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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 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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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 111/BIOMONITOR Illm 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), bradyarrhythmia, 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 document, K201865, is a 510(k) Premarket Notification for the BIOMONITOR III and BIOMONITOR IIIm, which are implantable cardiac monitors. The core of this submission is about confirming substantial equivalence to an existing predicate device (K200444). The specific change addressed in this 510(k) is the enabling of the temperature sensor for data transmission and its associated alerts and display.

Based on the provided text, the device itself (BIOMONITOR III/IIIm) already had acceptance criteria and studies for its primary function (arrhythmia detection) from when its predicate (K200444) was cleared. This 510(k) focuses specifically on the newly enabled feature – the temperature sensor. Therefore, the acceptance criteria and study detailed below will relate primarily to this new feature, as "no clinical performance data was submitted or relied upon in support of the substantial equivalence determination" for the overall device.

Here's an analysis of the provided text, focusing on the acceptance criteria and the study that proves the device meets them, specifically for the newly enabled temperature sensor feature:

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

The document does not provide a formal table of acceptance criteria for the temperature sensor feature in terms of numerical thresholds for accuracy, precision, or other performance metrics. However, it does state the reported device performance:

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

• Test Set Sample Size: "Performance of the temperature sensor was validated in swine". The exact number of swine (sample size) used is not specified in the provided text.
• Data Provenance: The study was "Animal Testing" (specifically in swine). The location of this animal testing (country of origin) is not specified in the document. It is implicitly a prospective study, as it describes a validation of the sensor.

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

The document states "when compared to a clinical reference" for the temperature sensor validation. It does not specify the number of experts, their qualifications, or how they established the "clinical reference" ground truth.

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

The document does not describe any human adjudication method. The comparison for the temperature sensor was against a "clinical reference," which implies a direct measurement or standard, not subjective expert agreement.

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 study was done, nor is it applicable to the specific change being addressed in this 510(k). This submission is for enabling a sensor and transmitting its data, not for an AI that assists human readers in interpreting an image or signal. The device is an "Arrhythmia Detector And Alarm," and its primary function involves automated detection. The new feature is a temperature sensor.

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

Yes, for the temperature sensor, the "Performance of the temperature sensor was validated in swine for detection of fever to a measurement accuracy of within 0.1℃ when compared to a clinical reference." This is a standalone validation of the sensor's accuracy. The device's primary arrhythmia detection functionality is also largely standalone/algorithm-only, as it automatically detects arrhythmias.

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

For the temperature sensor, the ground truth was a "clinical reference" measurement. This indicates comparison against a recognized standard or highly accurate measurement technique in a clinical setting (in this case, in swine).

8. The sample size for the training set

The document does not provide information about a training set. The device's primary function is based on established arrhythmia detection algorithms, and the temperature sensor is a direct physical measurement. There is no mention of machine learning models requiring training data for this specific 510(k) submission.

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

Not applicable, as no training set is mentioned for the temperature sensor feature, nor is the underlying arrhythmia detection algorithm (which would have had its own training/development data) the subject of this specific 510(k) clearance.

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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), bradyarrhythmia, 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.

Here's an analysis of the acceptance criteria and study information for the BIOMONITOR III and BIOMONITOR IIIm, based on the provided document:

This document primarily describes the substantial equivalence of the BIOMONITOR III and BIOMONITOR IIIm to a predicate device (BIOMONITOR III, K190548) for FDA clearance. The information provided is characteristic of a 510(k) submission, where the focus is often on demonstrating that a new device is as safe and effective as an already legally marketed device, rather than proving performance against novel acceptance criteria with a new clinical study.

The key study mentioned is the "AF Detect study" for the BIOMONITOR IIIm.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state specific quantitative acceptance criteria (e.g., sensitivity, specificity thresholds) for the updated BIOMONITOR III and BIOMONITOR IIIm. The "AF Detect study" is described as demonstrating "substantial equivalence" and "further improvement of the performance in terms of reduction of false AF snapshots," but specific metrics or thresholds for this improvement are not provided in the summary.

