods used for the test set.

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

Missing. The document does not mention an MRMC study or any assessment of human reader improvement with AI assistance. The device is an Insertable Cardiac Monitor, which automatically detects and records arrhythmias, implying less focus on real-time human interpretation with AI assistance in the same way an imaging AI might.

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

What is suggested: The mention of "algorithm validation" implies that the standalone performance of the algorithms was tested. The device's nature as an ICM that "marks" S-ECG signal when algorithm criteria are met suggests a primary focus on standalone algorithmic detection.

What is missing: Specific results or details of a standalone performance study.

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

Missing. The document does not specify how ground truth was established for "algorithm validation."

8. The sample size for the training set

Missing. No information about a training set is provided.

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

Missing. No information about a training set or its ground truth establishment is provided.

In summary, while the document confirms the device features new and enhanced algorithms for detecting cardiac arrhythmias, it fundamentally lacks the detailed performance study information, acceptance criteria, and ground truth methodologies that your prompt requests. The focus of this FDA 510(k) summary is on demonstrating substantial equivalence rather than providing a detailed performance study report.

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The BIOMONITOR IV is indicated to detect the following cardiac arrhythmias:

• · Atrial fibrillation
• · Bradycardia
• Sudden rate drop
• · Tachycardia
• · Pause

The BIOMONITOR IV is indicated for use in:

• Patients with clinical syndromes or situations at increased risk of cardiac arrhythmias
• · Patients who experience transient symptoms that may suggest a cardiac arrhythmia

The device has not been tested for and it is not intended for pediatric use.

BIOMONITOR IV is a programmable, subcutaneous insertable cardiac monitor able to record subcutaneous ECGs (sECGs) and other physiological parameters.

The BIOMONITOR IV is designed to automatically record the occurrence of arrhythmias in a patient. Arrhythmia may be classified as atrial fibrillation (AF), bradyarrhythmia, pause, sudden rate drop, or tachycardia. In addition, the BIOMONITOR IV can be activated by the patient using the Remote Assistant III to record cardiac rhythm during symptomatic episodes. BIOMONITOR IV may be used with the current legally marketed BIOTRONIK Home Monitoring® technology, which is an automatic, wireless, remote monitoring system for management of patients with implantable cardiac monitors.

The provided text describes the 510(k) premarket notification for the BIOMONITOR IV, an implantable cardiac monitor. However, it explicitly states that "No clinical performance data was submitted or relied upon in support of the substantial equivalence determination."

Therefore, I cannot provide information regarding acceptance criteria and a study that proves the device meets them, as such data was not provided in this FDA 510(k) summary. The submission focuses on validating the device against its predicate through non-clinical testing and functional equivalence.

The available information indicates that the device has undergone "thorough validation and verification testing to ensure final device functionality," including:

• Mechanical and Electrical Verification Testing for BIOMONITOR IV

This testing aimed to demonstrate that the BIOMONITOR IV functions as intended and is substantially equivalent to the predicate devices (BIOMONITOR III and BIOMONITOR IIIm) based on its principle of operation, physical characteristics, and software features. The submission does not detail specific performance metrics, sample sizes, ground truth establishment, or expert involvement for these verification tests, as those are generally internal engineering validations rather than clinical performance studies.

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The LINQ II ICM is an insertable automatically-activated and patient-activated monitoring system that records subcutaneous ECG and is indicated in adult patients who are at least 2 years old, in the following cases:

· patients with clinical syndromes or situations at increased risk of cardiac arrhythmias

· patients who experience transient symptoms such as dizziness, palpitation, syncope, and chest pain that may suggest a cardiac arrhythmia

The LINQ II Insertable Cardiac Monitor (ICM) Model LNQ22 is a programmable device that continuously monitors a patient's ECG and other physiological parameters. The device records cardiac information in response to automatically detected arrhythmias and patient-initiated activation or markings. The device is designed to automatically record the occurrence of an episode of arrhythmia in a patient. Note: Arrhythmias are classified as tachyarrhythmia, bradyarrhythmia, pause, atrial tachyarrhythmia, or atrial fibrillation. Patients may also manually record symptoms. In order to manually record symptoms, the patient will also need either the MyCareLink Heart App (patient app on mobile device) or the Patient Assistant Model PA97000. The patient can use the MyCareLink Heart App or the Patient to manually record his or her cardiac rhythm while experiencing or immediately after a symptomatic event. LINO II ICM includes the following accessories: LINO II Tool Kit Model LNO22TK, Reveal LINO™ Mobile Manager Model MSW002. Device Command Library Model 2692. Instrument Command Library Model 2691, and AccuRhythm AI ECG Classification System Models ZA400, ZA410, and ZA420. New to the LINO II ICM system is the CareLink SmartSync LINO II ICM Application Model D00U024.

