(47 days)
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:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set or data provenance.
- Number and qualifications of experts for ground truth.
- Adjudication method for the test set.
- Information about a multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
- Information about a standalone (algorithm only) performance study.
- The type of ground truth used (e.g., expert consensus, pathology, outcomes data).
- Sample size for the training set.
- 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.
§ 868.1890 Predictive pulmonary-function value calculator.
(a)
Identification. A predictive pulmonary-function value calculator is a device used to calculate normal pulmonary-function values based on empirical equations.(b)
Classification. Class II (performance standards).