(60 days)
The AS-101 is an electronic stethoscope intended for the detection and amplification 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.
This submission is for device "The AccurSound Electronic Stethoscope AS-101 ("AS-101")". This submission expands upon a previously 510(k)-cleared device(K221805) by introducing two new reusable sensors, whereas the original device only included disposable sensors..
The AccurSound Electronic Stethoscope AS-101 ("AS-101") in this submission 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 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 or reusable 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 provided text is a 510(k) Premarket Notification for the AccurSound Electronic Stethoscope (AS101), which is a modification of a previously cleared device (K221805). The modification involves the introduction of two new reusable sensors, whereas the original device only included disposable sensors. Based on the document, here's an analysis of the acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly present a table of acceptance criteria with corresponding performance results for specific clinical metrics. Instead, it relies on non-clinical testing and the substantial equivalence to the predicate device. The performance tests mentioned are general and not detailed with specific quantitative acceptance criteria in this document.
However, based on the information provided, the following non-clinical tests were conducted to ensure safety and performance:
| Acceptance Criteria Category | Reported Device Performance (Compliance) |
|---|---|
| Electrical Safety | In compliance with ANSI/AAMI ES60601-1:2005/(R)2012/A1:2012, C1:2009/(R)2012/A2:2010/(R)2012 |
| EMC (Electromagnetic Compatibility) | In compliance with ANSI/AAMI/IEC 60601-1-2:2014 |
| Biocompatibility | In compliance with ISO 10993-1 |
| Software Verification & Validation | Documentation provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" |
| Risk Management | According to ISO 14971:2019 |
| Human Factor Engineering | In compliance with IEC 62366-1: 2015 |
| Performance Test | Conducted (details not provided) |
| Cleaning Robustness Test | Conducted (details not provided) |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "This submission does NOT include animal or clinical performance testing." Therefore, there is no clinical test set, sample size, or data provenance (country of origin, retrospective/prospective) to report for the primary evaluation of this device (the modified AS-101 with reusable sensors). The assessment relies on non-clinical bench testing and the substantial equivalence to the predicate device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
As there was no clinical study conducted for this submission (specifically for the modified device), there is no information on experts used to establish ground truth.
4. Adjudication Method for the Test Set
Not applicable as there was no clinical test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done. The document states: "This submission does NOT include animal or clinical performance testing."
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable. This device is an electronic stethoscope intended for use by healthcare professionals for direct patient assessment, not an AI algorithm acting in a standalone capacity. The "diagnosis decision support" refers to the device aiding the human professional, not replacing them or offering an automated diagnosis.
7. Type of Ground Truth Used
For the non-clinical tests conducted, the "ground truth" would be established by the industry standards and regulatory requirements themselves (e.g., passing specific electrical safety thresholds, demonstrating biocompatibility as per ISO standards, software functioning as specified). There is no "ground truth" in the sense of clinical reference diagnoses (e.g., pathology, outcomes data, expert consensus) because no clinical performance testing was performed for this submission.
8. Sample Size for the Training Set
Not applicable. The AccurSound Electronic Stethoscope is a hardware device for sound amplification and filtering. It does not appear to incorporate machine learning or AI that would require a "training set" in the conventional sense of AI/ML algorithms. The software mentioned is for device control and processing, verified through standard software validation, not through learning from data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set mentioned or implied.
§ 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.