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The Nisus ONE Negative Pressure Wound Therapy System is indicated for use in patients who would benefit from negative pressure wound therapy particularly as the device allows wound management.

The Nisus ONE Negative Pressure Wound Therapy System is only intended to be used with the Cork NPWT Wound Dressing Kit (K132004)

The Nisus ONE Negative Pressure Wound Therapy System is suitable for use in both a professional healthcare facility and home use environment.

Cork Medical has developed a negative pressure wound therapy (NPWT) system with the same intended use as the predicate device (K140022). The subject device features a modified user interface, and an adjusted feature set intended to support ease of use, while maintaining the same fundamental therapeutic function and performance characteristics as the predicate device. The Nisus ONE Negative Pressure Wound Therapy System interface utilizes a single membrane switch keypad to power the device and switch between continuous and intermittent therapy modes.

The device display is limited to presenting critical operational parameters, including therapy mode, battery status, and target pressure settings. Visual and audible alarms are consistent with the predicate device (K140022) and alert critical battery, pressure leakage, system blockage, and full canister occur. While the Nisus ONE NPWT System's interface differentiates from the predicate Cork NPWT system, the mechanical components and therapy application are identical. The new model is intended to enhance accessibility by aligning with the needs of a broad and diverse patient population across various care settings.

The components included within the Nisus ONE NPWT System are:

• Nisus ONE Negative Pressure Wound Therapy Pump (OCMPP-100)
• Nisus ONE Pump Battery Charger (NIS-CHRG-A-18)
• Nisus NPWT Canister 500-mL (CPC-500)
• Nisus NPWT Canister 250-mL (CPC-250, previously cleared in K140022)

Accessory components are required to operate the device. Injection molded components are sonically welded to form a canister designed to mate with the pump and collect excess exudates, infectious material, and tissue debris. The Nisus NPWT Canister 250-mL design was previously cleared in the Nisus NPWT system 510k application (K140022). The Nisus NPWT Canister 500-mL is based on the same design as the Nisus NPWT Canister 250-mL. The dimensions were enlarged to provide a larger reservoir for patient convenience. Thus, the subject and predicate canisters have substantially equivalent characteristics.

The Wound Kit comes in multiple iterations containing a minimum of one port pad, wound foam and peel and stick drape. Integrated with the pump mechanism, these components ensure the safe and efficient removal of wound exudate. NPWT Accessories were previously cleared in K132004. Our application for the Nisus ONE NPWT system includes no revisions to these previously cleared components.

The provided FDA 510(k) clearance letter for the Nisus ONE Negative Pressure Wound Therapy System does not contain information related to an AI/ML-based device performance study.

The document details the substantial equivalence of the Nisus ONE system to a predicate device, focusing on changes to the user interface, physical dimensions, and technical specifications of a powered suction pump. The "Nonclinical Tests" section describes bench performance testing of the pump's functionality (e.g., pressure, alarms, flow rate) using simulated wound exudate and a test bed fixture, as well as software verification and validation, electrical safety, EMC, and usability testing. These are standard engineering and regulatory tests for medical devices, not performance studies of an AI/ML algorithm.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance for an AI/ML algorithm.
• Sample size, data provenance, expert qualifications, and adjudication methods for a test set related to an AI/ML algorithm.
• Details on MRMC studies or standalone AI performance.
• Information on training set size or ground truth establishment for an AI/ML algorithm.

The document explicitly states: "No Clinical Testing was required to support these 510(k) submissions. No clinical testing has been performed." This further indicates that no studies involving human data or expert review for AI/ML performance were conducted or reported in this submission.

If you have a document describing an AI/ML device, please provide that, and I would be happy to analyze it according to your criteria.

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The VERSA Negative Pressure Wound Therapy System is indicated for use in patients who would benefit from negative pressure wound therapy particularly as the device may promote wound healing by the removal of excess exudates, infectious material, and tissue debris.

