Search Results

Nonin's Models 6500MA and 6500SA Single-Patient Use Disposable Pulse Oximeter Sensors are indicated for non-invasive spot-checking and/or continuous monitoring of adult and pediatric patients who are well or poorly perfused, weighing greater than 60 pounds (30 kilograms). It is intended for use in environments including operating room, surgical recovery, critical care, emergency room, long-term care, home use and mobile environments.

The 6500MA (wrap-around model) and 6500SA (interlocking model) are fingertip single-patient use disposable, transmittance sensors. They are comprised of a lamination of two foams (patient contact side and external side) with the optical components and a malleable wire within the lamination. The optical components are identical to the currently marketed Model 7000 single-patient use disposable sensor. The sensors are compatible with all Nonin-branded pulse oximeters.

This is a 510(k) summary for a medical device, which typically focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study report for a new device's absolute performance. Therefore, many of the requested details about specific study methodologies (like sample size for training sets, adjudication, or MRMC studies) are not present in this type of document.

Here's an analysis of the provided text based on your request:

Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

The document states: "Nonin's Model 6500 sensor series have successfully undergone both bench and clinical testing in order to demonstrate that it meets the requirements of ISO 9919:2005 Clause 50 Accuracy of Operating Data, Clause 102 section 102.2 Labeling, and IEC 60601-1:1998 (ISO 10993-1:2003) Clause 48 Biocompatibility."

The table above demonstrates that the subject device (Model 6500 Sensor Series) meets or exceeds the performance criteria of the predicate device (Model 7000 Sensor Series) for SpO2 accuracy, and matches it for pulse rate accuracy. This forms the basis of the substantial equivalence claim.

Missing Information (Based on the Provided Text):

The following information is not detailed in the provided 510(k) summary:

2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): The document mentions "clinical testing" but does not provide details on the sample size of the test set, its provenance, or whether it was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified. For pulse oximetry, the "ground truth" for SpO2 accuracy is typically established by comparing the oximeter readings to arterial blood gas measurements (co-oximetry) in induced hypoxia studies, often without "experts" in the traditional sense for reading images, but rather with clinical staff performing procedures and measurements.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable or not specified.
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: Not applicable. This is a pulse oximeter sensor, not an AI diagnostic device that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: The device itself is an algorithm (oximeter) and sensor, so its performance is standalone in the context of its function. However, the exact methodology for this standalone performance (e.g., how the clinical test dataset was used to derive the accuracy metrics) is not detailed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For SpO2 accuracy, the ground truth is typically arterial blood gas analysis with co-oximetry, under controlled desaturation conditions, which is considered the gold standard for SpO2. This is implied by the standard ISO 9919:2005 for oximeters, but not explicitly stated as the method for this specific study.
8. The sample size for the training set: Not applicable or not specified. Pulse oximeters generally use established algorithms based on optical properties of blood, rather than machine learning training sets in the modern sense.
9. How the ground truth for the training set was established: Not applicable or not specified.

Ask a specific question about this device

OxiScan II Oximetry Data Management Software (OxiScan II) is a central server based software system that uses a personal computer based application written in Microsoft Dot Net protocol to capture oximetry data from an oximeter, and then transmit this data, in a secure encrypted file, via internet, to the central server. At the central server the data is used to render a standard report that is then transmitted via fax and/or email to the prescribing physician. The intended use of the report is to provide a physician with information to help determine the best pulmonary treatment.

The OxiScan II Oximetry Data Management Software is intended to collect, report and archive oximetry trend data to provide information to a medical professional, as a supplemental tool to assist in the timely identification of pulmonary needs.

The OxiScan II Oximetry Data Management Software is intended to (1) transfer oximetry data from a pulse oximeter to a central server data base in order to maintain unique records per patient and test of this pulse oximetry data, and (2) to generate and archive standard reports drawn from this data. A list of approved oximeters appears in the Capture software.

The OxiScan II Oximetry Data Management Software is not a diagnosis tool. It is a decision management support tool that allows medical personnel to securely and accurately upload and view data related to pulse oximetry and to provide output reports as feedback which may be used by a Heathcare professional to form a patient history.

OxiScan II Oximetry Data Management Software is an accessory for use with compatible pulse oximeters. OxiScan II Oximetry Data Management Software collects and stores patient information containing raw oximetery data captured by a pulse oximeter. This information is transferred by a personal computer to an internet Web server where a report which summarizes and graphically presents the data is prepared. This report is delivered to a Healthcare Professional who then uses it along with other information to determine a course of pulmonary treatment. The report may be retrieved, reviewed, and retransmitted via the OxiScan II Oximetry Data Management Software web site.