Therefore, a table of quantitative acceptance criteria and reported performance cannot be fully constructed from the provided text. The document focuses on the sameness of the device's fundamental function compared to the predicate.

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

• Test Set Sample Size: Not explicitly stated for the "AF Detect study." The document only mentions "utilizing real-world clinical data."
• Data Provenance: "real-world clinical data." The country of origin and whether it was retrospective or prospective is not specified in the provided text.

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

This information is not provided in the document. Ground truth establishment methods, including the number and qualifications of experts, are not detailed for the "AF Detect study."

4. Adjudication Method 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, and the effect size of how much human readers improve with AI vs without AI assistance

• No MRMC study described: The document does not mention an MRMC study. The study described focuses on the device's detection algorithm, not on human reader performance with or without AI assistance.
• Effect size: Not applicable, as no MRMC study was described.

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

Yes, the "AF Detect study" appears to be a standalone performance evaluation of the AF detection algorithm. It aims to demonstrate the performance of the algorithm in the BIOMONITOR IIIm, specifically the extended AF detection algorithm with an additional parameter for ectopy rejection. The comparison is made to the predicate BIOMONITOR III's AF detection algorithm, implying an algorithm-to-algorithm comparison.

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

The type of ground truth used for the "AF Detect study" is not explicitly stated in the provided document. It refers to "real-world clinical data," but the method by which AF events within this data were definitively identified (e.g., expert consensus of ECGs, other diagnostic tests) is not described.

8. The Sample Size for the Training Set

The document does not mention a training set sample size. The description of the BIOMONITOR IIIm's AF algorithm states it has been "extended with an additional parameter to identify and reject specific patterns associated with ectopy rhythms," which implies some form of development or training, but details regarding a training set are absent.

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

This information is not provided in the document, as no training set details were given.

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

The BIOMONITOR III is designed to automatically record the occurrence of arrhythmias in a patient. Arrhythmia may be classified as atrial fibrillation (AF), bradyarrhythmia, asystole, sudden rate drop, or high ventricular rate. In addition, the BIOMONITOR III can be activated by the patient to record cardiac rhythm during symptomatic episodes. BIOMONITOR III 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 BIOMONITOR III is smaller than the predicate BioMonitor 2 while maintaining the same clinical functionality.

This 510(k) summary does not contain the detailed clinical study information typically found in a clinical trial report. It states that "No clinical performance data was submitted or relied upon in support of the substantial equivalence determination." Instead, it focuses on demonstrating substantial equivalence to a predicate device (BIOTRONIK BioMonitor 2, K152995) through non-clinical performance data and technological characteristics.

Therefore, many of the requested details regarding acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, and ground truth for training sets cannot be extracted from this document because a clinical study of that nature was not provided.

However, based on the non-clinical data, we can infer some "acceptance criteria" through the validation testing described.

Here's a summary of the available information:

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

Since no clinical performance data for specific arrhythmias are provided, the "acceptance criteria" are implied through the successful completion of the non-clinical tests demonstrating equivalence and safety.

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 as a formal clinical study with a test set was not submitted. The "preclinical study" mentioned in section 7.1 would have involved a sample size (e.g., number of animals or in vitro samples), but these details are not specified in this 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)

This information is not applicable/not provided as no clinical study with expert-adjudicated ground truth was submitted.

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

This information is not applicable/not provided as no clinical study with expert adjudication was submitted.

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

An MRMC comparative effectiveness study was not done/not submitted. The device is an implantable monitor, and the focus is on its automated detection capabilities as substantially equivalent to a predicate device, not on human reader improvement with AI assistance.

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

While not explicitly called a "standalone study", the document states that the device automatically records arrhythmias and that its "detection algorithms of BIOMONITOR III being unchanged from the predicate device." The validation testing (e.g., QRS detection performance) inherently evaluates the algorithm's performance in detecting these events without human intervention during the detection process. The statement that "BIOMONITOR III has the same part-rigid part-flexible design and the same overall shape as the predicate device (BioMonitor 2)" and that "BIOMONITOR III implant hardware-platform has been miniaturized with respect to BioMonitor 2" further suggests the focus is on hardware changes while maintaining the proven algoritihms of the previous device.

