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

Device Description

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.

AI/ML Overview

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)

Functional/Performance Aspect	Acceptance Criteria (Implicit from Indications for Use and Device Description)	Reported Device Performance (as stated in the document)
Arrhythmia Detection:	The device must be capable of detecting the specified arrhythmias.	Indicated to detect:
Atrial Fibrillation	Capable of detecting Atrial Fibrillation.	Detected by BioMonitor 2.
Bradycardia	Capable of detecting Bradycardia.	Detected by BioMonitor 2.
Sudden Rate Drop	Capable of detecting Sudden Rate Drop.	Detected by BioMonitor 2.
High Ventricular Rate (HVR)	Capable of detecting HVR.	Detected by BioMonitor 2.
Asystole	Capable of detecting Asystole.	Detected by BioMonitor 2.
Recording Capability:	Must accurately record subcutaneous ECG (sECG) episodes.	Records automatically and via patient trigger.
Auto-activated events	Stores auto-activated sECG episodes.	Up to 55 episodes of 40 seconds each.
Patient-triggered events	Stores patient-triggered sECG episodes.	4 episodes of 7.5 minutes each.
Storage Duration	Sufficient sECG storage capacity.	>66 minutes total (30 min patient-triggered, 36.7 min auto-activated).
Safety/Usability:	Must be safe and function as intended in MRI environments.	Cleared for 1.5T and 3.0T full-body MRI scans.
Software Integrity	Software must be verified and validated to high standards.	Software considered "major" level of concern; verification/validation conducted per FDA guidance.
Compliance with Standards	Must comply with relevant medical device standards.	Tested in accordance with EN 45502, ISO 11135, ISO 14708, ISO/TS 10974.
Clinical Implantation	Implantation procedure and sensing quality must be demonstrated.	Data from 30 patients demonstrating implantation and sensing quality.

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.

Summary

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 11, 2016

Biotronik, Inc. Jon Brumbaugh Vice President, Regulatory Affairs and Compliance 6024 Jean Road Lake Oswego, Oregon 97035

Re: K152995

Trade/Device Name: BioMonitor 2 Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector and Alarm (Including ST-Segment Measurement and Alarm) Regulatory Class: Class II Product Code: MXD Dated: March 10. 2016 Received: March 11, 2016

Dear Jon Brumbaugh:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device

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related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mitchell Stein

forBram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K152995 - Page 1 of 1

Device Name BioMonitor 2

Indications for Use (Describe)

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

Type of Use (Select one or both, as applicable)
-------------------------------------------------

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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BioMonitor 2 Implantable Cardiac Monitor

Traditional 510(k) Premarket Notification

1. SUBMISSION INFORMATION

Date 510(k) Summary Prepared:	October 9, 2015
Name and Address of Sponsor:	BIOTRONIK, Inc.6024 Jean RoadLake Oswego, OR 97035
Establishment Registration Number:	1028232
Name and Address of Manufacturer:	BIOTRONIK SE & Co. KG (reg. no. 9610139)Woermannkehre 1,12359 Berlin, Germany011-49-30-689-05-1210Sterigenics Germany GmbHKasteler Straße 45D- 65203 Wiesbaden, Germany
Contact Person(s) and Phone Number:	Jon BrumbaughVP, Regulatory Affairs and CompliancePhone (888) 345-0374Fax (800) 913-6993jon.brumbaugh@biotronik.com
Device Name:	Trade Name: BioMonitor 2Common Name: Implantable Cardiac MonitorClassification Name: Arrhythmia detector and alarm (including ST-segmentmeasurement and alarm).Classification: Class II (21 CFR 870.1025)Product Code: MXD

General Description:

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Predicate Devices:

BIOTRONIK BioMonitor with AF Detection (K143503, cleared March 19, 2015) ●

Indication for Use:

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 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 ●

Technological Characteristics and Substantial Equivalence:

The substantial equivalence claim between the subject and the predicate device is supported by the information included in this premarket notification. This includes the following information:

Description of the subject and predicate devices -
-Intended use of the subject and predicate devices
-Performance of the subject and predicate devices
-Technological characteristics of the subject and predicate devices
-Validation testing

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Table 1: BioMonitor 2 Compared to Predicate Device (changes are highlighted)

Technical Data	BioMonitor	BioMonitor 2
FDA Clearance	K143503	Subject
Dimensions (mm)	53.3 x 42.7 x 7.1	88.4 x 15.2 x 6.2
Length x Width x Height		Rigid portion 55.5 x 15.2 x 6.2
Volume	12.5 cc	5 cc
Weight	26 g	10.1 g
Longevity	48 months (+ 12 months pre-implant shelf life + 2 months ERI life)
Subcutaneous ECG Recording	Yes
Pre and Post Event Storage	Yes
sECG Storage	35.8 min22.5 min for patienttriggered events13.3 min for auto-activated eventsLongest/oldest/newest	>66 min30 min for patient triggered events36.7 min for auto-activated eventsLongest/oldest/newest
Patient Activation	7.5 min per event7 min prior to activation0.5 min following activation
AsystoleBrady/rate dropVT-FVT	40 s/episode30 s prior auto activation10 s post auto activation
AF	40 s/episode30 s prior auto activation10 s post auto activation
Vector Mapping Required	No
Sampling Rate	128 Hz
Auto Activation Triggers	Yes
Manual (Patient) ActivationTrigger	Yes - via magnet	Yes - via Remote Assistant
High Rate Trigger	Yes
Programmable High Rate Count	Yes
Low Rate Trigger	Yes
Asystole Trigger	Yes
Remote Monitoring	Home Monitoring dailytransmissions, up to 1episode per day	Home Monitoring daily transmissions, upto 6 episodes (at least one per triggeredevent type) per day
QRS Detection	Combination signal out of3 vectors	Single vector
MR Conditional	1.5T, full body scan	1.5T and 3.0T, fully body scan

Performance Data:

The following performance data were provided in support of the substantial equivalence determination.

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Software Verification and Validation Testing

Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" in a separate submission. The software for this device was considered as a "major" level of concern, since a failure or latent flaw in the software could directly result in serious injury or death to the patient or operator.

3.0T MRI Scan Testing

BIOTRONIK conducted validation testing according to the Joint Working Group's International Technical Specification for ISO/TS 10974: 2012 (E). The following tests were performed:

·Gradient Induced Heating
•Vibration
·Static Malfunction
•Gradient Radiated Malfunction
•Vibration Malfunction

Clinical Study

The objective of this study was to provide clinical data of the implantation procedure and the sensing quality of BIOTRONIK's second generation of Implantable Cardiac Monitor (ICM) BioMonitor 2. Data from 30 patients at 5 Australian clinical sites from December 18, 2014 through July 06, 2015 is included to support the substantial equivalence of BioMonitor 2 when compared to the predicate device. Additional implantations have commenced recently in Europe as part of a controlled Post Market Observation (PMO), as of October 9, 2015 there have been 15 implantations.

List of Applied Standards

The BioMonitor 2 was tested in accordance with the following standards:

EN 45502-1 (1997) Section 21
EN 45502-2-1 (2003) Section 6.1.3 ●
. ISO 11135-1 (2007)
ISO 14708-1 (2014) ●
. ISO/TS 10974 (2012)

Conclusion:

BIOTRONIK considers the BioMonitor 2 implantable cardiac monitor to be substantially equivalent to legally marketed predicate devices through the data and information presented. No safety or effectiveness issues were identified.

Regulation Number and Section

§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).

(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.