(287 days)
The Stethee™ Pro 1 is an electronic stethoscope intended for screening and 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 or without the use of selective frequencies. It can be used on any person undergoing a physical assessment.
Stethee Pro 1 is intended for use with the Stethee Pro Software System, whose features enable recording, playback, visualization, analysis, management and reporting of patient samples, and sharing this data with other authorized users.
The Stethee Pro 1 is an electronic stethoscope intended for medical screening or diagnostic purposes only. Stethee Pro 1 may be used for detection and amplification of sounds from the heart, lungs, arteries, veins, and other internal organs with or without the use of selective filters. It can be used on any person undergoing a physical assessment.
The Stethee Pro 1 consists of hardware and embedded software which controls all of the various features found in the device, such as sound capture, digital signal processing, volume control, haptic feedback for user, LED display ring, and wireless data transfer (via Bluetooth®). No patient data is stored on the Stethee Pro 1 device itself.
After amplification and filtering of the sounds detected, Stethee Pro 1 transfers the sounds to the User's ears via any Bluetooth® connected headphones, or by wired headphones connected to Stethee Pro 1 using an AUX adaptor at the device's USB port.
The Stethee Pro 1 also includes features that permit it to stream sounds to a peripheral smart device (e.g., mobile phone) as an audio buffer to a smart device (iOS or Android) via a Bluetooth® connection. The audio buffer is handled on the smart device by a separate standalone software application called the Stethee Pro Software System.
Stethee Pro Software System (SPS) is a series of software applications (Stethee Pro Mobile Applications and the Stethee Pro Central Web Application) that work with the Stethee Pro 1 electronic stethoscope. Stethee Pro Software System is supported by M3DICINE's proprietary software platform M3DICINE Cloud Services (MCS) which provides various services including database, security, and core business logic services so that services for data sharing and multiple sign-ins from multiple devices can be implemented.
The provided text does not contain detailed information about the acceptance criteria or a specific study proving the device meets those criteria in the typical format of an AI/ML medical device submission. The document is a 510(k) summary for the Stethee Pro 1, an electronic stethoscope, and its accompanying software system.
It primarily focuses on demonstrating substantial equivalence to a predicate device (Stethee Pro 1 and Stethee App [K172296]) and outlining the device's features, intended use, and general compliance with medical device standards. While it mentions "successful clinical validation of the performance accuracy of the device's machine learning analysis algorithms was performed against the listed reference devices," it does not elaborate on the specific acceptance criteria, study design, sample sizes, ground truth establishment, or expert qualifications for this validation.
Therefore, I cannot fully complete the requested table and answer all questions directly from the provided text. However, I can extract what is implied or mentioned in general terms:
Inferred Information from the Document:
The acceptance criteria are implicitly related to the performance accuracy of features like "Heart Rate: Detection and Display" and "Respiration Rate" as validated against "Reference Device Capnostream 35."
Here's an attempt to structure the available information, with acknowledges of missing details:
1. Table of Acceptance Criteria and Reported Device Performance
| Feature | Acceptance Criteria (Implied / From Reference Device) | Reported Device Performance (as stated for Stethee Pro 1 / SPS) |
|---|---|---|
| Heart Rate: Range of Detection and Accuracy | 30-200 BPM with an allowable readout error rate of no greater than ±10% (i.e., 10% consistency) of the input rate or ±5 bpm, whichever is less (as per predicate device [K172296]). | 30-200 BPM with an allowable readout error rate of no greater than ±10% (i.e., 10% consistency) of the input rate or ±5 bpm, whichever is less. (States "Same" as predicate) |
| Respiration Rate | Clinically validated range of 6 - 50 breaths per minute with an accuracy of ±1 breath per min (against Capnostream™ 35 which has 0-70 bpm: ±1 bpm, 71-120 bpm: ±2 bpm, 121-150 bpm: ±3 bpm). | Accurately calculate and display respiration rates in respirations per minute for a clinically validated range of 6 - 50 breaths per minute ±1 breath per min. |
| Acoustic Performance (Pickup Sensor, Frequency Response, Max Sound Level, Volume Control) | Substantially Equivalent to predicate ([K172296]) which has: Microphone (-22 dB sensitivity), Sampling Rate: 16 kHz, Bit Rate: 16 bits. Responsive from 20-2000 Hz. Amplifies up to 24X. Volume control in 8 steps. | Microphone (-26 dBFS sensitivity), Sampling Rate: 16 kHz, Bit Rate: 16 bits. Responsive from 20-2000 Hz. Amplifies up to 24X. Volume control in 8 steps. (Stated as "Substantially Equivalent" or "Same" regarding predicate, despite slight microphone sensitivity difference) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated in the document for any specific clinical validation. The document states "successful clinical validation of the performance accuracy of the device's machine learning analysis algorithms was performed against the listed reference devices."
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication Method for the Test Set
- Method: Not specified.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size of how much Human Readers improve with AI vs without AI Assistance
- The document does not describe an MRMC comparative effectiveness study where human readers' performance with and without AI assistance was evaluated for improvement. The focus is on the device's standalone performance and its equivalence to established devices.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Yes, implicitly. The "successful clinical validation of the performance accuracy of the device's machine learning analysis algorithms" against reference devices (like the Capnostream 35 for respiration rate) suggests a standalone evaluation of the algorithm's performance against a clinical standard, separate from a human-in-the-loop study. The "Heart Rate: Methodology" Section mentions "Performs continuous real-time calculation after initial sampling and updates heart rate display after each heartbeat," indicating an algorithmic function.
7. The Type of Ground Truth Used
- For Heart Rate and Respiration Rate: The ground truth appears to be derived from the "Reference Devices" (Stethee App [K172296] and Capnostream™ 35 [K150272]). For respiration rate, it states "The Respiration Rate feature was clinically validated against the Reference Device Capnostream 35." This implies the Capnostream 35's readings served as the ground truth.
8. The Sample Size for the Training Set
- Not specified. The document only mentions "machine learning analysis algorithms" without detailing training data specifics.
9. How the Ground Truth for the Training Set was Established
- Not specified.
§ 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.