(227 days)
The Avance Solo NPWT System is indicated for patients who would benefit from wound management via the application of negative pressure wound therapy, particularly as the device may promote wound healing through the removal of exudate, infectious material.
Avance Solo NPWT System is indicated for removal of low to moderate amounts of exudates from chronic, acute, traumatic, subacute and dehisced wounds, ulcers (such as diabetic, venous or pressure), surgically closed incisions, flaps, and grafts.
Avance Solo NPWT System is intended for use by healthcare professionals for therapy on patients in healthcare facilities and home care settings.
Avance Solo Negative Pressure Wound Therapy (NPWT) System consists of Avance Solo Pump, Avance Solo Canister 50 mL, Avance Solo Border Dressing and Avance Solo Foam which together form a system for wound management via the application of negative pressure wound therapy.
- . Avance Solo Pump, a battery powered single patient use pump with a 14 day lifespan, single button operated with visual and audible alarms and notifications
- . Avance Solo Canister 50 ml, a single use canister attached to the pump for collection of wound fluid and exudate
- . Avance Solo Border Dressing, a single use breathable soft silicone absorbent dressing with acrylic fixation strips
- . Avance Solo Foam, a single use polyurethane foam wound filler for cavity wounds
Avance Solo NPWT System maintains negative pressure nominally at -125 mmHg to the wound and enables exudate management by absorption and evaporation in Avance Solo Border Dressing. Excess exudate is collected in Avance Solo Canister 50 ml.
Avance Solo NPWT System is intended for adults.
The provided text is a 510(k) summary for the Avance Solo Negative Pressure Wound Therapy (NPWT) System. It describes the device, its intended use, and a comparison to predicate devices, along with non-clinical testing performed.
However, the request asks for information regarding acceptance criteria and the study that proves the device meets the acceptance criteria, specifically in the context of:
- A table of acceptance criteria and reported device performance.
- Sample size and data provenance for test sets.
- Number and qualifications of experts for ground truth.
- Adjudication method for test sets.
- MRMC comparative effectiveness study results (human readers improve with AI vs without AI assistance).
- Standalone (algorithm only) performance.
- Type of ground truth (consensus, pathology, outcomes).
- Training set sample size and ground truth establishment.
The provided document does not contain information related to AI/algorithm performance, human reader studies, or how ground truth for an AI model would be established (e.g., expert consensus, pathology). It focuses on the safety and effectiveness of a physical medical device (a Negative Pressure Wound Therapy system) through bench testing, biocompatibility, software validation, and electrical safety testing.
Therefore, I cannot fulfill the request using only the provided text as it does not describe an AI medical device or a study of the type requested (e.g., MRMC, standalone algorithm performance).
Specifically, the document states:
- "No clinical data was provided to support substantial equivalence." (Page {8})
- It describes "Non-Clinical Testing" which includes:
- Biocompatibility
- Bench testing (fluid transport, pressure delivery, alarm functionality, device lifetime, pressure safety)
- Software validation (IEC 62304)
- Electromagnetic compatibility and electrical safety testing (various IEC/AAMI standards)
- Human factors/usability testing.
The "Bench testing" section does mention acceptance criteria were met, but it does not provide a detailed table, sample sizes for "test sets" in the context of an AI model, expert involvement for ground truth, or MRMC studies as it pertains to the performance of a physical device.
If the request implies that the provided text describes an AI device or a study involving an AI component, that is incorrect. The device is a traditional medical device for wound therapy.
§ 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.