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The MasterScreen IOS is intended to be used for measurement and data collection of lung function parameters in humans. The system performs cooperation-dependent pulmonary function tests which include Spirometry/Flow-Volume/Resistance measurements and the IOS (multifrequent oscillometry determination) measurement. Tests can be easily and quickly conducted on the basis of Impulse Oscillometry. The device is useful in the field of early diagnosis in every-day-routine, for clinical trend observations as well as for epidemiologic studies. As only a minimum of patient cooperation is required, Impulse Oscillometry is also suitable for pediatric and geriatric studies.

Measurements will be performed under the direction of a physician in the clinic, doctor's office or hospital.

The MasterScreen IOS is powered from 100-240 V / 50-60 Hz wall outlets. No energy is transferred to the patient.

MasterScreen IOS is a diagnostically medical device for lung function testing for the early detection of pathological changes and their onset in the small airways and provides the following advantages:
. Quick and low-cost noninvasive determination of Respiratory Impedance with low technical expenditure
Differentiation between proximal (central airways) and distal (peripheral . airways) pulmonary components
. Sensitive detection and differentiation of extrathoracic changes in the respiratory system
Save method for differentiation between trapped air or respiratory collapse . and obstruction
Recorded parameters provide valuable information for early diagnosis of . pulmonary diseases
Graphic interpretation of the results on the basis of a simple lung-thorax . model
Airway impedance via complete VC-maneuver allows to answer further clinical questions
. Differentiated determination of bronchial hyper reactivity of both provocation and spasmolysis independent of cooperation.
Determination of static (VCin, VCex, ... ) and dynamic (FVC, FEV1, FEF50, . ...) lung volumes by the proven Spirometry/Flow-Volume program.

Measurements:
. Impulse oscillometry
. Spirometry
. Flow / Volume
Maximal Voluntary Ventilation (MVV) .

This document (CareFusion Germany 234 GmbH 510(k) Summary for MasterScreen IOS) is a 510(k) submission for a device modification, specifically an upgrade of the software from a 16-bit to a 32-bit version. The document primarily focuses on establishing substantial equivalence to a legally marketed predicate device (MasterScreen IOS K954140/A001) rather than presenting a performance study against specific acceptance criteria for a new device.

Therefore, many of the requested criteria for describing an acceptance study are not applicable or not explicitly detailed in this type of submission for a software upgrade.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a table of acceptance criteria with corresponding performance metrics for the modified device. The core of this submission is to demonstrate that the new 32-bit software version performs identically to the predicate device, not that it meets new or updated performance specifications. The "Performance specification (measurement programs)" row in the summary table (Section 5.14) states "identical" for the modified device compared to the predicate, implying no change in fundamental performance.

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

• Sample size: Not specified. The submission does not detail a formal clinical or performance test study with a defined sample size for the modified device.
• Data provenance: Not applicable. There is no mention of country of origin or whether the data was retrospective or prospective, as no such performance data is presented. The submission focuses on internal development and risk analysis.

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

• Not applicable. There is no mention of experts or ground truth establishment for a test set. This type of submission relies on technical verification and validation of software changes against the predicate's established performance, rather than re-establishing clinical ground truth.

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

• Not applicable. No adjudication method is described as there isn't a performance test set requiring expert review.

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 device (a diagnostic spirometer with software for lung function testing) is not an AI-assisted diagnostic tool that would typically involve human readers or MRMC studies. Its function is to measure physiological parameters directly.

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

• The document implies that the device operates as a standalone system (algorithm only) in terms of its core measurement functions. However, the software itself is not the subject of a standalone performance study in the sense of demonstrating a new algorithm's diagnostic accuracy. The submission asserts the identical performance of the updated software version compared to the predicate. The "algorithm" here (the 32-bit JLAB software) is stated to perform the same measurement programs as the 16-bit version.

7. The type of ground truth used:

• Not explicitly stated. For a software upgrade of an existing device, the "ground truth" implicitly refers to the verified and validated performance of the predicate device (MasterScreen IOS K954140/A001) as understood by relevant standards and clinical expectations for spirometry and oscillometry. The submission aims to show that the new software does not alter this established performance.

8. The sample size for the training set:

• Not applicable. This is a software upgrade for a diagnostic measurement device, not a machine learning or AI model that requires a training set.

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

• Not applicable, as there is no training set mentioned or implied.

