(30 days)
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.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compliance with ATS (American Thoracic Society) spirometry standards | Device can apply ATS 1994 and ATS-ERS 2005 criteria for evaluation of measurements. |
| Biocompatibility of new mouthpiece material (Bormed GR 835 MO) | Biocompatibility test according to ISO 10993-1 was successful. |
| Efficacy of disinfection for reusable pneumotach | Validated for disinfection with an FDA approved disinfectant ("Cidex OPA Solution" with 510(k) K030004). |
| Safety requirements and mitigation of identified hazards | Safety test procedures demonstrate satisfaction of all safety requirements and mitigation of all identified hazards. |
| Compliance with Electromagnetic Compatibility (EMC) standards | EMC testing performed according to EN 60601-1-2. |
| Functional equivalence of Bluetooth data transmission | Bluetooth module (Mitsumi WML-C46) is identical to a previously cleared device (AM1+ / AM1+ BT, K090486). |
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.
§ 870.2700 Oximeter.
(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).