(62 days)
The DOCD Demand Oxygen Conserving Device is indicated for use to conserve oxygen for patients prescribed 0 to 6 liters per minute of supplemental oxygen and use nasal cannulas and USP bottled oxygen.
The DOC Demand Oxygen Conserving Device is indicated for use to conserve oxygen for patients prescribed 1 to 6 liters per minute of supplemental oxygen and oxygen for paliente procente oxygen.
The Demand Oxygen Conserving Device or "DOCD" 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 DOCD 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 for 1 second and delivers the flow rate of oxygen set at the regulator to the patient. The valve closes and conserves the oxygen that would have been wasted during exhalation.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Demand Oxygen Conserving Device (DOCD). Unfortunately, the supplied text is quite limited regarding detailed study information, especially for what would typically be considered "acceptance criteria" in a medical device study (e.g., specific quantitative benchmarks like sensitivity, specificity, accuracy, etc., for a diagnostic device). This document focuses more on the functional performance of the device and its substantial equivalence to existing predicate devices.
Summary of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|---|
| Functional Performance | Detect patient inhalation and deliver oxygen for 1 second. Conserve oxygen during exhalation. | The DOCD is a battery-operated, microprocessor-controlled device with a capacitive breath sensor and a normally closed valve. It detects inhalation, opens the valve for 1 second, and delivers the set flow rate of oxygen. The valve closes during exhalation to conserve oxygen. Extensive functional testing "demonstrated that it meets its performance objectives." |
| Oxygen Conservation | Reduce or conserve the amount of oxygen used by the patient. | The device functions by delivering oxygen only during inhalation (1 second pulse), thus "conserv[ing] the oxygen that would have been wasted during exhalation." |
| Alarm Mechanisms | Alert the user for cannula disconnection/restriction or device malfunction. | Produces an audible alarm if no sufficient negative pressure is detected within 30 seconds (cannula issue). Produces an intermittent audible tone if the continuous self-check detects a microprocessor/software malfunction. |
| Battery Status | Provide indication of battery condition and low battery warning. | A selector switch setting ("Bat") illuminates a battery status light. In "On" position, a flashing Red light indicates low battery (below 1.10V). Power supply testing "included battery life testing and low power indicator testing." |
| Environmental Durability | Withstand various environmental conditions (impact/drop, storage temperature, EMI, ESD, surface temperature). | Testing "under various environmental conditions, including impact/drop testing, storage temperature testing, electromagnetic interference testing, electrostatic discharge testing and surface temperature testing" was performed and "demonstrated that it meets its performance objectives." |
| Power Supply | Adequate battery life and accurate low power indication. | "Power supply testing was also performed; these tests included battery life testing and low power indicator testing." This testing "demonstrated that it meets its performance objectives." |
| Substantial Equivalence | Be substantially equivalent in intended use and principle of operation to predicate devices (Invacare IPD Oxygen Conserving Device (K953852) and CHAD Therapeutics Oxymatic Electronic Oxygen Conserver (K852650)). | The DOCD is considered substantially equivalent. It shares the intended use (oxygen conservation) and principle of operation (electronic, breath sensor, normally closed valve) with the predicates. Specifically, like the Invacare IPD, it opens the valve for 1 second during inhalation. |
In-Depth Analysis of Study Information:
Based on the provided text, the "study" conducted for the Demand Oxygen Conserving Device (DOCD) primarily consisted of "Extensive functional testing" and environmental/power supply testing. This appears to be more of a verification and validation (V&V) effort against design specifications rather than a clinical trial or a formal statistical study with defined acceptance criteria for diagnostic accuracy or clinical outcomes.
Here's what can be extracted based on your requested points:
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A table of acceptance criteria and the reported device performance
- See table above. The acceptance criteria are inferred from the description of the device's intended function and the types of tests explicitly mentioned. Specific quantitative thresholds for these criteria are largely absent from this summary.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified. The document states "Extensive functional testing" and lists various categories of tests (environmental, power supply). It does not indicate the number of devices or test conditions used for this testing.
- Data Provenance: Not specified. Given the nature of V&V testing, it would generally be prospective data generated in a lab setting, likely at the manufacturer's facility in Torrance, California, USA (Medical Electronic Devices Corp. location).
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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)
- Not applicable/Not specified. This device performs a mechanical/electronic function (oxygen delivery based on breath detection) rather than an interpretative or diagnostic one that would typically require expert ground truth. The "truth" in this context would be whether the device correctly detects a breath, whether it opens the valve for 1 second, whether alarms function, etc., which are measurable physical parameters.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not specified. Adjudication methods are typically used in studies where there is subjective interpretation or borderline cases (e.g., image reading). For functional and environmental testing of a mechanical device, performance is typically objectively measured against pre-defined specifications.
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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
- No. This type of study (MRMC, AI assistance) is not relevant to a Demand Oxygen Conserving Device, which is a therapeutic rather than a diagnostic or imaging-assistance device.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Yes, in essence. The "Extensive functional testing" and environmental/power supply testing represent the standalone performance of the device. The device's operation (detecting breath, opening valve, alarming) is algorithmic/automatic based on its programming and sensor input, without continuous human intervention during its core function. The reported performance relates to the device operating independently.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device's performance testing would be objective physical measurements and adherence to design specifications. Examples would include:
- Breath Detection: Verified by simulating inhalation (negative pressure) and observing if the valve opens.
- Oxygen Delivery Duration: Measuring the actual valve open time (e.g., using a flow sensor and timer) to confirm it is 1 second.
- Alarm Functionality: Triggering specific conditions (e.g., no detected breath for 30s, low battery voltage) and verifying the correct alarm output.
- Environmental Performance: Exposing the device to specified conditions (e.g., temperature ranges, drop height) and then verifying continued functional operation.
- The "ground truth" for this device's performance testing would be objective physical measurements and adherence to design specifications. Examples would include:
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The sample size for the training set
- Not specified. This device does not appear to employ machine learning algorithms that require a "training set" in the conventional sense. Its operation is based on pre-programmed logic and sensor thresholds.
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How the ground truth for the training set was established
- Not applicable, as there's no mention of a traditional "training set" for a machine learning model. The device operates based on fixed engineering principles and pre-set parameters.
§ 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).