(266 days)
The EPIFLO-28 is intended to provide topical oxygen to treat 1) skin ulcerations due to diabetes, venous stasis, post-surgical infections and gangrenous lesions, 2) pressure ulcers, 3) amputations/infected stumps, 4) skin grafts, 5) burns, and 6) frostbite.
EPIFLO-28 is an oxygen delivery device that incorporates a disposable oxygen concentrator. It consists of (1) the oxygen concentrator, and (2) the sterile cannula. The oxygen concentrator is a single patient, single use, disposable, battery-operated device that is capable of delivering 98 to 100 percent oxygen continuously for twenty eight days at a rate of ~3.0 ml/hour. The cannula conveys the oxygen from the oxygen concentrator to the area beneath the bandage overlying the wound.
The provided text is a 510(k) Summary for the EPIFLO-28 device. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria with quantified performance metrics against a defined ground truth.
Therefore, many of the requested elements for describing specific acceptance criteria and a study proving their attainment are not explicitly present in the provided text. The document describes performance testing to validate specifications and clinical studies for biocompatibility and usability but does not detail a study designed to prove acceptance criteria in the manner usually seen for AI/ML device clearances (e.g., sensitivity, specificity, AUC against a gold standard).
However, I can extract the information that is available and indicate where the requested information is not provided.
Acceptance Criteria and Device Performance (as inferred or generally stated):
| Acceptance Criteria (Inferred from 510(k) Summary) | Reported Device Performance (from 510(k) Summary) |
|---|---|
| Oxygen Delivery Duration: Continuous oxygen delivery for a specified period. | EPIFLO-28 delivers continuous oxygen for 28 days. (Predicate delivered for 15 days). |
| Oxygen Concentration: Delivery of near 100% pure oxygen. | EPIFLO-28 delivers 98 to 100 percent oxygen. |
| Oxygen Flow Rate: Consistent oxygen delivery rate. | EPIFLO-28 delivers oxygen at a rate of ~3.0 ml/hour. |
| Biocompatibility: No adverse biological reactions with patient contact. | Biocompatibility testing for enclosure (cytotoxicity, sensitization, irritation) and cannula (cytotoxicity, sensitization, irritation, material mediated pyrogenicity) were performed. A toxicological risk assessment found no chemical compound above the conservative threshold of toxicological concern. Clinical study evaluated local tissue response to the delivery cannula, showing a reduction in pro-inflammatory cytokines, proteases, and macrophages at Week 4. |
| Usability: User-friendly for lay users and healthcare professionals. | Usability study conducted with lay users (n=17) and healthcare professionals (n=18). (A separate clinical study with the predicate device also assessed usability with n=61 patients.) |
| Safety and Effectiveness: Comparable to the predicate device. | Concluded to be "as safe and as effective as the predicate device" based on performance tests and clinical validation. |
| EMC Compatibility: Meets electromagnetic compatibility requirements. | EMC compatibility testing was performed. |
| LED Operation: Indicator lights function correctly. | LED operation verification was performed, with EPIFLO-28 having two indicator LEDs (green and red) for normal operation and error state/end of life. |
Detailed Study Information:
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Sample size used for the test set and the data provenance:
- Biocompatibility (local tissue response): Wounds from an unspecified number of subjects were evaluated. Data provenance is not specified (e.g., country of origin, retrospective/prospective).
- Usability (EPIFLO-28): 17 lay users and 18 healthcare professionals. Data provenance is not specified.
- Usability (Predicate device): 61 patients over up to 12 weeks. Data provenance is not specified.
- For performance testing related to oxygen delivery specifications, LED operation, and EMC compatibility, specific sample sizes and data provenance are not provided.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / Not explicitly stated. For a medical device like the EPIFLO-28 (a topical oxygen delivery system), the "ground truth" for performance is typically objective measurements (e.g., oxygen concentration, flow rate, duration). For biocompatibility, it involves laboratory tests and clinical evaluation of tissue response by qualified personnel (e.g., pathologists, clinicians), but the number and specific qualifications are not detailed. For usability, the "ground truth" is user feedback and observations, not an expert-established clinical diagnosis.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable / Not explicitly stated. This type of adjudication method is usually relevant for diagnostic devices where subjective interpretation of images/data by multiple experts is involved to establish a consensus ground truth. For this device, performance is evaluated by objective measurements and biocompatibility by laboratory findings and clinical observations.
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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, an MRMC study was not done. This type of study is specific to diagnostic AI/ML systems where human readers interpret medical images/data. The EPIFLO-28 is a therapeutic device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. The EPIFLO-28 is a physical medical device, not an AI/ML algorithm. Its "performance" inherently involves its physical operation, not an algorithm's output.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Biocompatibility: Laboratory test results (cytotoxicity, sensitization, irritation, pyrogenicity, extractables/leachables analysis) and clinical evaluations of wound fluid, tissue punch biopsies for pro-inflammatory cytokines, proteases, and macrophages.
- Usability: User feedback, observations, and responses to questions in case report forms.
- Performance (Oxygen Delivery, etc.): Objective measurements against engineering specifications.
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The sample size for the training set:
- Training set concept is not applicable. As this is a physical medical device and not an AI/ML system, there is no "training set" in the context of machine learning.
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How the ground truth for the training set was established:
- Not applicable. See point 7.
§ 878.5650 Topical oxygen chamber for extremities.
(a)
Identification. A topical oxygen chamber for extremities is a device that is intended to surround a patient's limb and apply humidified oxygen topically at a pressure slightly greater than atmospheric pressure to aid healing of chronic skin ulcers such as bedsores.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance: Topical Oxygen Chamber for Extremities.” See § 878.1(e) for the availability of this guidance document.