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The BioMonitor 2 is indicated to detect the following cardiac arrhythmias:

• · Atrial fibrillation,
• · Bradycardia,
• · Sudden rate drop.
• · High ventricular rate (HVR),
• · Asystole.

The BioMonitor 2 is indicated for:

• · 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

The BioMonitor 2 senses subcutaneous electrocardiograms (SECG) using two integrated electrodes and has the capability of detecting a number of arrhythmias. The BioMonitor 2 uses BIOTRONIK's Home Monitoring to send recorded SECG and statistics to the Home Monitoring Service Center (P950037/S66, dated November 21, 2008; and P950037/S69, dated March 23, 2009) for further analysis. BioMonitor 2 is intended to aid in the diagnosis of cardiac arrhythmias that might otherwise go undetected.

BioMonitor 2 is designed to detect and trigger automatic recording of certain cardiac arrhythmias; these arrhythmias can be classified as follows:

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

Patients can also manually trigger recording of the cardiac information by use of the Remote Assistant. The memory capacity of BioMonitor 2 is such that the device can record at least 66 minutes of subcutaneous electrocardiograms (SECG). The device automatically stores a maximum of 55 separately recorded SECG-episodes of 40 seconds each (60 seconds maximum), and a maximum of 4 patient triggered SECG-episodes of 7.5 minutes. The BioMonitor 2 reports the recorded episodes and related statistical data through the physician's programmer and BIOTRONIK's Home Monitoring®

I am sorry, but the provided text does not contain the detailed information necessary to complete the table and answer all the questions regarding the acceptance criteria and the study that proves the device meets them.

Specifically, the document states: "To demonstrate that the modified BioMonitor 2 meets the same performance criteria, the following tests were conducted using the same test methods and acceptance criteria as for the predicate device." However, it does not provide the specific acceptance criteria themselves, nor does it report the device's performance against those criteria in a quantifiable manner (e.g., sensitivity, specificity, accuracy for arrhythmia detection).

Therefore, I cannot populate the table or answer questions 2 through 9 based solely on this document. The document lists various types of tests conducted (e.g., mechanical system verification, usability testing, packaging validation), but these are not the performance metrics of the device's arrhythmia detection capabilities. It also explicitly states, "No clinical testing was deemed necessary or completed in the premarket notification submission for a determination of substantial equivalence," which further limits the availability of data regarding clinical performance and ground truth.

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The BioMonitor 2 is indicated to detect the following cardiac arrhythmias:

• · Atrial fibrillation,
• · Bradycardia,
• · Sudden rate drop.
• · High ventricular rate (HVR),
• Asystole.

The BioMonitor 2 is indicated for:

• · 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

The BioMonitor 2 senses subcutaneous electrocardiograms (SECG) using two integrated electrodes and has the capability of detecting a number of arrhythmias. The BioMonitor 2 uses BIOTRONIK's Home Monitoring to send recorded SECG and statistics to the Home Monitoring Service Center (P950037/S66, dated November 21, 2008; and P950037/S69, dated March 23, 2009) for further analysis. BioMonitor 2 is intended to aid in the diagnosis of cardiac arrhythmias that might otherwise go undetected.

BioMonitor 2 is designed to detect and trigger automatic recording of certain cardiac arrhythmias; these arrhythmias can be classified as follows:

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

Patients can also manually trigger recording of the cardiac information by use of the Remote Assistant.

The memory capacity of BioMonitor 2 is such that the device can record at least 66 minutes of subcutaneous electrocardiograms (SECG). The device automatically stores a maximum of 55 separately recorded SECG-episodes of 40 seconds each (60 seconds maximum), and a maximum of 4 patient triggered SECG-episodes of 7.5 minutes. The BioMonitor 2 reports the recorded episodes and related statistical data through the physician's programmer and BIOTRONIK's Home Monitoring .

This document is a 510(k) premarket notification for the BioMonitor 2, a device described as an "Arrhythmia Detector and Alarm." The notification details that the device is a modified version of a previously cleared device (BIOTRONIK BioMonitor 2, K152995).

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance data. Instead, it states: "To demonstrate that the modified BioMonitor 2 meets the same performance criteria, the following tests were conducted using the same test methods and acceptance criteria as for the predicate device." It then lists the types of tests performed.

