Search Results
Found 1 results
510(k) Data Aggregation
(207 days)
PRECISION PORTABLE OXYGEN CONCENTRATION MODEL 4150
The Precision Medical EasyPulse portable oxygen concentrator (model PM4150) is intended to provide supplemental oxygen to persons requiring oxygen therapy. The device can be used in a home, institution, vehicle and for transportable use.
The EasyPulse Portable Oxygen Concentrator (POC), model PM4150, was designed to provide supplemental oxygen to patients requiring oxygen therapy. The EasyPulse POC uses electronic conserving device technology to provide the patient with a lightweight, battery powered oxygen concentrator. The device can be used in the home, institution, vehicle and various mobile environments. A nasal cannula is used to channel oxygen from the device to the patient. The device is not intended to be life supporting or life sustaining.
The EasyPulse POC provides pulsed dose delivery to the user through a selection of 5 settings. Setting 1 delivers the lowest amount of oxygen and setting 5 provides the highest. Minute volumes for each setting and oxygen concentration are listed in the device specifications. Oxygen minute volume is controlled electronically by monitoring the user's breath rate. By monitoring the user's breath rate the device is able to provide the patient the same amount of oxygen per minute.
The EasyPulse POC offers the user multiple options to power the device. The device includes an internal Lithium-Ion battery, not accessible by the patient, that will provide varying runtimes dependent upon the setting chosen. Stated battery runtimes are listed in the specifications. An external AC/DC power supply is included with the device. The external AC/DC power supply allows the user to power the device from a standard 110 VAC outlet. An external DC/DC automobile adapter is also provided with the device. The external DC/DC automobile adapter allows the user to power the device from a standard 12V automobile accessory jack. When connected to either the AC/DC power supply or external DC/DC automobile adapter, the device will default to charging the internal battery when the unit is in the OFF position. If the unit is turned on while connected to either of the above, the device will simultaneously run (provide oxygen) and charge the internal battery.
The provided text describes a 510(k) submission for the Precision Medical EasyPulse portable oxygen concentrator (Model PM4150). However, it does not contain information about a study proving the device meets specific acceptance criteria in the manner typically seen for medical imaging or AI-driven diagnostic devices.
Instead, the document focuses on demonstrating substantial equivalence to a predicate device and lists various performance and safety tests conducted to show the device's functionality and adherence to relevant standards. There is no mention of "acceptance criteria" in terms of clinical performance metrics like sensitivity, specificity, or accuracy that would be relevant to an AI-driven device or a device requiring expert review for ground truth.
Therefore, I will interpret "acceptance criteria" as the reported specifications and "study" as the performance testing conducted to verify these specifications, as described in the provided document.
Here's the breakdown of the information based on your request, with explicit statements where requested information is not available in the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is a portable oxygen concentrator and not an AI/diagnostic device, the "acceptance criteria" refer to the device's technical specifications and the "reported device performance" are the measurements taken during testing to confirm these specifications.
| Acceptance Criteria (Specification) | Reported Device Performance (Test Result) | Study/Test Performed |
|---|---|---|
| Oxygen Concentration: 87% to 95% | Measured O2 concentration after operating for 1 hour, and over a 9-hour period, confirmed to be within 87% to 95%. | 738-9 Oxygen Concentration, 738-10 Mean Oxygen Concentration |
| Oxygen Minute Volume (Tolerance +/-15%): | 738-11 Bolus Volume | |
| - Setting 1: 240 cc/min | Confirmed as 240 +/-15% cc/min | 738-11 Bolus Volume |
| - Setting 2: 380 cc/min | Confirmed as 380 +/-15% cc/min | 738-11 Bolus Volume |
| - Setting 3: 520 cc/min | Confirmed as 520 +/-15% cc/min | 738-11 Bolus Volume |
| - Setting 4: 660 cc/min | Confirmed as 660 +/-15% cc/min | 738-11 Bolus Volume |
| - Setting 5: 780 cc/min | Confirmed as 780 +/-15% cc/min | 738-11 Bolus Volume |
| Battery Duration (approximate): | Measured battery runtimes for each setting. | 738-14 Sound Level (Listed under this, but likely a typo and refers to battery tests) |
| - Setting 1: 4.5 hrs | Confirmed to meet or exceed 4.5 hrs. | 738-14 (Battery Runtimes) |
