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The Cardinal Health NPWT PRO HC system is an integrated wound management system, 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 fluids, including wound exudates, irrigation fluids, body 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 PRO HC system is an AC-powered, portable suction device with battery backup that provides localized negative pressure when used with the Cardinal NPWT Dressings to remove fluid, irrigation solutions and infectious materials from the wound. The systems consist of a powered suction pump device with a built-in placement holder for the fluid collection canister, various sizes and shapes of polyurethane foam dressings, canister tubing with clamps and connectors, and polyurethane drapes with adhesive. The systems are intended for use on patients with chronic, acute, traumatic, sub-acute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts. The Cardinal Health NPWT PRO HC system provides care in the acute, extended and home care settings.

The Cardinal Health NPWT PRO HC system functions the Cardinal Health NPWT PRO devices. The Cardinal Health NPWT PRO HC system includes a built-in placement holder for the 300cc or 500cc collection canisters. It has a pushbutton ON/OFF operation with five userselectable pressure settings. The system produces optional negative pressure settings of 50mmHg. 75mmHg. 100mmHg. 125mmHg. and 150mmHg. It has alarms for Low Pressure/Leak. Full Canister, and Low Battery and an alert when the device is due for service. These alarms include both audible and visual indications.

The purpose of this 510(k) submission is to introduce the Cardinal Health NPWT PRO HC system. The Cardinal Health NPWT PRO HC system is identical to the NPWT PRO with the exception of: 1) addition of two motorized pumps for increased air flow volume; (2) one additional battery; and (3) a slightly larger case to accommodate the additional pumps and battery. The user interface for the PRO HC is identical to the PRO.

The provided text describes a 510(k) premarket notification for the Cardinal Health NPWT PRO HC System, a negative pressure wound therapy device. The submission focuses on demonstrating substantial equivalence to a predicate device (Cardinal Health NPWT PRO Family) rather than proving the device meets new acceptance criteria for clinical efficacy. The device is a powered suction pump, and the "acceptance criteria" discussed are primarily related to its functional performance and safety, ensuring it performs comparably to the predicate device.

Here's an analysis of the provided information concerning acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Non-Clinical (Bench) Tests: The document does not specify a numerical sample size for the individual bench tests (e.g., how many times each pressure setting was tested, or how many simulated leaks were induced). These are typically engineering verification tests.
• Electrical Safety & EMC Tests: No specific sample size is given. These tests are usually conducted on a representative sample of the finished device.
• Software Verification & Validation: No specific sample size is given for tests of the software itself beyond the general statement of "testing was conducted."
• Clinical Usability Testing:
  • Sample Size: 17 healthcare providers and 16 patients (total 33 subjects).
  • Data Provenance: The study was conducted in a "home care setting," implying it was conducted domestically (likely USA, given the FDA submission context) and would be considered prospective for the usability aspect. The data relates to the predicate device (NPWT PRO) but is stated to be applicable to the PRO HC due to identical user interfaces.

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

• Functional, Electrical Safety, EMC, Software Tests: The "ground truth" for these tests is based on engineering specifications, recognized national/international standards (e.g., IEC 60601 series), and FDA guidance for software. These are not typically established by human experts in a "ground truth" sense, but rather by objective measurements against predefined criteria.
• Clinical Usability Testing: The "ground truth" was whether participants could properly use the device and meet "predetermined acceptance criteria." These criteria would have been established by the device manufacturer, likely with input from clinical experts or human factors engineers. The qualifications of these specific experts are not detailed in the provided text. The participants themselves (17 healthcare providers and 16 patients) were the subjects whose performance was evaluated against these criteria.

4. Adjudication Method for the Test Set

• For the functional, electrical safety, EMC, and software tests, adjudication is not explicitly described. These are objective tests where results either meet the specification/standard or they do not.
• For the Clinical Usability Testing, the document states, "All 33 subjects met the predetermined acceptance criteria." This implies a clear set of criteria were established beforehand, and subjects' performance was evaluated against these. There is no mention of an "adjudication method" like 2+1 or 3+1, which are typically used for subjective diagnostic interpretations. It was a direct assessment against predefined performance tasks.

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 MRMC or AI Comparative Effectiveness Study was done. This device is a medical pump for negative pressure wound therapy, not a diagnostic imaging device utilizing AI. The focus of the submission is on physical and software performance and user interaction, not on improving human reader performance with AI.

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

• No standalone "algorithm only" performance was done in the context of AI. As mentioned above, this is not an AI-driven diagnostic device. The "standalone" performance closest to this concept would be the device's functional performance (e.g., maintaining negative pressure) as measured in bench testing, independent of direct human interaction other than setting it up.

7. The type of ground truth used

• Functional Performance: Engineering specifications and objective measurements (e.g., pressure readings, alarm activation).
• Electrical Safety & EMC: Compliance with international standards (IEC 60601 family).
• Software Verification & Validation: Adherence to software development lifecycle processes and satisfactory performance during testing against requirements, guided by FDA software guidance.
• Clinical Usability Testing: Predetermined acceptance criteria for task performance and absence of new risks, likely established by human factors experts/designers, with patients' and healthcare providers' successful completion of tasks serving as the empirical data.

