(120 days)
The MaxMixing Block is designed to provide intermittent or continuous controlled flows of an air/oxygen gas mixture to infant, pediatric, and adult patients. The MaxMixing Block is intended to be used with a Maxtec Oxygen Analyzer device. The MaxMixing Block is a restricted medical device intended for use by qualified trained personnel under the direction of a physician in institutional environments where delivery and monitoring of air/oxygen mixtures is required.
The MaxMixing Block uses the well known technology of two compensated thorpe tube flowmeter to control and measure medical grade air and oxygen at an accurate flow rate as per a calibrated reference pressure (50 psig +/- 5 psig). The two gases are then mixing block for continuous air/oxygen delivery at oxygen concentrations of 21 - 100% as prescribed. There are no new technological characteristics introduced with respect to design, materials, chemical composition or energy source for the MaxMixing Block from those of flowmeters currently sold for medical use. There are differences with respect to mixers, in that the subject device has a wider pressure differential tolerance requirement since Oxygen concentration is much less affected by pressure differential as compared to the blender predicate devices. The blender predicate devices have a single gas failure alarm which is intended to indicate narrow pressure differential between air and Oxygen gas sources and failure of a single gas source, either air or Oxygen. The subject device also has a single gas failure alam which indicates a broader pressure differential between air and Oxygen gas sources and failure of a single gas source, either air or Oxygen.
The MaxMixing Block device is designed to provide intermittent or continuous controlled flows of an air/oxygen gas mixture. The stated accuracy for oxygen concentration measurement is at least +/- 3%.
Here's a breakdown of the acceptance criteria and study information:
1. Acceptance Criteria and Reported Device Performance:
The document mentions that both the subject device (MaxMixing Block) and predicate devices are capable of measuring oxygen concentration with an accuracy of at least +/- 3%. While the provided text doesn't contain a specific table detailing "acceptance criteria" versus "reported device performance" for the MaxMixing Block itself, it states that
"Non-clinical functional and performance tests for substantial equivalence testing and the results are noted in the attached table."
However, this "attached table" is not provided in the input text. Therefore, the specific performance data against explicit acceptance criteria cannot be directly extracted here. We can infer the primary acceptance criterion is related to oxygen concentration accuracy based on the comparison to predicate devices.
| Acceptance Criteria (Inferred from Predicate Devices) | Reported Device Performance |
|---|---|
| Oxygen concentration accuracy of at least +/- 3% | Not explicitly detailed in the provided text, but implied to meet this based on substantial equivalence. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: Not specified in the provided text. The document refers to "non-clinical functional and performance tests" but does not give details about the size or nature of the test set.
- Data Provenance: Not specified. It's a non-clinical test, so there's no mention of country of origin of data or whether it's retrospective or prospective with human subjects.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. The study involved "non-clinical functional and performance tests" and no clinical studies were performed. Therefore, no human experts were involved in establishing ground truth for a test set in a clinical context.
4. Adjudication Method for the Test Set:
Not applicable. Since no clinical studies were performed and no human experts established ground truth, there was no adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No. The document explicitly states: "No clinical studies were performed". Therefore, no MRMC comparative effectiveness study was conducted.
6. Standalone Performance Study:
Yes, a standalone study was done in the form of "non-clinical functional and performance tests". The device was evaluated on its own merits against expected performance, as indicated by the comparison to predicate devices.
7. Type of Ground Truth Used:
The ground truth for the non-clinical performance tests would likely be based on:
- Reference standards/calibrated instruments: For measuring gas flow and oxygen concentration to verify the accuracy of the MaxMixing Block.
- Engineering specifications and design requirements: To ensure the device operates within defined parameters.
8. Sample Size for the Training Set:
Not applicable. This is a medical device (mixer) employing "well known technology". Unless it utilizes Machine Learning/AI, there is typically no "training set" in the conventional sense for such devices. The document explicitly states "No clinical studies were performed" and also notes "There are no new technological characteristics introduced with respect to design, materials, chemical composition or energy source for the MaxMixing Block from those of flowmeters currently sold for medical use." This further supports the absence of a training set for an AI/ML model.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there was no training set for an AI/ML model.
§ 868.5330 Breathing gas mixer.
(a)
Identification. A breathing gas mixer is a device intended for use in conjunction with a respiratory support apparatus to control the mixing of gases that are to be breathed by a patient.(b)
Classification. Class II (performance standards).