(126 days)
The Avance Foam Abdominal Dressing Kit is indicated for temporary bridging of abdominal wall openings where primary closure is not possible and/or repeat abdominal entries may be required. Its intended use is with patients who have open abdominal wounds with exposed viscera and organs, and including but not limited to patients with abdominal compartment syndrome. It is intended for use in acute hospital settings (trauma, general and plastic surgery wards) and should ideally be applied in the operating theatre. The dressing kit is intended for use together with the Avance Max NPWT pump and its accessories.
The subject device consists of the components necessary to dress an open abdominal wound for NPWT. Kit components include: Avance ViewPad, Avance Abdominal Foam, Avance Transparent Film, and Avance Organ Contact Layer.
This document describes a 510(k) premarket notification for the Avance Abdominal Dressing Kit. It is not an AI/ML device, and therefore does not contain information about acceptance criteria for AI/ML performance, study details for AI/ML models, or ground truth establishment.
Based on the provided text, here's what can be extracted regarding the device's assessment:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility (ISO 10993-1) | Met criteria for intended use |
| Ability to transport fluid away from wound | Performed as intended in test setup; all predefined acceptance criteria were met. (Subject Avance Abdominal Dressing Kit performed as intended in the test setup, and all predefined acceptance criteria were met.) |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not explicitly stated. The document mentions "bench testing" but does not quantify the number of tests or samples.
- Data Provenance: Not applicable. This is bench testing, not patient data from a specific country or collected retrospectively/prospectively.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. The "ground truth" here refers to pre-defined engineering and biocompatibility standards, not expert interpretations of medical data.
4. Adjudication method for the test set
- Not applicable. Performance was assessed against pre-defined technical criteria.
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
- Not applicable. This is not an AI/ML device; therefore, no MRMC study with human readers and AI assistance was conducted or discussed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI/ML device. The "standalone" performance relates to the dressing kit's physical and functional properties, evaluated during bench testing.
7. The type of ground truth used
- Engineering and Biocompatibility Standards: The ground truth for this device's performance evaluation were established engineering specifications for fluid transport and ISO 10993-1 standards for biocompatibility.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device, so there is no training set.
9. How the ground truth for the training set was established
- Not applicable. No training set for an AI/ML model. The "ground truth" for the device's design and manufacturing is based on established medical device standards and engineering principles.
Summary relevant to the prompt:
This document describes a medical device undergoing 510(k) clearance, which is a process to demonstrate substantial equivalence to a legally marketed predicate device. The evaluation focuses on the device's physical and functional properties, as well as its biocompatibility. It is not an AI/ML device, hence most of the questions related to AI/ML specific criteria (like training/test sets, expert adjudication, MRMC studies, etc.) are not applicable. The studies mentioned are "non-clinical testing" focusing on ISO standards and bench testing for fluid transport.
§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.