(171 days)
The InvisionECG System is intended to acquire, display and record electrocardiographic information from adult and pediatric patients.
The InvisionECG System is intended to be used in a clinical or home environment by trained healthcare professionals.
The InvisionECG System is a hand-held, battery powered, 12 lead electrocardiograph (ECG) system. The InvisionECG System acquires ECG information via a patient-attached lead set, and processes and transmits the ECG information to a mobile device where the ECG waveform may be viewed in near real-time. A 12 second snapshot of the waveform can be acquired, and then uploaded to an medical device data system (MDDS) from where these records can be retrieved and analyzed by trained medical professionals. Patient data is also transmitted with the ECG waveform.
The primary functions of the InvisionECG System are to:
• Acquire ECG signals from the patient's body and display the near real-time ECG waveform.
The displayed waveform is intended to provide the bedside care provider with a preliminary view of the ECG and additional opportunity to control the quality of captured ECGs.
- Capture a 12-second ECG waveform. .
- Associate the captured ECG waveform to the patient. .
- . Forward captured ECG waveform to an MDDS for later retrieval. analysis and diagnosis by a trained professional.
The InvisionECG System is a hand-held, battery-powered 12-lead electrocardiograph (ECG) system. It acquires ECG information, processes and transmits it to a mobile device for near real-time viewing. It can capture a 12-second ECG waveform and associate it with the patient, then forward it to an MDDS for later retrieval, analysis, and diagnosis by trained professionals.
Here's an analysis of the acceptance criteria and supporting studies based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not contain a discrete table explicitly outlining acceptance criteria alongside device performance metrics for diagnostic accuracy. Instead, the performance testing section details compliance with various standards related to safety, electrical performance, and software. The "Conclusion" states that the device "performs as well as or better than the predicate device," implying that the performance of the predicate device (Midmark IQecg, K103640) set the de facto acceptance benchmark.
Below is a table summarizing the types of performance testing mentioned and their outcomes:
| Performance Area | Acceptance Criteria (Implied by Standards) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Materials with patient contact to comply with ISO 10993-1: 2009. | Complies with ISO 10993-1: 2009 for appropriate component materials. |
| Software | Compliance with FDA guidance documents for "MODERATE level of concern" software, including robust software development process, verification, and validation. | Complies with predetermined specifications and applicable FDA guidance documents. Software was rigorously verified and validated. |
| Electrical Safety | Compliance with ANSI/AAMI ES60601-1: 2005/(R)2012 (incl. amendments) and ANSI/AAMI HA60601-1-11: 2011 (home healthcare). | Complies with ANSI/AAMI ES60601-1 and ANSI/AAMI HA60601-1-11. |
| Electromagnetic Compatibility | Compliance with IEC 60601-1-2: 2007. | Complies with IEC 60601-1-2. |
| Performance Testing – Bench | Compliance with ANSI/AAMI EC53: 2013 (ECG Trunk Cables and Lead Wires), IEC 60601-2-25: 2011 (Basic safety & essential performance of electrocardiographs), IEC 62366: 2007 (Usability engineering), MIL-STD-810E (Environmental), ISTA Procedure 2a (Packaging). | Complies with its predetermined specifications and the applicable standards (ANSI/AAMI EC53, IEC 60601-2-25, IEC 62366, MIL-STD-810E, ISTA Procedure 2a). |
| Clinical Performance | Implied "as safe, as effective, and performs as well as or better than the predicate device" (Midmark IQecg, K103640). Specific metrics like sensitivity, specificity for disease detection are not stated in this document. | The conclusion states the device "is as safe, as effective, and performs as well as or better than the predicate device," but no specific clinical performance metrics (e.g., diagnostic accuracy) or studies are detailed in the provided text. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not mention any clinical test set, sample size, or data provenance (e.g., country of origin, retrospective/prospective) for evaluating diagnostic performance. The testing described is primarily for safety, electrical performance, software validation, and biocompatibility, which are typically bench or engineering tests, not clinical studies involving patient data for diagnostic accuracy.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Since no clinical test set for diagnostic performance is described, there is no information provided regarding experts used to establish ground truth or their qualifications.
4. Adjudication Method for the Test Set
As there is no mention of a clinical test set for diagnostic evaluation, no adjudication method is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not describe an MRMC comparative effectiveness study. The focus is on demonstrating substantial equivalence to a predicate device through technical and safety performance, not on comparing reader performance with or without AI assistance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
The document does not describe a standalone performance study for an algorithm in terms of diagnostic accuracy. The device "acquires, displays and records electrocardiographic information" and "forwards captured ECG waveform to an MDDS for later retrieval, analysis and diagnosis by a trained professional." This indicates that the device facilitates human diagnosis rather than providing an automated diagnosis itself, at least within the scope of this 510(k) summary. The "Technology Comparison" mentions "ECG Analysis and Measurement" for both predicate and proposed devices, but does not detail a standalone algorithm for automated diagnosis in the proposed device that would require such a study.
7. Type of Ground Truth Used
Given the absence of clinical diagnostic performance studies in the provided text, there is no mention of the type of ground truth used (e.g., expert consensus, pathology, outcomes data).
8. Sample Size for the Training Set
The document does not mention any machine learning or AI models that would require a training set. The described device functions as an ECG acquisition and display system.
9. How the Ground Truth for the Training Set Was Established
Since no training set for an AI/ML model is mentioned, there is no information provided on how ground truth for a training set was established.
§ 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).