Summary of the Study (as described in the 510(k) Summary):

The "study" described in the 510(k) is not a conventional clinical or performance study. Instead, it is a verification and validation process for a software modification.

• Objective: To demonstrate that the MasterScreen IOS with the new 32-bit JLAB software is substantially equivalent to the predicate device (MasterScreen IOS K954140/A001) and performs at least as well.
• Methodology:
  • Development of the modification according to Cardinal Health's standard operating procedures (Design Control).
  • Software development following IEC 62304 (Software life-cycle processes) and IEC 60601-1-6 (Usability) standards.
  • Risk analysis using Failure Modes and Effects Analysis (FMEA) to assess the impact of the 32-bit software.
• Results (Conclusion): "Based on the above, CareFusion Germany 234 GmbH concludes that the MasterScreen IOS with the 32 bit JLAB software is substantially equivalent to legally marketed predicate device and is safe and effective for its intended use, and performs at least as well as the predicate device."

In essence, the submission relies on demonstrating that changing the software from 16-bit to 32-bit, while maintaining identical indications for use, patient population, hardware, performance specifications (measurement programs), energy type, patient contacting parts, sterilization methods, and fundamental scientific technology, does not adversely affect the device's safety or effectiveness compared to the predicate. The "study" is the internal design control, software development, and risk analysis documented to support this claim.

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The MasterScreen Paed - Baby Body is a lung function measurement system for paediatric use. It is intended to be used under the direction of a physician. The MasterScreen Paed - Baby Body may be used in the clinic, doctor's office, or hospital. Patient populations that may benefit from the use of this device include newborns (neonate), infants, children and adolescent.

The lung function measurements including RTC and RV-RTC can be performed in term neonates (weight 3kg) up to toddlers (weight 13kg). The digital adult pneumotach with shutter feature is for use with children and adolescent from 4 up to 21 years. The device is AC powered from 115V-240V / 50-60Hz wall outlet.

MasterScreen Paed - Baby Body is a pediatrics device providing following characteristics:

• Mains operation .
• Trolley for device and Baby Body box .
• Personal Computer System .
• Graphic user interface Windows XP Professional .
• Powerful database for storing patient- and test data .
• Tidal Breathing Analysis .
• Baby-Body Plethysmography .
• Baby Resistance / Compliance .
• Rapid Thoracic Compression (RTC) .
• Raised Volume Rapid Thoracic Compression (RV-RTC) .
• Spirometry / Flow Volume / MVV for children and adolescents ◆
• Airway Resistance (R Occlusion) for children and adolescents .
• P.01 / PImax / PEmax for children and adolescents .

The provided 510(k) summary for the MasterScreen Paed - Baby Body (K081823) does not describe a clinical study comparing the device's performance against specific acceptance criteria. Instead, it focuses on demonstrating substantial equivalence to predicate devices through a comparison of intended use, patient population, performance (measurements), software, device specifications, and accessories.

The summary highlights that the new options for the device were developed in accordance with VIASYS's standard operating procedures (Design Control), and that risk analysis (FMEA), safety test procedures, software development (IEC 601-1-4), and EMC testing (EN 60601-2) were performed. However, these are general compliance and engineering validation activities, not a detailed clinical study with performance metrics and acceptance criteria as typically found in a comparative effectiveness or standalone performance study for an AI/CADx device.

Therefore, the specific information requested in the prompt regarding acceptance criteria, study design, sample sizes, ground truth establishment, expert qualifications, and MRMC studies cannot be extracted from this document as such a study is not described.

The comparison tables provided in the document indicate that the new features offer "Identical" performance to the predicate devices in terms of specific measurement capabilities, but they do not define numerical acceptance criteria or present data from a study to prove these criteria were met.

In summary, the 510(k) relies on demonstrating equivalency to existing, legally marketed devices and adherence to relevant standards for design, safety, software, and EMC, rather than presenting a novel clinical study with explicit acceptance criteria for device performance.

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The Masterscreen PFT Body is intended to be used for measurement and data collection of lung function parameters. The system performs cooperation-dependent pulmonary function tests which include Spirometry/Flow-Volume/Resistance measurements, lung diffusion measurements and bodyplethysmography measurement. The device provides data / information and supports help for a diagnosis.

MasterScreen PFT (Clinical Trial version) includes Spirometry/Flow-Volume/Resistance measurements and lung diffusion measurements with individual access rights defined for different user roles (e.g. Investigator, doctor, study nurse, trainer and service personnel).

