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PICO 7 is indicated for patients who would benefit from a suction device (Negative Pressure Wound Therapy) as it may promote would healing via removal of low to moderate levels of exudate and infectious materials. Appropriate wound types include: Chronic, Acute, Traumatic, Subacute and dehisced wounds, Partial-thickness burns, Ulcers (such as diabetic or pressure), Flaps and grafts, Closed Surgical incisions. PICO 7 Single Use Negative Pressure Wound Therapy System is suitable for use both in a hospital and homecare setting.

PICO 7 Single Use Negative Pressure Wound Therapy System is a small, lightweight, portable, magnet containing electro-mechanical pump system connected through a flexible tube to a super-absorbent, gentle adhesive dressing. Secondary fixation strips are also provided to ensure an adequate seal is achieved. The pump, the dressing and fixation strips are supplied sterile and for single use. PICO 7 was designed to deliver negative pressure wound therapy to low and to moderate exudate levels of acute and chronic wound types. PICO 7 Single Use Negative Pressure Wound Therapy System is suitable for use in both a hospital and homecare setting.

Based on the provided text, the acceptance criteria and the study proving the device meets them can be summarized as follows:

The device in question is the PICO 7 Single Use Negative Pressure Wound Therapy System.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not explicitly present a formal "acceptance criteria" table with specific quantitative benchmarks for each test. Instead, it describes the conditions under which tests were performed and states that the device "meets the test requirements" or "can be used for their intended purposes." The table below synthesizes the implied criteria and reported performance from the "Non-Clinical Tests (Bench)" section.

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

The document does not specify a numerical sample size for the "test set" in the traditional sense of a clinical trial. The "Non-Clinical Tests (Bench)" section refers to "Wound Model Testing of PICO 7 Kits" with various dressing sizes (10x20cm, 25x25cm, small multisite 15x20cm, large multisite 20x25cm dressings). This suggests a variety of kits were tested.

The data provenance is from bench testing and human factors studies. There is no mention of country of origin for this testing, but the submitting company is "Smith & Nephew Medical Limited" from the "United Kingdom." The tests are described as "Non-Clinical Tests (Bench)" and a "summative study" for human factors, indicating controlled laboratory or simulated environment testing, not retrospective or prospective clinical data from human subjects for performance evaluation.

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

This information is not provided in the given document. The "Non-Clinical Tests (Bench)" section describes physical assessments of fluid management and pressure, which do not typically involve human experts establishing a "ground truth" in the same way clinical image analysis would.

For the "Human Factors" study, "Critical tasks were identified following a risk management process and a series of preliminary testing carried out with the two identified user groups. Healthcare Professionals and Lay Users, in order to optimize the design." While it mentions "Healthcare Professionals," the number and specific qualifications of any experts involved in defining "safe and effective" for the human factors study are not detailed.

4. Adjudication Method for the Test Set

Adjudication methods (like 2+1, 3+1) are typically used in clinical studies involving human observers or readers interpreting data to establish ground truth. As the primary performance evaluation here relies on bench tests measuring physical parameters (fluid management, pressure), an adjudication method is not applicable or described. For the human factors study, there's no mention of an adjudication process for observed user performance or feedback.

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

No, an MRMC comparative effectiveness study was not done. The document focuses on bench testing, human factors, biocompatibility, and electrical safety to demonstrate substantial equivalence, not a comparative clinical effectiveness study involving human readers with and without AI assistance.

6. Standalone Performance Study (Algorithm Only)

No, a standalone (algorithm only) performance study was not done. This device is a physical medical device (negative pressure wound therapy system), not an AI algorithm. Therefore, "standalone algorithm performance" is not relevant in this context. The standalone performance here would refer to the device's ability to maintain pressure and manage fluid, which was assessed in the bench tests.

7. Type of Ground Truth Used

For the "Non-Clinical Tests (Bench)":

• Physical measurements/parameters: The "ground truth" for these tests was defined by the physical test requirements and measured outcomes (e.g., fluid flow rates, pressure ranges, test time percentages). These are objective, quantifiable criteria.

For the "Human Factors" study:

• User observation and feedback against safety/effectiveness criteria: The "ground truth" for determining if the device was "safe and effective for its intended users" was established through the human factors study findings, likely including observed user actions, task completion rates, error analysis, and user feedback against pre-defined usability and safety criteria.

8. Sample Size for the Training Set

This information is not applicable and not provided. This is a physical medical device, not an AI/machine learning algorithm that requires a training set.

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

This information is not applicable. As mentioned above, there is no AI algorithm or training set for this device.

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