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

For the "equivalent QRS detection performance" in the preclinical study, the ground truth would typically be established by a reference standard (e.g., human expert interpretation of ECGs, or another validated detection method) against which the device's QRS detection is compared. However, the exact nature of this ground truth is not detailed in this summary.

8. The sample size for the training set

This information is not applicable/not provided. The document states that the "detection algorithms of BIOMONITOR III being unchanged from the predicate device," implying that new training was not required for the algorithms themselves, or if training was done, it was for the predicate device and not detailed here.

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

This information is not applicable/not provided for the reasons mentioned in point 8.

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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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The BioMonitor 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 is a small, leadless, implantable device that uses three electrodes on the body of the device to continuously monitor the patient's subcutaneous ECG. The BioMonitor is designed to automatically record the occurrence of arrhythmias in a patient. Arrhythmia may be classified as bradyarrhythmia, asystole, or high ventricular rate. The device memory can store up to 13.3 min of ECG recordings from automatically detected arrhythmias and up to 22.5 min of ECG recordings from patienttriggered episodes. When a patient experiences symptoms, the ECG recordings can be manually triggered by placing a magnet over the BioMonitor. The BioMonitor is intended to aid in the diagnosis of cardiac arrhythmias in patients that may otherwise qo undetected.

The provided text describes a 510(k) premarket notification for the BioMonitor, an implantable cardiac monitor with AF detection. Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The main performance metrics reported are for Atrial Fibrillation (AF) detection. The text does not explicitly state pre-defined acceptance criteria values (e.g., "Sensitivity must be > 90%"). Instead, it presents the results of the clinical study as the device's performance.

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

• Sample Size: 50 participants. Of these, 27 showed at least one true AF episode.
• Data Provenance: Single-center, prospective, nonrandomized study. The text does not specify the country of origin, but given the manufacturer is BIOTRONIK SE & Co. KG (Germany) and the sponsor is BIOTRONIK, Inc. (USA), it's likely a study conducted in either the US or Europe, or both. The data is prospective as participants were equipped with both devices and monitored.

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

• Number of Experts: Not explicitly stated. The text mentions "expert-annotated, external Holter ECG recorder." It implies an expert (or team of experts) reviewed the Holter data, but the exact number isn't provided.
• Qualifications of Experts: Not explicitly stated. The term "expert" implies a qualified medical professional, likely a cardiologist or electrophysiologist, experienced in interpreting ECGs and diagnosing cardiac arrhythmias.

4. Adjudication Method for the Test Set

The text states that the ground truth was established by "expert-annotated, external Holter ECG recorder." It does not provide details on an adjudication method (e.g., 2+1, 3+1, none) among multiple experts, suggesting either a single expert annotation or a process that doesn't involve explicit adjudication steps among several.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly mentioned as being performed to compare human readers with and without AI assistance. The study described focuses on the standalone performance of the BioMonitor against an expert-annotated Holter ECG as the gold standard.

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

Yes, a standalone study was done. The clinical study aimed to "evaluate BioMonitor AF detection performance... in comparison with the gold standard, expert-annotated, external Holter ECG recorder." This demonstrates the algorithm's performance without direct human intervention in the detection process based on the BioMonitor's automated output.

7. The Type of Ground Truth Used

The ground truth used was expert consensus / expert annotation based on an external Holter ECG recorder. The text explicitly states: "The ability of BioMonitor to detect episodes of AF was quantified in comparison with the gold standard, expert-annotated, external Holter ECG recorder."

8. The Sample Size for the Training Set

The document does not provide information about the sample size used for the training set for the BioMonitor's AF detection algorithm. The clinical study described is a validation study, assessing the performance of the already developed device.

