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The V.A.C. DERMATACTM Drape is an accessory to the:

· ACTIV.A.C.™, INFOV.A.C.™, V.A.C. SIMPLICITY™, V.A.C.VIA™ and V.A.C. FREEDOM™ Negative Pressure Wound Therapy Systems, which are integrated wound management systems for use in acute, extended and home care settings.

· V.A.C.ULTA™ and V.A.C.RX4™ Negative Pressure Wound Therapy Systems, which are integrated wound management systems 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, they are intended to create an environment that promotes wound healing by secondary or tertiary (delayed primary) intention by preparing the wound bed for closure, reducing 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.

When used on closed surgical incisions, they are intended to manage the environment of surgical incisions that continue to drain following sutured or stapled closed environment and removing exudates via the application of negative pressure wound therapy.

The V.A.C. DERMATAC Drape is a semi-occlusive wound drape that is used as an accessory to the V.A.C. Therapy System. The V.A.C. DERMATAC Drape is single-use and it is provided sterile. The V.A.C DERMATAC Drape provides a sealed environment which allows for a moist wound environment and it allows for the delivery and maintenance of negative pressure at the wound site.

The drape consists of a polyurethane film with acrylic adhesive with a perforated silicone layer. The perforations in the silicone layer expose the acrylic adhesive coated on the polyurethane film. The acrylic adhesive secures the drape to the periwound and the silicone layer primarily provides a seal for negative pressure.

The V.A.C. Therapy System is comprised of the following:

• . Software controlled neqative pressure therapy unit
• . Disposable canister which collects wound exudate
• . Polyurethane foam dressing
• Semi-occlusive wound drape

The provided text describes the V.A.C. DERMATAC Drape, an accessory for Negative Pressure Wound Therapy (NPWT) Systems, and its substantial equivalence to a predicate device. However, the document does not contain information about acceptance criteria and a study proving the device meets those criteria in the format requested (e.g., performance metrics like sensitivity, specificity, AUC, or comparative effectiveness with human readers).

Instead, the document focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing and a human factors assessment. The "study" mentioned is a set of engineering and biocompatibility tests, not a clinical trial or an AI performance study with ground truth established by experts.

Therefore, I cannot populate the table or answer the specific questions about sample size, expert qualifications, adjudication methods, MRMC studies, or training set details as that information is not present in the provided text.

Here's what I can extract based on the provided document:

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

| Acceptance Criteria (Stated Requirements) | Reported Device Performance |
| Biocompatibility | Met requirements according to ISO 10993 series testing (Cytotoxicity, Sensitization, Irritation, Systemic Toxicity, Genotoxicity, Chemical Characterization, Leachable Substances). |
| Shelf Life (Packaging Integrity) | Met all requirements after 3 cycles of EtO sterilization and simulated shipping, for an accelerated aged equivalent of 2 years real time (shelf life stated as 1 year). |
| Adhesive Peel Test (Force required to remove drape) | Met specification requirements. |
| Moisture Vapor Transmission Rate (MVTR) | Met minimum requirements when using ASTM E96/E96M (Upright Cup Method at 38°C and 10%RH). |
| Negative Pressure Maintenance System Test (Maintain negative pressure with simulated wound exudate, maximum air leak, worst-case dressing, max use life, re-application cycling) | Capable of maintaining negative pressure within specification, including after re-application cycling. |
| Peel Adhesion with Re-Application Cycling Testing (Peel force after multiple re-applications) | Capable of meeting specification for peel adhesion after multiple re-applications and removals. |
| Human Factors (Safe and effective use by representative users) | 30 representative users found the new user interface could be safely and effectively used. |

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

• Test Set Sample Size:
  • Biocompatibility: Not specified, but involved testing according to ISO standards.
  • Shelf Life: Not specified for unit count.
  • Adhesive Peel Test: Not specified for unit count.
  • Moisture Vapor Transmission Rate Test: Not specified for unit count.
  • Negative Pressure Maintenance System Test: Not specified for unit count.
  • Peel Adhesion with Re-Application Cycling Testing: Not specified for unit count.
  • Human Factors: 30 representative users.
• Data Provenance: The tests described are laboratory/engineering tests conducted to assess physical and biological properties. A "country of origin for data" is not applicable in the context of these non-clinical tests. These are considered prospective tests performed on the device to prove its characteristics.

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

• This information is not applicable as the evaluations were non-clinical engineering and biocompatibility tests, not studies requiring expert-adjudicated ground truth. The human factors study involved "representative users" but didn't establish ground truth for a diagnostic task.

4. Adjudication method for the test set:

• This information is not applicable as the evaluations were non-clinical engineering and biocompatibility tests.

