(28 days)
The Electronic Stethoscope DS101 is intended for the detection, and recording of sounds from the heart, lungs, anterior and posterior chest, abdomen, neck, limbs, arteries, veins and other internal organs with selective frequency ranges. And the stethoscope chest piece is designed for use with child, adolescent and adult patients. It is used for any subject undergoing a physical examination and intended only for medical diagnostic purposes in clinic or hospital.
The Electronic Stethoscope Omni-Steth is intended for the detection, amplification and recording of sounds from the heart, lungs, anterior and posterior chest, abdomen, neck, limbs, arteries, veins and other internal organs with selective frequency ranges. And the stethoscope chest piece is designed for use with child, adolescent and adult patients. It is used for any subject undergoing a physical examination and intended only for medical diagnostic purposes in clinic or hospital.
The proposed Electronic Stethoscopes Models DS101 and Omni-Steth detect and display the sounds from the heart, lungs, anterior/posterior chest, abdomen, neck, limbs, arteries, veins and other internal organs from a patient's body. After amplifying and filtering, the sounds are also sent to the user's ears bilaterally through the active speaker embedded at the bottom of the stethoscopes. Sound processing is conducted with the aid of a digital signal processor. Power to the device is provided by two AAA1.2V batteries. The one-hand operable user interface consists of a full-color OLED display, the Record button, arrow keys, the OK button, and a tube connector to output sounds to the headset consisting of tubes and ear tips.
The proposed devices can detect and display an acoustic based heart rate when presented with consistent heart sounds.
In addition, using a Bluetooth wireless link, the proposed stethoscopes can exchange raw audio data with external devices such as personal computers.
Note: The models DS101 and Omni-Steth are standalone devices and do not require Bluetooth data transfer to fulfill their intended use.
The differences between the proposed stethoscope models DS101 and Omni-Steth are cosmetic: specifically, the design of top housing and keyboard layout. The OLED Display information are identical.
The provided text is a 510(k) premarket notification for a medical device (electronic stethoscopes). It outlines the device's features, intended use, and comparison to predicate devices, along with performance data from non-clinical studies. However, it explicitly states that "clinical testing was deemed unnecessary" because the device's intended use, operating principle, and fundamental technology are the same as existing predicate devices.
Therefore, the document does not contain information about acceptance criteria and a study that proves the device meets those criteria through clinical evaluation, an MRMC comparative effectiveness study, or a standalone algorithm performance study. The performance data section focuses on non-clinical evaluations like electrical safety, EMC, software verification, biocompatibility, usability, wireless coexistence, splash water, heart rate performance, and audio performance, primarily through bench testing and comparisons to predicate devices.
Here's a breakdown of what can and cannot be extracted from the provided text based on your request:
1. A table of acceptance criteria and the reported device performance
The document does not present formal acceptance criteria in a tabular format, nor does it detail specific performance metrics with numerical targets and results for clinical efficacy. Instead, it states compliance with various standards and demonstrates substantial equivalence through comparative bench testing.
Based on the "Performance Data" section, here's a summary of the performance claims and the studies that support them:
| Performance Aspect | Acceptance Criteria (Implied) | Reported Device Performance and Study |
|---|---|---|
| Risk Analysis | Compliance with ISO 14971:2007; identified risks controlled to acceptable levels. | Risk analysis conducted. Identified risks mitigated, and residual risks found at acceptable levels. |
| Electrical Safety | Compliance with ANSI/AAMI ES 60601-1:2005/(R)2012. | Complies with ANSI/AAMI ES 60601-1:2005/(R)2012. Tested by SGS Taiwan Limited. |
| EMC | Compliance with IEC 60601-1-2:2014 and FCC Part 15. | Complies with IEC 60601-1-2:2014 and FCC Part 15. Acceptable results for radiated emissions, immunity to electrostatic discharges, immunity to radio frequency electromagnetic fields, and power frequency magnetic fields. Tested by SGS Taiwan Limited. |
| Software V&V | Compliance with "Guidance for the content of premarket submissions for software contained in medical devices, May 11, 2005" and IEC/TR80002-1:2009. Failure or latent flaw could indirectly result in minor injury (moderate concern). | Documentation submitted in accordance with requirements. The software's "level of concern" is considered "moderate." |
| Biocompatibility | Compliance with AAMI ANSI ISO 10993-1:2009. | Complies with AAMI ANSI ISO 10993-1:2009. |
| Usability | Compliance with IEC 62366:2015, Clause 5.3 and 5.7.3. Acceptable usability, learnability, efficiency, satisfaction, and no identified hazards. | Usability is acceptable. Test participants successfully completed tasks and expressed satisfaction with learnability, efficiency, and size. No use problems or hazards identified. |