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

The document does not provide information on how the ground truth for the training set was established. It only details the validation study and its ground truth establishment.

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The BioMonitor 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 BioMonitor is a small, leadless, implantable device that uses three electrodes on the body of the device to continuously monitor the patient's subcutaneous ECG. The BioMonitor is designed to automatically record the occurrence of arrhythmias in a patient. Arrhythmia may be classified as bradvarrhythmia. asvstole, or high ventricular rate. The device memory can store up to 13.3 minutes of ECG recordings from automatically detected arrhythmias and up to 22.5 minutes of ECG recordings from patient-triggered episodes. When a patient experiences symptoms, the ECG recordings can be manually triggered by placing a magnet over the BioMonitor.

The BioMonitor Implantable Cardiac Monitor is designed to continuously monitor a patient's subcutaneous ECG and automatically record arrhythmias. The 510(k) summary provides details about its performance and the testing conducted to establish substantial equivalence to predicate devices.

1. Acceptance Criteria and Reported Device Performance:

The provided document does not explicitly state formal acceptance criteria with specific performance thresholds (e.g., "sensitivity must be >X%"). Instead, it focuses on demonstrating technological equivalence to predicate devices and verifying various functional and safety aspects. The "Summary of Testing" section lists the types of testing performed and concludes that "No safety or effectiveness issues were identified." The device performance is implicitly established by showing that its technical characteristics are comparable to cleared predicate devices.

However, based on the context of an arrhythmia detector and the technical characteristics provided, we can infer some implied performance areas.

2. Sample Size for Test Set and Data Provenance:

The document mentions "Analysis of clinical data to support QRS detection" but does not specify the sample size used for this analysis, nor does it detail the data provenance (e.g., country of origin, retrospective or prospective nature). The other validation tests listed (Functional, Mechanical, Biocompatibility, Electrical Safety/EMC, Packaging, Sterilization, Shelf life) are typically bench or lab tests and do not involve "patient data" test sets in the same manner as clinical performance evaluation.

3. Number of Experts and Qualifications for Ground Truth for Test Set:

The document does not provide any information regarding the number or qualifications of experts used to establish ground truth for any clinical data analysis mentioned (e.g., QRS detection).

4. Adjudication Method for Test Set:

No information is provided regarding any adjudication method for a test set. This type of detail would typically be found in a clinical study report, which is not present in this 510(k) summary.

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

The document does not mention any MRMC comparative effectiveness study where human readers' performance with and without AI assistance was evaluated, nor does it provide an effect size for such a study. The BioMonitor is presented as a standalone automated arrhythmia detector.

6. Standalone (Algorithm Only) Performance:

Yes, the information provided primarily describes the standalone performance of the BioMonitor algorithm. The device "automatically record the occurrence of arrhythmias" and the "Analysis of clinical data to support QRS detection" would inherently evaluate the algorithm's performance without human intervention in the detection process. The summary table comparing "Technical Data" to predicate devices focuses on the device's inherent capabilities (e.g., trigger types, storage, sampling rate), all indicative of standalone algorithmic function.

7. Type of Ground Truth Used:

The type of ground truth used for the "Analysis of clinical data to support QRS detection" is not explicitly stated. For arrhythmia detection studies, ground truth is typically established by:

• Expert Consensus: Independent review of ECGs by multiple cardiologists/electrophysiologists.
• Adjudicated ECGs: Often involving multiple experts reviewing and agreeing on arrhythmia events.
• Simulated Arrhythmias: In some functional testing, precisely controlled simulated signals might be used.

Given the context of "clinical data," it is most likely that expert consensus or adjudicated ECGs served as the ground truth, but this is not confirmed in the document.

8. Sample Size for Training Set:

The document does not provide any information about a training set or its sample size. This type of information is typically related to machine learning model development, which is not detailed in this 510(k) summary focused on hardware and basic algorithmic functionality comparison.

9. How Ground Truth for Training Set Was Established:

Since no information regarding a training set is provided, there is no information on how its ground truth was established.

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