The OxiScan II Oximetry Data Management Software is a software system intended to collect, report, and archive oximetry trend data from compatible pulse oximeters to provide information to a medical professional. It acts as a supplemental tool for timely identification of pulmonary needs and to form a patient history, but it is not a diagnostic tool.

The acceptance criteria for the OxiScan II Oximetry Data Management Software are primarily focused on its functional characteristics, safety, and effectiveness in meeting its stated intended use, and its substantial equivalence to a predicate device. The study demonstrating that the device meets these criteria is described as "Functional and Safety Testing."

Here's the breakdown of the information requested, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a numerical sample size for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It only states that "Representative samples of OxiScan II Oximetry Data Management Software were successfully performance tested."

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not provide information on the number of experts used or their qualifications for establishing ground truth. The testing mentioned appears to be software performance testing rather than clinical validation with expert review.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

The document does not describe any adjudication method for a test set. The validation described focuses on functional, safety, and effectiveness testing of the software itself and its equivalence to a predicate device.

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. The device is data management software, not an AI-assisted diagnostic tool. Its purpose is to collect, report, and archive oximetry data for review by healthcare professionals, not to provide interpretations or assist human readers in making diagnoses in the way an AI algorithm might.

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

The device, OxiScan II, is described as "Oximetry Data Management Software." Its standalone performance would relate to its ability to accurately capture, transmit, process, and report oximetry data as per its specifications. The document states that "Representative samples of OxiScan II Oximetry Data Management Software were successfully performance tested to verify compliance to appropriate functional characteristics." This implies standalone testing of the software's data management capabilities. However, it explicitly states it is "not a diagnosis tool" and relies on a "Healthcare Professional" for interpretation, meaning its intended use always involves human-in-the-loop for clinical decision-making.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The document does not detail the type of "ground truth" in the sense of clinical diagnoses or outcomes. Given the nature of the device as data management software, the "ground truth" for its performance testing would likely involve:

• Expected data values/formats: Verifying that captured oximetry data matches the source.
• Report accuracy: Confirming that generated reports correctly reflect the stored data.
• System functionality: Ensuring features like secure transmission, archiving, and retrieval work as designed.
• Compliance with specifications: Testing against pre-defined functional and technical requirements.

8. The Sample Size for the Training Set

The document does not mention a training set, as the device is not described as utilizing machine learning or artificial intelligence that would typically require a training set. The "Functional and Safety Testing" refers to performance verification, not an AI model's training.

9. How the Ground Truth for the Training Set was Established

As no training set is mentioned or applicable to this type of software, this information is not provided.

Ask a specific question about this device

Mediaid's compatible sensors are indicated as accessories to pulse oximeters used on Pulse Oximeters manufactured by Nonin Inc for continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring in infant, pediatric, and adult patients.

Mediaid SpO2 sensors are electro-optical sensors that function without skin penetration, electrical contact, or heat transfer. The sensor uses optical means to determine the light absorption of functional arterial hemoglobin by being connected between the patient and the oximeter. The sensor contains three optical components: two light emitting diodes (LED) that serve as light sources and one photodiode that acts as a light detector. The optical components are housed in adhesive film, rigid spring-loaded clip, or foam and Velcro wrap. The sensor cable is terminated in a DB-9 connector.

The Mediaid SpO2 Sensors are intended for continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring. The device's performance was evaluated through clinical hypoxia studies and bench testing.

Here's a breakdown of the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states "equivalent to predicate device accuracy claims" for SpO2 accuracy, but it does not explicitly state numerical acceptance criteria for SpO2 or pulse rate. It implies that the predicate device's accuracy claims serve as the benchmark.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not explicitly stated. The document mentions "clinical hypoxia studies" without providing the number of subjects.
• Data Provenance: Clinical hypoxia studies were conducted in an "independent research lab." The country of origin is not specified, but the submission is to the US FDA. The studies appear to be prospective, as they are described as "conducted" for the purpose of the device's evaluation.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not explicitly stated. The ground truth for SpO2 measurements was established using "arterial blood samples analyzed on a laboratory co-oximeter." The expertise of those analyzing the co-oximeter results is not detailed.

4. Adjudication Method for the Test Set

Not applicable. The ground truth for SpO2 was derived from objective measurements (laboratory co-oximetry of arterial blood samples), not from expert consensus requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. The evaluation focuses on the device's performance against a reference standard (co-oximetry) and predicate device equivalence, not on human reader performance with or without AI assistance.

