Search Results

The V.A.C.ULTA™ Negative Pressure Wound Therapy System is an integrated wound management system that provides Negative Pressure Wound Therapy with an instillation option.

Negative Pressure Wound Therapy in the absence of instillation 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.

Instillation Therapy is indicated for patients who would benefit from vacuum assisted drainage and controlled delivery of topical wound treatment solutions and suspensions over the wound bed.

The V.A.C.ULTA™ Negative Pressure Wound Therapy System with and without instillation is indicated for patients with chronic, acute, traumatic, sub-acute and dehisced wounds, partial-thickness burns, ulcers (such as diabetic, pressure and venous insufficiency), flaps and grafts.

Negative Pressure Wound Therapy in the absence of instillation may also be used for:

The temporary bridging of abdominal wall openings where primary closure is not possible and/or repeat abdominal entries are necessary and for open abdominal wounds with exposed viscera including, but not limited to, abdominal compartment syndrome. The intended care setting is a closely monitored area within the acute care hospital, such as the ICU. The abdominal dressing will most often be applied in the operating theater.

The management of 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 V.A.C.ULTA™ Negative Pressure Wound Therapy System is a negative pressure wound therapy system with an instillation feature which allows controlled delivery and drainage of topical wound treatment solutions and suspensions.

The unit is comprised of a vacuum pump and an instillation pump. The vacuum pump delivers negative pressure therapy for the removal of wound exudate and when applicable instilled solutions. The instillation pump provides controlled delivery of topical wound solutions and suspensions. Both pumps are software controlled. Instillation solutions and negative pressure are delivered through tubing to foam dressings in the wound covered by an occlusive drape. Software monitors both negative pressure during negative pressure wound therapy as well as positive pressure during instillation of fluids to the wound bed. Software also provides controls for help and alarm functions.

Here's a breakdown of the acceptance criteria and study information for the V.A.C.ULTA™ Negative Pressure Wound Therapy System, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics in a pass/fail format for a specific "device." Instead, it focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical testing and a human factors assessment. The "acceptance criteria" can be inferred from the tests performed and their documented positive results.

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

• Software and Electrical/EMC Testing: The sample sizes for these tests are not explicitly stated in terms of "cases" or "patients." These are typically engineering and laboratory tests performed on the device itself.
• Negative Pressure Performance Testing: The sample size for materials/configurations tested is not explicitly stated. This would involve laboratory testing of the device under various conditions (exudate, leaks, dressing configurations) rather than human subjects.
• Human Factors Engineering Assessment (Test Set):
  • Sample Size: 30 subject nurses and doctors.
  • Data Provenance: This was a prospective study, likely conducted in a controlled environment (e.g., simulation lab, usability testing facility) to assess the new software features. The country of origin is not specified but would presumably be the US given the FDA submission.

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

• For the non-clinical engineering tests (software, electrical, negative pressure performance), the "ground truth" is established by the specifications and standards themselves, and the expertise lies with the engineers and testing personnel who perform and verify compliance. The number and qualifications of these experts are not detailed in this summary.
• For the human factors engineering assessment, the "ground truth" is the ability of all 30 subject nurses and doctors to safely and effectively use the new features. These 30 subjects are the "test set" and implicitly establish the "ground truth" through their direct interaction and feedback, as they represent the intended end-users. Their overarching qualification is that they are healthcare professionals (nurses and doctors) who would typically use such a device. The summary does not specify their years of experience or sub-specialties.

4. Adjudication Method for the Test Set

• Non-clinical Tests: Adjudication is typically based on whether the device meets predefined technical specifications and standards. This would involve internal engineering verification and validation processes, and potentially third-party certification. The summary does not detail a specific adjudication method beyond stating that the device was "certified" and "documented" to meet standards.
• Human Factors Engineering Assessment: The summary states that the assessment "indicated that the new features could be safely and effectively used by all test subjects." This implies a consensus or universal success among the 30 subjects, effectively meaning no formal "adjudication" (like 2+1) was needed if all participants demonstrated safe and effective use. If there were discrepancies or difficulties, a different adjudication mechanism might have been employed, but it is not mentioned.

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. This document describes a 510(k) submission for a physical medical device (Negative Pressure Wound Therapy System) with updated software features. It is not an AI-powered diagnostic or interpretive device, so an MRMC study comparing human readers with and without AI assistance is not applicable here.

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

• Not applicable. The V.A.C.ULTA™ system is a therapy device that involves a human operator to apply and manage the therapy. It does not contain an "algorithm" in the sense of an AI or diagnostic algorithm that performs a standalone function without human interaction for which standalone performance would be measured. The software updates are for user enhancements and control of the therapy, not an autonomous diagnostic or interpretive function.

7. The type of ground truth used

• Non-clinical performance specifications and user experience.
  • For software, electrical safety, EMC, and negative pressure performance, the ground truth is established by adherence to recognized national and international standards (e.g., AAMI/ANSI ES60601-1, IEC 60601 series) and the internal performance specifications of the device (e.g., specific mmHg ranges for therapy).
  • For the human factors assessment, the ground truth is the demonstrable ability of typical users (nurses and doctors) to safely and effectively operate the device with its new features.

8. The Sample Size for the Training Set

• Not applicable. This document describes a 510(k) submission for a non-AI medical device. The software updates are for user interface and control enhancements, not for an AI model that requires a "training set" of data.

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

• Not applicable. As there is no AI model requiring a training set, the concept of establishing ground truth for a training set does not apply here.

Ask a specific question about this device

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.

Ask a specific question about this device