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510(k) Data Aggregation
(169 days)
The 6203 is indicated for use to conserve oxygen for patients prescribed 1 to 6 liters per minute of supplemental oxygen and use nasal cannulas and USP bottled oxygen.
The Wave Conserver Model 6203 is indicated for use to conserve oxygen for patients prescribed 1 to 6 liters per minute of supplemental oxygen and use of a nasal cannula and USP bottled oxygen.
The 6203 with integrated pressure regulator 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 6203 is a battery operated electronic device that is microprocessor controlled and contains a 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 flow rate set on the device and delivers a preset bolus of oxygen to the patient as determined by the device flow rate algorithm. The valve closes and conserves the oxygen that would have been wasted during the end of inhalation and during exhalation.
This device is an oxygen conserver and its performance is described in terms of its functional capabilities, alarm system, and environmental robustness, rather than diagnostic accuracy. As such, the typical acceptance criteria and study components requested for AI/ML devices (like sample size for test sets, expert ground truth, MRMC studies, or standalone performance) are not applicable or provided in this 510(k) summary.
Here's an analysis based on the provided text, focusing on what is relevant for this type of medical device:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Tests Performed | Reported Device Performance |
|---|---|---|
| Functional Performance | Delivering appropriate bolus size for given liter flow settings (1-6 lpm) | Met performance objectives; Chart 1 details bolus sizes delivered (e.g., 1 lpm: 15 ml, 6 lpm: 81 ml). |
| Alarm System | Detect insufficient negative pressure (apnea) within 45 seconds | Produces audible alarm tone if no sufficient negative pressure detected within 45 seconds. |
| Detect microprocessor failure | Flow/apnea light lights steady red if microprocessor fails. | |
| Environmental Robustness | Impact/drop testing | Demonstrated that it meets its performance objectives. |
| Storage temperature testing | Demonstrated that it meets its performance objectives. | |
| Electromagnetic interference testing | Demonstrated that it meets its performance objectives. | |
| Electrostatic discharge testing | Demonstrated that it meets its performance objectives. | |
| Surface temperature testing | Demonstrated that it meets its performance objectives. | |
| Power Supply | Battery life testing | Demonstrated that it meets its performance objectives. |
| Low power indicator testing | Battery LED winks every 2 seconds (3 hours remaining), every 1 second (30 minutes remaining), then lights steady (unit shut down). |
2. Sample Size Used for the Test Set and Data Provenance
- Not Applicable. The submission describes "Extensive functional testing" and testing under "various environmental conditions" for device performance. There is no mention of a human-centric or data-driven "test set" in the context of an AI/ML diagnostic device. The testing appears to be engineering and design validation on the physical device itself.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- Not Applicable. See point 2. The "ground truth" here is the device's adherence to its design specifications and safety standards, validated through engineering tests, not expert consensus on medical images or patient data.
4. Adjudication Method for the Test Set
- Not Applicable. See point 2 and 3.
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 a demand oxygen conserving device, not an AI/ML diagnostic or assistive tool for human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical electronic device, not a standalone algorithm. Its performance is inherent to its design and function. The device's operation is "algorithm only" in the sense that its microprocessor controls the valve based on its internal programming (e.g., the bolus size chart).
7. The Type of Ground Truth Used
- The "ground truth" for this device's performance is its engineering specifications and design requirements. This includes:
- Validated bolus delivery volumes corresponding to specified liter flow settings (Chart 1).
- Accurate detection of pressure changes indicating inhalation.
- Reliable alarm activation for apnea/disconnection and microprocessor failure.
- Durability and resilience to environmental factors (impact, temperature, EMI/ESD).
- Correct indication of battery status and low power.
8. The Sample Size for the Training Set
- Not Applicable. As a hardware device with embedded software (not a machine learning model), there is no concept of a "training set" in the conventional AI/ML sense. The device's software logic is developed based on engineering principles and validated through testing.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. See point 8. The "ground truth" for the device's design would be derived from clinical requirements for oxygen delivery, respiratory physiology, and safety standards for medical devices, which informed the device's engineering specifications.
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(69 days)
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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