(14 days)
Gem Heart One/One+ is a standard 12 leads electrocardiograph designed to register. analyze and display electrocardiograms at rest. It is capable of displaying up to 12 leads at a time on the screen and print 3/6 channels by means of its thermal printer of 112mm width.
It incorporates the Hannover Electrocardiogram System (HES) automatic interpretation program for cardiac signal analysis and has the possibility of introducing the patient's data, store the records and send them to a PC by serial communication (RS-232, USB and LAN). The interpretation by the Gem Heart One/One+ is only significant if it is considered and analysed by a qualified physician and used for patients over 16 years old. No therapy or drugs can be administered based solely on the interpretations statements obtained from the HES interpretation program.
For non-interpretative applications, the Gem Heart One/One+ can be used for patients with no limitations with respect to age, sex and race of the patient. It is intended for use in routine ECG recording by trained physicians in hospital environment.
- The Gem Heart One/One+ is a standard portable electrocardiograph that measures and records 12 channel electrocardiographic waveforms, measures ST segment level changes and gives real time heart rate measurements.
- Intended use is equivalent to the intended use of the predicate Cardioline AR . 1200 and CorScreen electrocardiograph.
The Gem Heart One/One+ is a portable electrocardiograph of 12 channels with simultaneous leads recording, with a high quality thermal printing of 112 mm, a lithium ion battery, high resolution screen, and connectivity through serial port (RS-232), local network LAN (10/100 Base T) and USB 2.0.
The device includes protection against defibrillation integrated. Provides the automatic interpretation based on the program Hannover Ecg System HES® developed by Biosigna GmbH under the standards IEC 60601-2-51:2003. Uses the format SCP (Standard Communications Protocol) to import and export the ECG records in the framework of the CSE (Common Standards for Quantitative Electrocardiography) of the European Union.
The Gem Heart One/One+ can operate in Spanish, Catalan and English and other languages can be implemented. It includes downloading and ECG viewing PC software gem heart viewer.
The provided text describes a 510(k) premarket notification for the "Gem Heart One/One+" electrocardiograph. It claims substantial equivalence to predicate devices based on meeting safety and effectiveness standards. However, it does not contain a separate study or detailed performance data to establish specific acceptance criteria and prove the device meets them, especially in the context of an AI-powered interpretation component.
The document mainly focuses on:
- Comparing technical specifications with predicate devices (Cardioline AR1200 and CorScreen).
- Stating compliance with general electrical and medical device safety standards (EN 60601-1, IEC 60601-2-25, EN60601-1-2).
- Mentioning the integration of the "Hannover Ecg System HES®" for automatic interpretation but explicitly states that interpretation is only significant if considered and analyzed by a qualified physician and no therapy or drugs can be administered based solely on these interpretations.
Therefore, I cannot fulfill all parts of your request as the information is not present in the provided text. Specifically, there is no:
- Table of explicit acceptance criteria and reported device performance for the interpretive function.
- Sample size used for a test set, data provenance, or details about the ground truth relevant to the interpretive function.
- Information on the number or qualifications of experts, or adjudication methods for an interpretive test set.
- Multi-reader multi-case (MRMC) comparative effectiveness study for the AI component.
- Standalone algorithm performance study.
- Sample size, ground truth establishment for a training set.
Below is a summary of what can be extracted or inferred based on the document's content, with strong limitations noted where information is absent.
Acceptance Criteria and Study Details for Gem Heart One/One+
The provided document, a 510(k) summary for the "Gem Heart One/One+" electrocardiograph, indicates that the device's acceptance criteria primarily relate to its technical specifications and compliance with general medical device safety and performance standards, establishing substantial equivalence to its predicate devices.
Critical Note: The document explicitly clarifies that the automated interpretation program (Hannover ECG System HES®) is not intended for standalone diagnostic use. Its output must be considered and analyzed by a qualified physician, and no therapy or drugs should be administered solely based on its interpretations. This indicates that the regulatory approval in this document does not hinge on the standalone diagnostic performance of the AI interpretation, but rather on the device as a safe and effective ECG recording and display system, with the interpretation as an assistive tool under physician oversight. Therefore, detailed performance metrics for the interpretive algorithm, as one would expect for an AI-diagnostic device, are not provided.
