(352 days)
The Intelli-OX is an integrated portable oxygen delivery system intended to provide supplemental oxygen to adults. The device is MR Conditional and suitable for use during MR imaging for MRI systems up to 3.0 Tesla. When administered by properly trained personnel for oxygen deficiency and resuscitation, the Intelli-Ox is for all other medical applications, the device is Rx only.
The Intelli-OX portable oxygen delivery system that supplies Oxygen USP using a device comprised of an integrated valve-regulator, flow meter and medical 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 standard high flow oxygen delivery. When administered by properly trained personnel for oxygen deficiency and resuscitation. 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 content gauge, indexed flow meter, and integrated valve-regulator. 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. The device is MR Conditional and suitable for use during MR imaging for MRI systems up to 3.0 Tesla.
The provided text describes the 510(k) submission for the Intelli-OX, an integrated portable oxygen delivery system, specifically focusing on its MR Conditional status. However, the document does NOT contain information related to a study proving the device meets acceptance criteria for an AI/ML-driven medical device, nor does it involve human readers, ground truth establishment by experts, or training sets.
The information provided pertains to the regulatory submission of a physical medical device (oxygen delivery system) to the FDA, and its testing for MR compatibility.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance for an AI/ML device.
- Sample size used for a test set or data provenance for an AI/ML device.
- Number of experts or their qualifications for establishing ground truth for an AI/ML device.
- Adjudication method for a test set for an AI/ML device.
- MRMC comparative effectiveness study or human reader improvement with AI assistance.
- Standalone algorithm performance.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for an AI/ML device.
- Sample size for the training set.
- How ground truth for the training set was established.
The document does mention "MRI performance testing" which was completed to support the substantial equivalence determination for its MR Conditional status. The acceptance criteria for this specific aspect are listed as compliance with:
- ASTM F2052-15: "Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment"
- ISO TIR 10974, 2012, Clause 21: "Assessment of the Safety Magnetic Resonance Imaging for Patients with an Active Implantable Medical Device"
This is a physical performance test for MR compatibility, not a study of an AI/ML device's diagnostic or predictive performance.
§ 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.