The VERSA Negative Pressure Wound Therapy System is only intended to be used with the Cork NPWT Wound Dressing Kit (K132004) and the VERSA NPWT 100ml Canister.

The VERSA Negative Pressure Wound Therapy System is suitable for use in both a professional healthcare facility and home use environment.

The Cork Medical VERSA Negative Pressure Wound Therapy System is designed to provide gentle powered suction to treat and promote wound healing by aiding in the removal of excess exudates, infectious material, and tissue debris. The single button design makes applying negative pressure wound therapy for patients and physicians without compromising the power and performance demanded for wound management.

The VERSA NPWT System interface utilizes a single membrane switch keypad to power the device and switch between continuous and intermittent therapy modes. One button power on and off the pump and the other button switches pressure settings from 75 mm/Hg and 125 mm/Hg continuous and a 10 second hold on this button switches the pump to a variable intermittent mode, unlike its predecessor Cork NPWT System which uses multiple buttons and menus to adjust settings.

The VERSA NPWT System includes a therapy pump, 100 ml collection disposable canister, and carrying bag. The VERSA NPWT System is only intended to be used with the Cork NPWT Wound Dressing Kit.

The provided document is a 510(k) premarket notification for a medical device, the VERSA Negative Pressure Wound Therapy System (VCMPP-100). This submission is for a modification to an already cleared device (predicate device K230677), specifically to allow for home use and to implement a firmware update.

Based on the provided text, the device in question (VERSA Negative Pressure Wound Therapy System) is not an AI/ML device. The document describes a powered suction pump used for wound healing and does not mention any artificial intelligence or machine learning components. Therefore, the requested information regarding acceptance criteria and a study proving an AI/ML device meets them (including elements like sample sizes for test/training sets, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, etc.) cannot be extracted from this document as it pertains to an entirely different type of medical device.

The document primarily focuses on demonstrating substantial equivalence to a predicate device for a change in environment of use and a minor firmware update. The "Nonclinical Tests" section details a series of bench performance tests for alarm functions and usability testing, which are standard for traditional medical devices, not AI/ML systems.

Therefore, I am unable to provide a response that directly addresses the specific requirements for an AI/ML device's acceptance criteria and study, as the provided input does not describe such a device or its evaluation.

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The VERSA Negative Pressure Wound Therapy System is indicated for use in patients who would benefit from negative pressure wound therapy particularly as the device may promote wound healing by the removal of excess exudates, infectious material, and tissue debris.

The VERSA Negative Pressure Wound Therapy System is only intended to be used with the Cork NPWT Wound Dressing Kit (K132004).

The VERSA Negative Pressure Wound Therapy System is not intended for home use environments.

Cork Medical has developed a negative pressure wound therapy pump with the same intended use as its predicate device, Cork Medical Products Nisus Negative Pressure Wound Therapy System (K140022) but with a compacted footprint compared to the predict device.

The VERSA Negative Pressure Wound Therapy System interface utilizes a single membrane switch keypad to power the device and switch between continuous and intermittent therapy modes. One button power on and off the pump and the other button switches pressure settings from 75 mm/Hg and 125 mm/Hg continuous and a 10 second hold on this button switches the pump to a variable intermittent mode, unlike its predecessor Cork NPWT System (K140022) which uses multiple buttons and menus to adjust settings.

The provided text is a 510(k) premarket notification for the Cork Medical VERSA Negative Pressure Wound System. It details the device's characteristics, intended use, and comparison to a predicate device. However, it explicitly states, "No clinical testing is required to support these 510(k) submissions. No clinical testing has been performed."

This means the document does not contain any information regarding acceptance criteria, study designs, sample sizes, expert involvement, or adjudication methods related to human clinical performance studies (such as MRMC or standalone AI performance studies) that would typically involve establishing ground truth from patient data.

The "NONCLINICAL TESTS" section (page 7) describes bench performance testing which focuses on hardware functionality and safety, not on diagnostic or therapeutic accuracy in a patient population.

