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The SpiroPro is a portable, battery operated device and can be used by physicians in the office or hospital, in occupational medicine or by patients in the home. The SpiroPro measures inspiratory and expiratory lung function parameters in adults and children 4 years and older. In addition to the pulmonary function measurements, oxygen saturation and heart rate can be recorded.

SpiroPro® is a recording and diagnostic system for measurement, recording and assessment of the Flow-Volume curve and Flow-Volume parameters. The analyzed data can be immediately printed out or saved to the internal memory.

The portable spirometer is small, easy to handle and allows determination of inspiratory and expiratory lung volumes (VCin, FVC, FEV1, MEF50, ... ) including pre and post measurement with date and time display. An interpretation program automatically assesses the measured data. Optionally, the measurement of the oxygen saturation of the blood (SpO2) and the pulse rate are available and a 6-minute walk test can be performed. The graphic LCD and the menu-guided graphical user interface comply with the latest technological developments. Just touch the appropriate icon with your finger to enter patient data or to select menu items (touch screen). Selfexplanatory icons and the logical menu structure safely guide you through the procedure Storage capacity is high: up to 550 measurements can be saved in the internal database.

The rechargeable lithium-ion battery allows operation of the SpiroPro® for approximately two weeks. A charging unit, able to charge the battery within two hours, is included in the delivery.

Patient data, recording results and graphs can be directly printed out on a PCL-compatible printer (for example HP DeskJet series). Of course, data transfer to a PC and vice versa is possible via the serial interface and the Bluetooth interface. The optional software package "SpiroPro® for Windows®" allows automatic transfer of data which are then saved on the PC. The easy-to-exchange, high-quality pneumotach guarantees a high degree of patient safety and provides precise recording results.

Here's a breakdown of the acceptance criteria and study information based on the provided text for device K092324 (SpiroPro):

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly present a defined set of "acceptance criteria" for the SpiroPro. Instead, it focuses on demonstrating substantial equivalence to a predicate device (SpiroPro SpO2, K031515) through a comparison of technological characteristics and adherence to relevant standards.

The primary performance "criteria" are implied to be compliance with ATS standards for spirometry measurements and successful biocompatibility testing for new materials.

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

The document does not specify a separate "test set" in the context of clinical data for performance evaluation. The primary evaluation method is a comparison to a predicate device and adherence to technical standards. There is no mention of a specific sample size for a test set of patient data, nor is there information on data provenance (country of origin, retrospective/prospective).

The "testing" referenced is primarily technical verification and validation of changes (e.g., biocompatibility testing of materials, disinfection validation, EMC testing, and functional testing of the Bluetooth module).

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

This information is not provided in the document. Given the nature of the submission (device modification for substantial equivalence based on technical changes and existing standards), there is no indication of a requirement for a ground truth established by experts in the context of clinical performance data.

4. Adjudication Method for the Test Set:

This information is not applicable/not provided. There is no mention of a clinical "test set" and thus no adjudication method for it.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance:

An MRMC study was not done. This device is a spirometer and oximeter, not an AI-assisted diagnostic tool for image interpretation or similar applications where MRMC studies are typically employed. There is no AI component mentioned that would assist human readers.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done:

Only parts of the device's performance are "standalone" in the sense that they are technical measurements or functions. For example, the spirometry measurements themselves (lung function parameters like FEV1, FVC) are generated by the device's algorithms based on sensor input. However, the device is intended for use by or with oversight from medical professionals (physicians in office/hospital, occupational medicine, or patients in the home under guidance). The document does not report on a standalone performance study in a clinical context separate from human-in-the-loop usage.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

For the core spirometry measurements, the "ground truth" is inherently defined by physical measurement standards and the ATS (American Thoracic Society) criteria. The device's accuracy for these measurements is presumably validated against calibrated instruments and the performance of the predicate device (SpiroPro SpO2, K031515), which was already cleared. For the new material and reusable pneumotach, the ground truth is established by biocompatibility testing standards (ISO 10993-1) and efficacy of FDA-approved disinfectants.

8. The Sample Size for the Training Set:

The document does not mention a training set. This type of submission (modification to an existing device, focusing on substantial equivalence for technical changes) generally does not involve machine learning or AI models that require training sets in the typical sense.

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

This information is not applicable/not provided as no training set is discussed.

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The PMP4 Spiro Pro is intended for pulmonary function testing for use in hospital, clinic or home settings. It allows patients to display and transmit their pulmonary function data via a communication device to medical professionals in a remote server.

PMP4 Spiro Pro is a portable spirometer designed to accurately measure lung ventilatory functions during the Forced Vital Capacity (FVC) tests. The system records the following: Volume-Time and Flow-Volume curves, FVC, Forced Expiratory Volume: FEV1, FEV3, Peak Expiration Flow (PEF), Forced Expiratory Flow: FEF75%, FEF50%, FEF25%, FEF25/75. PMP4 Spiro Pro operates in two modes: PDA and Stand-alone. In the PDA mode the test data is transmitted through a Bluetooth or infrared link to a PDA. In this mode all necessary calculations are performed by the PDA's software. In the stand-alone mode the Spiro Pro calculates all parameters and displays the results on its LCD. In conjunction with the pulmonary receiving station PMP4 Spiro Pro provides an important tool for monitoring COPD patients.

