(111 days)
The Avance NPWT system, with associated products, are indicated for patients who would benefit from a suction device (negative pressure wound therapy), as it may promote wound healing via the removal of fluids, including irrigation and body fluids, wound exudate and infectious materials. Examples of appropriate wound types include: chronic, acute, traumatic, sub-acute and dehisced wounds, ulcers (such as pressure or diabetic), partial-thickness burns, flaps and grafts.
The subject of this premarket notification are line additions to the Avance NPWT System: the Avance Gauze Dressing Kits. The subject kits consist of the following components:
- Antimicrobial gauze dressing
- Avance Transparent Film or Avance Film with Safetac technology
- Avance ViewPad
This document is a 510(k) premarket notification for "Avance Gauze Dressing Kits," which are line additions to an existing Negative Pressure Wound Therapy (NPWT) system. It focuses on demonstrating substantial equivalence to a legally marketed predicate device. Therefore, the information typically associated with a study proving a device meets acceptance criteria (like detailed performance metrics, sample sizes, expert involvement, and ground truth establishment) is not fully present in the document in the format you've requested for an AI model.
However, I can extract the relevant information regarding acceptance criteria and general statements about testing from the provided text:
1. A table of acceptance criteria and the reported device performance:
The document states that "all predefined acceptance criteria were met" for the bench testing. However, the specific quantitative acceptance criteria are not detailed in this summary.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Biocompatibility | Met (in accordance with ISO 10993) |
| Fluid Transport Efficiency | Performed as intended; did not negatively affect the ability of the NPWT system to transport fluid away from the wound. |
| Pressure Delivery | Performed as intended; pressure delivered in an acceptable manner. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
The document does not specify the sample sizes used for the bench testing. No clinical data was required or submitted, so there is no information on data provenance relating to clinical studies. The testing described is "non-clinical bench testing."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):
This information is not applicable and not provided. The testing described is bench testing, which typically relies on established engineering and materials science principles, not expert human assessment of images or patient data to establish ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not applicable and not provided. Adjudication methods are typically used in clinical studies or studies involving human readers, which this submission did not include.
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 MRMC study was done. This device is not an AI-assisted diagnostic tool; it is a medical dressing kit for Negative Pressure Wound Therapy.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This is not applicable as the device is not an algorithm or AI. The bench testing performed would be considered "standalone" in the sense that it evaluated the device's physical performance independently.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For biocompatibility, the ground truth would be established by the requirements of ISO 10993. For fluid transport and pressure delivery, the ground truth would be engineering specifications and functional parameters for NPWT systems, where "as intended" means meeting these predefined technical requirements.
8. The sample size for the training set:
Not applicable. This document describes a medical device (dressing kits) and its non-clinical bench testing, not an AI or machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set for this type of device submission.
§ 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.