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The COSMED K5 Wearable Metabolic Technology is a device designed to measure cardio-respiratory and metabolic functions during stress testing, rehabilitation, sports medicine and other related activities, performed in professional healthcare facilities only. The system is not intended for Home Use.

The main measurements reported by the system are Oxygen Uptake production, Ventilation, Heart Rate and Energy Expenditure.

K5 is intended to use with adults and children over the age of 14 years.

It is to be used by physicians or by trained personnel on a physician responsibility.

The system and its accessories are indicated for the acquisition, analysis, formatting, display, printing and storage of certain physiologic signals. It must not be intended as a monitoring device, nor as a sole means for determining a patient's diagnosis but for the purpose of assisting the clinician in the diagnosis of cardio-pulmonary diseases

The COSMED K5 Wearable Metabolic Technology is a portable unit, designed for the measurement of resting and exercise metabolism in the laboratory, utilizing international measurement quidelines published by relevant scientific societies. The K5 consists of the following main parts:

• Main portable unit
• Optional Bluetooth receiver
• PC software
• Face mask with head cap
• Turbine flowmeter with optoelectronic reader and wind cover
• Harness
• Heart rate monitor belt
• 02 sensor
• Battery charger + batteries
• AC/DC adapter
• USB cable
• Carrying case
• Optional pressure regulator for calibration

The K5 system is intended to be used the laboratory, by either direct connection or by telemetry. The system offers both 'breath-by-breath' and 'mixing chamber' operational modes.

Here's an analysis of the acceptance criteria and study information for the COSMED K5 Wearable Metabolic Technology, based on the provided FDA 510(k) summary:

Note: The provided document is an FDA 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed clinical study report. Therefore, some of the requested information, particularly regarding specific study details like training set provenance, expert qualifications, and detailed statistical methodologies for clinical trials, is not fully elaborated in this type of document.

1. Table of Acceptance Criteria and Reported Device Performance

The document mentions "Accuracy validation (Vt, RF, VO2, VCO2)" as a non-clinical test. The table on page 7 provides specific measurement accuracies for ventilation, VO2, and VCO2, which serve as the acceptance criteria and reported performance.

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The COSMED Quark Series system is a modular system with multiple configurations, allowing the following the following the final The COSMED Quart Senes System is a modular of the max maxple only and only in the managements. The system and its accessories are indicated for the acquisition, analysis, to display, printing and The system and its accessories are molcated for the acquisition in the diagnosis of carry of cardio-purnonary disease conditions.

Quark SPIRO: Pulmonary Function testing - Age 6 to adults
Quark PFT: Pulmonary Function testing - Age 6 to adults; Cardiopulmonary Exercise testing - age 6 to adults
Quark CPET: Pulmonary Function testing - Age 6 to adults; Cardiopulmonary Exercise testing - age 6 to adults
Quark RMR: Measurement of Resting Metabolism (face mask) - age 6 to adults; Measurement of Resting Metabolism (canopy dilution) -15Kg/30Lb to adults: Measurement of Resting Metabolism (Ventilated patients) - age 10 to adults

Specific Indications for use: Quark SPIRO and Quark PFT also allows the Airways Resistance Test with the occlusion technique (Rocc test) for young patients from 3 to 6 years old.

The COSMED Quark Series system is a modular system with multiple configurations.

The provided text is related to a 510(k) premarket notification for a medical device (Cosmed S.R.L.'s Quark Series). It primarily focuses on the FDA's determination of substantial equivalence and the device's indications for use.

Crucially, the document does NOT contain information about acceptance criteria, detailed study designs, performance metrics, ground truth establishment, or sample sizes for testing or training sets.

Therefore, I cannot fulfill your request for the specific details outlined in your prompt based on the provided input.

The document discusses the regulatory classification and general requirements but does not delve into the technical validation or clinical study data that would demonstrate the device meets performance criteria.

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The COSMED Spiropalm and Spiropalm Plus pulmonary function testing system are Spirometers for performing the basic lung function tests (basic spirometry: Forced Vital Capacity, Slow Vital Capacity, Maximal Voluntary Ventilation) and Pulse Oximetry tests in the physician's office or a hospital setting.

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The provided document is a 510(k) premarket notification letter from the FDA to COSMED S.R.L. regarding their Spiropalm Series device. This letter indicates FDA's determination of substantial equivalence to predicate devices.

