(76 days)
The V.A.C. Simplicity™ Negative Pressure Wound 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, pressure or venous insufficiency), flaps and grafts.
Negative pressure wound therapy unit component of an integrated negative pressure wound therapy system
The provided text describes the V.A.C. Simplicity™ Negative Pressure Wound Therapy Unit. Here's a breakdown of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are primarily focused on the device's ability to deliver negative pressure wound therapy (NPWT) comparably to a predicate device and its compliance with relevant safety standards.
| Acceptance Criteria / Specification | Reported Device Performance |
|---|---|
| Functional Performance | |
| Deliver NPWT at -125 mmHg | "Testing demonstrated that the V.A.C. Simplicity™ Therapy Unit delivers equivalent negative pressure wound therapy at -125 mmHg" compared to the ActiV.A.C. Therapy Unit. |
| Software Performance | |
| Software Verification & Validation | "Software verification and validation testing confirms that the software meets the requirements of the software requirements specification." |
| Electrical Safety | |
| Compliance with Electrical Safety | "The therapy unit was tested to all applicable electrical safety and electromagnetic emissions standards and was found to be in compliance." |
| Electromagnetic Emissions | "The therapy unit was tested to all applicable electrical safety and electromagnetic emissions standards and was found to be in compliance." |
| Usability | |
| Ease of use in home environment | "Usability studies were performed with 30 subjects representing home care nurses and patients to assure that the product could easily be used in the home environment and that labeling can be understood and followed." "The home care nurse responses in the V.A.C. Simplicity™ Therapy Unit usability test are supportive of usability in the extended care environment" (based on previous testing showing equivalence between home care and extended care nurse responses for a similar product). |
2. Sample Size Used for the Test Set and Data Provenance
- Functional Performance, Software, Electrical Safety, Electromagnetic Emissions: No specific sample sizes for these bench tests are explicitly stated. The documentation indicates "testing demonstrated" for functional performance and "testing confirms" for software, implying sufficient testing was conducted to meet internal specifications.
- Usability Study Test Set: 30 subjects (home care nurses and patients).
- Data Provenance: The document does not explicitly state the country of origin for the usability study data. Given the address for KCI USA, Inc. in San Antonio, Texas, it is safe to assume the data is from the United States. The study was prospective for the V.A.C. Simplicity™ device, as it was conducted specifically for its submission, though it leveraged prior prospective data from a similar device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- For the functional, software, electrical safety, and electromagnetic emissions tests, the "ground truth" refers to established engineering specifications, industry standards, and regulatory requirements. The document does not specify the number or qualifications of experts who established these standards, as these are generally accepted benchmarks.
- For the usability study, the "ground truth" was established by the 30 subjects (home care nurses and patients) themselves, through their ability to understand labeling and easily use the product. These individuals are the end-users and their experience forms the basis of the usability assessment. No external "experts" were used to establish this specific ground truth beyond the subjects providing direct feedback.
4. Adjudication Method for the Test Set
- For the technical performance tests (functional, software, electrical safety, electromagnetic emissions), the adjudication method is implied to be adherence to objective pass/fail criteria based on specifications and standards. No human-expert adjudication process is described separately from the testing itself.
- For the usability study, no formal adjudication method (like 2+1 or 3+1) is mentioned. The study "assured that the product could easily be used... and that labeling can be understood and followed" by the 30 subjects. This suggests a direct assessment of their interaction and comprehension, likely relying on observed performance and feedback without further external adjudication.
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 device is a negative pressure wound therapy unit, not an AI-powered diagnostic or assistive technology that would involve "human readers" or "AI assistance" in the typical sense of a MRMC study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device is a physical medical device (a pump) with embedded software. While "standalone" performance testing for the software was conducted ("Software verification and validation testing confirms that the software meets the requirements"), this is not in the context of a standalone algorithm in the way it's typically understood for AI/ML devices. The "algorithm" (software) runs intrinsically within the device to monitor and maintain pressure and alarms. Its standalone performance is assessed through its ability to meet the requirements of its specification, and its overall performance is inherently tied to the hardware it controls.
7. The Type of Ground Truth Used
- Functional Performance: Engineering specifications for negative pressure delivery (e.g., -125 mmHg).
- Software Performance: Requirements outlined in the "software requirements specification."
- Electrical Safety & Electromagnetic Emissions: Applicable electrical safety and electromagnetic emissions standards.
- Usability: User experience and comprehension (direct feedback from home care nurses and patients).
8. The Sample Size for the Training Set
This document describes a medical device clearance (510(k)) for a physical pump with embedded software, not an AI/ML device that typically involves distinct "training sets" for machine learning models. Therefore, the concept of a training set in that context is not applicable here, and no sample size for such a set is mentioned.
9. How the Ground Truth for the Training Set Was Established
As explained above, there is no "training set" in the context of AI/ML for this device. The ground truth for its various performance aspects (functional, safety, usability) was established through engineering specifications, regulatory standards, and direct user feedback, as detailed in point 7.
§ 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.