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510(k) Data Aggregation
(14 days)
PULSED OXYGEN CONSERVING DEVICE - EVERY BREATH, POCDEB, REACTEB
The modified Medical Electronic Devices Corp. POCD Pulsed Oxygen Conserving Device is intended for use in the same manner as the unmodified device, i.e., to conserve oxygen for patients prescribed 1 to 4 liters per minute of supplemental oxygen and use nasal cannulas and USP bottled oxygen.
The Medical Electronic Devices Corp. POCDFR intended to be used as an accessory to an oxygen supply system to reduce or conserve the amount of oxygen used by the patient. The POCDEe is a battery operated electronic device that is microprocessor controlled and contains a breath sensor and normally closed valve. It delivers boluses of oxygen every breath that is equivalent to 1 to 4 liters per minute constant flow, depending on the flow setting.
The provided text describes a Special 510(k) submission for a modified Pulsed Oxygen Conserving Device (POCDEB). It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a novel device that requires extensive clinical studies with specific acceptance criteria related to accuracy or diagnostic performance.
Therefore, much of the requested information regarding acceptance criteria, sample sizes for test and training sets, expert involvement, and ground truth establishment, which are typical for AI/ML device evaluations, are not applicable in this context. The document primarily discusses device modifications and functional equivalence.
Here's a breakdown of the relevant information from the provided text, addressing the requested points where possible, and noting where information is not available or not applicable given the nature of the submission:
1. Table of Acceptance Criteria and Reported Device Performance
This kind of table is not present in the document because the submission is for a modification of an existing device (POCD) and primarily claims substantial equivalence based on technological characteristics and functional testing, not on clinical performance metrics like sensitivity, specificity, or accuracy for a diagnostic task.
The key "performance" aspect is that the modified software delivers oxygen on every breath, similar to another predicate device.
| Acceptance Criteria (Implicit) | Reported Device Performance (Summary) |
|---|---|
| Technological Equivalence: Same technological characteristics as predicate device (POCD) except for software modification. | Hardware portion is identical to POCD except for labeling. Software modified to deliver a bolus of oxygen on every breath. |
| Dosing Algorithm Equivalence: New dosing algorithm should be identical to another predicate device's algorithm. | New dosing algorithm is identical to the algorithm used in the predicate device CHAD Therapeutics OXYMATIC Model 311. |
| Intended Use Equivalence: Performs as intended for oxygen conservation in patients prescribed 1 to 4 LPM supplemental oxygen using nasal cannulas and USP bottled oxygen. | "Appropriate performance, mechanical, electromagnetic and environmental testing was performed to demonstrate that the POCDEB would perform as intended." |
| Safety and Effectiveness: Safe and effective for its intended use. | "Based on the above, we concluded that the POCDEB is substantially equivalent to currently marketed devices and is safe and effective for its intended use." |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This submission concerns a physical device modification, not an AI/ML algorithm requiring a test set of data for performance evaluation in the way a diagnostic device would. There is no mention of a "test set" in the context of data. The "testing" mentioned refers to functional, mechanical, electromagnetic, and environmental testing of the device itself.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. There is no "ground truth" established by experts in the context of diagnostic data for this device. The evaluation is based on device functionality and equivalence to predicate devices.
4. Adjudication Method for the Test Set
Not applicable. There is no test set in the context of data requiring an adjudication method.
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/ML diagnostic or assistive device. It is an oxygen conserver, and no MRMC study was performed or needed for this type of submission.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML algorithm requiring standalone performance evaluation. The "algorithm" here refers to the device's dosing mechanism, which is embedded in its function.
7. The Type of Ground Truth Used
Not applicable. "Ground truth" in the context of clinical outcomes, pathology, or expert consensus on diagnostic images is not relevant to this device's submission. The "truth" here is established by demonstrating that the device functions as described and is equivalent to predicate devices.
8. The Sample Size for the Training Set
Not applicable. There is no AI/ML model being trained with a dataset, so there is no training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set for an AI/ML model, the concept of establishing ground truth for it does not apply.
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