(66 days)
The Audicor ™ Sensors with Adapters are a family of dual-function transducers for use on patients where combined ECG/heart sounds data are needed for the evaluation of patient status, to aid in diagnosis and determine effects of treatment on ECG and hemodynamics. Audicor Sensors with Adapters may be used only with a compatible Audicor System.
There are disposable and reusable versions of the Audicor Sensor component. Both can be used in the recording of resting ECG / heart sound reports. The disposable Audicor Sensor is also intended for longer term monitoring applications of up to 48 hours.
The Audicor sensors/adapters included in this submission 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. The mating cable adapter for Sensor 4.0 includes an accelerometer for detection of heart sounds. The sensor and adapter devices are intended for use on the chest wall in the V3 and V4 positions. Audicor sensors are available in two versions: 1) Single-use disposable sensors, for use up to 48 hours (Sensor 2.0 and Sensor 4.0) 2) Reusable sensors (Sensor 3.0)
The provided text describes a 510(k) summary for a medical device called the AUDICOR™ Sensor 4.0 with Adapter. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with detailed performance metrics against specific acceptance criteria.
Therefore, the information you've requested regarding acceptance criteria, device performance, sample sizes, expert involvement, and ground truth methodologies for a specific study is not available within the provided text.
Here's what can be extracted based on your requested format, highlighting the missing information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in the document as performance criteria against a clinical outcome or diagnostic accuracy. | The device is stated to "comply" with specific standards. However, actual performance metrics (e.g., sensitivity, specificity, accuracy) are not presented. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Test Set): Not specified.
- Data Provenance: Not specified. The document describes testing against engineering standards (ANSI/AAMI EC12:2000, ISO 10993-1:2009), not a clinical test set with patient data for diagnostic evaluation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not applicable. The "testing" referred to in the document is against engineering standards, not against a clinical ground truth established by experts.
- Qualifications of Experts: Not applicable.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study Done: No. The document does not mention any MRMC study.
- Effect Size with AI vs. Without AI: Not applicable. This device is a sensor, not an AI diagnostic tool that assists human readers in interpretive tasks.
6. Standalone (Algorithm Only) Performance Study
- Standalone Performance Study Done: No. The document focuses on the device's technical specifications and equivalence to a predicate device.
7. Type of Ground Truth Used
- Type of Ground Truth: The document refers to compliance with engineering and biocompatibility standards (ANSI/AAMI EC12:2000 for disposable ECG electrodes and ISO 10993-1:2009 for biological evaluation). There is no mention of a "ground truth" in the diagnostic or clinical sense.
8. Sample Size for the Training Set
- Sample Size (Training Set): Not applicable. This document does not describe an AI/machine learning model that would require a training set.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth Was Established: Not applicable.
Summary of what the document does provide:
- Performance Standards: The device was tested to and shown to comply with:
- ANSI/AAMI EC12:2000 – Disposable ECG Electrodes
- ISO 10993-1:2009 – Biological Evaluation of Medical Devices - Evaluation and testing.
- Substantial Equivalence: The primary basis for this 510(k) submission is to demonstrate substantial equivalence to the AUDICOR™ Sensor 2.0 (K080602), based on modifications such as replacing the microphone transducer with an accelerometer and moving the heart sound transducer function to the adapter.
- Intended Use: Dual-function transducers for combined ECG/heart sounds data for evaluation of patient status, diagnosis aid, and determining treatment effects on ECG and hemodynamics.
- Device Description: Sensors designed with conductive patient-contact surfaces for ECG data and an accelerometer in the mating cable adapter for heart sounds. Used on the chest wall in V3 and V4 positions. Available in disposable and reusable versions.
§ 870.1875 Stethoscope.
(a)
Manual stethoscope —(1)Identification. A manual stethoscope is a mechanical device used to project the sounds associated with the heart, arteries, and veins and other internal organs.(2)
Classification. Class I (general 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.(b)
Electronic stethoscope —(1)Identification. An electronic stethoscope is an electrically amplified device used to project the sounds associated with the heart, arteries, and veins and other internal organs.(2)
Classification. Class II (special controls). The device, when it is a lung sound monitor, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.