(413 days)
The VR Lung Electrosonograph is intended for use in monitoring and recording lung sounds.
The VR Lung Electrosonograph is intended for use in monitoring and recording lung sounds. The VR Lung Electrosonograph is a non-invasive device consisting 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 VR Lung Electrosonograph is intended to be used by trained healthcare practitioners, and has been designed to accommodate most clinic, treatment center, or hospital settings. While the VR Lung Electrosonograph may aid in diagnosis, the device is not intended to be used as a diagnostic instrument.
The provided text is a 510(k) summary for the Deep Breeze VR Lung Electrosonograph. This document is primarily focused on demonstrating substantial equivalence to predicate devices and does not contain detailed information about specific acceptance criteria, performance studies with quantitative results, or information typically found in clinical validation studies for AI/ML devices. Therefore, I cannot fully complete the requested table and answer many of the questions.
Here's what can be extracted and what information is missing:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| No specific performance metrics or acceptance criteria are provided in the document beyond a general statement of intended use. | No quantitative performance results are presented. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The filing does not describe a performance study with a test set of data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. The filing does not describe a performance study with a ground truth established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document. The filing does not describe a performance study with an adjudication method.
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
There is no indication that an MRMC comparative effectiveness study was done, nor any mention of AI assistance. The device is described as an "Electrosonograph" for monitoring and recording lung sounds, not an AI-driven interpretive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is described as a non-invasive tool to "aid in diagnosis," but "not intended to be used as a diagnostic instrument." It's an electronic stethoscope system designed for "trained healthcare practitioners" to collect, process, display, and store lung sound information. This suggests a human-in-the-loop scenario where the device provides data to the practitioner. There is no mention of standalone algorithmic performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This information is not provided in the document, as no specific performance study with ground truth is described.
8. The sample size for the training set
This information is not provided in the document. The 510(k) summary focuses on substantial equivalence, not on the development or training of an algorithm.
9. How the ground truth for the training set was established
This information is not provided in the document.
Summary of the Study (Based on available information):
The provided document describes a 510(k) submission for the VR Lung Electrosonograph. The study is implicitly a substantial equivalence comparison to predicate devices rather than a direct performance study with acceptance criteria and a test set against ground truth.
- The device, a "VR Lung Electrosonograph," is intended for "monitoring and recording lung sounds."
- It is compared for substantial equivalence to the "Meditron Stethoscope System" (K991367) and the "STG Monitor Multichannel Lung Sound Analysis System" (K012387).
- The argument for substantial equivalence rests on similar intended use and technological characteristics (design, materials, energy source, function).
- The device is explicitly stated as being able to "aid in diagnosis" but "not intended to be used as a diagnostic instrument." This implies that the device provides data to a healthcare practitioner, who then uses their clinical judgment for diagnosis, rather than the device performing a diagnosis itself.
- The regulatory pathway chosen (510(k)) and the content provided focus on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than proving performance against specific quantitative criteria.
§ 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.