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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 Capnostream™35 monitor is a portable capnograph/pulse oximeter, intended to provide professionally trained health care providers with continuous non-invasive monitoring of carbon dioxide concentration of the expired and inspired breath, respiration rate, arterial oxygen saturation (SpO2) and pulse rate of adult, pediatric, and neonatal patients. The pulse oximeter is intended for use during both no motion conditions and for patients who are well or poorly perfused.

The Capnostream™35 monitor also provides the clinician with integrated pulmonary index (IPI), apnea per hour (A/hr) and oxygen desaturation index (ODI) values. IPI is intended for pediatric and adult patients only. A/hr and ODI are intended for age 22 and up . The OxiMax SPD™ alert (SPD) feature is intended only for facility-use care of adults to detect patterns of desaturation indicative of repetitive reductions in airflow through the upper airway and into the lungs.

The Nellcor™ respiration rate parameter is intended for the continuous, non-invasive monitoring of respiration rate in adult patients in hospitals and hospital-type facilities.

Other than the OxiMax SPD™ alert and Nellcor™ respiration rate features, the device is intended for use in hospitals, hospital-type facilities, during intra-hospital transport, and out-of-hospital Emergency Medical Service applications that include ground and air transport.

The Capnostream™35 is a 4-inch color screen portable two-parameter monitor consisting of a microMediCO2 capnography module and a pulse oximetry module implemented in a host device. The host device displays parameters received from the respective modules and generates alarms when preset alarm thresholds are crossed.

The microMediCO2 module provides the following inputs to the host monitor: EtCO2 numeric, Respiratory Rate, IPI (integrated Pulmonary Index), Continuous CO2 waveform, Apnea per Hour (A/hr) and Oxygen Desaturation Index (ODI).

The SpO2 module integrated in the Capnostream™35 monitor presented in this submission provides SpO2, Pulse Rate, Respiratory Rate, and saturation pattern detection (SPD) parameters to the host for display. The SpO2 measurements are also provided to the microMediCO2 module, enabling the calculation of IPI and ODI.

The host monitor will display this data to the user on a screen as numeric values, and will also display the CO2 waveform and SpO2 (pleth) waveform or pulse bar graph.

The device is intended for use in hospitals, hospital-type facilities, and during intra-hospital transport as well as during out-of-hospital Emergency Medical Service applications. The device features IP54 Liquids & Solids ingress protection, 1.25M Shockproof status, sunlight readable display, automatic display brightness, hot swap battery capability and altitude use up to 15000 feet (4572m) for use in out-of-hospital Emergency Medical Service applications.

This document is a 510(k) summary for the Capnostream™ 35 Portable Respiratory Monitor. It details the device's indications for use, technological characteristics, and performance data from non-clinical testing.

Here's a breakdown of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state acceptance criteria in a quantitative manner for specific performance metrics like accuracy, precision, sensitivity, or specificity. Instead, it focuses on demonstrating substantial equivalence to predicate devices through validation of software functions, usability testing, and wireless connectivity.

• Software Validation: "to ensure that all modified software functions as intended."
  • Reported Performance: Passed. Implicitly, the software performed as expected and intended.
• Cybersecurity Documentation: "identified cybersecurity risks and summarized how they were mitigated."
  • Reported Performance: Cybersecurity risks were identified and mitigated.
• Usability Testing (per IEC 60601-1-6): "assessed the ability of 15 intended users with varying levels of experience to perform key tasks as well as understand Capnostream™35′s display."
  • Reported Performance: Passed.
• Wireless Connectivity Testing: "The wireless communication testing passed for all wireless key types compatible with the device."
  • Reported Performance: Passed.

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

• Usability Testing:

  • Sample Size: 15 intended users.
  • Data Provenance: Not explicitly stated regarding country of origin or whether it was retrospective/prospective. It's implied to be prospective testing specific to this device.

• Other tests (Software, Cybersecurity, Wireless Connectivity): Sample sizes for data points are not specified, as these are typically functional or engineering tests rather than studies on a "test set" of patients or data records.

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 listed tests (software validation, usability, wireless connectivity) do not typically involve establishing a clinical "ground truth" derived from expert consensus in the same way a diagnostic algorithm might. Usability testing relies on user feedback, and software/connectivity validation relies on engineering specifications.

4. Adjudication method for the test set

This information is not provided as it's not applicable to the types of tests described. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in clinical studies involving expert interpretation, which is not what was performed for these non-clinical tests.

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

There is no indication that an MRMC comparative effectiveness study was done. The device description and performance data focus on device functionality and its equivalence to predicates, not on AI assistance to human readers or effect sizes of such assistance. The device is a monitor, not an AI diagnostic tool.

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

The performance data listed (software validation, usability, wireless connectivity) are for the device as a standalone product in terms of its functions. There is no mention of an "algorithm only" performance study separate from the device's integrated operation. The device itself performs continuous non-invasive monitoring and provides specific parameters and alerts.

7. The type of ground truth used

• Software Validation: The "ground truth" is adherence to predefined software requirements and specifications.
• Usability Testing: The "ground truth" is the successful and easy completion of key tasks by users and their understanding of the display, measured against usability objectives.
• Wireless Connectivity Testing: The "ground truth" is successful connection and data transmission/reception according to wireless communication standards and protocols.

These are functional and engineering "ground truths," not clinical ones like pathology or expert consensus on patient conditions.

8. The sample size for the training set

This information is not provided. The document describes non-clinical performance tests of a medical monitor, not the development or training of a machine learning algorithm.

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

This information is not provided, as there is no mention of a training set or ground truth establishment for algorithm training in the context of this device's K200594 submission.

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