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The V.A.C. ® Therapy System is an integrated wound management system for use in acute, extended and home care settings. 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. It is indicated for patients with chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), 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.

The ActiV.A.C.® Therapy Unit is designed for the application of V.A.C. Therapy in the acute, extended and home care settings. The software-controlled therapy unit applies negative pressure to the wound bed. The open cells of the V.A.C. ® Foam Dressing to which the therapy unit is connected enable distribution of the negative pressure across the surface of the wound, while the tubing transfers accumulated fluids to the canister. The software monitors and maintains target pressure and alarms as needed to help assure target pressure is maintained and constant therapy is delivered. The safety features of the system include additional alarms, such as those that signal for tubing blockages, a full or missing collection canister, inactive therapy, low battery, and leaks in the seal of the dressing. Optional ancillary features include: Seal Check™ for identifying dressing leaks, a Therapy Settings Guide that provides options for therapy settings based on the recommendations in the KCI Clinical Guidelines, a screen guard feature that prevents unintentional screen changes, an exportable Therapy History Report via an IrDA or USB data port, and a Log Tool for recording canister changes, dressing changes and dressing pieces used.

The provided K063692 document is a 510(k) premarket notification for the ActiV.A.C.® Therapy Unit. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through novel studies.

Here's an analysis based on the information provided, explicitly addressing each point requested, even if the information is unavailable:

1. Table of Acceptance Criteria and Reported Device Performance

The 510(k) document for the ActiV.A.C.® Therapy Unit does not define explicit acceptance criteria in quantifiable terms for a new study. Instead, it relies on demonstrating equivalence to a predicate device (V.A.C. Freedom® Therapy Unit) through technological characteristics and existing clinical data for the predicate.

Therefore, a table of acceptance criteria and reported device performance as typically understood for a new study isn't presented in this document. The "performance" is implicitly deemed acceptable if it is equivalent to the predicate.

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

• Sample Size for Test Set: Not applicable. No new clinical "test set" in the context of typical AI/medical device performance evaluation was used. The submission relies on existing clinical data for the predicate device and nonclinical (engineering) verification/validation for the new features.
• Data Provenance: The "clinical data" referenced is from "randomized controlled trials, literature reports, and registry/MDR databases" related to the predicate V.A.C. Freedom® Therapy Unit. The country of origin is not specified, but these are generally international sources if not specified otherwise. This data is retrospective.

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

Not applicable. As no new clinical "test set" requiring ground truth establishment by experts for performance evaluation was conducted, this information is not provided. The study relies on existing clinical evidence from the predicate.

4. Adjudication Method for the Test Set

Not applicable. No new clinical "test set" requiring adjudication for ground truth was conducted.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size of Human Readers Improve with AI vs. Without AI Assistance

Not applicable. This document pertains to a hardware device (negative pressure wound therapy unit) with software control and optional ancillary features, not an AI or imaging diagnostic algorithm applied to human interpretation. Therefore, an MRMC study and AI assistance effect size are not relevant here.

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

Not applicable. The device is a therapy unit, not an AI algorithm performing a diagnostic task. Its "performance" involves delivering negative pressure therapies and managing alarms, which are functions of the integrated system, not a standalone algorithm.

7. The Type of Ground Truth Used

The concept of "ground truth" as typically applied to diagnostic algorithms (e.g., pathology, expert consensus) doesn't directly apply here. Instead, the "truth" for the device's function is its ability to:

• Deliver negative pressure wound therapy with performance characteristics equivalent to the predicate.
• Monitor and maintain target pressure.
• Signal alarms correctly (tubing blockages, full canister, low battery, leaks).
• Perform its ancillary features (Seal Check, Therapy Settings Guide, screen guard, data export, log tool) as designed.

These are verified through engineering analysis, verification, and validation testing against design specifications and comparison to the predicate's established performance. The clinical safety and efficacy are inferred from the predicate device's substantial body of clinical data and literature.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device that involves training data in the typical sense. The "training" for the device's development involves engineering design, prototyping, and iterative testing, not a dataset for algorithm training.

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

Not applicable, as there is no training set for an AI algorithm. The "ground truth" for the development and testing of the device's functions (e.g., proper pressure delivery, correct alarm activation) would be engineering specifications, validated measurement equipment, and established medical standards for negative pressure wound therapy.

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The V.A.C.® Therapy System is an integrated wound management system for use in acute, extended and home care settings. 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. It is indicated for patients with chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), 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.

