(211 days)
The MEDDORNA Wireless PRN Spirometer Model 100 is intended for use as a diagnostic spirometer, measuring FVC, MVV and SVC breathing functions.
The MEDDORNA Wireless PRN Spirometer 100 is a full featured spirometer allowing Forced Vital Capacity (FVC) spirometry, Maximum Voluntary Ventilation (MVV), and Slow Vital Capacity (SVC) and all spirometry tests will be available, including pre/post bronchodilator testing.
The MEDDORNA Wireless PRN Spirometer 100 utilizes wireless interface to a thin client Personal Computer or Internet Server. This allows real-time graphical display and review of the spirometry loop along with alpha character patient entry when desired.
The MEDDORNA Wireless PRN Spirometer 100 utilizes pre-calibrated plastic disposable mouthpieces; this negates the need for a 3-liter syringe. The MEDDORNA Wireless PRN Spirometer has a rechargeable battery pack and wireless (Bluetooth) data link output directly to a thin client PC for reporting purposes.
Here's an analysis of the provided text regarding the MEDDORNA Wireless PRN Spirometer 100, focusing on the acceptance criteria and study details:
Summary of Acceptance Criteria and Device Performance for MEDDORNA Wireless PRN Spirometer 100
Based on the provided 510(k) summary (K072722), the information regarding specific acceptance criteria and detailed study results is limited. The document primarily states that the device was tested and found to meet general resolution requirements.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Resolution meets American Thoracic Standard Pulmonary requirements | "found to have the resolution that meets the American Thoracic Standard Pulmonary requirements." |
| Safety equivalent to predicate devices | "equivalent in safety...to its predicated devices." |
| Efficacy equivalent to predicate devices | "equivalent in efficacy to its predicated devices." |
Important Note: The document does not provide specific numerical targets or thresholds for "resolution" according to the American Thoracic Standard Pulmonary requirements, nor does it quantify "safety" or "efficacy" beyond a qualitative statement of equivalence.
2. Sample Size Used for the Test Set and Data Provenance
This information is not explicitly stated in the provided 510(k) summary. The document mentions "testing" but does not detail the size of the test set or whether the data was retrospective or prospective, or its country of origin.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not explicitly stated in the provided 510(k) summary. Given the nature of a spirometer, ground truth would typically be established through established calibration methods and potentially comparison to reference spirometers, rather than expert consensus on interpretive data.
4. Adjudication Method for the Test Set
This information is not explicitly stated in the provided 510(k) summary.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not mentioned or implied in the provided 510(k) summary. The device is a diagnostic spirometer, not typically subject to interpretation by multiple human readers in the same way as imaging studies. The focus is on the accuracy and precision of the measurements themselves.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, a standalone performance evaluation was implied. The text states, "The MEDDORNA Wireless PRN Spirometer 100 has been tested and found to have the resolution that meets the American Thoracic Standard Pulmonary requirements." This refers to the performance of the device itself (algorithm + hardware) in measuring spirometry parameters accurately, independent of a human's interpretive input during the measurement process. The device's function is to output measurements, not to interpret complex data for a human.
7. The Type of Ground Truth Used
The ground truth for evaluating a spirometer's performance would primarily be based on:
- Reference Standards: Comparison against highly accurate and calibrated reference spirometers or flow/volume simulators that meet established industry standards (such as those from the American Thoracic Society).
- Calibration Standards: The device itself uses "pre-calibrated plastic disposable mouthpieces," suggesting that internal calibration and validation against known flow/volume standards are critical for establishing ground truth.
The document states, "found to have the resolution that meets the American Thoracic Standard Pulmonary requirements," which strongly indicates that the ground truth was based on these established reference standards and calibration protocols.
8. The Sample Size for the Training Set
This information is not explicitly stated in the provided 510(k) summary. For a medical device performing direct physical measurements (like a spirometer), "training set" in the context of machine learning is generally not applicable in the same way it would be for an AI-powered diagnostic image analysis tool. The device likely relies on engineering design and calibration, rather than statistical model training on a large dataset.
9. How the Ground Truth for the Training Set Was Established
As noted above, the concept of a "training set" for this type of device is not directly comparable to an AI algorithm that learns from data. If any internal "training" or calibration adjustments were performed during development, the ground truth would have been established through physical calibration against known flow and volume standards (e.g., using a 3-liter syringe for volume, or precise flow generators). The use of "pre-calibrated plastic disposable mouthpieces" reinforces the reliance on physical calibration standards.
§ 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).