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510(k) Data Aggregation
(69 days)
PULSED OXYGEN CONSERVING DEVICE, POCD
The POCD Pulsed Oxygen Conserving Device is indicated for use to conserve oxygen for patients prescribed 1 to 4 liters per minute of supplemental oxygen and use nasal cannulas and USP bottled oxygen.
The Pulsed Oxygen Conserving Device or "POCD" is 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 POCD is a battery operated electronic device that is microprocessor controlled and contains a capacitive breath sensor and a normally closed valve. When installed between the oxygen supply and patient's nasal cannula, the device detects the patient's inhalation opens the valve according to the device's breath skipping algorithm and delivers a preset bolus of oxygen to the patient. The valve closes and conserves the oxygen that would have been wasted during the end of inhalation and during exhalation.
The provided text describes a 510(k) submission for a Pulsed Oxygen Conserving Device (POCD). The submission focuses on demonstrating substantial equivalence to predicate devices through functional and environmental testing. However, the document does not contain the level of detail requested for acceptance criteria and a study proving those criteria, especially regarding clinical performance, human readers, or detailed ground truth establishment.
Here's a breakdown of what can be extracted and what information is missing:
1. Table of Acceptance Criteria and Reported Device Performance
The document describes functional, environmental, and power supply testing, and states that the device "meets its performance objectives and complies with applicable FDA guidelines." However, specific quantitative acceptance criteria for these tests are not provided, nor are the reported numerical results to compare against such criteria.
| Acceptance Criteria Category | Specific Acceptance Criteria (None explicitly stated in document) | Reported Device Performance (General statement only) |
|---|---|---|
| Functional Testing | e.g., Breath detection response time within X ms, Oxygen bolus volume within Y mL of target, Breath skipping algorithm accuracy within Z% | "demonstrated that it meets its performance objectives" |
| Environmental Testing | e.g., Withstands drop from X height, Operates within Y to Z temperature range, EMC compliance to standard A, ESD compliance to standard B | "demonstrated that it meets its performance objectives" |
| Power Supply Testing | e.g., Battery life of X hours at Y setting, Low battery indicator accuracy | "demonstrated that it meets its performance objectives" |
| Alarm Package | e.g., Disconnection alarm triggers within X seconds, Malfunction alarm triggers correctly | (Implied through functional testing, but no specific performance reported) |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not specified. The document mentions "Extensive functional testing" and testing under "various environmental conditions," but does not quantify the number of devices or test conditions.
- Data Provenance: Not specified. The testing described appears to be laboratory-based and conducted by the manufacturer, Medical Electronic Devices Corp. There is no mention of clinical data, patient origin, or retrospective/prospective study design regarding performance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. The described testing is technical and functional, not clinical where expert-established ground truth would typically be relevant (e.g., for diagnostic accuracy). The intended use is described, but no clinical study with expert ground truth is detailed.
4. Adjudication Method for the Test Set
Not applicable. Since no clinical test set with human assessment and ground truth establishment is described, there's no mention of an adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. The document makes no mention of an MRMC study or any study comparing human readers with and without AI assistance. The device is a "Pulsed Oxygen Conserving Device," not an AI diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device itself is an "algorithm only" device in a sense, as its core function (breath sensing, valve actuation, breath skipping) is automated. The "Performance Data" section describes "Extensive functional testing" which would fall under standalone testing of the device's operational characteristics. However, this is not a diagnostic algorithm.
7. The Type of Ground Truth Used
For the functional and environmental testing described:
- Ground Truth: Engineering specifications, design requirements, and applicable FDA guidelines. The device's performance was likely compared against these pre-defined technical standards.
For the breath skipping algorithm, the document states it is a "clinically proven method of maintaining equivalent blood oxygen saturation versus prescribed continuous oxygen flow rates and used in all three of the predicate devices." This implies that the concept of the algorithm has clinical backing from predicate devices, but the document does not detail a clinical study where the POCD's breath-skipping performance was verified against physiological ground truth (e.g., direct blood oxygen saturation measurements) for this specific device.
8. The Sample Size for the Training Set
Not applicable. This device is a hardware-based electromechanical device controlled by software and a fixed algorithm (breath skipping algorithm, alarm logic). It does not appear to use machine learning or AI that would require a "training set" in the conventional sense for a diagnostic algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there's no mention of a training set for machine learning. The "ground truth" for its operational logic would be based on engineering design, clinical understanding of oxygen delivery, and the established principles demonstrated by its predicate devices.
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