Based on the provided text, the device in question is the LINQ II Insertable Cardiac Monitor (ICM) and its associated CareLink SmartSync LINQ II ICM Application. The document describes a 510(k) submission, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a de novo clinical study with specific acceptance criteria related to disease detection performance.

Therefore, much of the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of a typical AI/ML medical device performance study (e.g., sensitivity, specificity, clinical accuracy) is not explicitly provided or applicable in this regulatory submission. This submission primarily addresses changes to a software application used with an existing, cleared device and demonstrates that these changes do not alter the existing device's safety, effectiveness, or indications for use.

However, I can extract information related to the design verification and validation testing that was performed to ensure the CareLink SmartSync LINQ II ICM Application meets its specified requirements and performs as intended.

Here's a breakdown of the requested information, with clarification where the document does not provide details relevant to a "performance study" as typically understood for AI algorithms:

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

The document states:

• "Software and system design verification were completed to ensure the design output meets specifications outlined in the design inputs. The CareLink SmartSync LINQ II ICM Application meets the functionality per the requirements and all test executions resulted in a status of Passed."
• "System validation testing and analysis were completed to ensure the CareLink SmartSync LINO II ICM Application meets design input requirements under actual or simulated use conditions. All results met the criteria in the Validation Plan."

This indicates that the acceptance criteria were the fulfillment of design input requirements and specifications, and the reported performance is that all tests "Passed" and "All results met the criteria in the Validation Plan."

Specific performance metrics (e.g., sensitivity, specificity, accuracy for arrhythmia detection) of the LINQ II ICM itself are not presented in this document, as the submission is for the accompanying software application's compatibility and functionality, not a re-evaluation of the ICM's core arrhythmia detection performance.

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

• Sample Size for Test Set: Not specified. The document mentions "Software and system design verification" and "System validation testing and analysis," but does not provide details on the number of cases, patient data, or exact nature of the "test sets" used. This testing appears to be focused on software functionality and connectivity rather than clinical data analysis with a specific sample of patient ECGs.
• Data Provenance: Not specified. Given the nature of the submission (software update/compatibility), it's highly likely that the testing involved internal simulated data or a small set of real-world scenarios to confirm software functionality, not a large-scale clinical dataset from a specific country or with a specific recruitment methodology.

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)

• Not applicable/Not specified. This information is typically relevant for studies evaluating the clinical performance of a diagnostic algorithm (e.g., how well it detects a disease compared to expert consensus). This 510(k) submission is for the software application's functionality with an existing device, not a re-evaluation of the device's diagnostic performance for arrhythmia. Therefore, "ground truth" in the clinical diagnostic sense with expert readers is not described.

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

• Not applicable/Not specified. As above, this applies to clinical performance studies, not primarily to software functionality verification and validation.

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 study was not described or implied in this submission. This type of study investigates the impact of AI assistance on human reader performance, which is not the focus of this 510(k) given its scope (addition of a new connectivity application).

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

• Not explicitly described in terms of diagnostic performance metrics for an "algorithm." The LINQ II ICM itself has embedded algorithms for arrhythmia detection, but this submission pertains to the CareLink SmartSync application used for data transmission and interaction. The original LINQ II ICM was cleared with its own performance data, which is not detailed here. The "standalone" performance described for the CareLink SmartSync app is its ability to meet "design input requirements" and "functionality per requirements," which are software engineering quality metrics, not clinical diagnostic performance metrics.

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

• For the LINQ II ICM's core arrhythmia detection (which is not the subject of this specific 510(k)'s new testing): This information would typically be established during its initial clearance via clinical studies correlating ECG recordings with expert interpretation or clinical outcomes. However, this submission does not detail how the ground truth for the ICM's performance was established.
• For the CareLink SmartSync Application: The "ground truth" was likely defined by the software's functional specifications and design requirements. Successful completion of automated and manual tests demonstrating that the software behaved as designed would constitute meeting its "ground truth" (i.e., it performs the specified functions correctly). No mention of expert clinical consensus or pathology data for this application's testing is made.

