Search Results

The Besmed 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 TriBall 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 series of balls which upon the patient inhaling, creates a vacuum, which causes the balls to rise, they reflect the inspiratory flow rate in cc/sec (600, 900 and 1200). It is a single patient, multi-use, disposable, non-sterile device. As a patient improves their respiratory capacity or gets stronger their inspiratory flow rate raises the balls. The principle 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 TriBall achieves the therapeutic intent by helping the patient to improve their inspiratory flow rate. It is a relative improvement device that as described offers the "incentive" to improve. This is the identical therapeutic intent of all predicate flow / volume based incentive spirometers.

The provided text describes the 510(k) summary for the Besmed TriBall Incentive Spirometer. I will extract the requested information based on the content.

Acceptance Criteria and Device Performance

Study Details

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
   The document states, "Multiple samples of each device were tested multiple times." However, specific numerical sample sizes for devices or tests, or data provenance (country of origin, retrospective/prospective) are not provided.

2. 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 device is a physical medical device (incentive spirometer), not an imaging or diagnostic AI-driven device that typically requires expert-established ground truth. Therefore, this information is not applicable and not provided in the document.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   Not applicable, as this is a performance test for a physical device, not an assessment requiring expert adjudication of data. The performance was measured directly against technical specifications.

4. 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 is a physical medical device, not an AI-assisted diagnostic tool involving human readers/interpreters.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   Not applicable. The "performance testing" described is for the physical device itself, in terms of its inspiratory rate/volume accuracy, and its ability to withstand environmental conditions, not for an algorithm.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   The "ground truth" for the performance testing of the incentive spirometer was based on pre-defined technical specifications for inspiratory rate/volume accuracy (+/- 5%) and the ability to maintain performance after environmental stressors. This is a direct measurement against engineering and design standards, not a clinical ground truth like pathology or expert consensus.

7. The sample size for the training set:
   Not applicable. This device does not involve a "training set" in the context of machine learning or AI models. The testing described is for the physical product’s performance characteristics.

8. How the ground truth for the training set was established:
   Not applicable, as there is no training set for this type of device.

Ask a specific question about this device