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The V.A.C.® Ulta Negative Pressure Wound Therapy System is an integrated wound management system that provides Negative Pressure Wound Therapy (V.A.C.® Therapy) with an instillation option ( Veraflo™ Therapy).

· V.A.C.® 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.

· Veraflo™ 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 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.

· V.A.C.® Therapy in the absence of instillation may also be used for:

o 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.

o 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. 8 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 therapy for the removal of wound exudate and instilled solutions when applied. The instillation pump provides controlled delivery of topical wound solutions and suspensions. Both pumps are software controlled. Instillations and negative pressure are delivered through tubing to foam dressings in the wound covered by an occlusive drape. Software monitors both negative pressure wound therapy as well as positive pressure during instillation of fluids to the wound bed. Software also provides controls for setting therapy parameters as well as help and alarm functions.

The document describes the V.A.C.® Ulta Negative Pressure Wound Therapy System, which is a negative pressure wound therapy system with an instillation feature. The submission for this device is a 510(k) premarket notification.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present acceptance criteria in a tabular format with corresponding device performance values for all features. However, it states the performance specification for the new Smart Instill™ Feature and the general performance testing conclusion.

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

The document does not provide details on the sample size or provenance for the "performance testing" that documented the Smart Instill™ Feature's compliance. This testing is described as non-clinical.

For the human factors engineering assessment:

• Sample Size for Test Set: 30 subject nurses and doctors.
• Data Provenance: Not specified, but generally, human factors studies for medical devices are prospective and conducted in a simulated or real-world use environment. The document does not specify the country of origin.

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

• The document does not mention the use of experts to establish "ground truth" in the conventional sense for the performance testing or the human factors study.
• For the human factors study, 30 "subject nurses and doctors" were used as participants to assess usability and safety, but they were not establishing ground truth, rather their interactions with the device were the data. Their specific qualifications (e.g., years of experience) are not detailed beyond "nurses and doctors."

4. Adjudication Method

• Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies or studies where expert consensus is needed to establish ground truth from ambiguous cases. This type of adjudication is not described or indicated for either the non-clinical performance testing or the human factors assessment mentioned in the document.

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

• No MRMC comparative effectiveness study is mentioned. The submission is for a medical device (Negative Pressure Wound Therapy System), not an AI-assisted diagnostic tool, so this type of study would not typically apply. The document focuses on performance specifications and human factors for the device itself.

6. Standalone Performance (Algorithm Only)

• The Smart Instill™ Feature involves software control, and its performance was "documented." This implies a standalone evaluation of the algorithm's ability to achieve saturation within the specified time frame. However, the exact methodology for this standalone testing is not detailed (e.g., if it was tested solely in simulation or on benchtop models without human interaction to verify the algorithm's output). The "performance testing" mentioned effectively serves as a standalone evaluation of the Smart Instill™ algorithm's functionality within the device.

7. Type of Ground Truth Used

• For the Smart Instill™ Feature: The "ground truth" would be objective measurements of fill volume and dressing saturation achieved within the 12-hour timeframe. This would likely be established through physical measurements on test setups (e.g., measuring liquid volume and observing saturation on wound models).
• For the human factors engineering assessment: The "ground truth" is established by observing user interactions and collecting feedback to determine if tasks can be performed safely and effectively. This is based on direct observation and qualitative/quantitative data from the participants.

8. Sample Size for the Training Set

• The document does not mention a "training set" as this is not an AI/machine learning model that requires a distinct training phase. It describes new software features, which are typically developed based on design specifications and then verified/validated.

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

• Since there is no mention of a training set in the context of an AI/ML model, this question is not applicable. The device's software features are developed based on established engineering principles and clinical requirements, rather than being "trained" on a dataset with ground truth labels.

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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.

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