The InfoV.A.C.® Therapy System is designed for the application of V.A.C.® Therapy in the acute, extended and home care settings. The software-controlled therapy unit applies negative pressure to the wound bed. The open cells of the V.A.C.® foam dressing to which the therapy unit is connected enable distribution of the negative pressure across the surface of the wound, while the tubing transfers accumulated fluids to the canister. The software monitors and maintains target pressure and alarms as needed to help assure target pressure is maintained and constant therapy is delivered. The safety features of the system include additional alarms, such as those that signal for tubing blockages, a full or missing collection canister, inactive therapy, low battery, and leaks in the seal of the dressing. Optional features include: Seal Check™ for identifying dressing leaks, a Therapy Settings Guide that provides options for therapy settings based on the recommendations in the KCI Clinical Guidelines, a Screen Guard feature that prevents unintentional screen changes, an exportable Therapy History Report, and a Log Tool for recording canister changes, dressing changes and dressing pieces used. Another new optional feature is the ability to receive and store digital images of the patient's wound throughout the healing process. By tracing the wound perimeter on the digital image, wound area can be calculated by the software. If the user inputs a wound depth value, wound volume can also be calculated. Wound images and area/volume calculations can be electronically transferred via a Patient History Report.

The provided text describes the InfoV.A.C.® Therapy Unit, a negative pressure wound therapy device. It does not contain specific acceptance criteria or details of a study that directly proves the device meets such criteria in a quantitative manner as typically requested for AI/ML device evaluations. Instead, the document focuses on demonstrating substantial equivalence to predicate devices and detailing the new optional features.

However, I can extract information related to the device's performance assertions and the general nature of the studies conducted.

Here's a breakdown of the available information based on your requested categories:

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

The document does not provide a table with quantitative acceptance criteria (e.g., specific sensitivity, specificity, or AUC targets) nor does it report specific numerical performance metrics for the InfoV.A.C.® Therapy Unit in the context of wound analysis. The performance is primarily assessed through verification and validation testing to assure "performance and conformance to design specifications" for its new features, and through a comparative analysis to predicate devices for its core function.

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

The document does not specify a distinct "test set" in the context of evaluating an AI/ML algorithm with a specific sample size. The "non-clinical tests" involved "verification and validation tests," but no sample sizes for these tests (e.g., number of wound images or wound measurements) are provided.

For the clinical context, the document states: "A review of a large body of clinical data from prospective randomized controlled trials, comparative and retrospective studies, payor/provider data, and retrospective review of independent electronic medical record data documents the safe use of the V.A.C. Freedom® Therapy Unit in the home care setting." This refers to clinical data for the predicate device, which is then extrapolated to the new device based on equivalence in core function and improved features. The provenance of this large body of clinical data is not specified beyond being "clinical data." Given the manufacturer, it is likely to include data from the USA, but no specific countries are mentioned.

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)

This information is not provided. The document outlines that the wound area is calculated by the software by "tracing the wound perimeter on the digital image," which implies a user-inputted tracing rather than an automated algorithm establishing a ground truth that needs expert validation. If wound depth is input, wound volume is calculated. The clinical data referenced is for the predicate device's overall safety and effectiveness, not for validating the accuracy of the new wound measurement feature.

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

No adjudication method is mentioned for any "test set" related to the wound measurement capabilities.

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 such MRMC comparative effectiveness study is mentioned. The AI-like functionality (wound measurement) in this device is presented as a tool for the user (caregiver/patient), not as an assistive AI for human readers/clinicians, nor is its impact on human performance quantified.

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

The device's wound measurement capability described involves human input ("By tracing the wound perimeter on the digital image, wound area can be calculated by the software. If the user inputs a wound depth value, wound volume can also be calculated."). This indicates a human-in-the-loop process, not a standalone algorithm that automatically detects and measures wounds without user interaction. Therefore, a standalone performance study as typically understood for an AI algorithm was not applicable or performed according to the provided text.

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

For the wound measurement features, the ground truth is established by the user's tracing of the wound perimeter and input of wound depth. This is not an external, independent ground truth like pathology or expert consensus on image analysis. For the broader clinical effectiveness, the "large body of clinical data" for the predicate device likely relied on clinical outcome data as ground truth.

8. The sample size for the training set

The document does not describe the use of a "training set" in the context of an AI/ML algorithm. The wound measurement function appears to be based on geometric calculations performed after user input (tracing and depth).

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

As there is no mention of an algorithm training set, this information is not applicable.

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The V.A.C. Therapy System 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. It is indicated for patients with chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), 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.

The components of the V.A.C.® Therapy System work as an integrated product to optimize both the delivery and the benefits of negative pressure. An open pore foam (reticulated polyurethane foam (GranuFoam®, GranuFoam® Silver, and Abdominal Dressings, etc.) or polyvinyl alcohol foam (Vers-Foam™ Dressing)] is cut to fit the wound, then covered with a semi-permeable adhesive drape. The software-controlled Therapy Unit applies negative pressure to the wound bed. The user can select continuous or intermittent therapy, depending upon wound type and the needs of each patient. The open cells of the foam enable equal distribution of the negative pressure across the surface of the wound, while the tubing transfers accumulated fluids to the canister. T.R.A.C.® (Therapeutic Regulated Accurate Care) technology monitors and maintains target pressure and alarms as needed to help assure target pressure is maintained and constant therapy is delivered. The safety features of the system include additional alarms, such as those that signal for tubing blockages, a full or missing collection canister, inactive therapy, low battery, and leaks in the seal of the dressing.

