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The Prevena™ Restor™ Adapti-Form™ Dressing is part of the Prevena™ Restor™ Incision Management System and 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 Prevena Restor™ Incision Management System consist of the following components for use together as a system:

• Prevena Plus Therapy Unit & canister
• Prevena Restor Adapti-Form Dressing:
  • Foam Dressing with a skin interface layer
  • V.A.C. Drape
  • SensaT.R.A.C. Pad
  • Hydrocolloid Sealing strips

The Prevena™ Restor™ Adapti-Form™ Dressing is designed to be compatible for use with previously cleared V.A.C. Negative Pressure Wound Therapy (NPWT) Units:

• ActiV.A.C. Therapy Unit,
• V.A.C. ULTA Therapy Unit, and
• V.A.C. Rx4 Therapy Unit.

The provided document describes the Prevena™ Restor™ Adapti-Form™ Dressing, a part of the Prevena™ Restor™ Incision Management System. It explicitly states that clinical and pre-clinical testing were NOT necessary to demonstrate substantial equivalence. Therefore, there are no acceptance criteria, performance data, or studies presented in this document that would typically involve sample sizes, expert qualifications, or ground truth establishment in the context of device performance in a clinical setting.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device (Prevena™ Restor™ Incision Management System, K181507) and a reference device (Prevena Plus Incision Management System, K153199) through a comparison of technological characteristics and non-clinical tests.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Since clinical performance criteria are not applicable based on the document's statement, the "acceptance criteria" here refer to the successful completion of non-clinical tests.

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

Not applicable. The document explicitly states that "Clinical and Pre-clinical testing were not necessary to demonstrate substantial equivalence." The non-clinical tests listed (e.g., negative pressure test, package integrity) do not involve human patient test sets in the typical sense; they assess product specifications and safety characteristics. Information about the sample size of materials or units used for these engineering/safety tests is not provided.

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

Not applicable. As clinical or pre-clinical performance studies were not conducted for substantial equivalence, there was no need for experts to establish ground truth on patient outcomes or diagnoses.

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

Not applicable. No clinical or pre-clinical performance studies involving adjudication were performed.

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. The device is a wound dressing, not an AI-assisted diagnostic tool.

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

Not applicable. The device is a wound dressing, not an algorithm.

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

Not applicable. As clinical performance studies were not conducted, there was no ground truth related to patient conditions or diagnoses. The "ground truth" for the non-clinical tests would have been the pre-defined engineering and safety specifications or industry standards.

8. The sample size for the training set

Not applicable. This is not an AI/algorithm-based device, so there is no concept of a "training set."

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

Not applicable. No training set was involved.

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PREVENA 125 and PREVENA PLUS 125 Therapy Units manage the environment of closed surgical incisions and remove fluid away from the surgical incision via the application of -125mmHg continuous negative pressure. When used with legally marketed compatible dressings, PREVENA 125 and PREVENA PLUS 125 Therapy Units are intended to aid in reducing the incidence of seroma and, in patients at high risk for post-operative infections, aid in reducing the incidence of superficial surgical site infection in Class I and Class II wounds.

The PREVENA 125 and PREVENA PLUS 125 Therapy Units ("PREVENA pumps") are singleuse, compact and portable powered suction pumps. The therapy units are packaged with compatible sterile canisters (45 ml for PREVENA 125 or 150 ml for PREVENA PLUS 125) and sterile tubing set. The therapy units can be used with compatible, legally marketed wound dressings classified under 21 CFR 878.4780, such as the PEEL & PLACE dressing and the CUSTOMIZABLE dressing, which, when combined are referred to as the PREVENA Incision Management Systems ("PREVENA systems"). The PREVENA Incision Management Systems deliver a pre-set, continuous negative pressure of 125 mmHz to the incision site. The systems are intended to be applied to incision sites immediately after surgery for a minimum of 2 days up to a maximum of 7 days depending on the surgeon's preference. The therapy units can be used up to 192 hours, after which they will automatically shut off.