8. The sample size for the training set

• Not applicable/Not specified. This submission does not describe an AI/ML model for arrhythmia detection that would require a "training set." The CareLink SmartSync Application is a software interface, not an independent diagnostic AI algorithm.

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

• Not applicable/Not specified. As above, no training set for an AI/ML model is described.

In summary: This 510(k) submission is focused on demonstrating that the CareLink SmartSync LINQ II ICM Application (a new software component for connectivity and data transmission) when used with the existing LINQ II Insertable Cardiac Monitor maintains substantial equivalence to the predicate device. The "acceptance criteria" and "study" described are primarily related to software verification and validation testing to ensure the new application functions as intended and does not introduce new safety or performance concerns, rather than a clinical performance study of a diagnostic AI algorithm.

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The Reveal LINQ ICM is an insertable automatically-activated monitoring system that records subcutaneous ECG and is indicated in the following cases:
• patients with clinical syndromes or situations at increased risk of cardiac arrhythmias
• patients who experience transient symptoms such as dizziness, palpitation, syncope, and chest pain that may suggest a cardiac arrhythmia
The device has not been tested specifically for pediatric use.

The Reveal LINQ Model LNQ11 Insertable Cardiac Monitors (ICM) is designed to automatically record the occurrence of arrhythmias in a patient. Arrhythmia may be classified as atrial tachyarrhythmia/atrial fibrillation (AT/AF), bradyarrhythmia, pause, or (fast) ventricular tachyarrhythmia. The Reveal LINQ ICM provides storage of ECG and Marker Channel during patient-activated and automatically-detected (auto-activated) events. Auto activation may help to detect abnormal heart rhythms in patients who may not activate/trigger the ICM. The Reveal LINQ ICM Model LNQ11 is a small, leadless device that is typically implanted under the skin, in the chest. Two electrodes on the body of the device continuously monitor the patient's subcutaneous ECG.

Reveal LINQ ICM includes the following accessories: LINQ Tool Kit Model LNQTOOL, Patient Assistant PA96000, Reveal LINQ™ Mobile Manager Model MSW002 used with Patient Connector Model 24967, CareLink Programmer Model 2090, Encore Programmer Model 29901, Reveal LINO Application Software Model SW026, MyCareLink Patient Monitor Models 24950 and 24955, CareLink Express Monitor Model 2020B, Device Data Management Application Model 2491, Device Command Library Model 2692 and Instrument Command Library Model 2691, CareLink Express Mobile Application Models 31302, and CareLink Network. New to the Reveal LINO ICM system is the AccuRhythm AI ECG Classification System Models ZA400, ZA410, ZA420, included in this submission.

The provided text describes the regulatory clearance of the Medtronic Reveal LINQ Insertable Cardiac Monitor (ICM) with AccuRhythm AI ECG Classification System. While it states that "Performance validation testing and analysis were completed to ensure the algorithms were able to reduce false alerts from ICM detected AF and Pause episodes while retaining true alerts," and "All results met or exceeded the criteria in the Validation Plan," the document does not explicitly detail the specific acceptance criteria or the numerical results of the device's performance against those criteria. It refers to the testing done for the predicate device (LINQ II ICM with AccuRhythm AI ECG Classification System K210484) and states that no new changes were made to the Reveal LINQ ICM itself.

Therefore,Based on the provided text, I can infer some aspects of the study and its criteria, but much of the specific numerical data requested (like actual performance results, sizes for test set, and detailed information about ground truth establishment for this specific submission) is not present. The document focuses on showing substantial equivalence to a previously cleared device (K210484), rather than providing a full detailed clinical study report for the AccuRhythm AI component.

Here's an attempt to answer your questions based on the available information:

Acceptance Criteria and Reported Device Performance

The document states that "All results met or exceeded the criteria in the Validation Plan." However, the specific numerical acceptance criteria and the reported device performance values are not provided in this document. The focus is on the function of the AI system: to "reduce false alerts from ICM detected AF and Pause episodes while retaining true alerts."

Study Details

1. Sample size used for the test set and the data provenance:

   • Sample Size: Not explicitly stated for the validation testing of the AccuRhythm AI ECG Classification System in this document. The document refers to "Performance validation testing and analysis."
   • Data Provenance: Not specified in this document (e.g., country of origin, retrospective or prospective).

