Search Results

Breezing Med™ Metabolism Analyzer measures metabolic functions including resting energy expenditure and respiratory quotient during resting conditions via direct measurement of oxygen uptake and carbon dioxide production to provide nutritional assessment, to optimize nutritional supplements, and to quantify substrate utilization. The nutritional assessment enables the healthcare professional to further assess energy expenditure and caloric intake for weight management, and to aid in the diagnosis of diseases related to abnormal metabolic parameters. Breezing Med is intended for use with adults breathing normally on their own in a sitting position in a healthcare environment. Since the device is designed for the patient to breathe ambient air, it is not intended for patients where supplementary oxygen is being provided. Breezing Med is not intended to use as sole means for any diagnosis, and ultimately will provide data for evaluation by the professional.

Breezing Med™ Metabolism Analyzer is a resting metabolic rate measurement system with an application installed on mobile devices that provides measurements of exhalation rate, oxygen uptake and carbon dioxide production. It is used to determine resting metabolic rates, teach energy balance, and pinpoint accurate caloric intake for weight management.

Breezing Med™ is a stand-alone and fully integrated mask-like wearable metabolic analyzer based on the principle of indirect calorimetry, which is a gold standard for energy expenditure measurement. Breezing Med is designed for metabolic rate and respiratory quotient measurement and the main outputs include Resting Energy Expenditure (REE), Respiratory Quotient (RQ), Volume of Oxygen consumption (VO2), and Volume of Carbon Dioxide production (VCO2), where REE and RQ are calculated from measured parameters VO2 and VC02.

Breezing Med measures the expiratory volume similar to the predicate device Medical Graphics Express® Series.

Breezing Med consists of five components: 1) a device body; 2) a mask; 3) headgear; 4) a sensor cartridge; and 5) an application.

The acceptance criteria information can be found on page 4, under item 8, "Performance Data."

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

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the sample size, country of origin, or whether the data was retrospective or prospective for the performance study. It mentions a "verification test" and a "study to simulate clinical use."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. The performance data seems to be based on direct measurements and comparison to performance specifications of the predicate device, rather than expert-established ground truth.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This device measures metabolic functions and does not involve human readers interpreting data in a way that an MRMC study would be applicable.

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

Yes, a standalone performance assessment was done. The "verification test" and "study to simulate clinical use" assessed the device's ability to measure O2 volumes, CO2 volumes, and flow rates against established specifications. The device operates as a standalone measurement system.

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

The ground truth for the performance study appears to be the specified accuracy ranges derived from the predicate device (Medical Graphics Express® Series). The device's measurements were compared against these predefined accuracy thresholds for O2 volumes, CO2 volumes, and flow rates. These specifications likely represent a gold standard for indirect calorimetry measurements.

8. The sample size for the training set

The document does not mention a training set, as it describes a medical device for direct measurement rather than an AI/ML algorithm that undergoes a training phase.

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

Not applicable, as no training set for an AI/ML algorithm is mentioned.

Ask a specific question about this device

The device is indicated for use in mechanically ventilated neonate, infant and pediatic patients where the precise and direct measurement of oxygen uptake (VO2), carbon dioxide excretion (VCO2), resting energy expenditure (REE) and respiratory quotient (RQ) will allow the attending physician to plan and monitor an optimal nutrition regime for the patient in terms of substrate composition and utilization.

The NICU V'O2 device is an indirect calorimeter that allows accurate and precise quantification of oxygen consumption (V'O2), carbon dioxide excretion (V'CO2), resting energy expenditure (REE, the number of calories consumed per day) and respiratory quotient (RQ, the ratio of V'CO2 to V'O2) in mechanically ventilated patients. Patients include neonate, infant and pediatric patients with a body weight from 0.5 kg, low minute ventilation, high respiratory rate, and receiving fluctuating and/or elevated inspiratory oxygen concentrations.

The device functions by measuring oxygen concentration (using laser diode sensor technology) and carbon dioxide concentration (using NDIR infrared sensor technology) in inspired and expired gas as well as inspiratory flow. The inspiratory flowmeter (differential pressure type pneumotach) is attached at the patient inspiratory outlet of the ventilator. An inspiratory gas sample line is connected to the inspiratory limb of the patient breathing circuit, and an expiratory gas sample line is connected to the ventilator exhaust. The device automatically alternates between these two sample points.

Oxygen consumption is determined by comparing the amounts of oxygen in inspired and expired gas, and carbon dioxide excretion is determined by comparing the amounts of carbon dioxide in expired and inspired gas, respectively, per unit of time. These amounts are calculated from the primary measurements of oxygen and carbon dioxide concentrations and gas flow.

