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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

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.

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The Stethee™ Pro 1 is an electronic stethoscope 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. It can be used on any person undergoing a physical assessment.

The M3DICINE Stethee™ Pro 1 is an electronic stethoscope that picks up sounds of the heart, arteries, veins, lungs and other internal organs. Stethee™ Pro 1 provides capability for auscultation in frequencies from 20-2000Hz.

After amplification and filtering, the sounds are transferred to the user's ears via any Bluetooth connected headphones. The Stethee™ Pro 1 includes features that permit it to record and store sounds on a peripheral smart device (e.g., mobile phone) by transferring the sounds as an audio buffer to the smart device via a Bluetooth® connection. The smart device makes use of a downloaded companion stand-alone Mobile Medical Application (MMA), Stethee™ App, to record, manage and replay the captured patient sounds on the smart device.

Stethee™ App is also able to display the audio file as a phonocardiograph (21 CFR 870.2390) on the user's smart device and can use the audio file to calculate and display a simple Heart Rate. Stethee™ App does not direct or influence the performance of Stethee™ Pro 1.

The Stethee™ Pro 1 device user interface includes a simple push down mechanism ("control knob") to start recording. It has a light-emitting diode (LED) display ring which indicates the device's status state (ON or OFF, charge status, and Bluetooth® synchronization status).

The Stethee™ Pro 1 operates on a rechargeable certified 3.7V lithium ion polymer battery.

The Stethee™ Pro 1 incorporates embedded software. The embedded software controls all the various features found in the Stethee™ Pro 1, such as sound capture, digital signal processing, volume control, LED display ring, and Bluetooth® transfer.

The document describes the Stethee™ Pro 1 electronic stethoscope and its equivalence to a predicate device, the 3M™ Littmann® Model 3200. However, it does not provide acceptance criteria in terms of specific performance metrics with numerical targets or a detailed study proving the device meets those specific acceptance criteria.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device through comparative performance testing.

Here's an attempt to answer your questions based on the provided text, highlighting what information is available and what is not:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in the format of defined thresholds for different performance metrics. It rather presents a comparison of technical characteristics between the Stethee™ Pro 1 and the predicate device. The implied "acceptance criteria" is that the Stethee™ Pro 1 performs substantially equivalent to the predicate device in these characteristics.

2. Sample size used for the test set and the data provenance

The document states: "M3DICINE submitted performance testing information in this 510(k) demonstrating that the Stethee™ Pro 1 can perform over its intended range of operation (20-2000Hz). Comparative performance testing submitted in the 510(k) demonstrated the two devices perform in a substantially equivalent manner."

However, no specific sample sizes for test sets or data provenance (e.g., country of origin, retrospective/prospective) are mentioned for this comparative performance testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. The testing described is comparative performance testing against a predicate device, not necessarily a diagnostic study requiring expert ground truth for classification.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the document.

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 MRMC comparative effectiveness study was described or performed. The device is an electronic stethoscope with an accompanying app that can display phonocardiographs and heart rate. It's not an AI-assisted diagnostic tool in the sense of improving human reader performance on complex image interpretation. The comparison is primarily on technical specifications and basic functionality.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

The document describes the performance of the Stethee™ Pro 1 device itself, which includes embedded software for sound capture, digital signal processing, volume control, and Bluetooth transfer. The heart rate calculation by the Stethee™ App can be considered an "algorithm only" function in terms of its calculation process.

• Heart Rate Calculation: The Stethee™ App "calculates and display a simple Heart Rate."
  • Minimum Audio Sample Requirements: Requires initial 0.3-2 second recording (predicate requires 5 seconds).
  • Methodology: Performs continuous real-time calculation after initial 0.3-2 second sampling and updates heart rate display after each heart beat (predicate updates every 2 seconds after initial 5 seconds).
  • Range of Detection and Accuracy: 30-200 BPM with an allowable readout error rate of no greater than ±10 % or ±5 bpm (predicate: 30-199 BPM with ±10% consistency).
• Visualization: "Sounds can be visualized as phonocardiograph using companion software Stethee™ App." This is a standalone function of the software.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the heart rate accuracy, the implied ground truth would be a validated heart rate measurement, likely from an ECG or a highly accurate reference device. However, the exact type of ground truth used for performance testing is not explicitly stated. For the broader "substantial equivalence" claim, the predicate device itself serves as the reference for comparison.

8. The sample size for the training set

The document does not mention a training set or any machine learning/AI model training in the context of diagnostic capabilities beyond basic heart rate calculation. The "embedded software" handles signal processing and device control but isn't described as a learnable AI model.

9. How the ground truth for the training set was established

As no training set is mentioned in the context of the device's diagnostic claims, this information is not applicable/provided.

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