6. Standalone Performance Study

Yes, a standalone performance study was done for the SpO2 sensor. The "clinical hypoxia studies" evaluated the Mediaid SpO2 sensors against arterial blood samples analyzed on a laboratory co-oximeter, demonstrating the algorithm's (sensor's) ability to measure SpO2 directly. Bench testing was also performed solely on the device to verify pulse rate accuracy.

7. Type of Ground Truth Used

• SpO2: Objective measurement from "arterial blood samples analyzed on a laboratory co-oximeter."
• Pulse Rate: Not explicitly stated, but likely derived from a validated reference method during bench testing.

8. Sample Size for the Training Set

Not applicable. The document describes a medical device (SpO2 sensor) rather than an AI-powered diagnostic algorithm that typically requires a distinct training set. The device's operation is based on established electro-optical principles, not on machine learning requiring a training phase with labeled data.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no specific training set for an AI/ML algorithm described.

Ask a specific question about this device

The MedStar System is indicated for Out-of-Hospital Use with any patient requiring Out-of-Hospital monitoring. The associated Collection Server is intended for use in a Disease Management Center, Hospital or Hospital-Type facility, Medical Clinic or Physician's Office.

The MedStar Monitoring System II comprises the MedStar Unit and the associated Collection Server. The MedStar Unit is a portable, battery-operated unit for controlling the transmission of data from a range of compatible patient monitors or measurement devices to a remote monitoring center. Data is transmitted via telephone lines to the associated data collection server at the remote site. The MedStar Unit is contained in a small plastic enclosure with an LCD screen mounted into the top of the case. The case is made of a strong impact resistant plastic material. A User push button control is located adjacent to the display. Four serial communication ports are located at the side of the unit for connection to the serial data ports of specific patient monitors. Two standard phone jacks are also located at the side of the unit for connection to standard phone outlets. Two recessed programming buttons are included on the opposite side of the enclosure to the phone jacks. The Collection Server comprises a Personal Computer-type Processor Unit incorporating an additional electronics board to control phone line transmission to and from the MedStar Unit.

The provided text lacks the detailed study information required to complete the table and answer all questions comprehensively. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than presenting a detailed performance study with acceptance criteria and specific statistical results.

Here's an attempt to extract the available information and highlight what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Test Set Sample Size: Not specified.
• Data Provenance: Not specified, but the "bench testing" mentioned suggests internal testing, not necessarily human patient data.

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

• Not applicable. The device's function is data transfer, not diagnostic interpretation requiring expert ground truth.

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

• Not applicable. The device's function is data transfer, not diagnostic interpretation.

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:

• Not applicable. The MedStar System II is a data transfer device, not an AI-powered diagnostic tool used by human readers.

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

• Yes, implicitly. The "bench testing" mentioned would be a standalone evaluation of the device's technical performance (e.g., successful data transmission, accuracy of data transfer) without human intervention in its core function. However, specific results are not provided.

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

• For a data transfer device, the 'ground truth' would likely involve verifying the integrity and accuracy of the transmitted data against the original source data (e.g., verifying that a blood glucose reading of 'X' from the monitor is correctly received as 'X' by the server). The document does not specify the method used for this verification.

8. The sample size for the training set:

• Not applicable. This device is not described as using machine learning or AI that would require a training set.

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

• Not applicable, as there's no mention of a training set.

Ask a specific question about this device

The CareCompanion Patient Station is intended to be used in conjunction with the CareCompanion Nurse Station to provide two-way video, audio and data communications between the patient and the health care professional.

The CareCompanion Patient Station is used upon prescription of an authorized healthcare provider by patients where regular monitoring of vital signs information is indicated. The information is collected from the CareCompanion Patient Station and transmitted over standard telephone lines to a health care professional.

The device does not send any real-time alarms. The device a aid. Clinical judgement and experience are required to check and interpret the information transmitted. The device is not intended as a substitute for medical care. The device is contraindicated for patients requiring direct medical supervision or emergency intervention.

The CareCompanion System consists of two components: a transportable Patient Station installed typically in a patient's home; and the Nurse Station, installed in a healthcare provider or professional caregiver's office. The two components communicate with each other through modems over standard telephone lines and transmit real-time video, audio and data between them.

The real-time video and audio communications allow the patient and the caregiver to view and speak with each other.

Using vital signs measurement devices integrated with the Patient Station, the Patient Station is designed to monitor the patient's blood pressure, pulse rate, blood glucose level, weight, blood oxygen saturation level and/or heart, lung and bowel sounds, and transmit this data to the Nurse Station. The data is displayed to the caregiver operating the Nurse Station and also automatically recorded in a patient information database. The heart, lung and bowel sounds may be listened to by the caregiver using a set of headphones supplied with the system.

