(454 days)
The Vcare a is intended for wound management via application of continual or intermittent negative pressure to the wound for removal of fluids, including wound exudate, irrigation fluids, and infectious materials. It is indicated for management of chronic, acute, traumatic, sub-acute and dehisced wounds. partial-thickness burns, ulcers (such as diabetic or pressure), flaps and grafts. The Vcare a may promote healing by removal of excess exudates, irrigation fluids, and infectious material.
The Vcare a - is a Negative Pressure Wound Therapy system that comprises fixed components and disposables. The Vcare a maintains the functionality of existing devices while enhancing safety. The system has features that optimize the delivery of negative pressure to open wounds. The software requires the user to profile the patient and the system then limits the device's operational parameters to be compatible with the patient profile. The system incorporates safety features that control the system to prevent risk to the patient. The sensors and controls monitor and maintain target pressure and alarms, as needed, to help assure that target pressure is maintained and constant therapy is delivered. The safety features of the system include additional alarms, such as those that signal for possible bleeding, tubing blockage, a full or missing collection canister, inactive therapy, low battery and leaks in the seal of the dressing.
The provided text is a 510(k) summary for the Vcare a Negative Pressure Wound Therapy (NPWT) device. It describes the device, its intended use, and compares it to a predicate device (V.A.C. Therapy System). However, it does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria related to a diagnostic or AI-driven performance study.
The document is focused on demonstrating substantial equivalence to a predicate device for regulatory clearance, primarily by outlining features and safety aspects. It is not a clinical study report or a performance study for an AI/diagnostic device.
Therefore, I cannot fulfill your request for the specific points listed below based on the provided text:
- A table of acceptance criteria and the reported device performance: The document compares features to a predicate device, but does not define acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) or provide performance metrics (e.g., AUC, F1-score) from a study in the way an AI/diagnostic device would.
- Sample size used for the test set and the data provenance: Not applicable, as no such performance study is described.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
- 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: Not applicable.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
The document is a regulatory submission for a physical medical device (NPWT system) and its features, focusing on safety and equivalence to an already marketed device, rather than a performance study of a diagnostic algorithm.
§ 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.