(146 days)
The Vitalograph Model 2120 In2itive eDiary device is a battery-operated spirometer which measures three basic patient respiratory parameters (FVC, MVV and VC). The Vitalograph Model 2120 In2itive eDiary is a handheld spirometer designed for lung function testing in a variety of environments such as hospital wards, health centres and private homes. It is intended for Adults and pediatrics, 5 years and older.
The Vitalograph Model 2120 In2itive eDiary can be configured as a stand-alone spirometer or connected to a printer.
The Vitalograph Model 2120 In2itive eDiary is a hand-held, battery-operated spirometer which measures the following lung function parameters FVC, MVV and VC in hospital, clinical and home settings.
It can be configured as a standalone spirometer or connected to a printer. Its primary functions and technology are:
- . Spirometry measurements using single breath and multiple-breath testing techniques, the
- display and recording of measured lung volumes and flow rates (including FVC, VC, ● MVV) and other parameters which are subsets of these measured parameters.
- . Record subject data. Storage of data and test results on unit for later printing or export to Spirotrac software
- The Flowhead utilizes a Fleisch Pneumotachograph.
- User Interface navigation via five buttons (Up, Down, Enter/Select, Cancel/Esc and . Power On/Off) or an optional touch screen.
The Vitalograph Model 2120 In2itive eDiary is a diagnostic spirometer. The device's acceptance criteria and the study proving it meets these criteria are outlined below.
1. Acceptance Criteria and Reported Device Performance:
The acceptance criteria are established by various international standards for spirometry and medical device safety. The reported device performance is compared to these standards and the predicate device (Vitalograph Model 2120).
| Feature | Acceptance Criteria (Predicate / Standard) | Reported Device Performance (Subject Device) | Outcome |
|---|---|---|---|
| Indications for Use | Measures FVC, MVV, VC for adults and pediatrics (5+ years) in various environments (hospital, health centers, private homes). Stand-alone or connected to printer. | Measures FVC, MVV, VC for adults and pediatrics (5+ years) in various environments (hospital, health centers, private homes). Stand-alone or connected to printer. | Identical |
| Fundamental Technology | Fleisch Pneumotachograph type Flowhead connected to transducer, with signal-processing circuitry. | Fleisch Pneumotachograph type Flowhead connected to transducer, with signal-processing circuitry. | Same |
| Parameters Measured | FVC, MVV, VC | FVC, MVV, VC | Same |
| Hand-held | Yes | Yes | Same |
| Patient Interface | Flowhead cone | Flowhead cone | Same |
| Cleaning | Unit surface cleaning and 70% alcohol | Unit surface cleaning and 70% alcohol | Same |
| Patient Use | Single Patient, multi-use | Single Patient, multi-use (implied, as cleaning is for multi-use) | Same |
| Back pressure | Less than 0.1kPa/L/second @ 14L/s | Less than 0.1kPa/L/second @ 14L/s | Identical |
| Volume detection | Flow integration sampling @ 100Hz | Flow integration sampling @ 100Hz | Identical |
| Maximum displayed volume | 10L | 10L | Identical |
| Volume accuracy | +3% or 0.05L (ATS/ERS, ISO 23747, ISO 26782 standards) | Yes (met standard) | Identical |
| Min. Volume | 0.01L | 0.01L | Identical |
| Flow Accuracy | Flow ±10% or 0.3 L/s, Max. flow rate ±16 L/s, Min. flow rate ±0.02 L/s (ATS/ERS, ISO 23747, ISO 26782 standards) | Flow ±10% or 0.3 L/s, Max. flow rate ±16 L/s, Min. flow rate ±0.02 L/s | Identical |
| Linearity | Better than ±3% | Better than ±3% | Identical |
| Operating temperature | 10-40°C | 10-40°C | Identical |
| Performance standards | ATS/ERS (2005), ISO 23747, ISO 26782 | ATS/ERS (2005), ISO 23747, ISO 26782 | Identical |
| Electrical Safety & EMC | ES 60601-1, IEC 60601-1-2 | ES 60601-1, IEC 60601-1-2, IEC 60601-1-11 (for home use) | Similar (Added new standard for home use) |
| Storage Temperature | 0-50°C | 0-50°C | Identical |
| Storage Relative Humidity | 10%-95% | 10%-95% | Identical |
| Communications | USB x 1 for connection to Spirotrac | USB x 1 for connection to Spirotrac | Identical |
| Biocompatibility | Surface Contact, Skin / Mucosa, Limited Duration (predicate's materials) | Surface Contact, Skin / Mucosa, Limited Duration (new material tested to ISO 10993-1, 5, 10, found non-cytotoxic, non-irritating, non-sensitizing) | Identical patient contact, new material tested. |
| Software Level of Concern | - | Moderate | N/A |
2. Sample size used for the test set and the data provenance:
The document does not explicitly state a 'sample size' in terms of patient data for the performance testing of the spirometer itself. The performance testing was primarily bench testing against established standards.
The provenance is implied to be laboratory/bench testing data, not patient data in the context of clinical trials. There is no mention of country of origin for any data or whether it was retrospective or prospective, as it appears to be primarily device performance verification against standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. The ground truth for this device's performance is established by international technical standards (e.g., ATS/ERS, ISO 23747, ISO 26782) for spirometry, and electrical safety standards (e.g., IEC 60601 series). These are objective measurements performed on the device.
4. Adjudication method for the test set:
Not applicable. The performance testing involves objective measurements against predefined technical standards, not subjective interpretations requiring expert adjudication.
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:
Not applicable. This device is a diagnostic spirometer, not an AI-assisted diagnostic imaging or interpretation tool that would involve "human readers" or AI assistance in that context. The device directly measures respiratory parameters.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The performance evaluation described is for the device as a standalone measuring instrument. This is implicitly how the "Bench Testing" for performance (peak flow, timed forced expired volume) was conducted against ISO standards. The product is a diagnostic spirometer that provides direct measurements, so its standalone performance is its primary function.
7. The type of ground truth used:
The ground truth used for performance validation is based on established international technical standards for spirometry (e.g., ATS/ERS, ISO 23747, ISO 26782) for parameters like volume accuracy, flow accuracy, and linearity, and electrical safety and EMC standards (e.g., IEC 60601 series). For biocompatibility, the ground truth is defined by ISO 10993 standards.
8. The sample size for the training set:
Not applicable. This device does not use machine learning or AI that would require a "training set" in the traditional sense. Its core functionality relies on physical measurement principles (Fleisch Pneumotachograph) and established algorithms for calculating spirometry parameters.
9. How the ground truth for the training set was established:
Not applicable, as no training set for machine learning was used.
§ 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).