Therefore, I cannot provide the requested information. The document focuses on demonstrating substantial equivalence to a predicate device through non-clinical bench testing and adherence to electrical safety and software validation standards, rather than proving performance against specific clinical acceptance criteria through patient studies.

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The Nisus Touch Negative Pressure Wound Therapy Pump is indicated for use in patients who would benefit from negative pressure wound therapy particularly as the device may promote wound healing by the removal of excess exudates, infectious material, and tissue debris.

Cork Medical Products has developed a negative pressure wound therapy pump with the same intended use as its predicate device (K140022) but has the addition of an integrated touch screen. The Nisus Touch and Nisus pumps are nearly identical in appearance and utilize the same buttons to power the device and adjust pump settings; however, the Nisus Touch offers the alternative touch screen to easily maneuver between settings based on operator preference. Visual and audible alarms are consistent with the predicate device K140022 and alert the user when critical battery, pressure leakage, system blockage, and full canister occurs. Additionally, the Nisus Touch mechanical components and therapy application are identical to the Nisus pump. The intent of the new model is to appeal to users who encounter touch screens in daily technology and might feel navigation by touch screen is more simplistic.

The components included within the Cork Nisus Touch NPWT Pump are:

• Nisus Touch Negative Pressure Wound Therapy Pump
• Nisus Touch Pump Battery Charger

Accessory components are required to operate the device. Iniection molded components are sonically welded to form a canister designed to mate with the pump and collect excess exudates, infectious material, and tissue debris. The canister design was previously provided clearance within the Nisus NPWT system 510k application (K140022).

The Wound Kit comes in multiple iterations containing a minimum of one port pad, wound foam and peel and stick drape. These components are used in coniunction with the pump to ensure safe transfer of the wound debris to the canister. The NPWT Accessories were previously provided clearance on K132004. Our application for the Nisus Touch NPWT system includes no revisions to these previously cleared components.

This document describes the Nisus Touch Negative Pressure Wound Therapy Pump, a device that facilitates wound healing by removing exudates, infectious material, and tissue debris.

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly present a table of acceptance criteria with numerical targets. Instead, it states that the device underwent "bench performance testing to establish basic functionality" and that "The testing results show the Nisus Touch NPWT pump functioned as expected."

Based on the "NONCLINICAL TESTS" section, here are the tests conducted and the general performance reported:

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

The document refers to "bench performance testing" using "simulated wound exudate" and a "wound test bed fixture." No specific sample size (e.g., number of devices tested, number of simulated scenarios) is mentioned for this testing. The data provenance is from non-clinical bench testing, not from human subjects or clinical data. Therefore, there is no country of origin or retrospective/prospective classification in the typical sense.

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

Not applicable. The ground truth for this device's performance was established through engineering specifications and bench testing against those specifications. No human expert consensus was used to establish ground truth for this type of performance testing.

4. Adjudication Method for the Test Set:

Not applicable. As the testing was bench performance testing against engineering specifications, there was no need for an adjudication method by human experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical testing required to support this 510(k) submission. No clinical testing has been performed."

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

Given that this is a physical medical device (a negative pressure wound therapy pump) and not an AI/software algorithm intended for diagnostic or prognostic purposes, the concept of "standalone (algorithm only)" performance does not directly apply. The performance evaluated was the device's physical and software-controlled functionality.

7. The Type of Ground Truth Used:

The ground truth used for these non-clinical tests was based on engineering specifications and expected functional behavior of a negative pressure wound therapy pump, including adherence to established electrical safety, EMC, and usability standards. For example, alarms for leakage or blockage are expected to activate under specific simulated conditions according to design specifications.

8. The Sample Size for the Training Set:

Not applicable. This device is a physical medical device with integrated software for control, not a machine learning or AI algorithm that requires a "training set" in the context of learning data. The software within the device operates based on pre-programmed logic.

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

Not applicable, as there is no "training set" for a machine learning algorithm. The software functionality is based on established engineering principles and medical device requirements.