The resting energy expenditure (or resting metabolic rate), which is defined as the number of calories the body expends daily during resting conditions, is calculated from the values of oxygen consumption and carbon dioxide excretion using the modified Weir equation:

REE = (V'O2 x 3.941 + V'CO2 x 1.106) x 1440 kcal min / day L

Respiratory Quotient is calculated as the ratio of carbon dioxide produced by the patient to oxygen consumed by the patient.

The duration of measurement can be from tens of minutes to 24 hours, partly because the inspiratory flowmeter only sees dry gas and therefore does not significantly change calibration over time.

The device consists of two main components. An analyzer unit to which the patient is connected via gas sample and flowmeter pressure lines, and a computer running the dedicated software application under the Windows operating system. The software application works in conjunction with the hardware, and the computer presents in real time measured signals and computed physiological parameters, both as numeric and graphical data. The computer is the main control interface for the ICU staff using the device and offers options for offline data management.

The device is powered through an external medical AC/DC power supply.

The information provided describes the NICU V'O2 device, an indirect calorimeter for neonate, infant, and pediatric patients.

1. Table of acceptance criteria and the reported device performance:

Ask a specific question about this device

The Anascient™ Breath Monitor is intended for use in clinical and research applications to measure oxygen uptake.

Not Found

The provided text is a 510(k) premarket notification letter from the FDA to Invoy Technologies, LLC regarding their Anascient™ Breath Monitor. This letter primarily focuses on the FDA's decision of substantial equivalence and regulatory compliance and does not contain the detailed information necessary to fully answer the request about acceptance criteria and the study proving the device meets them.

Specifically, the document lacks the following crucial information:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets, data provenance, expert details, or adjudication methods for any study.
• Information about multi-reader multi-case (MRMC) comparative effectiveness studies.
• Details about standalone algorithm performance studies.
• The type of ground truth used.
• Sample size and ground truth establishment for the training set.

The letter simply states that the FDA "reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent... to legally marketed predicate devices." This substantial equivalence decision is based on the information provided by the manufacturer in their 510(k) submission, which would have included performance data, but that specific data is not present in this FDA letter.

Therefore, I cannot provide a complete answer to your request based solely on the provided text.

Ask a specific question about this device

The Metaphor uses the direct measurement of Oxygen uptake (VO2) and Carbon Dioxide production (VCO2) to objectively and noninvasively assess breath by breath metabolic function during rest or exercise. The Metaphor can assess energy expenditure to support nutritional assessment. Optional measurement of Nitrous Oxide (N2O) is available for enhanced accuracy of the CO2 measurement in the presence of N2O.

The Metaphor is a comprehensive pulmonary mechanics monitor which can display graphic and numeric data in patients who are mechanically ventilated or breathing spontaneously.

The Metaphor pulse oximetry function provides continuous SpO2 and pulse rate measurements in neonatal through adult populations with appropriate probes.

The Metaphor provides adjustable visible and audible alarms. The device is not intended for use as a transport monitor.

The Metaphor Metabolic Monitor integrates the functions of a sidestream respiratory gas monitor (CO2, O2, N2O), and pulmonary mechanics monitor (pressure, flow, and volume). These features allow the Metaphor to measure Oxygen uptake (VO2) and Carbon Dioxide production (VCO2) to objectively and noninvasively assess breath by breath metabolic function during rest or exercise.

The system is comprised of two main elements:

• Metaphor PC software host application running on a dedicated touch screen computer terminal, which presents computed physiological monitoring parameters, including metabolic measurements, as graphic and numeric data. This application manages the user interface, including alarms, and it interfaces to the BXB_DAS.
• The BXB DAS embedded measurement platform this subsystem contains the sensor technology to perform the gas, pressure, and flow measurements, and integrates a 510(k) cleared third party pulse oximeter module. The BXB DAS subsystem interfaces with single patient use EZ-Flow sensors and SpO2 sensors.

This summary describes the acceptance criteria and the study that proves the Metaphor Metabolic Monitor meets those criteria, based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Sizes and Data Provenance

• Test Set Sample Size: Not explicitly stated for any specific test. The document refers to various "tests" and "testing" without providing breakdowns of the number of samples or cases used.
• Data Provenance: The study was a non-clinical evaluation. No human patient data (retrospective or prospective) was used for performance validation. The testing involved bench tests, simulations, and conformance to electrical and material standards. This suggests the data was generated in a lab setting by the manufacturer, TreyMed, Inc., located in Sussex, Wisconsin, USA.

