(294 days)
The OCD2001 is indicated for use to conserve oxygen for patients prescribed 1/2 to 6 liters per minute of supplemental oxygen and use nasal cannulas and USP bottled oxygen.
The OCD2001 is intended to be used as an accessory to an oxygen supply system to reduce or conserve the amount of oxygen used by the patient. The OCD2001 is a battery operated electronic device that is microprocessor controlled and contains a breath sensor and a normally closed valve. When installed between the oxygen supply and patient's nasal cannula, the device detects the patient's inhalation, opens the valve according to the flow rate set on the device and delivers a preset bolus of oxygen to the patient as determined by the device flow rate algorithm. The valve closes and conserves the oxygen that would have been wasted during the end of inhalation and during exhalation.
The device, OCD2001, is an oxygen-conserving device intended to reduce or conserve oxygen used by patients prescribed supplemental oxygen.
1. Table of Acceptance Criteria and Reported Device Performance:
The document primarily states that "Extensive functional testing of the OCD2001 has been performed," and "[The device] meets its performance objectives and complies with applicable FDA guidelines." However, specific numerical acceptance criteria (e.g., +/- X% accuracy for bolus size) and their corresponding reported performance values are not detailed in the provided text. The document lists the "Bolus Size" for each "Liter Flow Setting," which are the target performance specifications for oxygen delivery.
| Liter Flow Setting | Target Bolus Size | Reported Performance (Implied) | Acceptance Criteria (Implied) |
|---|---|---|---|
| 1/2 lpm | 5 ml | Achieved | 5 ml bolus delivery |
| 1 lpm | 10 ml | Achieved | 10 ml bolus delivery |
| 2 lpm | 20 ml | Achieved | 20 ml bolus delivery |
| 3 lpm | 30 ml | Achieved | 30 ml bolus delivery |
| 4 lpm | 40 ml | Achieved | 40 ml bolus delivery |
| 5 lpm | 50 ml | Achieved | 50 ml bolus delivery |
| 6 lpm | 60 ml | Achieved | 60 ml bolus delivery |
Additional Performance Testing Mentioned:
- Environmental conditions: Impact/drop testing, storage temperature testing, electromagnetic interference testing, electrostatic discharge testing, and surface temperature testing.
- Power supply testing: Battery life testing, low power indicator testing.
For these additional tests, the document only states that the testing "demonstrated that it meets its performance objectives and complies with applicable FDA guidelines," without providing specific numerical criteria or reported results.
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the sample size used for any of the functional, environmental, or power supply testing. It also does not mention the country of origin of the data or whether the data was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This information is not provided in the document. The testing described appears to be engineering and functional performance testing, not studies involving expert interpretation or medical ground truth establishment.
4. Adjudication Method for the Test Set:
This information is not applicable and is not provided in the document, as the testing described does not involve human interpretation or adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC study was conducted or mentioned, as the device is a medical accessory, not an AI diagnostic or interpretive tool.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Performance:
The described testing, including functional, environmental, and power supply tests, represents standalone performance evaluation of the device. The document explicitly states that "Extensive functional testing of the OCD2001 has been performed," and that this testing demonstrated the device "meets its performance objectives."
7. Type of Ground Truth Used:
The ground truth for the performance claims (e.g., bolus size delivery) appears to be derived from the device's design specifications and expected mechanical/electronic output. For the alarm functions, the ground truth is the occurrence of the condition the alarm is designed to detect (e.g., low battery, no breath detection within 30 seconds, microprocessor failure).
8. Sample Size for the Training Set:
This information is not applicable and is not provided. The OCD2001 is a microprocessor-controlled electronic device with a fixed algorithm, not a machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
This is not applicable, as there is no mention of a training set or machine learning algorithm. The device operates based on a pre-programmed algorithm and sensor inputs.
§ 868.5905 Noncontinuous ventilator (IPPB).
(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).