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Venturi™ Gauze Wound Care Sets with Portal Drain are intended to be used with the Talley Group range of negative pressure wound therapy pumps. The Talley Group NPWT pumps are indicated use for patients with acute or chronic wounds that may be benefitted by the application of continual negative pressure to the wound for removal of fluids, including wound exudate, irrigation fluids, and infectious materials. The device is intended for use by qualified healthcare professionals in a healthcare environment.

NPWT is contraindicated for patients with:

1. Malignancy in the wound
2. Untreated osteomyelitis
3. Non-enteric and unexplored fistulas
4. Wounds with difficult haemostasis
5. Necrotic tissue with eschar present
6. Exposed vasculature, bone, nerves, or organs.

With the exception of the Portal Drain, there are no changes to the components in the currently marketed gauze dressing kits cleared in 510(K) K080897. The wound care sets connect to Negative Pressure Wound Therapy (NPWT) suction pumps to carry exudate from the wound.

The Venturi™ Gauze Wound Care Sets with Portal Drain consist of the following components:

Venturi™ Gauze Wound Care Set: Kerlix Antimicrobial gauze wound filler, adhesive film dressing, Portal Drain Assembly; 20ml saline solution and comes with measuring tape and instructions for use. These are supplied as sterile and single use.

The Venturi™ MINO Gauze Wound Care sets are have identical contents with the addition of a canister that attaches to the Venturi™ MINO NPWT device to contain the exudate.

The Portal Drain assembly is consist of the portal drain which is adhered to a window dressing and is connected to the drain tube which connects at the other end to the NPWT pump via the canister connector assembly. There is a 90° drain tube guide and pinch clamp at the pump end of the assembly for additional safety.

The window dressing end of the Portal Drain Assembly is self-adhesive and a small hole is cut in the adhesive film dressing directly over the gauze and the Portal Drain Assembly is placed over the adhesive window dressing ensuring the portal drain is lined up with the hole. The other end of the tubing attaches to the pump to carry exudate from the wound.

The provided text describes a 510(k) premarket notification for the "Venturi Gauze Wound Care Sets With Portal Drain" and the FDA's determination of substantial equivalence. This document does not describe a study involving an AI/Machine Learning device or its acceptance criteria and performance.

The device in question is a medical dressing kit for Negative Pressure Wound Therapy (NPWT), and its substantial equivalence was determined based on its similarity to existing predicate devices and bench testing, not clinical or AI-related studies.

Therefore, I cannot provide the requested information as it pertains to AI acceptance criteria and study details. However, I can extract information about the predicate devices and the general testing approach for this non-AI medical device:

Device: Venturi™ Gauze Wound Care Sets with Portal Drain (K151263)

Predicate Devices:

• Venturi™ NPWT v.II Advanced Vacuum System (K080897) - Manufacturer: Talley Group
• Avance® Foam Dressing Kits (K122132) - Manufacturer: Mölnlycke Health Care US, LLC

Testing Approach Summary (for this non-AI device):
The device's substantial equivalence was established through:

• Comparison of intended use, design, and technological characteristics to predicate devices.
• Confirmation that the new component (Portal Drain Assembly) performs the same function as equivalent components in predicate devices.
• Bench testing to demonstrate that the device does not introduce any additional risks and meets its intended use.

Specific answers to your questions based on the provided text (and why most cannot be answered for an AI device):

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

   • Cannot provide this for AI. The document states "The bench testing has demonstrated that the device does not introduce any additional risks when undertaking Negative Pressure Wound Therapy and meeting the intended use." No specific quantitative acceptance criteria or performance metrics (like sensitivity, specificity, AUC) are listed because it's a physical device, not an AI algorithm.

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

   • Cannot provide this for AI. This device underwent "bench testing." Details about the sample size or provenance of data for bench tests are not provided in this summary.

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. This was bench testing for a physical device, not expert-adjudicated ground truth for an AI algorithm.

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

   • Not applicable. This was bench testing for a physical device.

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:

   • No, this was not done. This is a physical wound care device, not an AI system. The document explicitly states "No clinical data was required."

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

   • Not applicable. This is not an algorithm.

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

   • Not applicable for AI. For the physical device, conformity to established engineering standards and functional performance during bench testing served as the "ground truth" to show safety and effectiveness.

8. The sample size for the training set:

   • Not applicable. As this is a physical device, there is no "training set" in the context of machine learning.

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

   • Not applicable. There is no training set for an AI algorithm here.

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The Talley Venturi™ MiNO TG600/14 is intended for use for patients with acute or chronic wounds that may be benefitted by the application of continual negative pressure wound therapy to the wound for removal of fluids, including wound exudate, irrigation fluids, and infectious materials. The device is intended for use by qualified healthcare professionals in a healthcare environment.

Negative Pressure Wound Therapy (NPWT) is a wound care therapy that uses suction via an electrical pump and a wound dressing.

Vacuum Pump Unit: Venturi MiNO NPWT TG600/14
Construction: Flame Retardant ABS
Dimensions / Weight: 105mm x 52mm x 112mm / 290g
Pressure Range: 80mmHg and 120mmHg

Here's an analysis of the provided text regarding the Venturi MiNO TG600/14 device, focusing on acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes performance tests but does not explicitly state "acceptance criteria" in a quantitative, pass/fail threshold manner that would be typical for clinical studies. Instead, it describes general performance checks and comparisons to predicate devices.

Important Note: The document focuses on production unit testing for quality control and comparison to predicate devices, rather than a clinical study with quantifiable clinical outcome-based acceptance criteria or performance metrics (like sensitivity, specificity, accuracy) typically seen for diagnostic or AI-based devices. The "performance" here refers to the device meeting its specified technical functionalities.

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

The document does not describe a test set in the context of clinical or AI performance evaluation. The "tests" described are manufacturing quality control checks performed on 100% of production units (canister vacuum test, vacuum pump test, soak test, final system test).

• Sample Size for Test Set: Not applicable as this is a manufacturing quality control and non-clinical comparison for substantial equivalence, not a clinical study or AI model evaluation. The tests are applied to 100% of manufactured units.
• Data Provenance: The data comes from internal manufacturing testing of Talley Group Ltd. in Great Britain. This is non-clinical, internal test data.

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

Not applicable. Ground truth, in the context of clinical or AI studies, involves expert-derived labels or diagnoses. The tests described are functional and performance-based, where the "truth" is whether the device meets its engineering specifications. There is no mention of experts establishing a "ground truth" for these engineering tests.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1, 3+1) are used to resolve disagreements among multiple experts when establishing ground truth for clinical or image-based studies. This document describes functional engineering tests, not a study requiring expert 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

No. This document does not describe an AI medical device, nor does it present any MRMC comparative effectiveness study. The device is a "Negative pressure wound therapy pump," which is a physical medical device, not an AI or diagnostic imaging tool.

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

Not applicable. This device is not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the tests described is the engineering specification and expected functional behavior of the device (e.g., maintaining 120mmHg vacuum, air-tightness, correct alarm function). This is determined by the device's design and manufacturing standards, not by expert consensus, pathology, or outcomes data in a clinical sense.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI algorithm requiring a training set.

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

Not applicable. This device is not an AI algorithm.

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