(57 days)
The RENASYS AB Abdominal Dressing Kit with Soft Port is indicated for temporary bridging of abdominal wall openings where primary closure is not possible and/or repeat abdominal entries are necessary. It is intended to be used in open abdominal wounds with exposed viscera, including but not limited to abdominal compartment syndrome.
The RENASYS AB Abdominal Dressing Kit with Soft Port is intended for use in acute hospital settings (trauma, general and plastic surgery wards) and should ideally be applied in the operating theatre.
The RENASYS™ AB Abdominal Dressing Kit with Soft Port consists of two large hydrophobic reticulated polyurethane foam dressings that incorporate several cuts to facilitate custom sizing if needed. Also included in the kit are a polyurethane organ protection layer, six transparent film drapes and a Soft Port suction port assembly with tubing that attaches to the exudate canister. The kit is designed specifically for abdominal wounds and is supplied sterile, single use.
The modification to this kit is the inclusion of a Soft Port suction port, to replace the existing suction port.
The RENASYS AB Abdominal Dressing Kit is used in conjunction with Smith & Nephew RENASYS EZ and RENSASYS EZ PLUS negative pressure wound therapy pumps and canister kits, which have been cleared under 510(k) numbers K082426 and K091470.
The provided text describes a 510(k) summary for the RENASYS™ AB Abdominal Dressing Kit with Soft Port. It focuses on demonstrating substantial equivalence to predicate devices through non-clinical bench testing. Therefore, the requested information regarding acceptance criteria and studies largely pertains to these bench tests, not clinical performance or AI algorithm validation.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied from “Meets required specifications”) | Reported Device Performance |
|---|---|
| Comparable performance with clottable blood to existing suction port | Comparable performance patterns demonstrated (when tested with clottable blood). |
| Performs to specification under excessive weight | Performs to specification (under excessive weight, blockage by compression/folding, or particulate challenge). |
| Performs to specification when blocked by compression, folding | Performs to specification (under excessive weight, blockage by compression/folding, or particulate challenge). |
| Performs to specification when subjected to particulate challenge | Performs to specification (under excessive weight, blockage by compression/folding, or particulate challenge). |
| Effectively removes exudate at predetermined flow rate for a minimum of 48 hours | Effectively removes exudate from the abdomen at the predetermined flow rate for a minimum of 48 hours. |
| "Quick-click" connector establishes a secure connection to exudate canister tubing | Establishes a secure connection to the exudate canister tubing. |
2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: The document does not specify exact sample sizes (e.g., number of tests per criterion). It states "Laboratory testing was completed" and "Testing to verify".
- Data Provenance: The tests are described as "Laboratory testing" or "Bench" tests, implying they were conducted in a controlled lab environment. No information on country of origin or whether it was retrospective/prospective in a clinical sense is provided as these are non-clinical studies.
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 question is not applicable to the provided document. The ground truth for the non-clinical bench tests would be the measured physical performance against predefined engineering specifications, not expert interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable to the provided document. Adjudication methods like 2+1 or 3+1 are used for expert consensus on clinical data. For bench tests, performance is typically measured directly against specifications.
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
This question is not applicable to the provided document. The device is a medical dressing kit, not an AI-powered diagnostic tool. Therefore, an MRMC study or AI assistance is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable to the provided document. The device is a medical dressing kit, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical bench tests, the "ground truth" is the predefined engineering specifications and measurable performance characteristics of the device components (e.g., flow rate, connection security, performance under stress, biocompatibility).
8. The sample size for the training set
This question is not applicable to the provided document. The device is a medical dressing kit, not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established
This question is not applicable to the provided document. The device is a medical dressing kit, not an AI algorithm that requires a training set.
§ 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.