3. Number of Experts and Qualifications for Ground Truth

• Not Applicable. Since this was a non-clinical study involving bench testing and conformance to standards, there was no ground truth established by medical experts for diagnostic or clinical performance claims. The performance was assessed against engineering and safety standards.

4. Adjudication Method for the Test Set

• Not Applicable. No clinical test set or expert-driven adjudication was performed as part of this submission. The tests were objective engineering and safety evaluations against predefined criteria.

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

• No. The document explicitly states "Clinical Tests Submitted: (none)". Therefore, no MRMC study or AI-assisted human reader improvement was assessed or reported. This device does not involve image interpretation or diagnostic decisions that would typically necessitate such a study.

6. Standalone Performance Study

• Yes, in the context of a non-clinical device. The described testing largely represents standalone performance of the algorithm and hardware components (e.g., flow measurement, gas monitoring, pulse oximetry integration, software verification) against engineering standards and specified performance criteria. The device's various functions (e.g., measuring VO2, VCO2, CO2, O2, N2O, SpO2, and pulmonary mechanics) were tested for their inherent accuracy and functionality in a non-clinical setting.

7. Type of Ground Truth Used

• The "ground truth" for these non-clinical tests was based on engineering standards, predetermined specifications, and comparison to calibrated reference instruments or simulation data where applicable (e.g., pulse oximeter simulation). For example, electrical safety adherence is measured against established electrical safety standards, and gas concentration measurements would be validated against known gas mixtures.

8. Sample Size for the Training Set

• Not applicable / Not specified. This device is a metabolic monitor, not a machine learning or AI-driven diagnostic system that typically requires a 'training set' in the conventional sense of supervised or unsupervised learning from clinical data. The software was "verified to requirements" and "validated to meet intended use," which refers to standard software development and testing practices, not machine learning model training.

9. How Ground Truth for the Training Set Was Established

• Not applicable. As described above, there was no 'training set' in the context of machine learning. The device's functionality is based on established physical and chemical principles of measurement and data processing. The "ground truth" for the development of its software and hardware components would have been derived from physical laws, engineering specifications, and validated measurement techniques.

Ask a specific question about this device

This device is intended for use in clinical and research application to measure oxygen uptake. Fitmate and Fitmate Pro are designed for the measurement of Resting Metabolic Rate only. Fitmate Pro also measures maximal oxygen uptake (VO2max) that is used for assessing basic pulmonary function.

Fitmate is designed for measuring oxygen uptake at rest and during exercise (VO2max). The device is a metabolic monitor measuring Resting Metabolic Rate (RMR) and Exercise Capacity - VO2max (maximal oxygen uptake), during a sub-maximal or maximal exercise protocol. Fitmate series family includes Fitmate and Fitmate Pro. Fitmate is specifically designed for the measurement of Resting Metabolic Rate only, and Fitmate Pro includes also the measurement of maximal oxygen uptake (VO2max).

Here's a breakdown of the acceptance criteria and study information for the COSMED Fitmate device as provided in the document:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state specific acceptance criteria values (e.g., a required accuracy percentage or range) for the Fitmate device. Instead, the claim for substantial equivalence is based on the device having the same intended use and substantially the same characteristics as the predicate devices and meeting a general standard.

However, it does mention a standard that the device meets, which implies a level of performance.

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

The provided document does not specify a sample size for a test set. This submission focuses on demonstrating substantial equivalence to predicate devices rather than presenting the results of a specific performance study with a defined test set. The data provenance is also not explicitly stated as the document references compliance with a standard rather than a specific study.

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

This information is not provided in the document as it does not detail a specific performance study requiring expert adjudication.

4. Adjudication Method 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

No, the document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. This type of study comparing human readers with and without AI assistance is not relevant to the information provided for this device.

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

The document does not describe a standalone algorithm performance test. The Fitmate is a physical medical device designed to measure physiological parameters, not an AI algorithm.

7. The Type of Ground Truth Used

The document does not describe a specific ground truth for a test set in the context of a performance study. The "ground truth" for demonstrating the device's accuracy is implied to be its conformance to the EMC standard EN60601-1-2 for measurement accuracy and its functional equivalence to other legally marketed devices.

8. The Sample Size for the Training Set

This information is not relevant and therefore not provided in the document. The Fitmate is a device that collects physiological data directly, it is not an AI/ML algorithm that requires a training set.

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

This information is not relevant and therefore not provided in the document, as there is no training set for this device.

Ask a specific question about this device

The Express Series uses the direct measurement of oxygen uptake to objectively and noninvasively assess cardiac and pulmonary function during exercise. The system can be used to screen for early signs of cardiac and pulmonary dysfunction; differentiate heart and lung disease; assess dyspnea complaints; classify patients according to severity of disease as a guide for patient management; establish an optimal exercise prescription and training program; evaluate the efficiency of prescribed therapy.