MasterScreen PFT includes Spirometry/Flow-Volume/Resistance and lung diffusion measurements.

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I am sorry, but the provided text does not contain information about acceptance criteria, device performance, or any study details. It is a 510(k) premarket notification letter from the FDA to VIASYS Healthcare GmbH concerning their MasterScreen PFT devices. The letter primarily states that the device is substantially equivalent to legally marketed predicate devices and outlines regulatory compliance requirements.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on this input.

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The Viasys MASTERSCREEN CPX stationary pulmonary function test system is a device which monitors the cardio-respiratory functions during stress testing, rehabilitation, sports medicine and other related activities. The MASTERSCREEN CPX system allows the monitoring of metabolic parameters. The MASTERSCREEN CPX system is intended to use with adults and children over the age of 14 years.

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This document is a letter from the FDA to Viasys Healthcare GmbH regarding the clearance of their device, the MasterScreen CPX. It primarily focuses on the regulatory clearance process and does not contain detailed information about acceptance criteria or specific study results showing device performance.

Therefore, I cannot extract the requested information from the provided text. The document confirms the device's substantial equivalence to a predicate device but does not include the technical performance study details that would typically define acceptance criteria and prove their fulfillment.

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The Masterscreen Pneumo / Masterscope is intended to be used for measurement and data collection of lung function parameters. The system performs cooperation-dependent flowvolume measurements. Mostly it will be used for COPD and Asthma patients.
Measurements will be performed under the direction of a physician in the clinic, doctor's office or hospital. It can be utilized for patients from 4 years on and older as long as they can cooperate in the performance.
The Masterscreen Pneumo / Masterscope is powered from 100-240V / 50-60Hz wall outlets. No energy is transferred to the patient.

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This document is an FDA 510(k) clearance letter for the Maserscreen Pneumo / Masterscope device. It does not contain the detailed technical information required to answer your questions about acceptance criteria or study results. Specifically, the letter:

• Identifies the device: Maserscreen Pneumo / Masterscope.
• States its purpose: Measurement and data collection of lung function parameters, performing cooperation-dependent flow-volume measurements.
• Provides indications for use: For COPD and Asthma patients, from 4 years old and older who can cooperate, under the direction of a physician.
• Declares substantial equivalence to a predicate device, which is the basis for its clearance.

The document does NOT include any of the following information you requested:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set or data provenance.
3. Number and qualifications of experts for ground truth.
4. Adjudication method for the test set.
5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
6. Information about a standalone (algorithm only) performance study.
7. The type of ground truth used (e.g., expert consensus, pathology, outcomes data).
8. Sample size for the training set.
9. How the ground truth for the training set was established.

To obtain this information, you would typically need to refer to the 510(k) submission document itself, which is often much more extensive than just the clearance letter. The clearance letter only announces the FDA's decision based on that submission.

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The Viasys Masterscreen CPX stationary pulmonary function test system is a device which monitors the cardio-respiratory functions during stress testing, rehabilitation, sports medicine and other related activities. The Masterscreen CPX system allows the monitoring of metabolic parameters. The Masterscreen CPX system is intended to use with adults and children over the age of 14 years.

The Viasys Masterscreen CPX stationary pulmonary function test system is a device which monitors the cardio-respiratory functions during stress testing, rehabilitation, sports medicine and other related activities. The Masterscreen CPX system allows the monitoring of metabolic parameters.

This document is a 510(k) clearance letter for the Masterscreen CPX and Oxycon CPX pulmonary function data calculators. It does not contain the detailed information necessary to answer your request about acceptance criteria and a study proving the device meets them.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."

This means the FDA found the device "substantially equivalent" to existing devices already on the market, not that a specific study was performed to meet novel acceptance criteria for this particular device. The 510(k) process primarily relies on demonstrating equivalence to predicates, not necessarily on a new full-scale efficacy study with detailed acceptance criteria as you might find for a PMA (Premarket Approval) device, or a de novo classification.

Therefore, I cannot provide the requested information from this document. It does not contain:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes, data provenance, number of experts, qualifications of experts, or adjudication methods for a test set.
3. Information on MRMC comparative effectiveness studies or standalone algorithm performance.
4. Details on the type of ground truth used or sample sizes/methods for establishing ground truth for a training set.

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