| Wireless Coexistence | Compliance with ANSI C63.27-2017. Minimal interference, stable heart rate and peak-to-value. | Complies with ANSI C63.27-2017. Little interference from Bluetooth and Wi-Fi noted over different test distances; heart rate and peak-to-value remained stable. |
| Splash Water Test | Compliance with IEC / EN 60529:2001 (IPX4). Normal device function after testing. | Complies with IEC / EN 60529:2001 (IPX4). Device’s function was normal after testing. |
| Heart Rate Performance | Substantial equivalence to predicate devices (3M 3200 and DS3011A) within 30-180 bpm heart rate range. | Substantially equivalent to 3M 3200 and DS3011A within the heart rate range of 30-180 bpm. (Bench testing results compared to predicate devices). |
| Audio Performance | Substantial equivalence to predicate devices (3M 3200 and DS3011A) for specified audio characteristics (e.g., below 1 kHz, bell/diaphragm/wide frequency modes). | Substantially equivalent to 3M 3200 for audio frequency below 1 kHz. Substantially equivalent to DS3011A for bell, diaphragm, and wide frequency band modes. (Bench testing results compared to predicate devices). |
2. Sample size used for the test set and the data provenance
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Usability Evaluation (Non-clinical):
- Sample Size: 15 physicians and 15 registered nurses (Total: 30 participants)
- Data Provenance: Conducted in San Diego, California and Saint Louis, Missouri, USA. The setting simulated clinic, out-patient clinic, and in-hospital settings.
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Heart Rate Performance Testing & Audio Performance Testing (Non-clinical):
- These were bench tests comparing the proposed device to predicate devices (IMEDIPLUS Electronic Stethoscope DS3011A and 3M™ LITTMANN® ELECTRONIC STETHOSCOPE MODEL 3200). The "sample size" here refers to the number of devices tested, not human subjects or patient data. The document does not specify the number of units tested for these bench tests, or the origin of any acoustic data used for these comparisons.
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For clinical data: The document explicitly states: "There is no difference in the intended use, operating principle, and fundamental technology, in comparison to the predicate device, thus clinical testing was deemed unnecessary." Therefore, no clinical test set was used, and no related sample size or data provenance for clinical data is available.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Since no clinical study was performed, there was no clinical ground truth established by experts in this submission.
- For the Usability Evaluation, 15 physicians and 15 registered nurses participated. Their role was as users of the device for the usability test, not as experts establishing a diagnostic ground truth. No specific qualifications beyond "physician" and "registered nurse" were provided.
4. Adjudication method for the test set
- Not applicable, as no clinical test set or diagnostic adjudication process was described. The usability test involved participants providing feedback, but this is not a diagnostic adjudication.
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
- No, an MRMC comparative effectiveness study was not done. This device is an electronic stethoscope that amplifies and records sounds; it is not an AI-powered diagnostic algorithm that assists human readers in interpreting images or data. The submission focuses on the substantial equivalence of its physical and functional aspects to predicate stethoscopes.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not directly applicable in the context of an "algorithm only" performance for diagnosis. The device itself is a tool for clinicians. While it performs internal processing (e.g., heart rate detection, sound amplification/filtration), the document does not present it as a standalone diagnostic algorithm in the way AI for medical imaging would be. The performance bench tests (heart rate and audio) could be considered "standalone" in that they evaluate the device's technical output, but not a diagnostic "algorithm" in isolation from human use.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- No clinical ground truth (expert consensus, pathology, outcomes data) was used or established because clinical testing was deemed unnecessary.
- For the non-clinical performance tests:
- Heart Rate Performance: Ground truth was implicitly established by comparing the device's heart rate detection to that of the already cleared predicate devices (3M 3200 and IMEDIPLUS DS3011A) in controlled bench test settings.
- Audio Performance: Ground truth was similarly established by comparing the audio output (frequency bands) to the predicate devices in bench tests.
- Usability: "Ground truth" for usability was successful completion of tasks and participant satisfaction, reported through feedback collected during the study.
8. The sample size for the training set
- Not applicable. This submission is for an electronic stethoscope, not a machine learning or AI model that requires a "training set" of data in the conventional sense. The device's functionality is based on established acoustic and electronic principles, not on learned patterns from a dataset.
9. How the ground truth for the training set was established
- Not applicable (as per point 8).
§ 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.