(148 days)
The VBOX Trooper oxygen concentrator device is used on a prescriptive basis by patients requiring supplemental oxygen. It supplies a high concentration of oxygen and is used with a nasal cannula to channel oxygen from the concentrator to the patient. The VBOX Trooper may be used in home, institution, vehicle and various mobile environments.
The Trooper oxygen concentrator utilizes a molecular sieve and differential pressure swing adsorption to separate the gases in ambient air. The device takes the room air and concentrates the oxygen portion to produce a pulse of oxygen between 87-94 % in purity. When the patient inhales, the device senses the pressure change and is triggered to release the oxygen pulse. In between breaths, the device regenerates an oxygen pulse and waits for the next inhalation breath before dispensing it.
The front panel of the Trooper contains controls and indicators such as, device status indicator LEDs, an ON/OFF button, oxygen flow rate controls, and flow rate and battery status displays. The oxygen outlet is also located on the front panel of the device.
The VBOX Trooper oxygen concentrator system will be provided under a single model number, A-1000, which includes the following items:
- One (1) Trooper Oxygen Concentrator Unit
- Two (2) Li-Ion Batteries (only one connected to the device at a time)
- One (1) Auxiliary AC Power Supply
- One (1) Battery Charger
- One (1) Carrying case
- One (1) nasal cannula
- User manual
The VBOX Trooper Oxygen Concentrator's acceptance criteria and the study proving it meets these criteria are outlined below, based on the provided 510(k) summary.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the device specifications and the comparison to predicate devices, demonstrating substantial equivalence. The reported device performance is taken directly from the "Trooper Device Specifications" and the "Summary Comparison to Predicate Devices" tables.
| Parameter | Acceptance Criteria (Implied from Predicate/Standard) | Reported Device Performance (VBOX Trooper) |
|---|---|---|
| Dimensions (LxWxH) | Relevant to portability and size comparison | 6 x 2.5 x 6.25 inches |
| Weight | Relevant to portability and size comparison | 3.2 lbs (includes battery) |
| Sieve Bed Material | Synthetic zeolite | Synthetic zeolite |
| Nasal Cannula Material | PVC (standard cannula supplied by Salter Labs) | PVC (standard cannula supplied by Salter Labs) |
| Battery Type | Li-Ion | Li-Ion |
| Method of Oxygen Concentration | Molecular sieve (mechanical) | Molecular sieve (mechanical) |
| Oxygen Release Process | Differential pressure swing adsorption | Differential pressure swing adsorption |
| Flow Rate (settings) | 5 settings: 1 to 5 LPM | 5 settings: 1 to 5 (equivalent to 1 LPM to 5 LPM) |
| Duration of Flow | Pulsed | Pulsed |
| Trigger Sensitivity | ≤ 0.12 cm water (Inogen One) or ≤ 0.16 cm water (EverGo) | ≤ 0.13 cm water (≤ 12.7 Pa) |
| Oxygen Concentration | 87-93% (Inogen One) or 86-92% (EverGo) | 87-94% at all settings |
| Software/Hardware | Analog and digital electronics with microprocessor | Analog and digital electronics with microprocessor |
| Rechargeable Battery | Yes | Yes |
| Power Options | Battery, AC | Battery, AC |
| Output Gas Composition | Free of VOCs, particulate matter, ozone/carbon monoxide/carbon dioxide issues | Tested for conformance |
| User Display & LED Functions | Functional and compliant | Tested for conformance |
| Electromagnetic Compatibility | Compliant with EN 60601-1-2:2007, EN 55011:2007, FCC Part 15 Subpart B | Tested for conformance |
| Electrical Safety | Compliant with IEC 60601-1:2003 | Tested for conformance |
| Functional Performance | Compliant with standards (e.g., trigger sensitivity, pulse volume, duration) and comparable to predicate devices | Tested for conformance and side-by-side comparison |
| Output Gas Temperature | Within acceptable limits | Tested for conformance |
| Biocompatibility | Compliant with ISO 10993-1:2009 | Tested for conformance |
2. Sample Size for the Test Set and Data Provenance
The document does not explicitly state a specific "sample size" for the test set in terms of a number of devices. However, the testing involved:
- Bench testing of the VBOX Trooper Oxygen Concentrator unit(s).
- Functional side-by-side comparison testing using the proposed device (VBOX Trooper) and each of the predicate devices (Inogen One Oxygen Concentrator and EverGo Portable Oxygen Concentrator).
Data Provenance: The testing was conducted by VBOX, Inc. (the device manufacturer) under applicable standards (ASTM, ISO, EN, FCC, IEC). This indicates the data is from prospective bench and comparison testing performed in a controlled environment, likely in the United States (where VBOX, Inc. is located).
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 summary. The study is a technical/engineering assessment of a medical device's performance, not a diagnostic study relying on expert interpretation of data or images. Ground truth, in this context, would be established by technical specifications, established measurement standards, and the performance of predicate devices.
4. Adjudication Method for the Test Set
This information is not applicable as the testing described is technical performance evaluation, not a subjective assessment requiring adjudication by multiple experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic imaging devices where human readers evaluate cases with and without AI assistance. The VBOX Trooper is an oxygen concentrator, and its effectiveness is determined by its functional performance and safety, not by human reader interpretation.
Effect size of how much human readers improve with AI vs without AI assistance: Not applicable as no MRMC study was performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
This question is not applicable in the context of an oxygen concentrator. The "device" itself is the algorithm (control system) in conjunction with the physical components. The performance described (Oxygen concentration, Trigger Sensitivity, Flow Rate, etc.) is the standalone performance of the device without a "human-in-the-loop" directly affecting its primary function of oxygen delivery. The human interacts with the device by setting flow rates and inhaling, but these are inputs to the device's autonomous operation.
7. The Type of Ground Truth Used
The ground truth for the performance parameters was established by:
- Established technical standards: e.g., ASTM F1464-93:2005, ISO 8359:1996, EN 60601-1-2:2007, IEC 60601-1:2003 for various aspects of safety and performance.
- Comparison to legally marketed predicate devices: The "substantial equivalence" claim relies on demonstrating that the VBOX Trooper's performance is comparable to or better than the predicate devices (Inogen One and EverGo) across key performance indicators like oxygen concentration, trigger sensitivity, and flow rates.
- Internal device specifications and design requirements: Bench testing verified that the device met its own designed performance metrics.
8. The Sample Size for the Training Set
The concept of a "training set" is not applicable to this device. The VBOX Trooper Oxygen Concentrator is a mechanical and electronic device, not an AI/machine learning algorithm that requires a data-driven training set. Its design and development would have involved engineering principles and iterative testing, not machine learning model training.
9. How the Ground Truth for the Training Set was Established
This question is not applicable as there was no training set for an AI/machine learning model. The 'ground truth' for the development of the device would be based on engineering specifications, medical requirements for oxygen delivery, and adherence to relevant industry standards.
§ 868.5440 Portable oxygen generator.
(a)
Identification. A portable oxygen generator is a device that is intended to release oxygen for respiratory therapy by means of either a chemical reaction or physical means (e.g., a molecular sieve).(b)
Classification. Class II (performance standards).