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The Invia Abdominal Dressing Kit is indicated for temporary bridging of abdominal wall openings where primary closure is not possible and/or repeat abdominal entries may be required. Its intended use is with patients who have open abdominal wounds with exposed viscera and organs, and including but not limited to patients with abdominal compartment syndrome. It is intended for use in acute hospital settings (trauma, general and plastic surgery wards) and should ideally be applied in the operating theatre. The dressing kit is intended for use together with the Invia Liberty NPWT System.

The Invia Abdominal Dressing Kit consists of an Organ Contact Layer (OCL), two foam pads, four transparent films and a suction interface (Invia FitPad).

• -The OCL is an oval polyurethane film with fenestrations intended to protect the abdominal content and enable fluid drainage from the abdomen.
• -The foam pad is an oval hydrophobic polyurethane foam with open cell structure intended to be placed over the OCL in order to distribute the negative pressure across the wound surface and allow passage of fluids and exudates through to the negative pressure system.
• -The transparent film is a thin transparent polyurethane film with acrylic adhesive intended to fixate the wound filler and seal tight to the skin.
• The Invia FitPad is intended to distribute negative pressure to the wound and transport exudates from the abdominal cavity to the canister of the Invia Liberty Negative Pressure Wound Therapy (NPWT) pump.
  The components of the Invia Abdominal Dressing Kit are packaged sterile and are for single use only.

The provided document is a 510(k) summary for the Medela AG Invia Abdominal Dressing Kit. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with specific acceptance criteria and performance metrics in the way a clinical trial for a novel drug or high-risk device might.

Therefore, the information typically requested in your prompt regarding acceptance criteria, a standalone study, sample sizes, expert ground truth, adjudication methods, and MRMC studies, is largely not directly applicable or available in this document. This submission relies heavily on non-clinical tests to show that the new device performs similarly to its predicate.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in a quantitative, measurable sense for a clinical outcome. Instead, it demonstrates performance equivalence through non-clinical testing by comparing the Invia Abdominal Dressing Kit to its predicate. The "acceptance" can be inferred as successfully demonstrating equivalent functionality in laboratory settings.

2. Sample Size for Test Set and Data Provenance:

• Non-clinical Performance Testing (Wound Model): The document mentions "a wound model, simulated wound exudates, and multiple pressure sensors." It also states "Multiple vacuum settings over 30 minutes and 73 hours were used." However, a specific numerical sample size (e.g., number of test runs, number of models) is not provided. The provenance is laboratory testing.
• Human Factors Validation Testing: "15 surgeons" were used. The provenance is internal usability testing.

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

• Usability Experts: "Three usability experts" conducted heuristic evaluations. No specific qualifications beyond "usability experts" are provided in the document.
• Surgeons for Human Factors Validation: "15 surgeons with experience operating on open abdomens" were used. This indicates relevant expertise for the device's intended use. No further detailed qualifications (e.g., years of experience, subspecialty) are provided.

4. Adjudication Method for the Test Set:

• There is no mention of an adjudication method in the context of the non-clinical or human factors testing. These were primarily performance-based or observation-based assessments.

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

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "Clinical testing was not required to demonstrate the substantial equivalence of the Invia Abdominal Dressing Kit to its predicate device." This type of study focuses on device performance in a laboratory setting compared to a predicate, not how human readers improve with AI assistance.

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

• This question is not applicable. The Invia Abdominal Dressing Kit is a physical medical device (dressing kit for negative pressure wound therapy), not an AI algorithm. Its performance is inherent to its physical properties and interaction with the NPWT system, not an algorithm.

7. Type of Ground Truth Used:

• Non-clinical Performance Testing: The "ground truth" was established by physical measurements and simulated conditions within a controlled laboratory wound model, using established scientific principles and comparison to a legally marketed predicate device under identical test conditions.
• Human Factors Validation: The "ground truth" was established by observing user performance (surgeons) against predefined usability scenarios and identifying errors or successful task completion.

8. Sample Size for the Training Set:

• This question is not applicable. This is a physical medical device, not a machine learning model, so there is no "training set" in the context of AI.

9. How the Ground Truth for the Training Set was Established:

• This question is not applicable as there is no training set.

In summary:

This 510(k) submission primarily relies on non-clinical (laboratory) performance testing and human factors validation (usability) to demonstrate substantial equivalence to a predicate device. It explicitly states that clinical testing was not required. The "acceptance criteria" are therefore implicit in the successful demonstration that the device performs functionally and safely at least as well as the predicate in relevant non-clinical and simulated use environments.