The provided text describes the regulatory evaluation of the PREVENA 125 and PREVENA PLUS 125 Therapy Units, focusing on clinical evidence from a systematic literature review and meta-analyses rather than a single, dedicated device performance study with specific acceptance criteria that would typically be seen for AI/ML devices. Therefore, a direct table of "acceptance criteria and reported device performance" as one might expect for a diagnostic AI/ML device is not explicitly present in the document.

However, based on the meta-analysis results and the FDA's granted indications for use, we can infer the "acceptance criteria" were met by demonstrating a favorable trend in reducing SSI and seroma, particularly in specific subgroups. The study essentially is the meta-analysis of existing clinical data.

Here's an interpretation of the information provided, structured to address your points, with explanations where direct parallels to AI/ML device criteria are not exact due to the nature of this submission (a device for wound therapy, not an AI/ML diagnostic).

Inferred Acceptance Criteria and Reported Device Performance (Based on Meta-Analysis Conclusion)

While explicit numerical acceptance criteria for a single study were not provided, the FDA's granting of the De Novo request signifies that the overall body of evidence from the meta-analysis met the regulatory standard for demonstrating safety and effectiveness for the specified indications. The "acceptance" was based on a "small but consistent trend" and "greater absolute percentage reduction" in specific high-risk populations.

Study Details:

1. Sample sizes used for the test set and the data provenance:

   • Test Set Sample Size:
     • For SSI meta-analysis: 20 prospective studies, total of up to 6,403 evaluable patients (1,367 in PREVENA group, 5,036 in control group).
     • For Seroma meta-analysis: 7 prospective studies, total of 952 evaluable patients (366 in PREVENA group, 586 in control group).
   • Data Provenance: The data comes from a systematic literature review and meta-analyses of published and unpublished prospective clinical studies. The geographic origin of these individual studies is not explicitly stated but implied to be global as it's a literature search. The studies are prospective. Seven articles identified as retrospective were removed to minimize bias.

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

   • Study Selection/Ground Truth Establishment:
     • Study Selection: Six (6) independent reviewers performed the initial study selection. A subset of two (2) independent reviewers assessed abstracts and manuscripts for inclusion/exclusion criteria. When discordance was identified, these two reviewers deliberated until a consensus was reached.
     • Characteristic Extraction: At least two additional independent reviewers extracted study characteristics.
     • Wound Classification (Ground Truth for Subgroup Analysis): CDC wound classification was assigned to each study by "two individuals with appropriate medical and clinical trials background."
   • Qualifications: The specific qualifications (e.g., number of years of experience, board certification) of these reviewers/experts are not detailed beyond "independent reviewers" and "individuals with appropriate medical and clinical trials background."

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

   • Study Selection: "When discordance was identified, the two reviewers deliberated until a consensus was reached." This suggests a consensus-based adjudication among the two reviewers, rather than a third expert "tie-breaker" (2+1).
   • Wound Classification: "a CDC wound classification was assigned by two individuals with appropriate medical and clinical trials background." It is implied a consensus or adjudication method was used if there was disagreement, but not explicitly stated.

4. 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, an MRMC study was NOT done. This submission is for a medical device (a wound therapy unit), not an AI/ML diagnostic or assistive technology for human readers. The study is a meta-analysis of clinical trials comparing the device to conventional wound dressings. Therefore, the concept of "human readers improving with AI assistance" is not applicable here.

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

   • Not applicable. This is a physical wound therapy device, not a standalone algorithm. Its performance is evaluated in a clinical context on patients.

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

   • The "ground truth" for effectiveness (reduction in SSI and seroma) was the clinical outcomes data reported directly by the individual prospective studies included in the meta-analysis. These outcomes were typically assessed by the clinical investigators of each respective study.

7. The sample size for the training set:

   • Not applicable. This is a device, not an AI/ML model that requires a training set. The "training data" in a broader sense would be all the accumulated medical knowledge and device design iterations that led to the PREVENA system. The studies reviewed form the evidence base for its effectiveness, not a training set for an algorithm.

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

   • Not applicable. As stated above, there is no AI/ML training set in this context.

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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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