8. The Sample Size for the Training Set

• Not applicable in the context of typical AI/ML model training. The software on this device is stated as "firmware control of the device" in the full 510(k) and is not described as involving a learning algorithm that requires a "training set" in the machine learning sense. The software undergoes traditional verification and validation.

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

• Not applicable, as there is no "training set" in the AI/ML sense described for this device.

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The Cardinal Health NPWT PRO/PRO to GO/PRO at Home systems are an integrated wound management system. 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 fluids, including wound exudates, irrigation fluids, body fluids and infectious materials. The systems are intended for patients with chronic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), The systems are intended for use in acute, extended and home care settings.

The Cardinal Health NPWT PRO family of systems are AC-powered, portable suction devices with battery backup that provide localized negative pressure wound therapy when used with the Cardinal NPWT Dressings to remove fluid, irrigation solutions and infectious materials from the wound. The systems consist of a powered suction pump device with a built-in placement holder for the fluid collection canister, various sizes and shapes of polyurethane foam dressings, canister tubing with clamps and connectors, and polyurethane drapes with adhesive. The systems are intended for use on patients with chronic, acute, traumatic, sub-acute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts. The Cardinal Health NPWT PRO family of systems provides care in the acute, extended and home care settings.

The provided document is a 510(k) summary for the Cardinal Health NPWT PRO/PRO to GO/PRO at Home Systems. It outlines the device description, indications for use, comparison with a predicate device, and performance data submitted to support substantial equivalence.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state formal "acceptance criteria" for the device's main therapeutic function (wound healing or fluid removal) in a quantitative manner. Instead, the performance data focuses on demonstrating safety, basic functionality, and usability comparable to a predicate device.

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

• Clinical Usability Testing:
  • Sample Size: 34 adult Healthcare Professionals (HCPs) and lay-user Subjects as patient/caregiver surrogates.
  • Data Provenance: The study was a "single-center" evaluation, implying a single location (country not specified, but likely US given FDA submission). It was a "simulated use" study, making it prospective observational data for usability, not clinical efficacy in actual patient settings.

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

• Electrical Safety, EMC, Software V&V: These tests are typically performed by engineers and technicians following established protocols. The document does not specify the number or qualifications of experts involved in these specific tests.
• Clinical Usability Testing: The "Healthcare Professionals (HCPs)" served as subjects testing the device's usability. Their qualifications are not explicitly detailed beyond being "Healthcare Professionals." The "ground truth" for this test would be the objective observation of their interactions with the device and their subjective feedback on its usability and any errors/challenges encountered. No external experts were explicitly mentioned for establishing a ground truth of the usability itself, as the users were the evaluators.

4. Adjudication Method for the Test Set:

• Clinical Usability Testing: The document states that a "final interview to capture root cause for any use errors or close calls, and any remaining Subject feedback or questions was conducted." This suggests a form of 1:1 interview and data collection from each participant, rather than a multi-expert adjudication panel for the test results. There's no mention of a formal 2+1 or 3+1 adjudication method. For the other performance tests (Electrical Safety, EMC, Software V&V), these are typically pass/fail criteria based on objective measurements against standards, so adjudication is not usually applicable in the same way.

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

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted for this device. This type of study is typically used for diagnostic devices (e.g., imaging AI) and involves comparing human reader performance with and without AI assistance across multiple cases. The Cardinal Health NPWT system is a therapeutic device, not a diagnostic one, so an MRMC study is not relevant here.

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

• Not applicable. This device is a physical, powered suction pump system, not an AI algorithm. Its function inherently involves a human user (HCP or patient/caregiver). Performance is not assessed as an "algorithm only" in the way an AI diagnostic tool would be. The "software verification and validation testing" evaluates the internal logic and safety of the device's software, which is a component of the overall system, but not in a "standalone algorithm" context for clinical efficacy.

7. Type of Ground Truth Used:

• Electrical Safety & EMC: Compliance with international safety standards (IEC 60601 series). The "ground truth" is adherence to these objective, measurable standards.
• Software Verification & Validation: Adherence to defined software requirements and FDA guidance. The "ground truth" is the confirmation that the software performs as specified and safely.
• Clinical Usability Testing: Observations of user interaction, identification of use errors or close calls, and subjective feedback from the users (HCPs and lay-user surrogates). The "ground truth" here is the objective and subjective data collected on the device's practical usability.

8. Sample Size for the Training Set:

• Not applicable / Not explicitly stated. This device is a hardware system with embedded software. It is not an AI/machine learning device that typically involves a distinct "training set" of data in the way a diagnostic algorithm (e.g., for image analysis) requires. The software developed for the device would have undergone development and testing, but not typically referred to as a "training set" in this context.

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

• Not applicable. As implied above, this is not an AI/ML device requiring a data training set with established ground truth labels in the typical sense. The software development process would involve establishing "ground truth" for its own functionality through design specifications, coding standards, and rigorous testing against those specifications.

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