(219 days)
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.
| Acceptance Criteria Category | Acceptance Criteria (Not explicitly stated as criteria, but implied by the submission) | Reported Device Performance (as stated in the document) |
|---|---|---|
| Software Functionality | Device performs all functions of the predicate device (Impulse oscillometry, Spirometry, Flow/Volume, MVV) with 32-bit software. | "The JLAB Software changes from 16 bit version to 32 bit version." |
| "Performance specification (measurement programs) identical" | ||
| Intended Use | Device maintains the same intended use as the predicate device. | "Indications for Use identical" |
| Patient Population | Device is suitable for the same patient population as the predicate device. | "Patient population identical" |
| Safety and Effectiveness | Device is safe and effective for its intended use, and performs at least as well as the predicate device. | "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." |
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.
§ 868.1840 Diagnostic spirometer.
(a)
Identification. A diagnostic spirometer is a device used in pulmonary function testing to measure the volume of gas moving in or out of a patient's lungs.(b)
Classification. Class II (performance standards).