(274 days)
The AS-101 is an electronic stethoscope intended for the detection of sounds associated with the heart, lungs, arteries, veins, and other internal organs. It can be used on any person undergoing a physical assessment. The device is intended to be operated only by healthcare professionals for diagnostic decision support in clinical settings.
The AccurSound Electronic Stethoscope AS-101 ("AS-101") is a device designed for healthcare professionals used in clinical settings. The AS-101 can detect and amplify the sounds of the heart, lungs, arteries, veins, and other internal organs.
The microphone-equipped disposable sensor detects and amplifies the sounds from the patient's body. The auscultation sound is digitally processed and filtered, electronically amplified in the hub unit. The anti-noise function reduces ambient noise and echoes, then transferred to the earpiece.
The multi-channel design allows healthcare professionals to attach disposable sensors onto patient's body, by switching modes from handheld single-channel recording to four-channel stationery and continuously auscultation based on different requirements of clinical applications or physical assessments.
The associated accessories include:
- Disposable sensor(s)
- Patient cable(s)
- Earphone
- Power adapter with power cord
The provided text is a 510(k) Premarket Notification for the AccurSound Electronic Stethoscope AS-101. It describes the device, its intended use, and compares it to a predicate device (3M Littmann Electronic Stethoscope, Model 3200).
However, the document explicitly states that this submission "does NOT include animal or clinical performance testing" and focuses solely on non-clinical (bench) testing. This means the document does not contain information about studies involving human subjects to assess clinical performance or comparative effectiveness with human readers.
Therefore, I cannot provide information for several of your requested points, as they pertain to clinical studies, AI performance studies, or human expert consensus, which are not detailed in this 510(k) summary.
Here's what I can extract and address based on the provided text:
Acceptance Criteria and Device Performance (Based on Non-Clinical Testing):
Since no clinical study data is provided, the "acceptance criteria" discussed are for the device's engineering performance and safety, rather than clinical efficacy or diagnostic accuracy.
| Acceptance Criteria (Non-Clinical) | Reported Device Performance (as stated by declaration of compliance) |
|---|---|
| Electrical Safety and EMC compliance with ANSI/AAMI ES60601-1:2005/(R)2012/A1:2012, C1:2009/(R)2012/A2:2010/(R)2012 and ANSI/AAMI/IEC 60601-1-2:2014 | "in compliance with" |
| Biocompatibility evaluation in compliance with ISO 10993-1 | "performed." (Implies compliance, as no non-compliance is noted) |
| Software verification and validation (for moderate level of concern) as recommended by FDA Guidance for Software Contained in Medical Devices | "conducted, and documentation was provided as recommended" (Implies conformity) |
| Risk management according to ISO 14971:2019 | "according to ISO 14971:2019" (Implies conformity) |
| Human factor engineering in compliance with IEC 62366-1: 2015 | "in compliance with IEC 62366-1: 2015" |
| Bench tests for: LED Indicator Behavior, Button Selector, Hardware Sound Band Pass Filter, Total Harmonic Distortion and Noise, Acoustic Frequency Response, Sample Rate, Overall Sound Amplification Ratio, Multiple Channels, I2C Communication, Audio Comparison of Foam Sensors, Data Transmission, Degrees of Protection Provided by Enclosures. | "all tests were verified to meet the required acceptance criteria." (This is a general statement from Section 9. The specific quantitative results for each test are not provided in this summary, only the declaration that they met unspecified criteria.) |
Regarding the other requested information:
- Sample sizes used for the test set and the data provenance: Not applicable. No clinical test set. The non-clinical tests would have their own sample sizes (e.g., number of devices tested), but this is not detailed for each specific test in the summary.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical test set or human expert review.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No clinical test set requiring adjudication.
- 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: Not applicable. This device is an electronic stethoscope and is not an AI-assisted diagnostic tool in the typical sense that would involve interpretative reading and MRMC studies. The document explicitly states "This submission does NOT include animal or clinical performance testing."
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is an electronic stethoscope intended for human use, not a standalone diagnostic algorithm.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): For the non-clinical tests, the "ground truth" would be established engineering specifications and recognized safety standards.
- The sample size for the training set: Not applicable. This document is for a medical device (electronic stethoscope), not an AI/machine learning algorithm that would have a "training set."
- How the ground truth for the training set was established: Not applicable.
In summary, the provided document focuses on demonstrating substantial equivalence to a predicate device through non-clinical bench testing and compliance with relevant safety and performance standards, rather than clinical performance studies or AI validation.
§ 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.