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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.

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