Important Note: The document consistently states that "This performance testing demonstrates that the subject device meet the same functional acceptance criteria for the same intended use." However, it does not provide the specific numerical acceptance criteria or the raw performance data obtained from these tests. It only lists the types of tests conducted.

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

The document explicitly states: "No clinical testing was deemed necessary or completed in the premarket notification submission for a determination of substantial equivalence."

Therefore, there is no test set in the clinical sense, and thus no sample size or data provenance from clinical studies for this submission. The tests listed are likely engineering and bench-top validation tests rather than human clinical data.

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

Since no clinical testing was performed, there was no "ground truth" for a clinical test set established by experts in this submission.

4. Adjudication Method for the Test Set

As there was no clinical test set for which ground truth was established, there was no adjudication method described.

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 such study was conducted or reported in this submission, as indicated by the statement, "No clinical testing was deemed necessary or completed." The device described is an "Arrhythmia Detector and Alarm," which generally acts as a standalone detection system rather than an AI-assistance tool for human readers in the context of diagnostic image interpretation.

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

The document describes the BioMonitor 2 as sensing subcutaneous electrocardiograms (SECG) and having the "capability of detecting a number of arrhythmias." It also states, "The BioMonitor 2 uses BIOTRONIK's Home Monitoring to send recorded SECG and statistics to the Home Monitoring Service Center for further analysis." and "BioMonitor 2 is designed to detect and trigger automatic recording of certain cardiac arrhythmias."

This strongly implies that the device (or its integrated algorithm) operates in a standalone manner to detect arrhythmias and record data. While the "Home Monitoring Service Center" performs "further analysis," the initial detection and recording of events like atrial fibrillation, bradycardia, sudden rate drop, HVR, and asystole are described as capabilities of the BioMonitor 2 itself. The performance data section refers to "System verification testing" and "Software release testing," which would encompass standalone algorithm performance.

However, specific performance metrics (e.g., sensitivity, specificity, accuracy) for these standalone detections are not provided in this document.

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

The document does not detail the specific ground truth used for verifying the performance of the device's arrhythmia detection capabilities. Given that no clinical testing was performed for this submission, the "ground truth" for the predicate device's initial clearance for arrhythmia detection would have been established through a combination of simulated ECG signals, known cardiac events from existing databases, and potentially clinical studies at the time of the predicate's original submission. However, this submission relies on the "same test methods and acceptance criteria as for the predicate device" for its engineering and functional tests, rather than providing new ground truth establishment for arrhythmia detection.

8. The Sample Size for the Training Set

The document does not mention any training set or machine learning aspects for this submission. This 510(k) is for a "minor modification" to an already cleared device, and the focus is on demonstrating that the modified device meets the performance of the predicate, not on developing or training a new algorithm.

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

As no training set is mentioned, this information is not applicable and not provided.

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The BioMonitor 2 indicated to detect the following cardiac arrhythmias:

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

The BioMonitor 2 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 is not intended for pediatric use

The BioMonitor 2 is a small, leadless, implantable device that uses two electrodes on the body of the device to monitor continuously the patient's subcutaneous ECG. The BioMonitor 2 is designed to record automaticallythe occurrence of arrhythmias in a patient. Recordings can also be triggered by use of the associated Remote Assistant. Arrhythmia may be classified as atrial fibrillation, bradycardia, asystole, or high ventricular rate. The device memory can automatically store a maximum of 55 separately recorded SECG-episodes of 40 seconds each, and 4 patient triggered SECG-episodes of 7.5 minutes.

The provided text describes the BioMonitor 2, an implantable cardiac monitor intended to detect various cardiac arrhythmias. However, the document is a 510(k) premarket notification summary from the FDA, and as such, it focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed technical "acceptance criteria" table with specific metrics (like sensitivity, specificity, accuracy) for arrhythmia detection algorithms or a direct "study that proves the device meets the acceptance criteria" in the way one might expect for a novel AI/ML-based diagnostic device.

The document mentions a clinical study and software verification/validation, but it does not provide the granular details requested in your prompt regarding:

• Specific performance metrics (e.g., sensitivity, specificity) for arrhythmia detection.
• Quantitative results showing the device performance against specific acceptance criteria.
• Details about the ground truth establishment (number/qualifications of experts, adjudication methods).
• Sample sizes for training sets or the provenance of training data.
• Any MRMC studies or human-in-the-loop performance improvements.
• Standalone algorithm performance.

