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The PREVENA RESTOR(TM) Incision Management System is intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudate via the application of negative pressure wound therapy.

The negative pressure technology for the subject device is the same as that for the predicate device systems. The PREVENA RESTOR™ dressing is a component of the PREVENA RESTOR™ Incision Management System. The systems provide surgical incision management via the application of negative pressure wound therapy over an incision site that has been closed with sutures or staples. The systems are applied to the incision site immediately after surgery for up to seven (7) days depending on the surgeon's preference. The pump in the therapy unit delivers continuous negative pressure at -125 mmHg through tubing connected to a PREVENA RESTOR™ dressing placed over the incision site. The integrated one-piece dressing, which includes an occlusive film, provides a negative pressure environment and protects the incision from external contamination. The application of negative pressure draws the incision edges together and removes fluid from the incision site into a canister fitted to the therapy unit.

The provided text is a 510(k) summary for the PREVENA RESTOR™ Incision Management System. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving a device meets specific acceptance criteria through clinical studies typical of novel algorithms.

Therefore, the requested information regarding "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of an FDA 510(k) clearance for this device is not applicable in the way it might be for a new AI/ML-based diagnostic device requiring performance against clinical endpoints.

Instead, the submission relies on demonstrating that the new device (PREVENA RESTOR™) is substantially equivalent to previously cleared predicate devices (K180855, K161897, K153199) by comparing technological characteristics and showing that a specific performance aspect (delivery of continuous negative pressure) is equivalent.

Here's a breakdown of the relevant information provided, with explanations for why some requested elements are not present:

1. Table of acceptance criteria and the reported device performance

• Acceptance Criteria: For this 510(k) submission, the "acceptance criteria" were demonstrating substantial equivalence to predicate devices in areas such as design, materials, principles of operation, mode-of-action, safety, performance, type of packaging, and indications for use.
• Reported Device Performance:
  • Performance Claim: The PREVENA RESTOR™ Incision Management System is substantially equivalent to the predicate in the delivery of continuous negative pressure at -125 mmHg within specifications under worst-case conditions of air leak rate and fluid input over the intended duration of use.

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

• Not Applicable in this context. The "test set" here refers to bench testing performed on the device itself, not a clinical data set or a dataset for an AI algorithm. The text describes "bench testing" to demonstrate performance, but does not specify sample sizes or data provenance for this engineering testing. It falls under "non-clinical tests."

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 device is a negative pressure wound therapy system, not a diagnostic AI/ML algorithm requiring expert ground truth for interpretation of medical images or other diagnostic data. The "ground truth" for its performance is its ability to mechanically deliver negative pressure as specified, which is evaluated through engineering bench tests, not expert review.

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

• Not Applicable. As explained above, this is not a study assessing diagnostic performance where adjudication methods for ground truth would be relevant.

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-assisted diagnostic device. Therefore, no MRMC study or assessment of human reader improvement with AI assistance would have been performed.

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

• Not Applicable. This is a medical device, not a standalone algorithm.

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

• Not Applicable in the traditional sense of diagnostic devices. For this mechanical device, the "ground truth" for its function is its ability to maintain a specified negative pressure. This is determined by engineering measurements against known physical standards and specifications during bench testing.

8. The sample size for the training set

• Not Applicable. This device does not involve machine learning or AI, and therefore does not have a "training set."

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

• Not Applicable. As there is no training set, there is no ground truth to establish for it.

Summary regarding the study:

The study referenced is "Bench testing" which demonstrated substantial equivalence to predicate devices. This bench testing focused on the device's ability to maintain continuous negative pressure at -125 mmHg within specifications under various conditions (worst-case air leak rate and fluid input) over its intended duration of use. The 510(k) states that "No clinical tests were necessary" and "No usability testing was required as there has been only minor changes to the user interface and to the Instructions for Use." This indicates that the regulatory pathway for this particular device relied entirely on non-clinical (bench) testing to demonstrate substantial equivalence, rather than extensive clinical trials or performance studies against defined clinical endpoints.

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The V.A.C. Rx4 Negative Pressure Wound Therapy (NPWT) System is an integrated wound management system for use in acute care settings and other professional healthcare environments where product use is conducted by or under the supervision of a qualified healthcare professional.

When used on open wounds, it is intended to create an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing edema, promoting granulation tissue formation and perfusion, and by removing exudate and infectious material. Open wound types include: chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, pressure or venous insufficiency), flaps and grafts.

The V.A.C. GranuFoam Silver™ Dressing is an effective barrier to bacterial penetration and may help reduce infection in the above wound types.