The Nurse Station consists of two sub-components, the Nurse Station PC, which is a standard PC with supporting peripherals connected to a videophone, which provides the video conferencing functions for the Nurse Station. The Nurse Station PC may also operate as a standalone device for patient data management and record keeping functions.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Neptec CareCompanion system.

Based on the provided text, the Acceptance Criteria and the Study that proves the device meets them are primarily focused on Substantial Equivalence to a predicate device, specifically regarding the addition of a pulse oximeter. There's limited information on standalone performance metrics for each vital sign, rather the testing emphasizes functional equivalence.

Acceptance Criteria and Reported Device Performance

Study Details

1. Sample Size Used for the Test Set and Data Provenance:

   • Test Set Sample Size: The document does not specify the sample size for any of the performance tests. It states "Testing was performed" and "The pulse oximeter was tested."
   • Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The testing appears to be internal validation by the manufacturer, rather than a clinical study.

2. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

   • Not applicable. The document describes functional testing against existing specifications and predicate devices, not the establishment of ground truth by human experts for a diagnostic or interpretive task.

3. Adjudication Method for the Test Set:

   • Not applicable. The testing described focuses on functional performance and conformance to specifications, not on inter-rater agreement for a diagnostic outcome.

4. 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. This is not an AI-assisted diagnostic device, but rather a telemedicine system for vital signs collection and communication. Therefore, an MRMC study is not relevant here.

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

   • The core of the "Performance Testing" section describes standalone testing of the integrated vital signs measurement devices (e.g., "show that they operate equivalently when integrated with CareCompanion as when operated as independent devices") and the pulse oximeter against its manufacturer's specifications. This can be considered a form of standalone performance assessment for the individual measurement components within the system. The system itself is explicitly designed to be human-in-the-loop, with a "caregiver operating the Nurse Station" and clinical judgment required.

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

   • The "ground truth" for the performance testing cited appears to be:
     • Manufacturer's specifications: For the pulse oximeter.
     • Performance of independent devices: For the other integrated vital signs measurement devices. The equivalence to these "independent devices" is the reference.
     • Applicable mechanical, electrical, and environmental standards: For general system performance.

7. The sample size for the training set:

   • Not applicable. This is not a machine learning or AI device that would require a "training set."

8. How the ground truth for the training set was established:

   • Not applicable, as there is no training set.

Ask a specific question about this device

Vasomedical, Inc.'s EECP® Therapy System Model TS3 with Pulse Oximetry is a non-invasive external counterpulsation device intended for use in the treatment of patients with congestive heart failure, stable or unstable angina pectoris, acute myocardial infarction, or cardiogenic shock.

The EECP® Therapy System Model TS3 with Pulse Oximetry is comprised of three major components, a Control Console, a Treatment Table, and a patient Cuff Set. The Control Console accommodates the air compressor and reservoir, a signal module panel, a power module, a microprocessor with touch screen/keyboard interface, data storage drives and printer, and components for acquiring and processing ECG, finger plethysmograph and oxygen saturation signals. The microprocessor is used to operate and monitor the system by means of proprietary custom software, with the operator using the touch screen/keyboard interface to control its operation. The screen displays information pertinent to operating the system, as well as treatment parameters and patient waveforms during use. Treatment pressure is monitored with an internal pressure sensor and the operator-selected set-point maintained by a closed-loop control system. The touch screen employs "hardware-less keys" which the operator touches to select a function or execute a command and the keyboard enables alphanumeric text entries. An internal hard disk drive is used to store data on the system, an internal floppy disk drive is used to record data onto transferable media, and a printer is used to produce hard copy of site and patient identifiers and physiologic data. The Treatment Table accommodates a motorized lifting mechanism, mattress and the pneumatic circuit valve assembly. The motorized lifting mechanism is used to move the mattress up and down, providing a convenient height for patient and operator use. The valve assembly consists of three pairs of inflation/deflation valves that open and close on command to inflate or deflate the patient Cuff Set with air. The valve assembly is connected to the air compressor and reservoir components in the Control Console via connecting air hoses. External pressure is applied via the patient Cuff Set to the lower extremities of the patient in synchronization with the heart, i.e. the cuffs compress vascular beds in the calves, lower thighs and upper thighs/buttocks on inflation. When the heart is in its relaxed state during the diastolic period, pressure is applied sequentially from the calves, to the lower thighs, to the upper thighs and buttocks, forcing blood back to the heart, increasing coronary perfusion pressure and coronary blood flow (diastolic augmentation), as well as venous return. Immediately before the heart begins to eject blood during the next systolic phase, the cuffs are rapidly deflated and all externally applied pressure is eliminated. The vasculature in the lower extremities reconforms and is able to receive the output of the heart with lessened resistance, thereby reducing systolic pressure and the workload of the heart (decreased afterload). Stretchable treatment pants comprised of cotton and Lycra (Spandex) are worn by the patient under the Patient Cuff Set to allow for greater comfort during treatment. The Model TS3 with Pulse Oximetry incorporates a noninvasive sensor and electronic module to acquire and process the patient's oxygen saturation. These same components functions can be used separately or simultaneously.

