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The Theia NPWT Foam Wound Dressing Kit is intended to be used in conjunction with the Simex Negative Pressure Wound Therapy Pumps (K113291) for the application of negative pressure wound therapy to the wound. When used in conjunction with the Simex Negative Pressure Wound Therapy Pumps, the Theia NPWT Foam Wound Dressing Kit is indicated for patients who would benefit from a suction device, particularly as the device may promote wound healing by removal of excess exudates, infectious material and tissue debris.

The Theia NPWT Foam Wound Dressing Kit is appropriate for use on the following wounds;

• Pressure Ulcers
• · Diabetic/Neuropathic Ulcers
• Venous Insufficiency Ulcers
• · Traumatic Wounds
• · Post-Operative and Dehisced Surgical Wounds
• · Skin Flap and Grafts

The Theia NPWT Foam Wound Dressing Kit without the pump includes a foam dressing composed of a reticulated flexible polyether based polyurethane hydrophobic foam material, an occlusive drape and silicon suction dome with negative pressure tubing. Theia NPWT Foam Wound Dressing Kits are available in three sizes; 1) small, 2) medium and 3) large.

The provided text is a 510(k) Summary for the Theia NPWT Foam Wound Dressing Kit. It describes the device and its claimed substantial equivalence to a predicate device, the UNI NPWT Foam Wound Dressing Kit (K133333).

Based on the document, the following can be extracted:

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

The document does not specify quantitative acceptance criteria or a direct performance table for the Theia NPWT Foam Wound Dressing Kit against such criteria. Instead, it relies on substantial equivalence to a predicate device. The "Technical Characteristics: Feature Comparison Chart" (page 4) lists features of both the proposed device and the predicate device, showing identical characteristics across all listed categories. This implies that the 'acceptance criteria' are met by demonstrating that the device is identical in all relevant technical characteristics to the legally marketed predicate device.

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

The document explicitly states: "No clinical study was conducted" (page 5). Therefore, there is no test set, no sample size, and no data provenance from clinical data for this specific device. The device's safety and effectiveness are established through non-clinical testing and comparison to a predicate device. The non-clinical testing for the Theia NPWT Foam Wound Dressing Kit is stated to be "identical to the testing conducted in K133333 for the predicate device." However, the results or details of that non-clinical testing (including sample sizes, if applicable) are not provided in this document.

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)

Not applicable, as no clinical study with a test set was conducted.

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

Not applicable, as no clinical study with a test set was conducted.

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

Not applicable. This is a medical device (wound dressing kit) and not an AI-powered diagnostic or interpretive tool that would involve human readers or AI assistance.

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

Not applicable. This is a medical device (wound dressing kit) and not an algorithm.

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

Given that no clinical study was conducted, there is no ground truth established from clinical data for this device. The basis for acceptance is substantial equivalence to a legally marketed predicate device, meaning the 'ground truth' for its performance and safety is implicitly derived from the predicate's regulatory clearance and presumed safe and effective use. The non-clinical testing for the predicate is stated to be the basis for this device.

8. The sample size for the training set

Not applicable, as no clinical study was conducted and there is no AI component requiring a training set.

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

Not applicable, as no clinical study was conducted and there is no AI component requiring a training set.

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The UNI NPWT Foam Dressing Kit is intended to be used in conjunction with the Simex Negative Pressure Wound Therapy Pumps (K113291) for the application of negative pressure wound therapy to the wound. When used in conjunction with the Simex Negative Pressure Wound Therapy Pumps, the UNI NPWT Foam Dressing Kit is indicated for patients who would benefit from a suction device, particularly as the device may promote wound healing by removal of excess exudates, infectious material and tissue debris.