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

   • This information is not provided in the document.

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

   • This information is not provided in the document.

4. 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 does not mention an MRMC comparative effectiveness study where human readers' performance with and without AI assistance was evaluated. The testing described is focused on the algorithm's ability to reduce false alerts and retain true alerts, implying a standalone performance evaluation or an evaluation within the device's existing automatic detection framework.

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

   • Yes, the description of "Performance validation testing and analysis were completed to ensure the algorithms were able to reduce false alerts from ICM detected AF and Pause episodes while retaining true alerts" strongly suggests a standalone (algorithm-only) performance evaluation was conducted for the AccuRhythm AI component. The specific metrics, however, are not provided.

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

   • The type of ground truth used is not explicitly stated. However, given the context of ECG classification for arrhythmias (AF and Pause), it is highly probable that the ground truth was established through expert adjudication of ECG recordings, possibly referring back to established clinical diagnoses or reference standards.

7. The sample size for the training set:

   • The sample size for the training set is not provided in this document.

8. How the ground truth for the training set was established:

   • This information is not provided in this document.

In summary, this FDA clearance letter emphasizes the substantial equivalence to a previously cleared device that includes the AccuRhythm AI system (K210484). While it states that performance validation was done and met criteria for reducing false alerts and retaining true alerts, the detailed specifics of the study design, sample sizes, expert involvement, and numerical performance metrics for the AI component itself are not included in this high-level summary. These details would typically be found in the full 510(k) submission and associated scientific documentation, not necessarily in the publicly available clearance letter.

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The LINQ II ICM is an insertable automatically activated and patient-activated monitoring system that records subcutaneous ECG and is indicated in adult patients, and in pediatric patients who are at least 2 years old, in the following cases:

· Patients with clinical syndromes or situations at increased risk of cardiac arrhythmias

· Patients who experience transient symptoms such as dizziness, palpitation, syncope, and chest pain that may suggest a cardiac arrhythmia

The LINO II Insertable Cardiac Monitor (ICM) Model LNQ22 is a programmable device that continuously monitors a patient's ECG and other physiological parameters. The device records cardiac information in response to automatically detected arrhythmias and patient-initiated activation or markings. The device is designed to automatically record the occurrence of an episode of arrhythmia in a patient. Note: Arrhythmias are classified as tachvarrhythmia. bradyarrhythmia, pause, atrial tachyarrhythmia, or atrial fibrillation. Patients may also manually record symptoms. In order to manually record symptoms, the patient will also need either the MyCareLink Heart App (patient app on mobile device) or the Patient Assistant Model PA97000. The patient can use the MyCareLink Heart App or the Patient to manually record his or her cardiac rhythm while experiencing or immediately after a symptomatic event. LINQ II ICM includes the following medical accessories: LINQ Tool Kit Model LNQ22TK, Patient Assistant Model PA97000, Reveal LINQ™ Mobile Manager Model MSW002 with patient connector Model 24967, Device Command Library Model 2692, Instrument Command Library Model 2691, and the Zelda (AccuRhythm) AI ECG Classification System Models ZA400, ZA410, and ZA420.

This document describes the 510(k) premarket notification for the LINQ II Insertable Cardiac Monitor (ICM) Model LNQ22, which is being cleared for expanded indications for use. The submission focuses on expanding the existing indications to include the pediatric patient population and expanding MRI conditions for use.

Here's the information extracted:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide a specific table in the typical format of acceptance criteria with corresponding performance metrics for the device itself as a diagnostic tool. Instead, the "acceptance criteria" discussed are related to design validation and regulatory compliance for the expanded indications.

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

The document describes a retrospective clinical evaluation.

• Sample Size: Not explicitly stated as a numerical sample size. It refers to an evaluation of "published literature, post-market surveillance data, and studies," suggesting a review of existing data rather than collection of new patient data for a specific test set.
• Data Provenance: Retrospective, derived from "published literature, post-market surveillance data, and studies." No specific country of origin is mentioned, but post-market surveillance data would likely span various regions where the device was previously marketed.

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

Not applicable. The study was a retrospective clinical evaluation of existing data (published literature, post-market surveillance, and studies) to assess safety and effectiveness in the pediatric population for expanded indications. It did not involve establishing a new ground truth for a test set through expert adjudication of individual cases.

4. Adjudication Method for the Test Set:

Not applicable. As noted above, this was a retrospective review of existing data, not a study involving expert adjudication of a new test set.