The provided text describes the Vasomedical EECP® Therapy System Model TS3 with Pulse Oximetry and mentions non-clinical and clinical tests. However, it does not explicitly state acceptance criteria or provide specific quantitative results of a study to demonstrate the device meets those criteria.

Instead, the documentation details:

• Non-clinical tests: Software verification and validation, including functional requirements, boundary values/stress testing, and safety requirements. It also mentions verification of system operation at both system and component levels, and biocompatibility testing. These are primarily focused on device functionality, safety, and software integrity rather than a quantitative performance metric against a defined clinical acceptance criterion.
• Clinical evaluation: A qualitative statement that "Clinical evaluation of EECP® in patients with congestive heart failure has been performed in multi-center, single center and registry-based clinical investigations. Results of these investigations have demonstrated clinical benefit in patients treated with Vasomedical EECP® Therapy Systems. Objective measures such as peak oxygen consumption, exercise duration and pre-load adjusted maximal left ventricular power are improved following EECP® therapy, as well as subjective measures of patient response to therapy, such as quality of life and functional ability measures."

Given this, I cannot construct the table of acceptance criteria and reported device performance as requested, nor can I provide specific details like sample sizes for test sets, data provenance, number/qualifications of experts, or adjudication methods, as these are not present in the provided text for a performance study.

Here's a breakdown of what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

• Not explicitly stated. The document details types of tests performed (software, safety, biocompatibility, clinical evaluation) but does not provide specific acceptance criteria or corresponding quantitative performance metrics from those tests.

Regarding the study proving the device meets criteria (based on the "Clinical Evaluation" section):

• Type of Study: Clinical evaluation (multi-center, single-center, and registry-based clinical investigations) of EECP® in patients with congestive heart failure.
• Study Purpose: To demonstrate clinical benefit in patients treated with Vasomedical EECP® Therapy Systems.
• Outcomes Measured:
  • Objective: Peak oxygen consumption, exercise duration, pre-load adjusted maximal left ventricular power.
  • Subjective: Quality of life, functional ability measures.
• Reported Finding: "Results of these investigations have demonstrated clinical benefit in patients treated with Vasomedical EECP® Therapy Systems." and that "Objective measures such as peak oxygen consumption, exercise duration and pre-load adjusted maximal left ventricular power are improved following EECP® therapy, as well as subjective measures of patient response to therapy, such as quality of life and functional ability measures."

Missing Information (not found in the provided text):

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

• Not specified. The document mentions "multi-center, single center and registry-based clinical investigations" but provides no numbers for patient samples or data provenance (e.g., country of origin, retrospective/prospective).

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

• Not applicable/Not specified. For a therapy system like EECP, the "ground truth" relates to clinical outcomes and physiological changes, which are measured directly rather than established by expert review of data/images. The document does not mention experts establishing ground truth in this context.

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

• Not applicable/Not specified. This typically applies to studies involving human interpretation (e.g., image reading), which is not the primary focus of the performance evaluation described here.

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. This is not an AI-assisted diagnostic device, but a therapy system. Therefore, an MRMC study is not relevant.

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

• Not applicable. This is not an algorithm-only device; it's a medical device used in a clinical setting by an operator.

7. The type of ground truth used:

• For the clinical evaluation, the "ground truth" would be the actual physiological measurements (peak oxygen consumption, exercise duration, pre-load adjusted maximal left ventricular power) and patient-reported outcomes (quality of life, functional ability measures) obtained during the investigations.

8. The sample size for the training set:

• Not applicable. This device is not an AI/ML algorithm that requires a training set in the conventional sense. The "training" for the device would be its design, engineering, and software development based on medical principles and prior knowledge.

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

• Not applicable. See point 8.

In summary, while the document indicates that clinical evaluations were performed and demonstrated clinical benefits, it lacks the specific, quantifiable details regarding acceptance criteria and performance metrics that would typically be found in a robust study summary for a diagnostic or AI-powered device. The emphasis is on overall safety, functionality, and qualitative clinical benefit for a therapy delivery system.

Ask a specific question about this device