(155 days)
The Model 9160 VitaloQUB is a whole-body plethysmograph device, when used with the Vitalograph Model 9100, is designed for lung function testing on adults and pediatrics, 6 years and older, by trained medical healthcare professionals in a variety of professional healthcare environments e.g., primary care, hospitals, and pharmaceutical research centers.
The proposed Model 9160 VitaloQUB incorporates the cleared Model 9100 (K221030) with integrated LCD display and ComPAS2 software (K213872).
The ComPAS2 software controls valves and reads unprocessed data from the sensors in the Model 9100 and from Model 9160. The ComPAS2 software then determines respiratory parameters including the 2 new parameters.
The ComPAS2 software is unchanged from K213872. The Model 9160 and Model 9100 firmware does not determine any respiratory parameters.
The Model 9160 is adding 2 additional parameters:
- TVG – Thoracic Gas Volume
- Raw Airway resistance
The provided text describes the regulatory clearance for the VitaloQUB Model 9160, a whole-body plethysmograph device. However, it does not contain specific details on the acceptance criteria or a dedicated study report that demonstrates the device explicitly meets numerical acceptance criteria. The text focuses on establishing substantial equivalence to predicate devices.
Here's an analysis based on the information available and what is missing:
The submission states that "Performance testing demonstrated that the subject device met its acceptance criteria," and then lists the types of testing performed. However, it does not provide the specific numerical acceptance criteria or the reported device performance for these criteria.
1. Table of acceptance criteria and the reported device performance:
| Parameter/Test Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Thoracic Gas Volume (VTG) | Not explicitly stated in the provided text | Not explicitly stated in the provided text |
| Airway Resistance (Raw) | Not explicitly stated in the provided text | Not explicitly stated in the provided text |
| FVC, SVC, MVV, CPF, RMS, SNIP, DLCO, MBN2, SBN2 | Not explicitly stated as specific acceptance criteria for the new device, but implied to meet predicate performance | Not explicitly stated as specific performance for the new device, but implied to meet predicate performance |
| Flow accuracy | ± 2 % over range of -14 to + 14 L/s | Subject Device: ± 2 % over range of - 14 to + 14 L/s (Stated in comparison table, implying performance matches requirement) |
| Volume accuracy | ± 2.5 % or 0.050 L | Subject Device: ± 2.5 % or 0.050 L (Stated in comparison table, implying performance matches requirement) |
| CO Sensor Accuracy | ±1 % of full scale | Subject Device: ±1 % of full scale (Stated in comparison table, implying performance matches requirement) |
| CO2 (NDIR) Sensor Accuracy | ±2.5 % of full scale | Subject Device: ±2.5 % of full scale (Stated in comparison table, implying performance matches requirement) |
| CH4 Sensor Accuracy | ±2.5% of full scale | Subject Device: ±2.5% of full scale (Stated in comparison table, implying performance matches requirement) |
| O2 Sensor Accuracy | ±0.2% of Full Scale | Subject Device: ±0.2% of Full Scale (Stated in comparison table, implying performance matches requirement) |
| CO2 (N2 washout) Sensor Accuracy | ±0.1% of Full Scale | Subject Device: ±0.1% of Full Scale (Stated in comparison table, implying performance matches requirement) |
| Compliance with Performance Standards | ISO 23747:2015, ISO 26782:2009, ATS/ERS: 2002, 2005, 2013, 2017 and 2019 | Subject Device: Complies with these standards (Implied by inclusion in comparison table and statement of updated performance testing) |
| Electrical Safety | ES 60601-1 | Subject Device: Complies with ES 60601-1 (Implied by inclusion in comparison table and statement of updated performance testing) |
| EMC | IEC 60601-1-2 | Subject Device: Complies with IEC 60601-1-2 (Implied by inclusion in comparison table and statement of updated performance testing) |
| Cleaning High-level disinfection | Not explicitly stated | Performance testing for cleaning/disinfection was completed (leveraged from predicate) |
| Software | Verification and Validation | Verification and Validation completed |
| Biocompatibility | Not explicitly stated | Biocompatibility testing completed (leveraged from predicate) |
| Transportation | Not explicitly stated | Transportation testing completed |
Missing Information: For VTG and Raw, while the document states performance testing was done, the specific acceptance criteria and the results demonstrating compliance are not provided. The accuracy values listed in the table are copied directly from the "Subject Model 9160" column, indicating that these are the device's inherent specifications, and the comparison section implies they are similar to or meet expectations based on the predicate.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This information is not provided in the document. The text mentions "Bench testing" but does not detail the sample sizes for any of the performance tests, nor does it specify if any clinical data with human subjects (and thus data provenance) was used for direct performance evaluation of VTG and Raw measurements. The comparison tables focus on technological characteristics and principle of operation similarities to predicates.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
This information is not provided in the document. The device outputs objective physiological measurements, rather than interpretations requiring expert consensus as ground truth. If clinical studies were performed for the new parameters (VTG, Raw), the method of establishing ground truth would depend on the study design. However, the document provided does not detail such clinical studies or the involvement of experts in establishing ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not provided in the document. Given the nature of the device (measuring physiological parameters rather than rendering diagnoses or classifications), an adjudication method for a test set as described is unlikely to be directly applicable in the same way as for image-based diagnostic AI. If human subject studies were conducted to compare measurements, adjudication of patient conditions might be relevant, but this is not detailed.
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:
This is not applicable to this device. The VitaloQUB Model 9160 is a pulmonary function measurement device. It measures physiological parameters and does not involve "readers" or "AI assistance" in the diagnostic interpretation sense for which MRMC studies are typically performed. The device itself performs the measurements and calculations (via the ComPAS2 software), it does not assist human interpretation of complex data (like images) in a way that would be quantified by an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
The device is inherently a standalone measurement system in terms of calculating the parameters. The ComPAS2 software, which is part of the system, outputs the respiratory parameters. This is the "algorithm only" performance. The document states: "The ComPAS2 software controls valves and reads unprocessed data from the sensors in the Model 9100 and from Model 9160. The ComPAS2 software then determines respiratory parameters...". The performance testing mentioned ("Bench testing", "ATS / ERS (2002, 2005, 2013, 2017 and 2019) Static condition") assesses the accuracy of these measurements directly from the device/software. Specific performance for VTG and Raw measurements would have been assessed in this standalone manner, but the numerical results are not provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For physiological measurement devices, the "ground truth" is typically established by physical standards, calibration gases, and established reference methods or simulated physiological conditions that adhere to recognized industry standards (e.g., ATS/ERS standards). The document mentions compliance with various ISO and ATS/ERS standards, which dictate the methods and accuracy requirements for such measurements. For example, gas concentrations for DLCO are compared against medical-grade gas mixes, and flow/volume against calibrated instruments.
8. The sample size for the training set:
This information is not provided. As the device is a measurement instrument incorporating software (ComPAS2) for calculations based on physical readings, it's not described as an AI/ML device that requires a "training set" in the conventional sense (e.g., for pattern recognition or classification). The software implements algorithms for physiological calculations rather than learning from data in a machine learning paradigm.
9. How the ground truth for the training set was established:
This information is not provided, and likely not applicable as the device is not described as an AI/ML system requiring a training set with ground truth in the context of machine learning. The algorithms are based on established physiological principles and equations.
§ 868.1760 Volume plethysmograph.
(a)
Identification. A volume plethysmograph is an airtight box, in which a patient sits, that is used to determine the patient's lung volume changes.(b)
Classification. Class II (performance standards).