(300 days)
The VRIxy is intended for use in monitoring and recording lung sounds.
The modified VR Lung Electrosonograph, the VRIxy is intended for use in monitoring and recording lung sounds. The VRIxy is a non-invasive device designed to facilitate visualization and monitoring of regionally distributed vibration energy. The VRIxy is comprised of three primary components: 1) Electronic stethoscopes designed to collect lung sounds via dermal contact with the human thorax; 2) A Digital Collection Module ("DCM") for the conversion of analog data to digital data; and, 3) A mobile computer workstation to assist in processing, displaying, and/or storing recorded information.
The VRIxy represents a natural progression in the company's desire to improve bedside monitoring capabilities, and is designed to provide lung imaging capability in spontaneously breathing patients, as well as mechanically ventilated patients. In the latter, monitoring capabilities are enhanced by the synchronization of the VRIxy image and vibration energy graph, with the pressure and flow waveform sampled from a ventilator. All dynamic images can be viewed as video file or frame-by-frame. The vibration energy of the lungs can be depicted in grayscale or color. Patient recording and all associated data are stored in the VRIxy system. Current and/or previous recordings can be viewed side-by-side in order to compare patients' lung sound images during hospitalization. These recordings and associated reports can be viewed or exported for offline viewing or printed on a conventional PC computer.
The VRIxv is intended to be used by trained healthcare practitioners and has been designed to accommodate most clinic, treatment center, or hospital settings. The VRIxy is not intended to be used as a diagnostic instrument.
The provided text from K073582 does not contain detailed information about specific acceptance criteria, a study proving device performance against such criteria, sample sizes for test or training sets, ground truth establishment methods for either set, or the involvement of experts, adjudication methods, or MRMC studies.
Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (VR Lung Electrosonograph, K061495) rather than on specific clinical or performance studies with defined acceptance criteria for the VRIxv System itself.
Therefore, many of the requested details cannot be extracted from this document. The existing information is presented below, with "N/A" for unavailable data.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (e.g., Sensitivity, Specificity, Accuracy) | Reported Device Performance (Value/Metric) |
|---|---|
| N/A (No specific performance criteria stated) | N/A |
Explanation: The 510(k) submission states, "The VRIxv System is substantially equivalent in all aspects, e.g., technological characteristics, mode of operation, performance characteristics, intended use, etc., to the VR Lung Electrosonograph cleared under K061495." This indicates that the device aimed to meet the equivalence of the predicate device's performance rather than predefined numerical metrics for its own performance. No specific performance metrics (e.g., sensitivity, specificity, accuracy) or acceptance thresholds for these metrics are provided.
2. Sample Size used for the Test Set and Data Provenance
- Sample Size for Test Set: N/A (No separate test set for performance evaluation is described as part of this 510(k) submission. The equivalence argument relies on the predicate device.)
- Data Provenance: N/A
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: N/A
- Qualifications of Experts: N/A
4. Adjudication method for the test set
- Adjudication Method: N/A
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
- MRMC Study Done: No. The device itself is described as "not intended to be used as a diagnostic instrument," and there is no mention of an AI component or assisting human readers.
- Effect Size: N/A
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Study Done: No. The VRIxv is a system for "monitoring and recording lung sounds" which would inherently involve a human user interpreting the generated data. There's no mention of a standalone algorithm performance study.
7. The type of ground truth used
- Type of Ground Truth: N/A (No specific studies requiring a ground truth are described in the provided text.)
8. The sample size for the training set
- Sample Size for Training Set: N/A (No machine learning or AI component with a training set is described.)
9. How the ground truth for the training set was established
- Ground Truth Establishment for Training Set: N/A
§ 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.