The UNI NPWT Foam Dressing Kit is appropriate for use on the following wounds:

• Pressure Ulcers
• Diabetic/Neuropathic Ulcers
• Venous Insufficiency Ulcers
• Traumatic Wounds
• Post-Operative and Dehisced Surgical Wounds
• Skin Flap and Grafts

The UNI NPWT Foam Dressing Kit without pump is manufactured using a reticulated flexible polyether based polyurethane hydrophobic foam material. The UNI NPWT Foam Dressing Kit includes the (1) foam dressing, (2) occlusive drape and (3) silicon suction dome with (4) negative pressure tubing.

UNI NPWT Foam Dressing Kit is available in three sizes; 1) small, 2) medium and 3) large.

Here's an analysis of the acceptance criteria and study information based on the provided document:

This document is a 510(k) premarket notification for a medical device called the "UNI NPWT Foam Dressing Kit." It primarily focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and performance data from a standalone clinical trial for novel device approval.

It's important to note that for a 510(k) submission, the "acceptance criteria" are often related to demonstrating equivalence to a predicate device through non-clinical testing and comparison of technological characteristics, rather than meeting pre-defined clinical performance metrics for a completely new device.

Based on the provided text, here's the information as requested:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Size: Not applicable in the context of a 510(k) non-clinical submission. The document explicitly states: "No clinical study was conducted." The "test set" here refers to samples of the device and predicate device used for mechanical and biocompatibility testing, not patient data.
• Data Provenance: The document does not specify the country of origin for the non-clinical test data. The tests are based on recognized international (ISO) and national (ASTM, USP) standards. The study is not a clinical study, so terms like "retrospective" or "prospective" clinical data don't apply. It's a non-clinical, laboratory-based study.

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

• Not applicable. As no clinical study was conducted, there was no "ground truth" derived from expert consensus for clinical outcomes. The "ground truth" for the non-clinical tests would be the established scientific and engineering principles behind the test methods (e.g., how to measure tensile strength, how to assess cytotoxicity).

4. Adjudication Method for the Test Set

• Not applicable. There was no clinical study involving human assessment or interpretation for which adjudication would be needed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of how much Human Readers Improve with AI vs without AI Assistance

• Not applicable. This device is a negative pressure wound therapy foam dressing kit, not an AI-powered diagnostic or assistive technology. No MRMC study was performed.

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

• Not applicable. This device is a dressing kit, not an algorithm or software.

7. The Type of Ground Truth Used

• Non-Clinical Ground Truth: For the mechanical and biocompatibility tests, the "ground truth" is defined by the validated and standardized test methods themselves (e.g., ISO 10993, ASTM F88, USP pyrogen test). The results are compared against these established standards or directly against the predicate device's performance under identical testing conditions. There is no pathology, outcomes data, or expert consensus on clinical findings mentioned to establish a "ground truth."

8. The Sample Size for the Training Set

• Not applicable. There is no "training set" as this is not a machine learning or AI device.

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

• Not applicable. As no training set exists, no ground truth was established for it.

Summary of the Study:

The study described is a non-clinical comparative study designed to demonstrate substantial equivalence of the UNI NPWT Foam Dressing Kit to a legally marketed predicate device (Genadyne Biotechnologies, Inc. A4-XLR8 Foam Dressing) per 21 CFR 807.92(a)(6) and 807.92(b)(1). The key findings are:

• Technological Characteristics Comparison: The device shares the same indications for use, uses similar materials (flexible polyether and polyester polyurethane foam), is hydrophobic, sterile, and offered in various sizes as the predicate.
• Non-Clinical Testing: A series of standardized biocompatibility tests (cytotoxicity, irritation, sensitization, systemic toxicity, bacterial endotoxins, pyrogen) and physical/mechanical tests (sterilization, seal strength, dye penetration, foam properties) were conducted.
• Mechanical Comparative Test: A specific mechanical comparative test against the predicate demonstrated substantial equivalence in terms of tensile strength, stress (elongation), ultimate elongation, tear resistance, and fluid removal rate.
• No Clinical Study: Importantly, no clinical studies were performed to establish safety or effectiveness directly from patient data. The assertion of safety and effectiveness relies on the demonstrated substantial equivalence to a device already deemed safe and effective.

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