1. Table of Acceptance Criteria & Reported Device Performance
Based on the provided text, the acceptance criteria are implicitly tied to the technical specifications being comparable or superior to the predicate devices and the device's compliance with safety and effectiveness standards. No explicit "acceptance criteria" for the interpretive function (e.g., sensitivity, specificity, or F1 score) are given, nor are specific performance results for such criteria reported in this document.
| Parameter | Predicate Device (Cardioline AR 1200 / CorScreen) Acceptance Range (Implicit) | Gem Heat One (Reported Performance) | Notes |
|---|---|---|---|
| Technical Specifications: | |||
| Input dynamic range | +/-300mV @ DC; +/-10.0mV within bandpass | +/-300mV @ DC; +/-18.0mV within band pass | Gem Heart One exceeds the predicate in bandpass dynamic range, indicating potentially better signal capture. |
| Frequency response | 0.05-150Hz (-3dB) | 0.05-150Hz | Matches predicate device. |
| A/D conversion | 12 bits (AR1200) / 24 bits (CorScreen) | 16 bits | Falls between the two predicates, but is an improvement over AR1200. |
| Leads | 12 Standard / 12 Cabrera (AR1200) / 3+3 / 12 Standard (CorScreen) | 12 Cabrera / Orthogonal | Offers Cabrera and Orthogonal leads, comparable lead capabilities to predicates. |
| Sensitivity | 2.5, 5, 10, 20 mm/mV +/-5% | 2.5, 5, 10, 20 mm/mV | Matches predicate device sensitivity options. The +/-5% tolerance for predicate implies this is also expected for the new device. |
| Writing system | Thermal head 108mm, 8 dots/mm (AR1200) / Ink Printer (CorScreen) | Thermal head, 110mm, 16dots/mm - 8dots/mm | Improved resolution (16 dots/mm) over AR1200, broader paper width, and thermal head like AR1200. |
| Printed channels | 3/4/6 (AR1200) / 1/2/6/12 (CorScreen) | 1/3/6 | Channel output options are within the range provided by predicate devices. |
| Paper speed | 5mm/s +/-10% & 50mm/s +/-5% (AR1200) / 25 50 mm/s (CorScreen) | 10, 25, 50 mm/s | Offers speeds comparable to or broader than predicates. |
| Mode of operation | Manual and Automatic recording | Manual and Automatic recording | Matches predicate device. |
| Input/output | Infrared digital interface (AR1200) / SD Memory card (CorScreen) | RS 232, Ethernet, USB | Offers modern connectivity options exceeding predicates. |
| Display Size | 120x32 pixels / 240x320 pixels (AR1200) | 240X320 pixels | Matches the higher resolution predicate display. |
| Number of displayed channels | 3/6 (AR1200) / 1/3/6/12 (CorScreen) | 1/3/6/12 | Matches or exceeds predicate display channel options. |
| Traces speed | 12.5 25.50 mm/s (AR1200) / 5 10 25 50 mm/s (CorScreen) | 10, 25, 50 mm/s | Comparable trace speed options. |
| Safety and Effectiveness: | Compliance with EN 60601-1, IEC 60601-2-25, EN60601-1-2 standards | Passed EN 60601-1, IEC 60601-2-25, EN60601-1-2 standards and showed full compliance. | This is the core "acceptance criteria" presented regarding safety and effectiveness, confirming the device operates safely and as intended when measured against established medical device standards. The "study" proving this is stated as "The device has completely passed the tests and has shown full compliance to the standards." |
| Interpretive Function: | N/A (Predicate devices may or may not have had integrated interpretation) | Integrates Hannover Ecg System HES®; interpretation requires physician analysis and oversight. | No specific acceptance criteria or performance metrics for the interpretive function are provided. The document states its interpretation "is only significant if it is considered and analysed by a qualified physician" and "No therapy or drugs can be administered based solely on the interpretations statements." This indicates that the interpretive function is considered an aid, not a standalone diagnostic. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not specified for the interpretive function. The document mentions "The Gem Heart One/One+ has been tested under the same standards to its predicate device... in accordance with the EN 60601-1 and IEC 60601-2-25, as well as for EMC tests EN60601-1-2 standards." This refers to hardware and electrical safety testing, not a clinical performance test of the interpretation algorithm.
- Data Provenance: Not specified for any algorithm performance testing. For the general device testing, no specific "dataset" or "provenance" is discussed beyond compliance with international standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not Applicable / Not Provided. Since no specific "test set" for the interpretive algorithm's performance is described in terms of a clinical study, there is no mention of experts to establish its ground truth.
4. Adjudication Method for the Test Set
- Not Applicable / Not Provided.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. The document does not describe any MRMC comparative effectiveness study where human readers' performance with and without AI assistance was evaluated.
6. Standalone (Algorithm Only) Performance Study
- No. The document does not provide details of a standalone performance study for the Hannover ECG System HES® algorithm. Furthermore, it explicitly states that the interpretation is not for standalone use, requiring physician oversight.
7. Type of Ground Truth Used (for the interpretation program)
- Not Provided. Since no specific performance study of the interpretive algorithm is detailed, the type of ground truth used for its development or validation is not mentioned in this document.
8. Sample Size for the Training Set (for the interpretation program)
- Not Provided. The document mentions the Hannover ECG System HES® is "developed by Biosigna GmbH," implying it's an existing, established program, but does not give details about its training data.
9. How the Ground Truth for the Training Set Was Established (for the interpretation program)
- Not Provided.
§ 870.2340 Electrocardiograph.
(a)
Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).