However, the document does NOT contain information about specific acceptance criteria for a study, the results of such a study, the sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, or details about training sets. These types of details are typically found in the 510(k) submission itself (which is not provided) and summarized in an FDA summary document or a scientific publication, rather than in the substantial equivalence determination letter.

Therefore, I cannot provide the requested information based on the given text.

The provided document does not contain the information necessary to answer the questions regarding acceptance criteria and study details.

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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.

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The COSMED Pony FX pulmonary function testing system is a standalone and modular laboratory device for performing the basic lung function tests (Basic Spirometry: Forced Vital Capacity, Slow Vital Capacity, Maximum Voluntary Ventilation) and pulse oximetry.

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This document is a 510(k) clearance letter for the COSMED Pony FX, a pulmonary function testing system. It indicates that the device is substantially equivalent to legally marketed predicate devices.

However, the provided text does not contain the information requested in your prompt regarding:

• Acceptance criteria and reported device performance (Table 1)
• Sample size and data provenance for the test set
• Number and qualifications of experts for ground truth
• Adjudication method
• MRMC comparative effectiveness study results
• Standalone algorithm performance
• Type of ground truth used
• Sample size and ground truth establishment for the training set

The document primarily focuses on the regulatory clearance process, the device's indications for use (basic lung function tests and pulse oximetry), and regulatory compliance. It does not include details about specific performance studies or the methodology used to demonstrate substantial equivalence beyond a general statement of review.

Therefore, I cannot fulfill your request for a detailed description of the acceptance criteria and study findings based on the provided text.

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The COSMED microQuark pulmonary function testing system is a modular laboratory device for performing the basic lung function tests (Basic Spirometry: Forced Vital Capacity, Slow Vital Capacity, Maximum Voluntary Ventilation).

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Here's an analysis of the provided text regarding the COSMED microQuark device:

Based on the provided FDA 510(k) summary for the COSMED microQuark device, the information required to fully answer your questions regarding acceptance criteria and study details is not present. The FDA letter primarily states that the device is substantially equivalent to a predicate device and outlines general regulatory information. The "INDICATIONS FOR USE STATEMENT"
section only describes the intended use of the device.

However, I can extract what is available and indicate what information is missing.

1. Table of Acceptance Criteria and Reported Device Performance

Explanation: The document does not contain any specific acceptance criteria for the device's performance (e.g., accuracy, precision, sensitivity, specificity, or specific tolerances for pulmonary function measurements). Consequently, there is no reported device performance against such criteria.

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

• Sample Size for Test Set: Not specified.
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective).

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

4. Adjudication method for the test set

• Adjudication Method: 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

• MRMC Study: Not applicable. The device is described as a "Pulmonary Function Data Calculator" for "performing the basic lung function tests." This suggests it's a measurement device, not an AI-assisted diagnostic tool that would involve human "readers" or an "effect size of human readers improving with AI."

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

• Standalone Study: The document does not describe the methodology of any performance studies, standalone or otherwise. The device appears to be a hardware/software system for direct measurement, rather than a purely algorithmic diagnostic tool.

7. The type of ground truth used

• Type of Ground Truth: Not specified. For a pulmonary function device, ground truth would typically be established by established reference methods or highly accurate gold-standard equipment, but this is not detailed.

8. The sample size for the training set

• Sample Size for Training Set: Not specified. (It's unclear if a "training set" in the machine learning sense is even applicable, as the device is described as a "calculator" rather than a learning algorithm).

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

• Ground Truth Establishment for Training Set: Not specified.

Summary of Missing Information:

The provided document is a boilerplate FDA 510(k) clearance letter and an "Indications for Use" statement. It confirms the device's regulatory clearance based on substantial equivalence to a predicate device but does not contain any details about the performance studies (validation, clinical, or technical) that would typically include acceptance criteria, test set sizes, ground truth methodology, or expert involvement. These details would usually be found in the 510(k) submission itself, which is a much more comprehensive document than the clearance letter.

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The COSMED Quark C12 (Quark T12 in telemetric version) is an electrocardiograph designed for cardiological stress testing, or cardiopulmonary stress testing, if used integrated with a COSMED metabolic cart (Quark b², Quark PFT ergo or K4 b²).