When used on closed surgical incisions, it is also intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closure by maintaining a closed environment and removing exudates via the application of negative pressure wound therapy.

The V.A.C.Rx4™ Negative Pressure Wound Therapy (NPWT) System, model number 60600, is a therapy unit capable of providing Negative Pressure Wound Therapy for up to four wounds simultaneously with individual wound channel controls and feedback. The device is intended to be used only in acute care.

The V.A.C.Rx4™ NPWT System consists of a four-channel therapy unit, disposable exudate canisters and dressings. The V.A.C.Rx4™ NPWT System utilizes the same KCI dressing systems and canisters that have been cleared for use with the predicate device system.

The software-controlled therapy unit applies a selectable range of negative pressure wound therapy to the wound bed or incision site. It can provide continuous or intermittent application of negative pressure wound therapy to the wound in the selectable range of 50mmHg to 200mmHg (in increments of 25mmHg). The dressing, to which the therapy unit is connected, enables distribution of the negative pressure wound therapy across the surface of the wound or incision, while the tubing transfers accumulated fluids such as wound exudates and infectious material to a disposable canister. The device can operate either by a mains power supply or internal battery.

For the KCI USA, Inc. V.A.C. Rx4 Negative Pressure Wound Therapy (NPWT) System, the provided document details bench testing and a usability study rather than a traditional study with acceptance criteria for device performance related to treatment efficacy. The substantial equivalence determination is based on the device's functional similarity to a predicate device and successful verification of its engineering and usability aspects.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal acceptance criteria in a quantitative table format for treatment efficacy. Instead, it relies on demonstrating substantial equivalence to the predicate device through various tests. The reported performance relates to the device's ability to deliver negative pressure wound therapy as intended and its usability.

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

• Bench Testing: The document does not specify a numerical "sample size" for the bench testing beyond stating that the V.A.C.Rx4™ was tested under various conditions and configurations (continuous/intermittent modes, wet/dry conditions, different pressure levels, and with various dressing configurations for each of the four channels). Data provenance is internal (KCI USA, Inc.) and prospective, as it describes the testing performed for this specific device for its 510(k) submission.
• Usability Evaluation (Simulated-Use Testing):
  • Sample Size: 15 subjects.
  • Data Provenance: Prospective, generated specifically for this device submission within a simulated use environment. The country of origin is not explicitly stated but can be inferred as the USA, given the submitting company's location and FDA submission.

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

• Bench Testing: Not applicable in the sense of expert-established ground truth for clinical outcomes. The "ground truth" here is the established scientific and engineering principles for negative pressure wound therapy and the performance of the predicate device.
• Usability Evaluation: The "ground truth" or reference for safe and effective use during the usability study would have been the defined critical tasks and expected user interactions established by human factors engineering principles and potentially validated by subject matter experts in negative pressure wound therapy usage. The subjects themselves were representative users from key healthcare professional groups: Surgeon/Physician, Surgical Scrub/Theatre Nurse, and Acute Care Nurse. The number of experts involved in the design or evaluation protocol of the usability study, or in interpreting the results, is not specified, but the users involved were qualified practitioners.

4. Adjudication Method for the Test Set

• Bench Testing: Not applicable. Performance was measured against predefined engineering specifications and compared to the predicate device.
• Usability Evaluation: Not explicitly stated as a formal adjudication method. However, "Multiple formative evaluations led to the selection of an optimal user interface design," indicating an iterative design and evaluation process. The summative evaluation involved observing user performance on critical tasks, and a "residual risk analysis" was performed. This implies direct observation and assessment of user interaction against safety and effectiveness criteria.

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

No, an MRMC comparative effectiveness study was not done. The V.A.C. Rx4™ is a hardware device for wound therapy, not an imaging or diagnostic AI device where reader performance is typically assessed.

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

Not applicable. The V.A.C. Rx4™ System is a medical device that assists in wound management through applied negative pressure, not an AI algorithm performing diagnostic or predictive functions. The "algorithm" here refers to the software controlling the pump, which was tested during bench testing within the context of the device's functionality. The usability study evaluated the human-device interaction.

7. Type of Ground Truth Used

• Bench Testing: Engineering specifications, physical measurements of pressure, flow rates, alarm functionality, and comparison to the predicate device's established performance.
• Usability Evaluation: Defined critical tasks, user safety and effectiveness criteria, and human factors engineering principles.

8. Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a training set in the conventional sense. The "training" for the device would have been its design and development process, informed by engineering principles and previous device designs like the predicate.

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

Not applicable, as there is no training set for an AI/ML algorithm.

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