(42 days)
The Chad Therapeutics Lotus (modified Chad Therapeutics OXYMATIC Model 411) is intended for use in the same manner as the unmodified device, i.e., for prescription use only, to be used as a portable oxygen delivery system for patients who require supplemental oxygen at flow rates equivalent to 1 to 6 liters per minute, in their home and for ambulatory use.
The Chad Therapeutics Lotus is a microprocessor-controlled device, which is a combination of a low-pressure regulator and an oxygen conserver, designed for use with a compressed oxygen source to provide a pulse of oxygen that is equivalent to 1 to 6 liters per minute, depending on the flow rate setting.
This document is a 510(k) premarket notification for a medical device modification, not a study report. Therefore, it does not contain the detailed information typically found in a study proving a device meets acceptance criteria. A 510(k) submission, especially a "Special 510(k)," primarily focuses on demonstrating substantial equivalence to a predicate device rather than conducting a full-scale clinical trial to prove efficacy against acceptance criteria.
However, I can extract the information that is present and explain why certain information is not available in this type of document.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety: Device operates safely | Met: - The regulator in the device passed the ASTM PS 127-00 Promoted Ignition Safety Test. - Electromagnetic Compatibility, Electrostatic Discharge, Immunity, Magnetic Fields Immunity, Magnetic Fields Emissions, Quasi-Static Electric Fields, Radiated and Conducted Field Emissions, etc., were conducted in accordance with the FDA Reviewer Guidance for Premarket Submissions, Anesthesiology and Respiratory Devices Branch, Division of Cardiovascular, Respiratory and Neurological Devices Document and applicable EN 60601 Medical Electrical Equipment specifications. - The software complies with applicable standards per FDA Reviewers and content of premarket submissions for software contained in medical devices. |
| Functionality: Device performs as intended (delivering oxygen equivalent to 1 to 6 liters per minute) | Met (by substantial equivalence): The document states that "All risk assessment, design verification and validation activities were conducted in accordance with device requirements to demonstrate that the Chad Therapeutics Lotus would perform as intended." It also claims that the modified device "has the same technological characteristics" and "the software and the patient inhalation detection sensor portion of the device are identical to the predicate device." While specific performance metrics against an explicit numerical acceptance criterion are not provided, the conclusion of "substantial equivalence" implies that its performance is considered equivalent to the predicate device, which was already cleared for this function. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in this 510(k) submission. The testing described (ASTM, EMC, software compliance) involves engineering and bench testing, not typically a "test set" in the context of human data. There's no human subject data mentioned, so concepts like country of origin, retrospective/prospective, or sample size are not applicable here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not applicable/provided. The testing performed is primarily technical and regulatory compliance (e.g., engineering standards, software standards). There is no mention of "ground truth" being established by medical experts for a diagnostic or interpretative purpose.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. Adjudication methods are typically used in clinical studies where multiple human readers or experts are involved in interpreting data (e.g., radiology images). The tests described are bench tests and engineering compliance checks.
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
There was no MRMC comparative effectiveness study done. This is a special 510(k) for a device modification (oxygen conserver), and it does not involve AI or human interpretation of cases. The document focuses on demonstrating physical and software modifications maintain safety and effectiveness equivalent to the predicate device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is an oxygen conserver, a physical medical device, not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" in this context is based on engineering standards, safety standards (e.g., ASTM PS 127-00), and regulatory compliance specifications (e.g., EN 60601 for EMC, FDA guidance for software). These standards define the acceptable performance characteristics and safety profiles for the device. There's no biological or clinical "ground truth" derived from patient data mentioned.
8. The sample size for the training set
This is not applicable. The device is a hardware product with software; it is not a machine learning model that requires a "training set" of data in the AI sense.
9. How the ground truth for the training set was established
This is not applicable for the same reason as point 8.
§ 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).