(175 days)
The Walk-O2-Bout® is an integrated portable oxygen delivery system intended to provide supplemental oxygen to pediatrics and adults in hospital, sub-acute care, and pre-hospital / ground transport settings. It is offered in models that are MR-conditional (per ASTM F2052-15), and intended for use during MR imaging for static magnetic fields of 3.0 T or less. Compressed gas cylinders in service or in storage shall be stabilized or otherwise secured to prevent falling and rolling.
The Walk-O2-Bout® regulator is designed to be installed on a medical grade aluminum cylinder having 0.750-16 UNF-2B threads; regulate high pressure oxygen from 300-2000 psig nominal; deliver a prescribed amount of oxygen; and be ignition fault resistant. The device consists of: A threaded fill fitting per CGA 540. It shall allow the regulator installed on a cylinder to be refilled to its service pressure. It also allows for the pulling of a vacuum on the system. A pressure regulator section to reduce the pressure from 300-2000 psig to 50 psig nominal. Options of flow selector valves to control the flow between 0 and 25 L/min, at the regulated pressure. A vinyl dipped handle for ease of carrying. A DISS 1240 check valve to deliver 50 psig of oxygen high flow rates of oxygen to ventilators. There are several models offered. In all cases the basic pressure regulator is identical for all models. The models are offered with the following options: Flow rate range of 0 4 L/min (Pediatric), 0 15 L/min and 0 25 L/min (adult) Check Valve Swivel or Fixed Barb Fitting Handle style MR Conditional.
The provided text describes the 510(k) premarket notification for the Walk-O2-Bout®, a portable oxygen delivery system. However, it does not contain the detailed acceptance criteria and study results in the format requested. The document focuses on demonstrating substantial equivalence to a predicate device (K101792 – Linde – LIV Portable Oxygen System) rather than providing specifics of direct performance against pre-defined acceptance criteria with empirical data.
The "Acceptance Test Procedure" mentioned under "Non-clinical Testing Summary" suggests that such tests were performed, but the results and specific criteria are not detailed. Similarly, while "Flow accuracy: +/- 10%" is listed as a specification, the study proving the device meets this accuracy is not described.
Therefore, I cannot fulfill all parts of your request with the provided input. However, I can extract the available information as much as possible.
Here's a breakdown of what can be extracted and what information is missing from the provided document:
1. A table of acceptance criteria and the reported device performance
Based on the document, the acceptance criteria are generally implied by the specifications and compliance with standards. The specific reported device performance values against these criteria are not explicitly provided in a quantitative table within this document.
| Acceptance Criteria (from "Specifications" and standards) | Reported Device Performance |
|---|---|
| Flow accuracy | ±10% (Stated as specification, not a measured performance) |
| Maximum inlet pressure | 2000 psig (Stated as specification) |
| Outlet pressure range | 48-65 psi (Stated as specification) |
| Operating Pressure range | 300-2000 psig (Stated as specification) |
| Operating Temperature Range | -20°F to 130°F (Stated as specification) |
| Oxygen cylinder size | E (Stated as specification) |
| MR Conditional (per ASTM F2052-15) | 3.0 Tesla or less (Stated as specification, tested per ASTM F2052-06 which is acknowledged to be different than -15 but testing was done for -06, not -15 |
| CGA E-7 Guidelines | Testing performed per CGA E-7 (not specific results) |
| ASTM G175-03 (Ignition) | Materials evaluated per ASTM G175-03 |
| Biocompatibility | Materials evaluated for biocompatibility via VOC and PM2, "demonstrated that the materials were safe for their intended use." |
| Specific Non-clinical Tests (e.g., Gas tightness, Endurance Inlet, Drop, Burst pressure, etc.) | Tests were performed, but specific acceptance criteria and results are not detailed. |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample size for any test set or the data provenance (e.g., country of origin, retrospective/prospective). It mentions "a number of tests appropriate for the proposed device" were performed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable and not provided. The testing appears to be primarily engineering and bench testing, not involving expert interpretation or "ground truth" in the clinical sense.
4. Adjudication method for the test set
This information is not applicable and not provided. The testing appears to be primarily engineering and bench testing.
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
A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a medical gas pressure regulator, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable. The device is a physical medical device, not an algorithm.
7. The type of ground truth used
The concept of "ground truth" as it applies to clinical diagnoses (e.g., pathology, outcomes data) is not relevant here. The ground truth for this device's performance would be established by physical measurement against engineering standards and specifications.
8. The sample size for the training set
This is not applicable as the device is a physical product and not an AI/machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
This is not applicable.
Summary of Study (Based on Provided Text):
The "study" described in this document is a series of non-clinical, bench-testing evaluations to demonstrate the physical and functional performance of the Walk-O2-Bout® device. The primary goal was to show substantial equivalence to a legally marketed predicate device (Linde – LIV Portable Oxygen System, K101792) and compliance with relevant industry standards (ISO, ASTM, CGA).
- Type of Study: Non-clinical bench testing.
- Purpose: To demonstrate the device's physical performance, safety (ignition, MR compatibility), and biocompatibility, and to support a claim of substantial equivalence to a predicate device.
- Key Tests Mentioned: Acceptance Test Procedure, Low/High temperature, Gas tightness, Flow regulation (Flow capacity), Outlet Flow vs. inlet pressure, Pressure regulation, Static increment, Pressure relief, Mechanical resistance, Endurance Inlet, Fill fitting endurance, Safety, Drop, Vibration and Shock, Proof pressure, Burst pressure, Ignition (ASTM G175), MR Conditional Testing (ASTM F2052-15, tested per ASTM F2052-06), Biocompatibility.
- Clinical Testing: "There was no clinical testing."
In conclusion, while the document confirms that various tests were performed to assess the device's performance against established standards and specifications, it does not provide the quantitative results or detailed acceptance criteria for each test in a manner that would fully answer your request. It mainly serves as a summary for a 510(k) submission, confirming adherence to regulatory requirements and substantial equivalence.
§ 868.2700 Pressure regulator.
(a)
Identification. A pressure regulator is a device, often called a pressure-reducing valve, that is intended for medical purposes and that is used to convert a medical gas pressure from a high variable pressure to a lower, more constant working pressure. This device includes mechanical oxygen regulators.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9.