FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

· 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.

Device Description

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.

AI/ML Overview

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.

Summary

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.