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The Cardinal Health NPWT device is an integrated wound management system, indicated for the application of continual or intermittent negative pressure wound therapy. The system may promote wound healing by the removal of fluids, including wound exudates, irrigation fluids and infectious materials. The system is intended for patients with chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts. The system is intended for use in acute, extended and home care settings.

The Cardinal Health NPWT system consists of a powered suction pump device that provides continuous or intermittent negative pressure (SVED – K142916, PRO/PRO to GO/PRO at HOME – K143016, PRO HC – K150124) with a built-in placement holder for the fluid collection canister, various sizes and shapes of polyurethane foam dressing, canister tubing with clamps and connectors, polyurethane drape with adhesive, and fluid collection canisters. The pump devices are AC-powered, portable suction devices with battery backup that provide localized negative pressure to remove fluids and infectious materials from the wound. The devices must be used with the Cardinal Health NPWT dressing kits, which are available in various foam sizes. Each Cardinal Health NPWT dressing kit contains an occlusion detection tubing set. various sizes of polyurethane foam, and a polyurethane drape with adhesive.

The purpose of this submission is to modify 1) the tubing in the dressing kits and 2) the disposable fluid collection canister to allow detection of blockage or an occlusion that may occur in the dressing or within the tubing, which in turn triggers an alarm on the pump. The modification consists of a dual lumen tubing set with a twist and lock port that attaches to a disposable fluid collection canister. The canister is modified with three ports in the cap of the canister. One port accepts the twist and lock end of the tubing set for collection of exudate from the wound, and two ports connects to sensors within the pump device. The modifications to the tubing set and the fluid collection canister cap do not require any software or hardware changes to the NPWT pump devices. There are no changes to the Indications for Use for any of the NPWT devices.

This document is a 510(k) premarket notification for a medical device modification, not a study report detailing performance of an AI/ML algorithm. Therefore, many of the requested criteria regarding AI model performance, training sets, ground truth establishment, expert adjudication, and MRMC studies are not applicable.

However, I can extract the relevant information from the provided text regarding the device modification and its acceptance criteria as presented in a regulatory context.

The device in question is a Cardinal Health NPWT Occlusion Detection Dressing Kit and Canister, a modification of an existing Negative Pressure Wound Therapy (NPWT) system. The modification aims to allow the detection of blockages or occlusions in the dressing or tubing, triggering an alarm on the NPWT pump.

Here's a breakdown of the information based on your request, focusing on what can be gleaned from a 510(k) submission for a physical device modification:

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

The document does not explicitly present a table of quantitative acceptance criteria with corresponding performance metrics like a typical AI/ML study would. Instead, it lists the types of bench testing conducted to verify the intended performance of the physical modifications. The "acceptance criteria" are implied to be "proper functioning as intended" for each test.

2. Sample sized used for the test set and the data provenance

• Sample Size: The document refers to "Bench Testing" but does not specify the sample sizes (e.g., number of dressing kits, canisters, or test runs) for each type of test.
• Data Provenance: The document does not provide details on data provenance like country of origin or whether the data was retrospective or prospective. Given it's bench testing for a physical device, this level of detail is typically not reported in a 510(k) summary for such modifications.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is a physical device modification, not an AI/ML diagnostic or prognostic device requiring expert-established ground truth from medical images or clinical data. The "ground truth" for these tests would be the controlled experimental conditions and the direct measurement of the device's functional response.

4. Adjudication method for the test set

Not applicable. As this is not a study requiring human interpretation or labeling, there would be no adjudication method.

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 not an AI/ML study.

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

Not applicable. This is not an AI/ML algorithm. The device itself (the tubing and canister modification) performs the "detection" of the occlusion, which then triggers an existing alarm system on the pump. It's a mechanical/sensor-based function, not an algorithm.

7. The type of ground truth used

For this physical device modification, the "ground truth" for the bench testing would be the controlled experimental conditions designed to simulate blockages, measure pressure, and evaluate exudate removal. The success or failure is determined by whether the device functions within pre-defined engineering specifications for detecting blockages and triggering alarms, maintaining pressure, and removing exudate. This is not established by expert consensus, pathology, or outcomes data in the way an AI/ML model for diagnosis would be.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a "training set."

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

Not applicable. As there is no training set mentioned or implied for an AI/ML model, this question is not relevant.

Summary of what the document does tell us about proving the device meets criteria:

• The study done was bench testing.
• The purpose of the testing was to verify that the modifications (dual lumen tubing, modified canister with three ports) perform as intended by allowing the detection of blockages/occlusions and triggering an alarm on the pump.
• The specific tests included:
  • Proper functioning of device features and alarms (specifically the new occlusion detection alarm).
  • Pressure stability testing.
  • Exudate removal testing.
  • Usability testing.
• The conclusion was that the performance data demonstrated the modifications function as intended with no change in safety or effectiveness compared to the predicate device, leading to a determination of substantial equivalence.
• No clinical or animal performance studies were required for this specific substantial equivalence determination for the modification.

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The Cardinal Health NPWT Irrigation Tubing Set and Delivery Set are intended for use with the Cardinal Health NPWT SVED, PRO Family and PRO HC devices, which are indicated for the application of continual or intermittent negative pressure wound therapy to the wound as the device may promote wound healing by the removal of fluid including wound exudates, irrigation fluids, body fluids and infectious materials. The NPWT system is intended for patients with chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts. The NPWT system is intended for use in acute, extended and home care settings, however wound irrigation is not intended for use in a home care setting.

The Cardinal Health NPWT Irrigation Tubing Set consists of single-lumen PVC tubing, a pinch clamp, an adhesive SpeedConnect flange and a universal luer lock connector wherein the caregiver can attach the universal connector to an irrigation source obtained by the caregiver. The Cardinal Health NPWT Irrigation Delivery Set consists of single-lumen PVC tubing with an integrated irrigation solution bag (to be filled by the caregiver), tubing roller clamp and an adhesive SpeedConnect flange to provide a convenient way for caregivers to utilize the proprietary simultaneous irrigation feature with the various Cardinal Health NPWT devices. The tubing sets are supplied sterile and will be available as new accessories to the PRO HC and PRO family devices.

The provided text is a 510(k) Summary for a medical device (Cardinal Health NPWT Irrigation Tubing Set and Delivery Set). It describes the device, its intended use, and indicates that non-clinical performance data was provided to support substantial equivalence.

However, the document does not contain the detailed study information required to answer your request regarding acceptance criteria and a study proving the device meets those criteria. Specifically, it states:

• **"The following non-clinical performance data were provided in support of the substantial equivalence determination:
  • Pressure stability testing with irrigation using a worst-case dressing set spanning the range of pressure settings
  • Irrigation bag printed scale accuracy test"**

This lists the types of tests performed, but does not provide:

• A table of acceptance criteria
• The reported device performance against those criteria
• Sample sizes used for the test set or data provenance
• Information about experts establishing ground truth or adjudication methods
• Details about MRMC comparative effectiveness studies
• Confirmation of standalone algorithms
• Type of ground truth used
• Training set size or ground truth establishment for training data

The document concludes that "The non-clinical tests demonstrate that the irrigation tubing sets are compatible with the Cardinal Health NPWT PRO HC and PRO family devices, function as intended and therefore are equivalent to the predicate devices for their intended use." This is a general conclusion, not a detailed report of the study results against specific criteria.

Therefore, based only on the provided text, I cannot complete the requested tables and information. The document focuses on demonstrating substantial equivalence through non-clinical testing, rather than providing a detailed clinical or performance study report with specific acceptance criteria and outcome metrics.

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