(225 days)
The V.A.C. System is a powered suction pump system that is intended for use on patients who would benefit from a suction device, particularly as the device may promote wound* healing, including patients who would benefit from vacuum assisted drainage and removal of infectious material or other fluids from wounds under the influence of continuous and/or alternating suction pressures.
- The V.A.C. is intended for patients with chronic, acute, traumatic, subacute and dehisced wounds, partial-thickness burns, diabetic ulcers, pressure ulcers, flaps and grafts.
This notification for The V.A.C. device is for labeling change only, to include an additional indication. There have been no significant modifications or design changes to the currently cleared and marketed V.A.C. device, 510(k) No.K992448.
The provided text describes the V.A.C. System, a powered suction pump intended to promote wound healing. However, the document provided is a 510(k) summary and subsequent FDA approval letter for a labeling change only, not a new device submission that would typically include a detailed clinical study for novel acceptance criteria.
The key statement is: "This notification for The V.A.C. device is for labeling change only, to include an additional indication. There have been no significant modifications or design changes to the currently cleared and marketed V.A.C. device, 510(k) No.K992448."
Therefore, the document does not contain specific acceptance criteria from a new study proving performance against those criteria in the way one would expect for a novel device or a major design change. Instead, it refers to existing market experience and previously established safety and effectiveness.
Here's a breakdown of what can be inferred or is explicitly stated, addressing the prompt's questions as much as possible, while also noting what is not present:
1. Table of Acceptance Criteria and Reported Device Performance
This table cannot be created from the provided text, as formal acceptance criteria for a new clinical study are not presented. The document focuses on expanding the "Indications for Use" based on existing data and market experience of an already cleared device.
The implied acceptance criteria for the labeling change appear to be:
- Safety and Effectiveness for Partial-Thickness Burns: Demonstrated through existing clinical experience and literature for an already cleared device.
The reported "performance" (or evidence supporting the labeling change) is:
- "KCI has worked through non-KCI clinicians to gather data to establish the safety and effectiveness of the V.A.C. System."
- "V.A.C. units have been used internationally treating well over 20,000 acute and chronic wound patients."
- "Major burn centers have been using V.A.C. therapy to assist with healing burns for several years."
- "We believe the findings of the clinical studies, cases reported in the literature, as well as informal reports by clinicians warrants the additional claim that V.A.C. treatment assists in healing partial-thickness burns."
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: "well over 20,000 acute and chronic wound patients" used internationally prior to this submission. This is the collective experience, not a single 'test set' for this specific labeling change. The document does not specify a separate 'test set' for the partial-thickness burn indication beyond the general market experience.
- Data Provenance: The data comes from "non-KCI clinicians" and "Major burn centers" using V.A.C. internationally. This suggests a collection of real-world use data, likely a mix of prospective and retrospective observations, reported cases, and literature. Specific countries are not mentioned beyond "internationally."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not provided. The text mentions "non-KCI clinicians" and "Major burn centers" but does not detail a specific panel of experts used to establish ground truth for a controlled test set in the context of this submission. The "ground truth" seems to be derived from the accumulated clinical experience of various practitioners.
4. Adjudication Method for the Test Set
This information is not provided. Given that the evidence is based on accumulated market experience and literature reviews rather than a single, controlled clinical trial, a specific adjudication method as typically understood for a new study's test set would not apply.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No, an MRMC comparative effectiveness study was not done (or at least not reported in this document). The submission is for a labeling change based on existing device use and general clinical experience, not a study comparing human readers with and without AI assistance. The device in question is a medical pump, not an AI diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
- Not applicable. The V.A.C. System is a medical device (powered suction pump), not an algorithm or AI system. Its performance is intrinsically linked to its application by a healthcare professional ("human-in-the-loop").
7. The Type of Ground Truth Used
- The ground truth relies on clinical outcomes and observations from real-world usage ("safety and effectiveness," "healing burns," "assists in healing"). This is based on aggregated clinical experience, reports, and published literature, rather than a single, pre-defined ground truth like pathology or a tightly controlled expert consensus for a specific test set.
8. The Sample Size for the Training Set
- Not applicable in the AI/Software sense. The V.A.C. System is a hardware device. If "training set" refers to the prior data informing its original clearance and subsequent use, it would be the "well over 20,000 acute and chronic wound patients" mentioned. However, this is not a 'training set' in the context of machine learning.
9. How the Ground Truth for the Training Set was Established
- Not applicable in the AI/Software sense. For a medical device like the V.A.C., the "ground truth" for its efficacy and safety (which guides its development and indications) is established through established medical practices, clinical trials (for its initial clearance, K992448), and ongoing clinical experience and research.
In summary, this document is an FDA 510(k) summary for a labeling change of an already cleared medical device. It does not describe a new clinical study with defined acceptance criteria, test sets, or ground truth establishment in the way one would for a novel device or an AI/software product. Instead, it leverages the extensive real-world experience and existing literature on the device to justify the expanded indication.
§ 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.