(114 days)
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.
| Acceptance Criterion (Inferred from testing) | Reported Device Performance |
|---|---|
| Software Assessment: Compliance with FDA Guidance for Software in Medical Devices. | Assessed in accordance with FDA Guidance, May 11, 2005. |
| Electrical Safety & Electromagnetic Compatibility: Conformance to specific IEC/AAMI/ANSI standards. | Certified as conforming with AAMI/ANSI ES60601-1:2005/(R)2012 And A1:2012, C1:2009/(R)2012 And A2:2010/(R)2012; IEC 60601-1-6:2013; IEC 60601-1-8: 2012-11; IEC 60601-1-2: 2007-03. |
| Negative Pressure Performance (PREVENA Therapy settings): Delivery of negative pressure within established parameters (-125 mmHg, continuous mode). | Results documented that selection of PREVENA Therapy settings resulted in delivery of negative pressure within established parameters. |
| Negative Pressure Performance (ABTHERA Therapy settings): Delivery of negative pressure within established parameters (-100, -125 and -150 mmHg, continuous mode). | Results documented that selection of ABTHERA Therapy settings resulted in delivery of negative pressure within established parameters. |
| Negative Pressure Performance (General): Performance during wound exudate removal, maximum air leak rate, worst-case dressing configurations, and maximum use life of dressings. | Negative pressure performance testing was conducted for these aspects. (Implied successful demonstration of performance within acceptable limits, though specific numerical results aren't provided in the summary). |
| Human Factors Engineering: New software features and labeling can be safely and effectively used by intended users. | Assessed with 30 subject nurses and doctors; indicated new features could be safely and effectively used by all test subjects. |
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.
§ 878.4780 Powered suction pump.
(a)
Identification. A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.(b)
Classification. Class II.