(206 days)
The Audicor® Sensors are a family of dual-function sensors for use on adult patients (≥ 18 years) for acquisition of both heart sounds and ECG electrical signals and to transmit these signals to a compatible Audicor system to allow for the evaluation of patient status, to aid in diagnosis, and to determine effects of treatment on ECG and hemodynamics.
There are disposable and reusable versions of the Audicor Sensor. Both can be used in the collection of resting ECG reports. The disposable Audicor Sensor is also intended for longer term monitoring applications of up to 48 hours.
The Audicor Sensors are a group of devices that are intended for use with Audicor-enabled ECG/heart sounds detections systems. Sensors are designed with conductive patient-contact surfaces to enable capture of ECG data, and include a microphone for detection of heart sounds. The devices are intended for use on the chest wall in the V3 and/or V4 positions.
Audicor sensors are available in two versions:
- Single-use disposable sensors, for use up to 48 hours
- Durable reusable sensors
Here's an analysis of the provided text regarding the acceptance criteria and study for the Inovise Medical, Inc. AUDICOR Sensor 2.0 and 3.0:
The provided document is a 510(k) premarket notification summary and approval letter, which primarily focuses on establishing substantial equivalence to a predicate device based on performance standards and technological characteristics. It does not contain information about a clinical study involving a test set, ground truth established by experts, or efficacy measures like sensitivity, specificity, or reader improvement.
The "Test Summary & Conclusion" section refers to compliance with performance standards rather than a clinical performance study measuring diagnostic accuracy.
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of the provided document (510(k) summary for substantial equivalence), the "acceptance criteria" discussed are primarily related to compliance with recognized standards for safety and basic functionality, rather than specific performance metrics like sensitivity or specificity of a diagnostic algorithm.
| Acceptance Criteria (Standard Compliance) | Reported Device Performance |
|---|---|
| ANSI/AAMI EC12:2000 - Disposable ECG Electrodes | Shown to comply |
| ISO 10993-1:2003, Biological Evaluation of Medical Devices - Evaluation and testing | Shown to comply |
Note: These are compliance standards, not diagnostic performance metrics or clinical acceptance criteria in the typical sense of AI/CADe device evaluation. The document highlights "substantial equivalence" to the predicate device (Audicor™ COR Sensor, K030316) through technological characteristics.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. The document does not describe a clinical study with a test set of patient data to evaluate the device's diagnostic performance. The testing mentioned refers to compliance with electrical and biocompatibility standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. No clinical study involving expert-established ground truth is described in the provided material.
4. Adjudication Method for the Test Set
Not applicable. No clinical study with a test set requiring adjudication is 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
Not applicable. The document does not describe an MRMC study or any study evaluating reader improvement with AI assistance. The device in question is a sensor for acquiring signals, not an AI interpretation system.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Not applicable. The device is a sensor, not an algorithm for standalone diagnostic performance. Its function is to acquire and transmit signals to a compatible Audicor system. The compliance testing mentioned is for the sensor itself (electrical safety, biocompatibility) rather than diagnostic accuracy.
7. The Type of Ground Truth Used
Not applicable. As no clinical performance study for diagnostic accuracy is described, no ground truth type (e.g., expert consensus, pathology, outcomes data) is mentioned. The "ground truth" for the tests performed would be the specifications outlined in the standards (e.g., impedance values, biocompatibility metrics).
8. The Sample Size for the Training Set
Not applicable. The device is a sensor; it does not involve machine learning or an "algorithm" in the sense of one that requires a training set. The reference to "Audicor-enabled ECG/heart sounds systems" implies that the system may have interpretive capabilities, but the submission is for the sensors only.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set for an algorithm, there is no discussion of how ground truth would be established for it.
§ 870.2360 Electrocardiograph electrode.
(a)
Identification. An electrocardiograph electrode is the electrical conductor which is applied to the surface of the body to transmit the electrical signal at the body surface to a processor that produces an electrocardiogram or vectorcardiogram.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9. The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Electrocardiograph Electrodes.” See § 870.1(e) for availability information of guidance documents.