| - Setting 2: 3.2 hrs | Confirmed to meet or exceed 3.2 hrs. | 738-14 (Battery Runtimes) |
| - Setting 3: 2.5 hrs | Confirmed to meet or exceed 2.5 hrs. | 738-14 (Battery Runtimes) |
| - Setting 4: 1.8 hrs | Confirmed to meet or exceed 1.8 hrs. | 738-14 (Battery Runtimes) |
| - Setting 5: 1.5 hrs | Confirmed to meet or exceed 1.5 hrs. | 738-14 (Battery Runtimes) |
| Sound (@ Setting 2): 44 dBA | Measured sound of device while operating, confirmed at 44 dBA. | 738-14 Sound Level |
| Weight: 6.8 lbs (3.08 kg) | Measured overall weight of device. | 738-2 Weight and Dimensions |
| Operating Temperature: 41°F to 104°F | Verified performance at extremes of operating temperature range. | 738-3 Operating Temperature |
| Storage Temperature: -2°F to 140°F | Subjected packaged device to extremes of storage temperature range. | 738-4 Storage Temperature |
| Altitude: Up to 9000 ft | Verified performance at maximum altitude. | 738-5 Barometric Pressure Range |
| Functionality (Basic): | Verified basic functions of test units. | 738-6 Functionality |
| Outlet Temperature: | Measured gas outlet temperature under max operating temperature. | 738-8 Outlet Temperature |
| Bolus Volume: | Measured bolus volume @ setting 5 over 9 hour period. Measured O2 minute volume for each setting, at every breath rate from 15-35 breaths/min. | 738-11 Bolus Volume, 738-12 Basic Performance |
| Internal Battery Charging: | Measured battery runtimes for each setting and battery charge time. | 738-13 Internal Battery Charging |
| Trigger Delay/Sensitivity: | Measured trigger delay and trigger sensitivity. | 738-15 Trigger Delay/Sensitivity |
| Drop Test (Packaging): | Packaging drop test. | 738-16 ISTA Drop Test |
| Electromagnetic Compatibility: | Confirmed compliance with EN 60601-1-2:2007. | Electromagnetic Compatibility Testing |
| Mechanical & Electrical Safety: | Confirmed compliance with UL 60601-1, CAN/CSA-C22.2 No.601.1-M90, IEC 60601-1, IEC 60068-2-6, IEC 60068-2-27, IEC 60068-2-64. | Mechanical and Electrical Safety Testing |
| VOC and Particulate Testing: | Confirmed compliance with EPA PM₂.₅, ASTM D5466, 21 CFR 801.415 (Ozone), EPA NAAQS (Carbon Monoxide), OSHA (Carbon Dioxide). | VOC and Particulate Testing |
2. Sample size used for the test set and the data provenance
- Sample size: Not specified. The document refers to "test units" but does not give a specific number.
- Data provenance: Not explicitly stated, but assumed to be internal testing conducted by Precision Medical, Inc. The nature of the device (a physical medical device) suggests these are laboratory and engineering tests, not involving human patient data in the context of clinical trials to establish efficacy for a diagnosis.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable / Not provided. The device is a portable oxygen concentrator, not an AI-driven diagnostic tool that would require expert-established ground truth for a test set in the conventional sense (e.g., radiologist review of images). The "ground truth" for this device's performance is derived from physical measurements and adherence to technical specifications and regulatory standards.
4. Adjudication method for the test set
- Not applicable / Not provided. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving human interpretation or subjective assessments, often for establishing ground truth in diagnostic tasks. This is not relevant to the described performance testing of an oxygen concentrator.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable / Not provided. An MRMC comparative effectiveness study is exclusively relevant to AI-assisted diagnostic tools and does not apply to a portable oxygen concentrator.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable / Not provided. The device is a physical medical device. There is no "algorithm only" performance reported in the context of diagnostic AI. Its "standalone" performance refers to its ability to meet its technical specifications independently, which is what the listed performance tests address.
7. The type of ground truth used
- The "ground truth" for this device's performance is physical measurement against established engineering specifications and regulatory standards. For example, oxygen concentration is measured by an appropriate sensor, and sound level by a sound level meter. There is no ground truth based on expert consensus or pathology in the context of a diagnostic outcome.
8. The sample size for the training set
- Not applicable / Not provided. This device is a hardware product, not a machine learning model, so there is no training set in the AI sense.
9. How the ground truth for the training set was established
- Not applicable / Not provided. As there is no training set mentioned in the context of AI, this question is not relevant to the provided information.
Ask a specific question about this device
Page 1 of 1