The provided text describes the PMP4 Spiro Pro, a portable spirometer. However, it does not contain details about a specific study or acceptance criteria with reported device performance metrics. The document is a 510(k) summary for premarket notification to the FDA, focusing on substantial equivalence to predicate devices and adherence to standards.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about a study that proves the device meets these criteria as the information is not present in the provided text.

Here's what I can extract based on the information given, and indicate what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria: Not explicitly stated in the document with quantitative thresholds for performance. The document generally states that the device "meets the requirements of the following Standards, Regulations and Guidances" and that "performance tests according to the Thoracic society standardization were performed and assured the safety and efficacy of the device."
• Reported Device Performance: Not provided in the document.

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). The document mentions "laboratory testing," but no specifics about the data used for performance claims.

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. This device is a spirometer for measuring lung function, not an AI-assisted diagnostic tool that would typically involve human "readers" or AI improvement.
• Effect Size of AI Improvement: Not applicable.

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

• The PMP4 Spiro Pro operates in two modes:
  • Stand-alone mode: "the Spiro Pro calculates all parameters and displays the results on its LCD." This indicates standalone performance of the device's inherent algorithms for calculating spirometry parameters.
  • PDA mode: "In this mode all necessary calculations are performed by the PDA's software." This also reflects an algorithmic standalone calculation, albeit on an external device.
• However, the document does not provide performance metrics specifically from these standalone calculations, only that they occur. It states "performance tests according to the Thoracic society standardization were performed," which implies a standalone evaluation of the device's accuracy in measuring various respiratory parameters.

7. The type of ground truth used

• The document states "performance tests according to the Thoracic society standardization were performed." The American Thoracic Society (ATS) guidelines for spirometry typically define the gold standard for measurements using calibrated volume-time sources (e.g., syringes) and/or clinically validated reference spirometers.
• Therefore, the implied ground truth would be measurements from a calibrated reference standard or another highly accurate spirometer adhering to ATS guidelines.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable / Not specified. This device describes a spirometer for direct measurement, not an AI/ML algorithm that typically requires a large training set of data.

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

• Ground Truth for Training Set Establishment: Not applicable / Not specified. As above, this device does not appear to employ AI/ML in a way that would necessitate a "training set" in the conventional sense for a prediction model. Its function is based on direct physical measurement and calculation.

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The SpiroPro SpO2 is a portable, battery operated device and can be used by physicians in the office or hospital, in occupational medicine or by patients in the home. The SpiroPro SpO2 measures inspiratory and expiratory lung function parameters in adults and children 4 years and older. In addition to the pulmonary function measurements, oxygen saturation and heart rate can be recorded.

The pocket spirometer SpiroPro® SpO2 is a portable, electronic measuring device for the determination of expiratory and inspiratory parameters (Vcin, FVC, FEV1, MEF50 etc.) including Pre/Post testing, date and time stamps as well as the complete registration of spirogram and flowvolume curves by a very precise pressure transducer (pneumotachograph). The built-in interpretation module enables an easy quality check and an automatic selection of the best measuring result. The unique SpO2 option completes the range of functions of the versatile spirometer. SpO--spot and trend measurements can be performed also oxygen saturation and heart rate can be recorded over a period of 60 minutes. Equipped with a graphical LCD display, an innovative touch-screen technology and a user-friendly graphical user interface, the SpiroPro® SpO2 provides the latest developments in technology. The input of patient data and the selection of the menu functions is realised by just touching the corresponding icon with your finger tips. The SpiroPro® SpO2 can store up to 600 measurements in its non-volatile memory. If required also versions with higher capacity are available. The rechargeable battery allows an operation time of approximately 2 weeks. A charger that recharges the battery within 2 hours is supplied with the unit. With the built-in communication module a direct printout of results and graphs to a PCL-compatible printer is possible. Of course, data transmission to and from a PC by a serial port is an integral part of the innovative concept. The optional software package "SpiroPro® SpO2 for Windows" receives the data all-automatically and stores them on the PC. The unit can work stand alone or in combination with a PC for measurements with real-time display, questionnaire functionality, data analysis and long term storage. Combining the two diagnostic devices into one device is very cost effective for the user. A pulmonary function calculator and a pulse oximeter are two devices that a physician will use on a regular basis for patient care. The handy, modular design allows the use of the SpiroPro® SpO2 in many fields of primary care.

The provided text is a 510(k) summary for the SpiroPro® SpO2 device. It describes the device, its intended use, and compares it to predicate devices. However, this document does not contain any information about acceptance criteria or a study proving that the device meets such criteria.

The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a performance study with detailed acceptance criteria. Performance data related to the accuracy of the spirometry and pulse oximetry functions would typically be found in engineering or validation reports, which are usually not included in the public-facing 510(k) summary.

Therefore, I cannot fulfill your request for the tables and details about the study because the necessary information is not present in the provided document.

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