(209 days)
The Intelli-Ox is an integrated portable oxygen delivery system intended to provide supplemental oxygen to adults. When administered by properly trained personnel for oxygen deficiency and resuscitation, the Intelli-Ox is for emergency use only. For all other medical applications, the device is Rx only.
The Intelli-Ox portable oxygen system is a solution for supplying Oxygen USP using a device comprised of an integrated valve-regulator, flow meter and medical Oxygen aluminum cylinder with handle and shroud all integrated into a single unit. A range of user-selectable flow setting is available with the user being able to control the flow rate, including low flows that may be clinically appropriate for certain classes of patients. An additional DISS-1240 connection provides high flow oxygen delivery. When administered by properly trained personnel for oxygen deficiency and resuscitation, the Intelli-Ox is for emergency use only. For all other medical applications, the device is Rx only.
Key specifications include hose barb connection, protective shroud, carrying handle, easy to read digital content gauge, indexed flow meter, integrated valve-regulator and user instructions. This design allows medical personnel the ability to provide patient care and treatment sooner without delays caused by the need to mount a conventional regulator.
This document describes the regulatory submission for the Intelli-Ox portable oxygen delivery system, not a study evaluating its performance against acceptance criteria in the context of an AI/human-in-the-loop system. The document focuses on demonstrating substantial equivalence to a predicate device (EZ-OX Plus) for FDA clearance. Therefore, many of the requested categories related to AI/human performance studies and ground truth establishment are not applicable.
Here's an analysis based on the provided text, addressing the applicable points:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not present specific acceptance criteria in the form of performance metrics (e.g., sensitivity, specificity, accuracy) that the device must meet, nor does it provide reported device performance in that sense. Instead, it relies on demonstrating substantial equivalence to a predicate device through technological characteristics and compliance with recognized industry standards. The key "performance" reported is compliance with these standards.
| Parameter | Acceptance Criteria (Implied by Predicate & Standards) | Reported Device Performance (Compliance) |
|---|---|---|
| Valve/Regulator Low Flow | Yes (≥ .5L) | Yes (≥ .5L) |
| Flow Between Settings | No | No |
| Cylinder on/off | No | No |
| Filling Port | Active | Active |
| Contents Gauge | Active | Active (Digital) |
| Filters | 3 | 3 |
| Pressure Design (max) | 3,000 psi | 3,000 psi |
| Single stage piston style | Yes | Yes |
| Guard Hand Grip | 1 grip | 1 grip |
| Access Ports | Yes | Yes |
| Flow selector/hose barb/gauge | Aligned | Aligned |
| Color | Green | Green |
| Height (guard + valve-regulator) | 7" | 7" |
| Cylinder Sizes | E | E |
| Weight (E) (product) | 950 gr | 950gr |
| Materials/construction | Aluminum | Aluminum |
| ISO 14971 Compliance | Yes | Yes |
| ISO 13485 Compliance | Yes | Yes |
| IEC 60513 Compliance | Yes | Yes |
| UN Manual of Tests & Criteria | Yes | Yes |
| IP Rating | IP55 | IP55 |
| IEC 61326-2-6-2 Compliance | Yes | Yes |
| ISO 21730 Compliance | Yes | Yes |
| IEC 61000-6-4 Compliance | Yes | Yes |
| IEC 60601-1-2 (various) | Yes | Yes |
| ISO 10651-3 Compliance | Yes | Yes |
| 21 CFR Parts 210/211 Compliance | Yes | Yes |
2. Sample size used for the test set and the data provenance
This is not applicable as the submission is for a medical device (oxygen delivery system) and not an AI algorithm evaluated on a typical "test set" of data. The "test" involved physical and engineering evaluations against standards and comparison to a predicate device. Data provenance (country of origin, retrospective/prospective) is not mentioned for such testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. There is no concept of a "ground truth" established by experts in the context of an image or data interpretation for this device. The evaluation is based on engineering specifications and compliance with standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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. This is not an AI-assisted device requiring a MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The "ground truth" in this context is adherence to validated engineering specifications and recognized industry standards.
8. The sample size for the training set
Not applicable. No training set is involved for this type of device submission.
9. How the ground truth for the training set was established
Not applicable.
Summary of the Study and Device Clearance:
The provided document (K143060) is an FDA 510(k) premarket notification for the "Intelli-Ox" portable oxygen delivery system. The "study" described is a demonstration of substantial equivalence to a previously cleared predicate device, the "EZ-OX Plus" (K053117).
The basis for substantial equivalence is primarily through:
- Comparison of technological characteristics: The Intelli-Ox is described as "very similar" to the EZ-OX Plus, with the main modification being the replacement of an analog gauge with a digital gauge. Both gauges serve informational purposes and do not control flow. The submission details a table (page 5) comparing various parameters (e.g., low flow settings, filters, pressure design, materials, dimensions) and states that the technological characteristics are the same.
- Compliance with recognized voluntary standards: The Intelli-Ox system complies with a list of industry and international standards applicable to medical gas regulators (listed on page 6). These include standards for risk management (ISO 14971), quality management (ISO 13485), electrical safety (IEC 60513, 60601-1-2), electromagnetic compatibility (IEC 61326-2-6-2, ISO 21730, IEC 61000-6-4, ISO 10651-3), and others like the United Nations Manual of tests and Criteria, IP rating, and 21 CFR regulations.
The ultimate conclusion is that "Based upon the performance testing and compliance with voluntary standards, the manufacturer believes that the Intelli-OX portable oxygen delivery system is substantially equivalent to the predicate device, and does not raise any new questions of safety and effectiveness."
This document does not describe a clinical trial or performance study against specific, quantified acceptance criteria in the manner one might find for a novel diagnostic or therapeutic device requiring clinical validation or an AI algorithm. Instead, it leverages the regulatory pathway of substantial equivalence based on established predicates and adherence to existing safety and performance standards for a well-understood type of medical device.
§ 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.