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The VRIxp is intended for monitoring and recording lung sounds and automatic detection of crackles and wheezes. When interpreted by physicians with general medical training and experience, the VRIxp aids in diagnosis and patient management. The VRIxp is intended to be used in healthcare facilities on adults, adolescents, and/or children over the height of 2 feet 9 inches.

The VRIxp is a non-invasive, non-energy emitting device indicated for monitoring and recording lung sounds and automatic detection of crackles and wheezes. When interpreted by physicians with general medical training and experience, the VRIxP aids in diagnosis, monitoring, and patient management.

The VRIxp consists of same fundamental components as its predecessors the VRLE and the VRIxy, which are I) sound sensors designed to collect lung sounds via dermal contact with human skin; 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 recording information.

During the breathing process, the VRIxp detects lung sounds (i.e., acoustic energy) and converts them into a visual display, which can be viewed via a personal computer (PC) monitor and stored for future review. The device is designed to record breath sounds based on sensor location. Additionally, the VRIxp has an automated feature for detecting sounds consistent with crackles and wheezes for further clinical evaluation. Lung sounds can be viewed collectively as a grayscale image, as well as audibly by sensor. This latter feature provides greater flexibility for physicians to validate visual lung data by applying his or her previous clinical experience with conventional auscultation (gold standard).

Here's an analysis of the provided text regarding the VRIXP device, broken down by your requested criteria:

1. Table of Acceptance Criteria & Reported Device Performance

The provided text does not explicitly state acceptance criteria in a quantitative format (e.g., "sensitivity must be > X%, specificity must be > Y%"). Instead, the performance is described in relation to a predicate device.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the sample size used for the test set, nor does it provide information on the data provenance (e.g., country of origin, retrospective or prospective). It simply states "Non-clinical testing has been conducted to demonstrate the performance of VRIxp and that it meets its intended use."

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

The document does not provide information on the number of experts used to establish ground truth or their qualifications.

4. Adjudication Method

The document does not specify any adjudication method used for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. It discusses "interpretation by physicians with general medical training and experience" but doesn't quantify improvement with or without AI assistance.

6. Standalone Performance

The device does perform standalone detection of crackles and wheezes, as stated: "Additionally, the VRIxp has an automated feature for detecting sounds consistent with crackles and wheezes for further clinical evaluation." The "similar accuracy" claim implies this standalone performance was evaluated against the predicate's reported accuracy.

7. Type of Ground Truth Used

The ground truth for the "automatic detection of crackles and wheezes" functionality appears to be expert consensus or traditional auscultation. The text states:

• "This latter feature provides greater flexibility for physicians to validate visual lung data by applying his or her previous clinical experience with conventional auscultation (gold standard)." This suggests that conventional auscultation by an expert is considered the 'gold standard' against which the device's visual and automated detection is compared.
• The indications for use state, "When interpreted by physicians with general medical training and experience, the VRIxp aids in diagnosis and patient management," further emphasizing the human role in validating the device's output.

8. Sample Size for the Training Set

The document does not specify the sample size for the training set.

9. How the Ground Truth for the Training Set Was Established

The document does not explicitly state how the ground truth for the training set was established. Given the nature of the device and the comparison to "conventional auscultation (gold standard)," it is highly probable that expert auscultation alongside other clinical assessments would have been used.

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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

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

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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

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.

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