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510(k) Data Aggregation
(266 days)
VRLXP, MODEL XP
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.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate for intended use and technology. | Stated as "substantially equivalent" to VRLE, VRIxy, and Meditron stethoscope system. |
| Similar accuracy in crackle and wheeze detection to predicate. | "The VRIxp testing has demonstrated similar accuracy in crackles and wheezes detection as the reported accuracy of the predicate device [STG Monitor Multichannel Lung Sound Analysis System]." |
| Biocompatibility requirements met. | "The VRIxp has been evaluated for biocompatibility." |
| Software verification and validation conducted. | "appropriate software verification and validation testing was conducted." |
| Predetermined product specifications met. | "Pre-determined product specifications were met." |
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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