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, an MRMC comparative effectiveness study was not done. The device is a wound drape, not an AI diagnostic tool for human readers.

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

• This question is not applicable as the device is a wound drape, not an algorithm or AI system.

7. The type of ground truth used:

• Not applicable in the context of diagnostic ground truth. The "ground truth" for these tests was established by meeting engineering specifications and ISO standards (e.g., passing a biocompatibility test means no cytotoxic effect, maintaining negative pressure within a specified range).

8. The sample size for the training set:

• Not applicable. There is no "training set" as this is not an AI/machine learning device.

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

• Not applicable. There is no "training set" as this is not an AI/machine learning device.

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The ACTIV.A.C.™ Negative Pressure Wound Therapy System is an integrated wound management system for use in acute, extended and home care settings.

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.

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

The ACTIV.A.C.™ Therapy Unit is a component of the ACTIV.A.C.™ Negative Pressure Wound Therapy (NPWT) System. The ACTIV.A.C.™ Negative Pressure Wound Therapy (NPWT) system consists of:

• ACTIV.A.C. TM Therapy Unit (the subject of this submission)
• disposable canister which collects wound exudate
• a wound interface dressing
• . semi-occlusive wound drape
• sensing pad and lumen

The ACTIV.A.C. ™ Therapy Unit is a portable, battery-powered, reusable, software-controlled therapy unit that can provide continuous or intermittent applications of negative pressure to the wound bed in the selectable range of -25mmHg to -200mmHg. The ACTV.A.C.™ Therapy Unit is designed for the application of Negative Pressure Wound Therapy in the home, acute or extended care setting. The open cells of the dressing, to which the therapy unit is connected via pad and lumen, enables distribution of the negative pressure across the surface of the wound bed, 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 contains preset therapy settings based on wound type, a screen guard feature that prevents unintentional screen changes, an exportable Therapy History Report via USB data port, and a Log Tool for recording canister changes, dressing changes and dressing pieces used.

The provided text describes the ACTIV.A.C.™ Therapy Unit, a negative pressure wound therapy (NPWT) system. It outlines the device's indications for use, technological characteristics, and a summary of non-clinical tests conducted to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

The document focuses on demonstrating substantial equivalence to pre-existing devices (predicates K063692 and K120033) rather than defining specific, quantifiable acceptance criteria with numerical performance targets in the context of a "device performance" column. Instead, the "reported device performance" is described as the device functioning "as intended" and all test results being "as expected."

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

The document describes non-clinical testing for the ACTIV.A.C.™ Therapy Unit. It does not refer to a "test set" in the context of patient data or clinical trials. The tests conducted are:

• Conformance to 60601-1 standards: This likely involved laboratory testing of the device itself.
• Software assessment: This involved reviewing the software against FDA guidance.
• Negative Pressure Maintenance System Test: This involved testing the device's ability to maintain negative pressure and manage fluid.
• Extreme Environmental Storage Conditions test: This involved subjecting the device to various temperatures.

Therefore, there is no patient-specific sample size for a test set, and no data provenance in terms of country of origin or retrospective/prospective study design as these were non-clinical, in-vitro tests of the device's engineering performance.

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

Not applicable. As described above, this was non-clinical engineering and software testing. Ground truth in this context would be defined by engineering specifications and regulatory standards, not by expert medical opinion on patient data.

4. Adjudication Method for the Test Set:

Not applicable. There was no need for adjudication of patient data.

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

No. This document describes a 510(k) submission for a medical device (ACTIV.A.C.™ Therapy Unit), which focuses on demonstrating substantial equivalence through non-clinical performance and technological characteristics. It does not involve a multi-reader multi-case (MRMC) study or evaluate the improvement of human readers with or without AI assistance. The device is a physically applied NPWT unit, not an AI diagnostic tool.

6. Standalone (Algorithm Only) Performance Study:

No. The ACTIV.A.C.™ Therapy Unit is a hardware and software system, not an algorithm. The software is integral to the device's function (e.g., controlling pressure, alarms). Therefore, a standalone algorithm performance study is not applicable.

7. Type of Ground Truth Used:

The "ground truth" for the non-clinical tests described would be based on:

• Engineering specifications and design requirements: For tests like negative pressure maintenance and environmental conditions.
• Regulatory standards: Specifically, IEC 60601-1 for basic safety and essential performance.
• FDA guidance documents: For software assessment.

This is primarily engineering and regulatory compliance-based ground truth, not expert consensus, pathology, or outcomes data.

8. Sample Size for the Training Set:

Not applicable. This is a medical device, not a machine learning algorithm that requires a training set of data. The "software" mentioned refers to the operational software embedded in the device, not an AI model trained on a dataset.

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

Not applicable, as there is no training set for a machine learning algorithm.

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