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The Invia White Foam in conjunction with the Invia Foam Dressing Kits with FitPad, the Invia Motion and Invia Liberty Negative Pressure Wound Therapy (NPWT) systems is indicated for patients who would benefit from a suction device (Negative Pressure Wound Therapy) as it creates an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and perfusion, and by removing exudate and infectious material.

The Invia White Foam is appropriate for use for the following wounds:

• Acute or sub-acute wounds
• Chronic wounds
• Dehisced wounds
• Pressure ulcers
• Diabetic/neuropathic ulcers
• Venous insufficiency ulcers
• Traumatic wounds
• Partial thickness burns
• Flaps and grafts

The Invia White Foam is a single packed, sterile, polyvinyl alcohol (PVA) foam intended for use in conjunction with the previously cleared Invia Foam Dressing Kit with FitPad (K170088), Invia Motion (K161128) and Invia Liberty (K142626) negative pressure wound therapy (NPWT) systems. It is a stand-alone wound dressing used as an alternative or as a supplement to the wound dressing in the Invia Foam Dressing Kit with FitPad. The Invia White Foam is available in two sizes (small, large). The Invia White Foam is for use by healthcare professionals in acute, extended and home care settings.

The Invia White Foam NPWT is an open cell, hydrophilic, PVA foam moistened in sterile water. Like other NPWT foams, the Invia White Foam NPWT is an effective wound dressing, allowing a controlled application of sub-atmospheric pressure to the local wound environment to remove wound exudate. The Invia White Foam NPWT allows the passage of fluid through the foam and away from the wound bed. The foam can be used with both constant and intermittent NPWT delivery. It is able to be cut to size to suit a particular wound size.

This document is a 510(k) premarket notification approval letter from the FDA for a medical device called "Invia White Foam NPWT". It outlines the device's characteristics, intended use, and a summary of non-clinical tests conducted to demonstrate substantial equivalence to predicate devices. It explicitly states that clinical testing was not required.

Therefore, many of the requested details about acceptance criteria, study sample size, expert involvement, and ground truth establishment for a human-AI comparative study or standalone algorithm performance are not applicable to this document. This submission did not involve a study for an AI-powered diagnostic device, but rather a negative pressure wound therapy (NPWT) foam.

However, I can extract the information related to the acceptance criteria and performance of this non-AI device from the "Summary of Non-Clinical Tests" section.

Here's a breakdown of the requested information, indicating where it's not applicable (N/A) for this specific FDA submission:

1. A table of acceptance criteria and the reported device performance

Based on the "SUMMARY OF NON-CLINICAL TESTS" section, the device's performance was evaluated against established standards and predicate device performance.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: This refers to the number of physical devices or samples tested in the non-clinical studies (e.g., how many foam samples for biocompatibility, how many units for sterilization testing, how many test runs in the wound model). The document does not specify the exact number of samples tested for each non-clinical evaluation (e.g., "The Invia White Foam was tested..." rather than "100 samples of the Invia White Foam were tested...").
• Data Provenance: The document does not specify the country of origin for the data or whether the non-clinical studies were prospective or retrospective. These types of studies are inherently prospective as they involve conducting new tests.

3. 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)

N/A. This device is a negative pressure wound therapy foam, not an AI-powered diagnostic device that requires expert review for "ground truth" establishment in a clinical setting. The "ground truth" for its performance is based on engineering and materials science principles and direct measurement of physical properties (e.g., pressure, fluid removal).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

N/A. As above, this is not an AI diagnostic study requiring multi-reader adjudication.

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

N/A. This is not an AI diagnostic device. No human-in-the-loop studies or MRMC studies were conducted. The non-clinical studies focused on the performance of the device itself and its equivalence to predicate devices, not on human readers or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

N/A. This is not an AI algorithm. Its "standalone performance" refers to its physical and functional properties, as described in the table above, not an algorithmic output.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

For this device, the "ground truth" is established by:

• Adherence to recognized standards (e.g., ISO-10993 for biocompatibility).
• Direct measurement against physical and functional specifications (e.g., achieving constant vacuum, efficient fluid removal).
• Comparative performance against a legally marketed predicate device in a wound model.

8. The sample size for the training set

N/A. This is not an AI device, so there is no training set in the context of machine learning.

9. How the ground truth for the training set was established

N/A. As above, this is not an AI device, so there is no training set or ground truth establishment in that context.

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