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510(k) Data Aggregation
(114 days)
ULTRAMAXO2 OXYGEN ANALYER
The UltraMaxO2 Oxygen Analyzer is a tool used to measure oxygen purity, flow and pressure at the outlet of an oxygen concentrator. The UltraMaxO2 Oxygen Analyzer is intended to be used in an environment where oxygen concentrators are being serviced or repaired. This includes Hospitals, Nursing Homes, Extended Care Facilities, Patient Homes, and Respiratory Device Service and Repair Centers.
The UltraMaxO2 device is used for checking oxygen concentrator performance with the measure of oxygen purity, and flow at the outlet of an oxygen concentrator. The UltraMaxO2 Oxygen Analyzer functions by passing an ultrasonic pulse through the gas sample and measuring the amount of time required for the pulse to transit the sample chamber. The transit time is converted into a gas concentration via calibration data stored in the device. This can be done because the transit time varies according to the molecular mass of the gas in the chamber. Flow is determined using the difference between the ultrasonic pulse traveling against the flow and the ultrasonic pulse traveling with the flow. Pressure is measured using a separate pressure sensor that measures the pressure build-up in the device when the output port is blocked. The pressure is displayed in either kPa or PSI determined by a user operable switch in the battery compartment. The materials of the UltraMaxO2 include ABS plastic for the enclosures and the ultrasonic oxygen sensor tube body, adhesive backed Polycarbonate labels, PVC tubing and nickel plated brass fittings for the flow path, electronic circuitry including transducers/receivers, pressure, temperature and humidity sensors and an LCD screen.
The UltraMaxO2 Oxygen Analyzer is a device designed to measure oxygen purity, flow, and pressure from oxygen concentrators.
Here's a breakdown of its acceptance criteria and the study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the UltraMaxO2 Oxygen Analyzer are implicitly derived from the performance claims and comparison to predicate devices. The study demonstrates that the UltraMaxO2 meets or exceeds the performance of its predicates.
| Parameter | Acceptance Criteria (Predicate Performance - typically the most stringent or comparable) | Reported UltraMaxO2 Performance |
|---|---|---|
| Oxygen Concentration | ||
| Measurement Range | 20.8 – 95.7% (DigiFlo), 73 – 95.6% (Check O2 Plus), 20.9 – 100% (Pro2 Check) | 20.9 – 96% |
| Accuracy | ± 1.8% (DigiFlo), ± 2% Full Scale (Check O2 Plus), ± 2% Full Scale (Pro2 Check) | ± 1.5% Full Scale (at constant temp. & optimal flow) |
| Flow Measurement | ||
| Measurement Range | 0 – 20 LPM (O2, DigiFlo), 0 – 10 LPM (Air, DigiFlo), 0 – 6 LPM (Check O2 Plus), 0 – 10 LPM (Pro2 Check) | 0 – 10 LPM |
| Accuracy | ± 0.2 LPM (DigiFlo), ± 0.3 LPM (Check O2 Plus), ± 0.3 LPM (Pro2 Check) | ± 0.2 LPM |
| Pressure Measurement | ||
| Measurement Range | 0 – 35 PSI (DigiFlo), 0 – 10 PSI (Check O2 Plus), 0 – 10 PSI (Pro2 Check) | 0.5 – 50 PSI (3.4 – 344 kPa) |
| Accuracy | ± 0.5% (DigiFlo), ± 2% Full Scale (Check O2 Plus), ± 1% Full Scale (Pro2 Check) | ± 0.5% |
| Response Time | 0.1 sec (DigiFlo), 1 min and 45 sec ± 5 sec (Check O2 Plus), 10 sec (Pro2 Check) | Less than or equal to 17 sec. |
| Operating Temperature | 10 – 40 C° (DigiFlo), 15 – 35 C° (Check O2 Plus), 0 – 41 C° (Pro2 Check) | 15 – 40 C° (59 – 104 F°) |
| Other Features | ||
| Sensor | Ultrasonic (All Predicates) | Ultrasonic |
| Low Battery Alarm or Indicator | Low Battery Indicator (All Predicates) | Low Battery Indicator |
| Power Source | 1 Battery: Alkaline 9V (All Predicates) | 2 Batteries: AA (Alkaline) – 2 x 1.5 V |
| Display | LCD (All Predicates) | LCD |
| Dimensions | 9" x 1.5" x 1" (DigiFlo), 3.3" x 7.5" x 1.25" (Check O2 Plus), 3.60" x 5.75" x 1.29" (Pro2 Check) | 3.16" x 5.10" x 1.04" (80.3mm x 129.5mm x 26.4mm) |
| Weight | 179 g (DigiFlo), 10 oz. (295 g) (Check O2 Plus), 9 oz. (255.15 g) (Pro2 Check) | 0.4 lbs (181 g) |
Study Proving Device Meets Acceptance Criteria:
The provided document refers to non-clinical functional and performance tests that were conducted to establish substantial equivalence. These tests aimed to demonstrate that the UltraMaxO2 performs as well as, or better than, the legally marketed predicate devices.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The document mentions "non-clinical functional and performance tests" but does not detail the number of units tested or the number of measurements taken.
- Data Provenance: The tests were non-clinical, likely conducted in a laboratory or manufacturing environment. The country of origin of the data is not specified, but the submitter (Maxtec, LLC) is based in Salt Lake City, Utah, USA, implying the testing likely occurred in the USA. The data is prospective as it was generated specifically for the submission to demonstrate performance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not applicable. This was a non-clinical device performance test, not an evaluation requiring expert interpretation of results for ground truth. The 'ground truth' would have been established by reference standards or calibrated measurement equipment.
- Qualifications of Experts: N/A
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. As this was a non-clinical performance test comparing measurements against known standards or predicate device specifications, an adjudication method for interpretations is not relevant.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No, an MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical studies were performed for the UltraMaxO2 as the device represents a well known technology for a recognized indication as evidenced...by comparison to the predicate devices currently cleared for sale in the US market."
- Effect Size of Human Readers Improve with AI vs. without AI Assistance: Not applicable, as no MRMC or clinical study involving human readers or AI assistance was conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance: Yes, the fundamental performance evaluation was a standalone assessment of the device's accuracy in measuring oxygen purity, flow, and pressure. While not an 'algorithm-only' test in the AI sense, it represents the device's inherent capability independent of human interpretation. The "non-clinical functional and performance tests" assess the device's outputs directly against established standards or predicate device performance.
7. The Type of Ground Truth Used
- Type of Ground Truth: For the non-clinical functional and performance tests, the ground truth would have been established using calibrated reference standards or known gas mixtures/flow rates/pressures. For example, a known concentration of oxygen gas would be fed into the device, and the device's reading would be compared to that known concentration. Similarly, known flow rates and pressures would be applied. When comparing to predicate devices, the predicate device's established performance served as a benchmark for substantial equivalence.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. The UltraMaxO2 Oxygen Analyzer is a measurement device, not an AI/ML algorithm that requires a "training set" in the conventional sense. The device uses an ultrasonic pulse measurement method with "calibration data stored in the device." This calibration data would be established during manufacturing and testing, and is not a "training set" like those used for machine learning models.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable in the AI/ML context. The device's internal calibration data is established by feeding known, precise inputs (e.g., specific oxygen concentrations, flow rates, pressures) into the device during its manufacturing and calibration process. The device's internal algorithms are then set to accurately report these known inputs. This would involve highly accurate laboratory equipment as the ground truth.
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