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

No. The document does not mention an MRMC comparative effectiveness study where human readers improve with or without AI assistance. The submission is for an expanded indication for an existing device, not a new AI-assisted diagnostic tool comparison.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

While the LINQ II ICM includes the "Zelda (AccuRhythm) AI ECG Classification System," this submission focuses on the expanded indications for use of the overall device (LINQ II ICM) for pediatric patients and MRI conditions. It does not provide details on standalone performance studies specifically for the AI component within this context. The core device functions to automatically detect arrhythmias, but the focus of this particular 510(k) is the hardware's expanded use.

7. The Type of Ground Truth Used:

For the clinical evaluation: The "ground truth" for assessing safety and effectiveness in the pediatric population was based on existing published literature, post-market surveillance data, and previous studies. This implies that clinical outcomes and established diagnostic criteria within those existing data sources served as the basis for evaluation.

8. The Sample Size for the Training Set:

Not applicable. This submission concerns the expansion of indications for an existing device, not the development or training of a new algorithm. If the "Zelda (AccuRhythm) AI ECG Classification System" was trained, information about its training set is not provided in this document as it pertains to the overall device's market clearance.

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

Not applicable, as this submission does not detail the training of a new algorithm.

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The BIOMONITOR III/BIOMONITOR IIIm is indicated to detect the following cardiac arrhythmias:

• atrial fibrillation
• · bradycardia
• · sudden rate drop
• · high ventricular rate (HVR)
• · asystole

The BIOMONITOR III/BIOMONITOR IIIm is indicated for use in:

• · Patients with clinical syndromes or situations at increased risk of cardiac arrhythmias
• · Patients who experience transient symptoms that may suggest a cardiac arrhythmia

The device has not been tested for and it is not intended for pediatric use.

BIOMONITOR III and BIOMONITOR IIIm are programmable, subcutaneous insertable cardiac monitors able to record subcutaneous ECGs (sECGs) and other physiological parameters.

The BIOMONITOR III and BIOMONITOR IIIm are designed to automatically record the occurrence of arrhythmias in a patient. Arrhythmia may be classified as atrial fibrillation (AF), bradvarrhythmia, asystole, sudden rate drop, or high ventricular rate. In addition, the BIOMONITOR III and BIOMONITOR IIIm can be activated by the patient using the Remote Assistant III to record cardiac rhythm during symptomatic episodes. BIOMONITOR III and BIOMONITOR IIIm may be used with the current legally marketed BIOTRONIK Home Monitoring® technology, which is an automatic, wireless, remote monitoring system for management of patients with implantable cardiac monitors.

This FDA filing (K221856) addresses changes to the BIOMONITOR III and BIOMONITOR IIIm, rather than a new device. Therefore, a full clinical study to prove the device meets acceptance criteria as would be required for a completely novel device is not presented. The submission focuses on demonstrating substantial equivalence to the predicate device (BIOMONITOR III and BIOMONITOR IIIm, K201865) following minor hardware changes.

The document explicitly states: "No clinical performance data was submitted or relied upon in support of the substantial equivalence determination." and "The BIOMONITOR III and BIOMONITOR IIIm have undergone thorough validation and verification testing to ensure final device functionality." and "Verification Testing for BIOMONITOR III and BIOMONITOR IIIm hardware changes".

Based on this information, we cannot provide the requested details about acceptance criteria derived from a substantial new clinical study, as such a study was not performed or deemed necessary for this specific submission. The focus was on demonstrating that the minor hardware changes did not negatively impact the established performance and safety characteristics of the already cleared predicate device.

Therefore, the questions regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment (items 1-9 in your request) cannot be answered from the provided document, as these typically relate to a de novo device approval or a submission requiring new clinical evidence.

The document primarily states that the updated device maintains the same principle of operation, physical device characteristics, software features, and functionality as the predicate, with minor component changes for manufacturing optimization. The validation and verification testing mentioned (Section 7.1) would likely be engineering-focused and aimed at confirming that the hardware changes did not introduce new risks or alter the device's electrical or mechanical performance, ensuring it still meets the specifications of the predicate device.

In summary, as per the provided text, a comparative effectiveness study or a new standalone clinical performance study was NOT conducted to prove the device met acceptance criteria, because the submission was a "Special 510(k)" for hardware changes to an already cleared device, not a new device.

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