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The NPB-500 Spirometry System's intended use is simple diagnostic forced vital capacity (FVC) testing for adults of all ages plus pediatric patients, in the patient examination rooms of a physician's practice and in hospital-type facilities such as respiratory care centers. The NPB 500 Spirometry System is for prescription use only.

The NPB-500 Spirometry System comprises the following five components, including accessories: NPB-500 Spirometer (hand held), Flow Sensor II, Pressure Tubing, NPB-510 Spirometer Base (optional) and Printer/PC Cable (optional). Two versions of the cable are available, namely, a parallel cable for a Printer and a serial cable for a PC. The NPB-500 is a hand held diagnostic Spirometer intended for patient use in the performance of Forced Vital Capacity, FVC, testing. The patient performing a test is requested to take a deep breath and then exhale vigorously and continuously into the sensor's mouthpiece until complete exhalation is achieved. Initially, the testing process requires patient cooperation and supervisory coaching to achieve optimum results. FVC parameter test results may be displayed on the Spirometer's front face LCD display. Alternatively, the Spirometer can be inserted into the optional Spirometer Base, enabling data to be interfaced, via an output data port, to a parallel printer for graphical printout of the patient's test record, or to a PC. In addition to the above mentioned device features, the instrument has been designed to satisfy the needs of both the user and the patient. An audible, mid frequency, beep tone is provided to prompt the User for input, inform the User of the successful completion of a process step or warn of low battery condition. The NPB-500 System is powered by two AA size standard alkaline batteries which can provide an estimated operating time of six months under normal use.

The provided text does not contain detailed information about specific acceptance criteria for the NPB-500 Spirometry System, nor does it describe a detailed study proving the device meets those criteria with specific performance metrics.

However, based on the general information provided, here's what can be extracted and inferred:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not directly available in the provided text. The document primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting a performance study with explicit acceptance criteria and corresponding results for the NPB-500.

However, it states: "Safety and environmental testing to accepted industry standards has been conducted as well as in-vitro testing to confirm the accuracy of the NPB-500 Spirometry System." This implies that some form of accuracy testing was performed.

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

This information is not provided in the text. The document mentions "in-vitro testing," which generally refers to testing in a controlled environment, often on simulated biological materials or using calibrated equipment. It does not mention patient data.

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

This information is not provided. Since the document mentions "in-vitro testing," it's unlikely that human experts were used to establish ground truth in the traditional sense of clinical studies.

4. Adjudication Method for the Test Set

This information is not provided. As no clinical test set with human assessments is described, an adjudication method would not be applicable within the scope of the provided text.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, the provided text does not mention an MRMC comparative effectiveness study. The document primarily focuses on demonstrating substantial equivalence by comparing product features and in-vitro testing.

6. If a Standalone Performance Study was done

Yes, a standalone performance study in the form of "in-vitro testing" was performed. The text states: "...as well as in-vitro testing to confirm the accuracy of the NPB-500 Spirometry System." However, the details of this testing (e.g., methodology, specific measurements, acceptance thresholds, and actual results) are not provided.

7. The Type of Ground Truth Used

Based on "in-vitro testing," the ground truth would likely be established by:

• Calibrated reference standards: Using precisely known flow and volume measurements from calibrated spirometry testing equipment.
• Simulated breath profiles: Generating known breath patterns to test the device's accuracy in measuring FVC parameters.

8. The Sample Size for the Training Set

This information is not explicitly provided. The document mentions: "The embedded software contains substantially the same software algorithm for determining test values of FVC parameters as used on the predicate device, the NPB-Renaissance, cleared under K944762, except for the inclusion of non-linear correction terms in the pressure/flow equation of the sensor." This suggests that the algorithm was likely developed and refined using data, but the size and nature of this "training set" (if applicable in the modern sense of machine learning) are not specified.

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

This information is not explicitly provided. Given the nature of spirometry algorithms, the ground truth for training (or development/calibration) would typically involve:

• Highly accurate reference spirometry systems: Gold-standard devices providing precise flow and volume measurements.
• Known physical models: Data generated from mechanical lung simulators with controlled parameters.
• Clinical data with expert review: Though less likely for pure algorithm training in this context, it could involve data where respiratory physiologists or similar experts confirm the accuracy of reference measurements.

In summary, the provided document does not offer the detailed breakdown of acceptance criteria and performance study results as requested, but rather focuses on substantial equivalence based on device features and general "in-vitro accuracy testing."

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