Analysis of Acceptance Criteria and Study for K062227 (V.A.C.® Therapy System)

This 510(k) submission (K062227) by KCI USA, Inc. is for a modification to the V.A.C.® Therapy System, specifically a revision to the Indications for Use statement. It's crucial to note that this is not a submission for a new device, but rather an update to the labeling of an already legally marketed device. Therefore, the typical structure for a new device's performance study and acceptance criteria may not apply in the same way.

The submission states: "Because the V.A.C.® Therapy System has not been modified for the purposes of this submission, the predicate products are the V.A.C.® Therapy Family of Products (Therapy Units ATS, Freedom and Instill and their associated disposable components), which were most recently cleared under 510(k)s: K032310 (V.A.C.® ATS and V.A.C.® Freedom® Therapy Units), K021501 (V.A.C.® Instill Therapy Unit), K053627 (V.A.C.® GranuFoam® Silver Protection Dressing) and K022011 (V.A.C.® Abdominal Dressing)."

Furthermore, under the "Summary of nonclinical tests" and "Summary of clinical tests" sections, it explicitly states:

• "Not applicable; no new nonclinical tests were performed for the purposes of this submission."
• "Not applicable; no new clinical tests were performed for the purposes of this submission, except as described in the submitted literature."

This indicates that no new performance studies with pre-defined acceptance criteria were conducted or are being presented in this specific 510(k) for the V.A.C. Therapy System. The basis for the revised Indications for Use relies entirely on published literature documenting the effective use of the V.A.C.® Therapy System.

Therefore, instead of a table of specific acceptance criteria and device performance from this submission, the "acceptance criteria" here is met by demonstrating that the proposed revised indications are consistent with existing scientific and clinical evidence from published literature.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of this 510(k) as an "Indications for Use" revision based on existing literature, a traditional table of acceptance criteria and reported device performance from new studies in this submission is not applicable.

Instead, the "acceptance criteria" here would be demonstrating that the proposed revised indications are supported by the body of existing clinical evidence available in published literature.

Reported Device Performance (as inferred from the literature review context): The V.A.C.® Therapy System is reported to effectively:

• Create an environment that promotes wound healing by secondary or tertiary (delayed primary) intention.
• Prepare the wound bed for closure.
• Reduce edema.
• Promote granulation tissue formation and perfusion.
• Remove exudate and infectious material.
• Be indicated for patients with chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts.
• The V.A.C.® GranuFoam® Silver™ Dressing acts as an effective barrier to bacterial penetration and may help reduce infection in the above wound types.

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

As per the submission, "Not applicable; no new clinical tests were performed for the purposes of this submission, except as described in the submitted literature."

Therefore, there is no specific test set or associated sample size detailed within this 510(k) document. The clinical evidence is derived from the broad existing body of published literature on the V.A.C.® Therapy System. Details of specific studies (sample size, provenance, retrospective/prospective nature) would be found within the referenced published literature, which is not provided in this document.

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

Not applicable, as no new clinical study with a defined test set and ground truth establishment process was conducted for this submission. The "ground truth" for the expanded indications is implicitly established by the consensus and findings across the body of published medical literature.

4. Adjudication Method for the Test Set

Not applicable, as no new clinical study with a defined test set requiring adjudication was conducted for this submission.

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

Not applicable. This submission is not evaluating human reader performance or the improvement with AI assistance. It's focused on the clinical indications for a wound therapy device.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

Not applicable. The V.A.C.® Therapy System is a physical medical device (negative pressure wound therapy system), not an algorithm or AI.

7. Type of Ground Truth Used

The "ground truth" for the updated indications is based on published clinical outcomes data and expert consensus as documented in the medical literature. The submission explicitly states: "Published literature documenting the effective use of the V.A.C.® Therapy System in a variety of wound types and clinical situations support the following revision to the Indications for Use statement."

8. Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a training set. If "training set" refers to the data that informed the original clearance of the device, that information would be in the predicate 510(k) submissions, not this one.

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

Not applicable, as there is no training set for this device in the context of this 510(k) notification.

In summary: This 510(k) notice is a request for a labeling change (expanded Indications for Use) for an existing medical device. The "study" that proves the device meets the acceptance criteria is explicitly stated as the body of published literature on the V.A.C.® Therapy System, rather than new, dedicated preclinical or clinical studies conducted for this specific submission. Therefore, many of the typical data points for AI/ML device evaluations (test set, training set, expert consensus for ground truth, MRMC studies) are not applicable to this particular 510(k) document.

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