(103 days)
The Besmed Volumetric Incentive Spirometer is intended as an inspiratory deep breathing positive exerciser. Intended for single-patient, multi-use in a hospital or home care setting.
The Besmed Volumetric Incentive Spirometer has a flexible tube and mouthpiece which the patient inhales through. This tube connects to the inspiration port of the unit. The chamber has a ball and piston which upon the patient inhaling, creates a vacuum, which causes the ball and piston to rise, the piston reflects the inspiratory volume while the ball is an indicator for the user to maintain the optimum inspiratory flow rate. Two (2) models are offered - 2500 cc and 5000 cc. It is a single patient, multi-use, disposable, non-sterile device. The mouthpiece may be removed and cleaned by the user as needed but the main device is not to be cleaned.
As a patient improves their respiratory capacity or gets stronger they improve their inspiratory volume raising the piston. The principle of the ball indicator is to provide the user a visual indicator of their inspiratory flow rate and help them to improve the respiratory function with repeated uses. Incentive spirometers are commonly referred to as "lung exercisers".
The Besmed Volumetric ICS achieves the therapeutic intent by helping the patient to improve their inspiratory volume. It is a relative improvement device that as described offers the patient the "incentive" to improve. This is the identical therapeutic intent of the predicate volume based incentive spirometer.
The provided document describes the 510(k) premarket notification for the "Besmed Volumetric Incentive Spirometer." This document focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than a clinical study proving device acceptance criteria in the context of diagnostic accuracy or comparative effectiveness with human readers.
Therefore, many of the requested sections related to clinical study design, sample sizes for test/training sets, expert adjudication, and MRMC studies are not applicable to the information contained within this 510(k) summary. This document primarily details non-clinical performance and comparisons to a predicate device.
Here's an analysis of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Volume Accuracy | For 2500 cc model: 4 – 15% |
| For 5000 cc model: 3 – 12% | |
| Age Testing | Pre and post-exposure |
| Environmental Testing (High/Low Temp, Humidity, Drop test) | Met performance specifications |
Note: The acceptance criteria here are derived from the observed performance of the proposed device and are compared to the predicate's (Hudson RCI K801199), which reported an accuracy of ~21%. The Besmed device's performance is stated as "equivalent (or better)."
2. Sample size used for the test set and the data provenance
The document states: "Multiple samples of each device were tested multiple times and then evaluated for consistency of performance." However, specific sample sizes (number of devices, number of tests per device) for the non-clinical performance evaluation are not explicitly provided.
Data provenance: Non-clinical testing appears to have been conducted by the manufacturer, Besmed Health Business Corp. The country of origin of the data is not explicitly stated beyond the manufacturer's location (Taiwan). It is a retrospective analysis of device performance against internal specifications and comparison to a predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This pertains to non-clinical device performance testing, not a study involving expert interpretation or diagnostic performance.
4. Adjudication method for the test set
Not applicable. This pertains to non-clinical device performance testing, not a study involving expert interpretation or diagnostic performance.
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 document describes a physical medical device (incentive spirometer), not an AI-powered diagnostic tool. No MRMC study was conducted.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device; there is no "algorithm only" performance separate from the device's inherent mechanical function.
7. The type of ground truth used
For volume accuracy, the ground truth would be the accurately measured volume of air moved by a calibrated testing system.
For age testing and environmental testing, the ground truth is the "performance specifications" that the device is expected to meet both before and after exposure to certain conditions.
8. The sample size for the training set
Not applicable. This is a physical medical device; there is no "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
Not applicable. See point 8.
§ 868.5690 Incentive spirometer.
(a)
Identification. An incentive spirometer is a device that indicates a patient's breathing volume or flow and that provides an incentive to the patient to improve his or her ventilation.(b)
Classification. Class II (performance standards).