The "acceptance criteria" presented are primarily functional (what the device does and what arrhythmias it detects) and safety/technological (MRI compatibility, software validation, meeting standards), rather than detailed performance metrics of its arrhythmia detection capability against a ground truth dataset.

Given these limitations of the source text, I will construct a response based on what is provided and explicitly state where information is not available in the document.

Acceptance Criteria and Device Performance for BioMonitor 2

Based on the provided FDA 510(k) summary for the BioMonitor 2, the acceptance criteria are implicitly defined by its intended use and functional capabilities, and its demonstrated substantial equivalence to a predicate device. The document does not provide specific quantitative acceptance criteria for arrhythmia detection performance (e.g., specific sensitivity or specificity thresholds) in the way one might see for a diagnostic AI algorithm. Instead, the "performance" demonstrated is primarily about the device's ability to consistently perform its intended functions and its safety.

Here's a table based on the functional aspects the device is indicated to detect:

1. Table of Acceptance Criteria (Implicit) and Reported Device Performance (Functional)

Study Details Proving Device Meets Acceptance Criteria

The document refers to a "Clinical Study" and "Software Verification and Validation Testing" as evidence supporting substantial equivalence, which implicitly means meeting the functional "acceptance criteria" described above and ensuring safety.

2. Sample Size and Data Provenance:

• Test Set Sample Size: 30 patients were included in the primary clinical study.
• Data Provenance: Data sourced from 5 Australian clinical sites.
• Retrospective/Prospective: The study duration (December 18, 2014, through July 06, 2015) suggests it was a prospective clinical data collection. An additional "Post Market Observation (PMO)" commenced in Europe with 15 implantations as of October 9, 2015, which would also be prospective.

3. Number of Experts and Qualifications for Ground Truth:

• The document does not specify the number of experts used to establish the ground truth for arrhythmia detection, nor their qualifications (e.g., electrophysiologists, cardiologists, years of experience). The study objective was on implantation procedure and sensing quality, not explicitly on algorithmic arrhythmia detection accuracy against a human expert reference standard.

4. Adjudication Method for the Test Set:

• The document does not specify any adjudication method for establishing ground truth for arrhythmia events. Given the focus on "sensing quality," it's plausible that sensed events were reviewed, but the process is not detailed.

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

• No, an MRMC comparative effectiveness study was not mentioned. The study's objective was to demonstrate the sensing quality and implantation procedure of the BioMonitor 2, not to compare human reader performance with and without AI assistance. This device is an implanted monitor, not an AI-assisted diagnostic workstation for human readers.

6. Standalone (Algorithm Only) Performance Study:

• The document does not explicitly describe a standalone algorithm-only performance study with quantitative metrics like sensitivity, specificity, or accuracy for arrhythmia detection. The "Clinical Study" assesses general sensing quality in implanted patients. The device itself is an algorithm-driven monitor, so its in-vivo performance is its "standalone" performance in the clinical context. However, the study results do not include specific performance metrics for individual arrhythmia types.

7. Type of Ground Truth Used:

• The document does not explicitly state how the ground truth for arrhythmia events was established (e.g., expert consensus, independent ECG reviews, pathology, outcomes data). The study assessed "sensing quality," which implies that the device's ability to sense and record heart activity was evaluated, but the method for verifying the true occurrence and classification of arrhythmias against which the device's output would be measured is not detailed. It's likely that adjudicated clinical events from the patient's records or an independent review of the collected sECG data constituted the ground truth but this is not confirmed.

8. Sample Size for the Training Set:

• The document does not provide any information about the sample size used for training the device's algorithms. As an implanted cardiac monitor, its algorithms for arrhythmia detection are likely developed and validated using extensive physiological data, but these details are not part of this 510(k) summary.

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

• The document does not provide any information on how the ground truth for the training set (if applicable for algorithm development) was established.

In summary, the FDA 510(k) process for the BioMonitor 2 focused on its substantial equivalence to an existing predicate device based on similar indications, technological characteristics, and safety data. While a clinical study was performed, its primary reported outcomes were related to the implantation process and "sensing quality" in a small patient cohort, rather than a detailed, quantitative analysis of its arrhythmia detection performance against a rigorously established ground truth using metrics common for AI/ML diagnostics.

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