(203 days)
The Chad Therapeutics Sage is intended for prescription use only, to be used as part of a portable therapeutic oxygen system for patients that require supplemental oxygen while at rest or during activity.
The Chad Therapeutics Sage is a microprocessor-controlled device, which is a combination of a low-pressure regulator and a therapeutic oxygen device, designed for use with ambulatory oxygen systems. It delivers boluses of oxygen that is equivalent to 1 to 6 liters per minute, depending on the flow rate setting and whether the user is at rest or active.
The provided 510(k) submission for the Chad Therapeutics Sage does not provide detailed acceptance criteria or a specific study proving the device meets acceptance criteria in the manner typically expected for AI/ML-based medical devices.
Instead, this submission is for a physical medical device (a non-continuous ventilator/oxygen conserver) and its acceptance criteria and "studies" are focused on demonstrating substantial equivalence to predicate devices through various types of engineering and performance testing.
Here's a breakdown of the information that can be extracted, and where the requested AI/ML specific information is not applicable or not provided in this type of submission:
Acceptance Criteria and Device Performance (Based on the document):
The document does not list specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy targets) as would be the case for an AI/ML algorithm. Instead, the "acceptance criteria" are implied by demonstrating that the device performs as intended and is substantially equivalent to predicate devices.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional Equivalence: Delivers oxygen boluses equivalent to 1-6 LPM (at rest/activity). | The device is a "microprocessor-controlled device... designed for use with ambulatory oxygen systems. It delivers boluses of oxygen that is equivalent to 1 to 6 liters per minute, depending on the flow rate setting and whether the user is at rest or active." This is the core functionality description, implying it meets this range successfully. |
| Safety and Effectiveness: Performed as intended and is safe and effective. | "Performance, mechanical, electrical, electromagnetic compatibility, magnetic fields immunity, magnetic fields emissions, quasi-static electric fields and environmental testing was conducted to demonstrate that the Sage would perform as intended." "Based on the above, we concluded that the Chad Therapeutics Sage is substantially equivalent to legally marketed predicate devices and is safe and effective for its intended use." |
| Technological Equivalence: Incorporates a motion sensor for automatic mode switching. | "The Sage has both a rest and activity setting and incorporates a motion sensor to detect user activity to switch the device automatically from an at rest to an active flow setting." (This is a differentiating feature, implying it functions as designed.) |
Since this is a submission for a physical device, not an AI/ML algorithm, most of the specific questions regarding test sets, ground truth, experts, and AI-specific studies are not applicable (N/A) for this document.
Detailed Breakdown of Requested Information:
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A table of acceptance criteria and the reported device performance:
- See table above. The acceptance criteria are inferred from the device description and the claim of substantial equivalence, as specific performance metrics like sensitivity/specificity are not relevant for this type of device.
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Sample size used for the test set and the data provenance:
- N/A. This device does not use a "test set" in the context of AI/ML data. The "testing" involved engineering and performance verification of the physical product, likely involving a limited number of physical prototypes or production units, not a dataset of patient information. The document does not specify the number of units tested.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- N/A. Ground truth in the AI/ML sense (e.g., expert-labeled images) is not applicable here. The "ground truth" for a physical device is its adherence to engineering specifications and performance standards, verified through objective measurements and physical tests.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- N/A. Not relevant.
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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:
- N/A. This is a physical oxygen delivery device, not a diagnostic or AI-assisted interpretation tool. MRMC studies are not applicable.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. There is no standalone algorithm being evaluated in this submission. The device is a physical product.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for this device's performance would be derived from objective engineering measurements, calibration standards, and validated test methods (e.g., precise oxygen flow meters, pressure gauges, electrical safety testers). These are not typically described as "ground truth" in regulatory summaries for physical devices.
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The sample size for the training set:
- N/A. This is not an AI/ML device; there is no "training set." The microprocessor controls are programmed based on engineering design and performance requirements.
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How the ground truth for the training set was established:
- N/A. Not applicable.
In summary: The provided 510(k) is for a hardware medical device (an oxygen conserver). The acceptance criteria are implicitly met by demonstrating that the device functions as described, meets safety standards, and is substantially equivalent to existing predicate devices. The "studies" involve various engineering, electrical, mechanical, and environmental tests, rather than clinical studies or AI/ML performance evaluations with specific datasets and ground truth.
§ 868.5905 Noncontinuous ventilator (IPPB).
(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).