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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

Device Description

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.

AI/ML Overview

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.

Acceptance Criteria Category	Specific Acceptance Criteria (Inferred)	Reported Device Performance
Risk Management	Device risk analysis completed and acceptable.	Risk Analysis performed. (Explicitly stated)
Sterility & Shelf Life	Sterilization information compliant with 2016 guidance; demonstrated sterility and a 2-year shelf life.	Sterilization information provided according to 2016 guidance, Invia White Foam NPWT is gamma sterilized and has been shown to have a shelf life of 2-years. (Explicitly stated)
Biocompatibility	Biocompatibility evaluation and testing completed according to ISO-10993 Part 1; direct contact with the tissue is considered safe for the intended use.	Biocompatibility evaluation and testing completed according to FDA guidance "Use of International Standard ISO- 10993, Biological Evaluation of Medical Devices Part 1: Evaluation and Testing." All tests passed demonstrating the biocompatibility of the Invia White Foam for its intended use. (Explicitly stated)
Usability/Human Factors	Usability Engineering Report prepared following FDA's 2016 guidance; device found to be safe and effective for intended users, uses, and environments when used with cleared components.	A Usability Engineering Report was prepared following FDA's 2016 guidance. It concludes that the Invia White Foam NPWT, used in conjunction with the previously cleared Invia Foam Dressing Kits with FitPad components (K170088) has been found to be safe and effective for the intended users, uses and use environments. (Explicitly stated)
Functional Performance (Fluid Removal)	Functionality and performance in conjunction with Invia Foam Dressing Kit, Invia Liberty, and Invia Motion pumps across minimal and maximal pressure settings in a wound model, under various worst-case scenarios and experimental settings. This includes constant vacuum value, efficient liquid removal, and proper notification functionality.	The Invia White Foam was tested to verify its functionality and performance in conjunction with the Invia Foam Dressing Kit with FitPad, the Invia Liberty, and the Invia Motion pumps at the minimal and maximal pressure settings using a wound model. Various worst case scenarios and experimental setting combinations were applied to validate the system performance. The Invia Liberty and the Invia Motion pumps both showed a constant vacuum value within the wound model, with efficient liquid removal discharged through the external suction interface and draining into the canister. In addition, the notification information functionality was found to be in accordance with pump specifications. (Explicitly stated)
Equivalence to Predicate (PVA Foam)	Equivalent performance to the predicate Genadyne PVA White Foam (K142646) in terms of vacuum performance and suction of fluid in a wound model across specified pressure settings, under worst-case conditions.	The Invia White Foam was tested to demonstrate equivalent performance to the predicate Genadyne PVA White Foam (K142646). Testing of the Invia White Foam NPWT in conjunction with the Invia Foam Dressing Kit with FitPad, the Invia Liberty and the Invia Motion pumps in comparison to the Genadyne XLR8 pump together with Genadyne's White Polyvinyl Alcohol (PVA) Foam across the specified pressure settings using a wound model was performed. The test results confirm equivalent vacuum performance and suction of fluid in the wound model throughout the entire duration of test when applying the worst case conditions. (Explicitly stated)

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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