Not Found

This is a 510(k) premarket notification for an electrocardiograph, a device that records the electrical activity of the heart. The provided text doesn't contain information about AI/ML algorithms, performance studies with acceptance criteria, sample sizes, expert ground truth, or MRMC studies. These types of studies and details are typically associated with the evaluation of AI-powered diagnostic tools.

Therefore, I cannot provide the requested information based on the provided document. The document primarily focuses on the regulatory clearance process for a traditional medical device, confirming its substantial equivalence to a predicate device.

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The Cosmed K4 is a metabolic measurement system that allows telemetry monitoring of cardiorespiratory function during physical activities as well as in sports medicine and rehabilitation. The K4 measures, in real conditions, the O2 consumption the CO, production and the heart rate of the person being monitored.

The subject wears equipment by a harness and breathes into a face mask held on by an anatomic cap. The respiratory flow, expiratory flow, gas concentrations (02 and C02) and heart rate are measured and transmitted to the Receiver Unit. Data collected are stored for later analysis on a personal computer for which software is supplies and run in Windows Application.

The Cosmed K4 Portable Metabolic Measuring System is deemed substantially equivalent to the AeroSport Teen 100 / KB1-C Ambulatory Metabolic Measurement System. However, the provided text does not contain specific acceptance criteria for the Cosmed K4 device, nor does it detail a standalone study proving the device meets particular acceptance criteria.

The submission focuses on demonstrating substantial equivalence to a predicate device, the AeroSport KB1-C, rather than presenting a study against predefined acceptance metrics for the new device.

Here's a breakdown of the information that is available in the provided text, and what is missing based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

Not available. The document does not explicitly state acceptance criteria (e.g., specific accuracy thresholds, precision targets, or ranges for V02, VC02, VE, HR measurements) for either the Cosmed K4 or the AeroSport KB1-C.

The document states:

• "No, metabolic measurements are still accurately measured with both products. The software validation included in Attachment #6, demonstrates accuracy."
• "Performance has been verified via Quality Control testing as explained in Attachment #8."

However, the contents of Attachment #6 and Attachment #8, which would presumably contain the actual performance data and what constitutes "accuracy" and "verified performance," are not provided in this extract.

The comparison chart lists the metabolic measurements provided by both devices (V02, VC02, VE, HR), but does not give performance metrics for these measurements for either device.

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

Not available. The provided text does not describe a "test set" in the context of an accuracy or performance study with a specified sample size. It refers to "software validation" and "Quality Control testing," but no details on the participants, number of tests, or data provenance (country of origin, retrospective/prospective) are given for these activities.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not available. Since an external test set with ground truth is not described, there is no information about experts used for this purpose.

4. Adjudication Method for the Test Set

Not available. No test set or expert adjudication is described.

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

Not available. The document describes a comparison between two devices, but not an MRMC study related to human reader performance with or without AI assistance. This device measures physiological parameters, not typically something that would involve human "readers" interpreting output in the same way, for example, a radiologist reads an image.

6. Standalone Performance Study

Partially indicated, but details missing. The text mentions "The software validation included in Attachment #6, demonstrates accuracy" and "Performance has been verified via Quality Control testing as explained in Attachment #8." These suggest that some form of standalone performance evaluation was done. However, specific results, methodologies, and quantitative data are not provided in the extracted document. The conclusion states, "The Cosmed K4 Portable Metabolic Measuring System and the AeroSport Teen 100 / KB1-C Ambulatory Metabolic Measurement System are substantially equivalent as demonstrated by information and literature contained in this pre-market notification document." This implies the "performance data" was primarily to support the claim of equivalence rather than meeting independent acceptance criteria for the new device.

7. Type of Ground Truth Used (for standalone performance)

Not available directly from the text. While it can be inferred that for metabolic measurements (V02, VC02, VE, HR), the ground truth would likely involve highly accurate reference measurement systems or established physiological standards, the document does not specify how the ground truth was established for the "software validation" or "Quality Control testing" mentioned.

8. Sample Size for the Training Set

Not applicable/Not available. Since the device appears to be hardware-based with associated software for data elaboration and does not explicitly refer to "AI" or machine learning models requiring training data for a test set described here, the concept of a "training set" in this context is not directly applicable. If "software validation" involved internal model calibration, those details are not provided.

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

Not applicable/Not available. (See point 8.)

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