(201 days)
The VoqX Electronic Stethoscope is intended for medical diagnostic purposes only. It may be used for the detection and amplification of sounds from the heart, lungs, arteries, veins, and other internal organs with the use of a selective frequency and with an integrated graphics display to show amplified heart sounds as phonocardiograms. It can be used on any person undergoing a physical assessment.
The VoqX Electronic Stethoscope is intended for medical diagnostic purposes. It may be used for the detection and amplification of sounds from the heart, lungs, arteries, veins, and other internal organs with the use of a selective frequency and with an integrated graphics display to show amplified heart sounds as phonocardiograms.
The VoqX Electronic Stethoscope is comprised of two parts: Back Unit (head piece) and Front Unit (chest piece).
The device has 3 modes of operation: General - emphasizes sounds from 20 to 2000Hz, Heart emphasizes sounds from 20 to 200Hz and Lungs - emphasizes sounds from 100 to 500Hz. In addition, the VoqX Electronic Stethoscope incorporates a software feature that displays sounds as a "Sound Signature". The "Sound Signature" algorithm generates intensity image based on the spectrogram of the output audio data. The device is supplied with an AC/DC power supply adapter and a charging cable.
Here's a breakdown of the acceptance criteria and study information for the VoqX Electronic Stethoscope, based on the provided document:
1. Acceptance Criteria and Reported Device Performance
The document states that a "Performance Testing" study was conducted to compare the VoqX Electronic Stethoscope to its predicate device (3M Littmann Electronic Stethoscope, Model 3200). The main purpose was to verify that the VoqX's performance is similar to that of its predicate device in terms of frequency response.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Frequency Response Similarity to Predicate Device | The test passed and met the predefined acceptance criteria. (Implies the frequency response of VoqX is similar to the 3M Littmann 3200). |
| Biocompatibility in compliance with ISO 10993-1 | Performed and successfully completed. |
| Transportation validation | Performed and successfully completed. |
| Cleaning and disinfection validation | Performed and successfully completed. |
| Software verification and validation testing (Level of Concern: Moderate, per FDA Guidance) | Conducted, and documentation was provided. (Implies successful validation). |
| Electrical Safety per IEC 60601-1 | Tests passed. |
| Electromagnetic compatibility (EMC) per IEC 60601-1-2 | Tests passed. |
| Usability per IEC 60601-1-6 | Tests passed. |
Note: The document does not provide specific numerical values for the frequency response acceptance criteria or the actual measured performance of the VoqX. It only states that the tests "passed and met the predefined acceptance criteria" and that the performance is "similar to that of its predicate device."
2. Sample Size and Data Provenance
The document does not specify the sample size used for the performance testing related to "frequency response."
The data provenance is not explicitly stated in terms of country of origin of the data or whether it was retrospective or prospective. Given that this is a premarket notification, the performance testing would typically be prospective, conducted by the manufacturer, Sanolla Ltd., which is based in Israel.
3. Number of Experts and Qualifications for Ground Truth
For the performance testing focused on frequency response, there's no mention of "experts" being used to establish a ground truth. This type of testing often relies on instrumental measurements and comparisons to a validated standard (the predicate device) rather than human expert interpretation of an outcome.
4. Adjudication Method
Not applicable for frequency response testing, as it's an objective measurement.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned or implied in the provided document. The performance testing described is focused on the inherent technical performance (frequency response) of the device itself compared to a predicate, not on how human readers' diagnostic accuracy is affected by using the device.
6. Standalone Performance Study
Yes, the "Performance Testing" described appears to be a standalone (algorithm only without human-in-the-loop performance) study in the sense that it evaluates the technical characteristics of the device (frequency response) objectively, rather than assessing a human user's performance with the device.
7. Type of Ground Truth Used
For the "Performance Testing" related to frequency response, the ground truth appears to be based on instrumental measurements and comparison to the technical specifications/performance of the legally marketed predicate device (3M Littmann Electronic Stethoscope, Model 3200).
8. Sample Size for the Training Set
The document does not mention a training set, as the device's main function is the detection and amplification of sounds, and the "Sound Signature" algorithm generates an intensity image based on the spectrogram of output audio data. This typically implies signal processing rather than a deep learning model that requires a large labeled training set for classification or detection.
9. How Ground Truth for Training Set Was Established
Not applicable, as a training set for a machine learning model is not explicitly mentioned for the described "Sound Signature" feature. The "Sound Signature" algorithm's output is described as an "intensity image based on the spectrogram of the output audio data," which suggests a deterministic signal processing method rather than a data-driven machine learning approach requiring a training set with established ground truth.
§ 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.