The Express Series uses the direct measurement of oxygen uptake and carbon dioxide production to provide nutritional assessment, to optimize nutritional supplements and quantify substrate utilization.

The Express Series can also provide direct Fick determination of cardiac output using real time oxygen uptake measurements.

The Express Series is a cardiopulmonary exercise or resting metabolic measurement system with an integrated touch screen computer that provides breath by breath measurements of flow, oxygen uptake and carbon dioxide production.

The provided text is a 510(k) Special Summary for the Medgraphics Express Series, an Oxygen Uptake Computer. This type of regulatory submission typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical study results with specific acceptance criteria and performance metrics in the way a novel AI device might.

Based on the provided text, here's an analysis of the information requested. Many fields will be marked "Not Applicable" or "Not Provided" because the document is a summary for a traditional medical device (an oxygen uptake computer) and not an AI/ML device, and thus doesn't include the type of detailed study information typically found in submissions for AI products.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: 10 systems (for laboratory and clinical testing).
• Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The testing appears to be internal "Laboratory and clinical testing."

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

• Number of Experts: Not applicable/Not provided. The ground truth appears to be established by comparison to the predicate device's output, not by expert interpretation.
• Qualifications of Experts: Not applicable/Not provided.

4. Adjudication method for the test set

• Adjudication Method: Not applicable/Not provided. The study compares a new device's measurements to a predicate device's measurements, not human interpretations requiring 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

• MRMC Study: No. This is not an AI device, and the study design is not an MRMC study.

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

• Standalone Performance: Yes, in the sense that the device itself (the Express Series) was tested against the predicate device (Ultima System) in a "tandem gas exchange system validator studies." This evaluates the device's measurement capabilities directly.

7. The type of ground truth used

• Type of Ground Truth: The "ground truth" for this substantial equivalence study is the performance and data output of the predicate device, the Medgraphics Ultima System (K061731). The study aimed to show that the new device's measurements (VO2, VCO2, tidal volume) had less than 5% variability when compared to the predicate device.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable/Not provided. This is not an AI/ML device, so there isn't a "training set" in that sense. The device is a measurement system.

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

• Ground Truth for Training Set Establishment: Not applicable/Not provided.

Ask a specific question about this device

The Ultima system uses the direct measurement of oxygen uptake to objectively and noninvasively assess cardiac and pulmonary function during exercise. The system can be used to screen for early signs of cardiac and pulmonary dysfunction; differentiate heart and lung disease; assess dyspnea complaints; classify patients according to severity of disease as a guide for patient management; establish an optimal exercise prescription and training program; evaluate the efficiency of prescribed therapy.

The Ultima system uses the direct measurement of oxygen uptake and carbon dioxide production to provide nutritional assessment, to optimize nutritional supplements and quantify substrate utilization.

The Ultima system can also provide direct Fick determination of cardiac output using real time oxygen uptake measurements.

The Ultima system is a cardiopulmonary exercise system that provides breath by breath measurements of flow, oxygen uptake and carbon dioxide production.

The Medgraphics Ultima System, categorized as an Oxygen Uptake Computer, has been found substantially equivalent to its predicate device, the Medgraphics Desktop Diagnostic System with 15% CO2 Analyzer (K955432).

Here's an analysis of the acceptance criteria and the study that supports the device's performance:

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: 11 Ultima systems were used for laboratory testing.
• Data Provenance: The document does not explicitly state the country of origin. It is implied to be internal laboratory testing conducted by Medical Graphics Corporation. The study is retrospective, as it compares the new Ultima system to a previously marketed predicate device.

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

• The document does not specify the number of experts or their qualifications used to establish ground truth for the test set. The study relies on direct comparison to the predicate device's output and internal laboratory testing.

4. Adjudication Method for the Test Set:

• The document does not describe an adjudication method for the test set. The evaluation focuses on the direct comparison of performance metrics (VO2, VCO2, tidal volume) between the Ultima system and the predicate device.

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:

• A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted as this is a device for physiological measurement (Oxygen Uptake Computer), not an imaging or diagnostic AI system requiring human interpretation comparison. This device provides quantitative data, not interpretations that would be compared to human readers.

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

• Yes, the study primarily represents standalone algorithm/device performance. The laboratory testing assessed the device's output and precision independently, comparing it to a predicate device. While a human operates the device, the performance evaluation itself is based on the device's measured outputs compared to established benchmarks or the predicate.