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The Cork Medical Products Nisus Negative Pressure Wound Therapy System is indicated for use in patients who would benefit from negative pressure wound therapy particularly as the device may promote wound healing by the removal of excess exudates, infectious material, and tissue debris.

Cork Medical Products has developed a negative pressure wound therapy system. The Cork Medical Products Nisus Negative Pressure Wound Therapy System is indicated for use in patients who would benefit from negative pressure wound therapy particularly as the device may promote wound healing by the removal of excess exudates, infectious material, and tissue debris.

The components included within the Cork NPWT System are:

• Nisus Negative Pressure Wound Therapy Pump
• Nisus NPWT Canister 250-mL
• Nisus Pump Battery Charger
• Cork Medical Products NPWT Wound Dressing Kit – Medium
• Cork Medical Products NPWT Wound Dressing Kit - Large

This document is a 510(k) premarket notification for the "Cork Medical Products Nisus Negative Pressure Wound Therapy System." It details the device, its intended use, and a comparison to a predicate device to establish substantial equivalence.

Here's an analysis of the provided text in relation to your questions:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" for each performance test in a tabular format with corresponding reported performance metrics for the Cork Medical Products Nisus NPWT System. Instead, it states that "All biocompatibility test results were negative and passed the pre-defined test acceptance criteria," and that nonclinical tests were conducted "to ensure the Cork Medical Products Nisus Negative Pressure Wound Therapy System is substantially equivalent to the Genadyne A4 Wound Dressing Vacuum System Kit and A4-XLR8 Foam Dressing." This implies the acceptance criteria for the nonclinical tests were equivalence to the predicate device's performance characteristics.

The comparison table on pages 5 and 6 provides a direct comparison of technical data between the new device and the predicate device. This essentially serves as the 'performance' of both devices that the FDA used to determine substantial equivalence.

Here's a summarized table based on the provided "Predicate Product Comparison Table" and "Nonclinical Tests" section, inferring acceptance criteria as being substantially equivalent to the predicate:

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

• Sample size for nonclinical tests: Not explicitly stated for each test beyond "head to head performance testing," "Canister Real-Time Aging," and "Wound Dressing Kit Aging." For the biocompatibility tests, the sample size refers to the "wound foam and wound drape components" and "individual components included in the Cork Medical Products Wound Dressing Kit." Specific numbers are not provided.
• Data provenance: The tests were conducted internally by Cork Medical Products ("Cork Medical conducted head to head performance testing") and a Biocompatibility Risk Assessment was completed by "Nelson Laboratories." The data origin is thus from Cork Medical's testing and a third-party lab. No information about country of origin of the data or whether it was retrospective or prospective is mentioned, which is typical for premarket notifications focus on non-clinical engineering and bench testing.

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

Not applicable. This device is a negative pressure wound therapy system, not an AI/imaging device requiring expert interpretation for ground truth. The "ground truth" for its performance is derived from physical measurements (pressure, flow, alarm functionality) and standardized biocompatibility testing.

4. Adjudication method for the test set

Not applicable. As noted above, this device does not involve expert adjudication for establishing ground truth, as it's a mechanical/electrical 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

Not applicable. This device is not an AI-assisted diagnostic or 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, but a physical medical device.

7. The type of ground truth used

• Nonclinical Performance Tests: The "ground truth" for the nonclinical performance tests (e.g., pressure, alarms) was established through engineering and bench testing protocols using "simulated wound exudate" and a "wound test bed fixture." The implicit ground truth standard for these tests was the demonstrated performance of the legally marketed predicate device.
• Biocompatibility Tests: The ground truth was based on international standards, specifically ISO 10993 testing standards, with predefined acceptance criteria for cytotoxicity, intracutaneous reactivity, and sensitization.

8. The sample size for the training set

Not applicable. This device does not use machine learning or AI, and therefore does not have "training sets" in that context. Its performance is based on engineering design and testing, not learned data.

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

Not applicable (as above).

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