(459 days)
The Oxy2Pro is a single patient, disposable procedural mask with access for the insertion of oral scopes, probes, delivery of supplemental oxygen and monitoring breathing by providing a means to sample exhaled CO2. It is for nonintubated, adult patients who are breathing spontaneously.
The Southmedic Oxy2Pro is designed to have a flexible, thin membrane that is intended to be breached when requiring oral access for scope entry. This slitted membrane is intended to allow the mask to return to a closed- mask functionality after having been used with a scope. This device is to be used in conjunction with FDA cleared capnographs.
Here's a breakdown of the acceptance criteria and study information for the Oxy2Pro device, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that the acceptance criteria for the Oxy2Pro mask was that its performance for FiO2 (fraction of inspired oxygen) and EtCO2 (end-tidal carbon dioxide) should not be statistically significantly less than the predicate device (K172365) at the tested flow rates.
The study results demonstrate the following:
| Oxygen Flow Rate | Oxy2Pro FiO2 | Oxy2Pro EtCO2 | Predicate (K172365) FiO2 | Predicate (K172365) EtCO2 |
|---|---|---|---|---|
| 5 l/min | 53.3% | 6.13% | N/A | N/A |
| 8 l/min | 64.0% | 4.87% | 52.3% | 4.03% |
| 10 l/min | 64.7% | 4.70% | 48.3% | 4.17% |
| 12 l/min | 67.3% | 3.77% | 54.7% | 3.30% |
| 15 l/min | 72.3% | 3.70% | 52.0% | 3.53% |
The document concludes that the "Oxy2Pro mask was not statistically significantly less than the predicate for FiO2 or EtCO2 at the tested flow rates, meeting the acceptance criteria."
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated in terms of a number of masks or subjects. The document mentions "testing was completed under simulated conditions at various flow rates." This implies a series of measurements were taken at different flow rates, but the number of devices tested or repetitions of each test is not specified.
- Data Provenance: The testing was "completed to evaluate the ability to deliver FiO2 and sample EtCO2 relative to the predicate device." It was performed by an "Accredited third-party testing" organization. The location of this organization and whether the data is retrospective or prospective is not specified. Given the context of a 510(k) submission, it is likely prospective testing specifically conducted for this submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
N/A. This information is not relevant or applicable to the type of performance testing described. The "ground truth" (or reference standard) in this context is the measured FiO2 and EtCO2 values under controlled simulated conditions, using calibrated equipment. It does not involve expert interpretation or consensus.
4. Adjudication Method for the Test Set
N/A. As the testing involved objective measurements under simulated conditions, there was no need for an adjudication method by experts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
N/A. This type of study is typically performed for AI/image analysis devices where human readers provide interpretations. The Oxy2Pro is a medical device for oxygen delivery and CO2 sampling, and its performance is evaluated objectively through physical measurements, not human interpretation.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
N/A. This concept is for software algorithms. The Oxy2Pro is a physical device; its performance is standalone in the sense that it functions physically to deliver oxygen and sample gas.
7. Type of Ground Truth Used
The ground truth used was simulated conditions with true baseline EtCO2 at 5%. This implies a controlled environment where the actual concentration of inspired oxygen and exhaled CO2 was known and measured with high precision using reference instruments.
8. Sample Size for the Training Set
N/A. The Oxy2Pro is a physical medical device, not an AI or machine learning algorithm, so there is no training set in this context.
9. How the Ground Truth for the Training Set Was Established
N/A. As there is no training set, this question is not applicable.
§ 868.1400 Carbon dioxide gas analyzer.
(a)
Identification. A carbon dioxide gas analyzer is a device intended to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory, circulatory, and metabolic status. The device may use techniques such as chemical titration, absorption of infrared radiation, gas chromatography, or mass spectrometry.(b)
Classification. Class II (performance standards).