7. The Type of Ground Truth Used:

• The ground truth in this study is based on the performance and output of the legally marketed predicate device (Medgraphics Desktop Diagnostic System with 15% CO2 Analyzer, K955432), as well as the inherent physiological measurements (VO2, VCO2, tidal volume) for which the device is designed to accurately measure. The "less than 3% variability" indicates an acceptable deviation from the predicate's established measurements.

8. The Sample Size for the Training Set:

• The document does not mention a separate "training set" in the context of machine learning or AI development. For a physiological measurement device like this, the "training" would typically refer to the calibration, design, and internal validation processes during its development, which are not detailed as a distinct "training set" here.

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

• As a "training set" is not explicitly mentioned, the method for establishing its ground truth is not provided. For a device of this nature, the "ground truth" during development and calibration would likely rely on established physiological models, controlled gas mixtures, and comparison to highly accurate reference instruments.

Ask a specific question about this device

The device is intended for use in clinical and research applications to measure oxygen uptake.

The REEVUE is an indirect calorimeter. The REEVUE device measures oxygen consumption (VO2) and estimates Resting Metabolic Rate (RMR) based on the measured VO2 using an assumed respiratory quotient (RQ=0.83). Resting metabolic rate can also be referred to as Resting Energy Expenditure (REE).

Measurement of energy requirements can be used for nutritional assessment. A typical application would be for counseling obese patients on their caloric intake requirements.

During a test the patient breathes through a mouthpiece with unidirectional breathing valves. These valves allow the patient to breath in ambient air and then direct the expiratory gas down a hose to the device. The flow rate of the expiratory gas is measured and the patient's tidal volume and respiratory rate is calculated. The expiratory gas passes through a mixing chamber so that the mixed expiratory oxygen concentration can be found. The oxygen concentration of the mixed expiratory gas is measured.

Oxygen consumption can be expressed as the volume of oxygen breathed in minus the volume of oxygen breathed out. This can be described as:

[VO2 - VI|IO2 - VE|E O2] (1)

where VO2 is the oxygen consumption, VI is the inspiratory volume, FIO2 is the inspiratory oxygen fraction, VE is the expiratory volume, and FEO2 is the expiratory oxygen fraction.

Since the REEVUE only measures the expiratory volume of gas breathed out, the inspired volume must be estimated. This is similar to other legally marketed medical devices. When measuring both CO2 and O2 this is often referred as the Haldane method.

To estimate the inspired volume, the components of the expiratory and inspiratory volumes need to be accounted for. In estimating the inspiratory volume the REEVUE requires an estimate of the Respiratory Quotient (Ro). The REEVUE uses an assumed RO of 0.83. The RO is defined as:

RQ = VCO2 / VO2 (2)

where VCO2 is the carbon dioxide eliminated by the patient's breathing.

An estimate of Resting Energy Expenditure (REE) is calculated using the Weir Equation with the assumed RO value of 0.83. Substituting for the VCO2 using the RO and the VO2 the Weir Equation can be expressed as:

Calories = { 3.941 VO2-STPD + 1.106 RQ VO2-STPD } x { 1 - 0.082 PF } (3)

Where

Calories .......... is the calories burned per liter of oxygen consumed. PF ......................is the fraction of total energy production due to protein oxidation.

Typical values for Pr range from 0.08 to 0.2, corresponding to 8 to 20% protein. We selected a default value of 0.125 for our calculations. In reporting (REE) in Kcal/day, this simplifies to:

RMRKcal/day = 6.925 x VO2-ml/min-STPD (4)

Here's a breakdown of the acceptance criteria and study details for the REEVUE Indirect Calorimeter, based on the provided 510(k) summary:

REEVUE Indirect Calorimeter: Acceptance Criteria and Study Details

1. Table of Acceptance Criteria and Reported Device Performance

Non-Clinical Performance Criteria (Nitrogen Injection Method):

Ask a specific question about this device

The MedGem is intended for use in clinical and research applications to measure oxygen uptake.

Not Found

I am sorry, but the provided text does not contain the detailed information necessary to answer your request regarding the acceptance criteria and the study that proves the device meets them. The document is an FDA 510(k) clearance letter for the MedGem device, stating its intended use and regulatory classification. It does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for a test set.
3. Information on experts used to establish ground truth.
4. Adjudication methods.
5. Results of a multi-reader multi-case (MRMC) comparative effectiveness study or any effect sizes related to AI assistance.
6. Results of a standalone algorithm performance study.
7. The type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The document primarily focuses on the regulatory clearance of the device based on substantial equivalence to a predicate device, rather than a detailed performance study report.

Ask a specific question about this device

Ask a specific question about this device