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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):

Detailed Study Information:

1. 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.

2. 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.

3. 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.

4. 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.

5. 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.

6. 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.

7. 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.

8. How the ground truth for the training set was established:

   • Not applicable. See point 7.

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The EPIFLO System 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 is an oxygen delivery system 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 seven or fifteen days (depending on the model) 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 describes the EPIFLO System, a transdermal continuous oxygen therapy device. However, it does not include a detailed study or specific acceptance criteria for device performance in the way typically expected for a medical device with measurable outcomes like accuracy or sensitivity/specificity.

Instead, the performance testing section (Section 7) states: "Testing was conducted to validate that the EPIFLO performed according to its specifications. These tests included performance testing for oxygen delivery per the specification for labeled durations, EMC compatibility and sterilization validation."

This indicates that the acceptance criteria were related to the device's functional specifications (e.g., oxygen delivery rate, duration, safety features) rather than clinical efficacy or diagnostic accuracy, as this is an oxygen delivery system, not a diagnostic or screening tool.

Given the information, I can only describe the reported device performance as it relates to its functional specifications, as specific metrics for clinical efficacy are not provided in this document.

Here's the breakdown of what can be extracted and what is not available in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document only states that testing was conducted to validate performance "according to its specifications." Specific numerical acceptance thresholds (e.g., "oxygen delivery must be 3.0 +/- 0.1 ml/hour") are not explicitly stated, but the reported performance values are presented as meeting these underlying, implied specifications.

2. Sample Size Used for the Test Set and Data Provenance

This information is not provided in the document. The text mentions "Performance Testing" but does not detail the methodology, sample sizes, or nature of the test set (e.g., in-vitro, in-vivo, clinical subjects).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided. As this is a device for oxygen delivery, not a diagnostic system requiring expert interpretation of images or data, the concept of "ground truth" established by clinical experts in the traditional sense (e.g., radiologists for imaging) is not directly applicable to the functional performance testing described. Ground truth for functional tests would typically be established by calibrated measurement instruments.

4. Adjudication Method for the Test Set

This information is not provided.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A multi-reader multi-case (MRMC) comparative effectiveness study was not done or at least not described in this document. Such studies are typically for diagnostic or screening devices where human readers interpret data, often with and without AI assistance, to measure changes in diagnostic performance. The EPIFLO System is an oxygen delivery device, not a diagnostic tool requiring human interpretation.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The described performance testing focuses on the device's functional operation (oxygen delivery rate, purity, duration, EMC, sterilization). This is inherently a "standalone" evaluation of the device's physical and operational characteristics without human intervention influencing its core function. However, it's not "algorithm-only" performance as the device's primary function is mechanical/chemical oxygen generation and delivery, not data processing.

7. Type of Ground Truth Used

For the functional performance testing described (oxygen delivery, EMC, sterilization), the ground truth would likely be established by:

• Instrumental Measurement: Calibrated sensors and measurement tools for oxygen flow rate, purity, and duration.
• Standardized Test Methods: Protocols for EMC (Electromagnetic Compatibility) and sterilization validation, which typically have defined pass/fail criteria.
  The document does not explicitly state the type of ground truth used, but these are the standard approaches for such device validations.

8. Sample Size for the Training Set

This information is not provided. As the EPIFLO System is a physical medical device (oxygen concentrator and cannula) and not an AI/ML algorithm requiring a training set, this question is not applicable in the context of this device.

9. How the Ground Truth for the Training Set Was Established

This information is not provided and is not applicable, as the device is not an AI/ML algorithm that requires a training set and corresponding ground truth.

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