Search Results

MEDINET INCENTIVE SPIROMETER – RESPIPROGRAM is intended as an inspiratory deep breathing positive exerciser.
MEDINET INCENTIVE SPIROMETER - RESPIPROGRAM is intended for single use in a hospital or home care setting.

The RESPIPROGRAM is an inspiratory device used as breathing exerciser; RESPIPROGRAM is a FLOW exerciser.
The RESPIPROGRAM is intended as an inspiratory deep breathing positive exerciser. It is intended for single-patient, single use both in a hospital or for home care therapy.
RESPIPROGRAM is a single patient, single use, disposable, non-sterile device.
RESPIPROGRAM is a single use device that allows the patient to indicate visually the capacity of inhaling, even though RESPIPROGRAM doesn't have a specific measuring function. The device is a stimulator for inspiration; therefore it is indicated in all situations for when it is necessary to stimulate the patient's inhalation, under the prescription of a physician. The patient inspires through a mouthpiece that is connected to 3 chambers that have 3 balls of different colors (red, yellow and green) each one indicating a different approximate flow rate (respectively 600, 900 and 1200 ml per second).

This document describes the Medinet Incentive Spirometer - Respiprogram, an inspiratory deep breathing positive exerciser. The information provided outlines the device's technical specifications and the tests conducted to demonstrate its substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The data provided for the Medinet device under various humidity conditions are:

• Low humidity (cc/sec):
  • 600 cc/sec: 604.6 ± 5.5
  • 900 cc/sec: 925.2 ± 3.28
  • 1200 cc/sec: 1222.8 ± 10.0
• High humidity (cc/sec):
  • 600 cc/sec: 593.5 ± 4.9
  • 900 cc/sec: 887.3 ± 3.7
  • 1200 cc/sec: 1177.3 ± 7.5
    These values are within a ±5% range of their nominal flow rates (e.g., 5% of 600 is 30, and 604.6 is certainly within 570-630). The predicate device's specified accuracy of +/- 5% is shown to be met by the Medinet device. |
    | Resistance (Drop Test) | No breakage or crack | Met Predetermined Criteria: "The results showed that the samples tested met the pre-determined acceptance criteria without any breakage or crack." |
    | Biocompatibility | Conforming to ISO 10993 testing | Conforming to ISO 10993 testing:
• Cytotoxicity (ISO 10993-5): Performed
• Irritation (ISO 10993-10): Performed
• Sensitization (ISO 10993-10): Performed |

2. Sample Size Used for the Test Set and Data Provenance:

The document does not explicitly state the numerical sample size for the test set used in the flow accuracy or drop tests. It refers to "new and aged samples" and "samples tested" without providing a specific count.

• Data Provenance: The tests were conducted internally by Medinet SRL to compare their device with the predicate device (BESMED TriBall). The country of origin of the data is Italy (Medinet SRL is located in Milan, Italy). The studies appear to be prospective comparative tests designed for this 510(k) submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

This question is not applicable to the type of device and study described. The Medinet Incentive Spirometer is a mechanical device, and its performance (flow accuracy, structural integrity, biocompatibility) is measured against objective technical standards and a predicate device, not against expert interpretation of medical images or symptoms. Therefore, no medical experts were involved in establishing "ground truth" for the technical performance tests.

4. Adjudication Method for the Test Set:

This question is not applicable. Adjudication methods (like 2+1, 3+1) are used to resolve disagreements among multiple experts when establishing ground truth for diagnostic or prognostic tasks. Since this device's performance is measured objectively against technical specifications, no adjudication was necessary.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices (e.g., AI algorithms for medical imaging) to assess the impact of the device on human reader performance. The Medinet Incentive Spirometer is a therapeutic/exerciser device, not a diagnostic one that would involve human "readers" interpreting output.

6. If a Standalone (i.e., Algorithm Only Without Human-in-the-Loop Performance) Was Done:

This question is not applicable. The device is a mechanical incentive spirometer, not an algorithm. Its "standalone performance" is its inherent mechanical function as described by the flow accuracy and physical integrity tests.

7. The Type of Ground Truth Used:

The "ground truth" for these tests consisted of:

• Technical Specifications: The defined flow rates (600, 900, 1200 ml/sec) and the accepted accuracy tolerance (±5%).
• Predicate Device Performance: The predicate device's established performance served as a benchmark for comparison during the comparative flow accuracy and drop tests.
• ISO 10993 Standards: For biocompatibility, the ground truth is compliance with the specified parts of the ISO 10993 series.

8. The Sample Size for the Training Set:

This question is not applicable. The Medinet Incentive Spirometer is a mechanical device and does not involve AI algorithms that require a "training set" of data.

9. How the Ground Truth for the Training Set Was Established:

This question is not applicable, as there is no training set for a mechanical device.

Ask a specific question about this device

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

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.

Ask a specific question about this device

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

Ask a specific question about this device

Ask a specific question about this device