(78 days)
The ABThera™ Open Abdomen Dressing is indicated for temporary bridging of abdominal wall openings where primary closure is not possible and or repeat abdominal entries are necessary. The Intended use of this system is for use in open abdominal wounds, with exposed viscera, including but not limited to abdominal compartment syndrome.
The intended care setting is the acute hospital setting: in trauma, general and plastic surgery wards. The abdominal dressing will most often be applied in the operating theater.
The ABThera™ Open Abdomen Dressing is a specialty dressing, supplied sterile for single use only. It is double pouched and packaged as a kit with One Internal Contact Layer Two Outer Layer open-cell foam pieces Four V.A.C.® Drapes One T.R.A.C.™ Pad Assembly
The provided text is a 510(k) summary for a medical device called the ABThera™ Open Abdomen Dressing. It describes the device, its intended use, and claims substantial equivalence to a predicate device (V.A.C.® Abdominal Dressing).
However, the document does not contain the kind of detailed information requested in the prompt regarding acceptance criteria, reported device performance in a table, sample sizes, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone algorithm performance, or training set details. This information is typically found in design validation reports or clinical study summaries, which are not part of this 510(k) summary.
The document only states:
- Acceptance Criteria/Reported Device Performance: "The dressing design was evaluated under a number of design verification and validation tests in order to assure performance and conformance to design specifications." And "Verification and validation testing conducted under design control requirements document that the ABThera™ Open Abdomen Dressing is equivalent to the predicate in terms of technology and performance requirements for its intended use." No specific quantitative acceptance criteria or reported performance metrics are provided.
- Study That Proves the Device Meets Acceptance Criteria: The document refers to "design verification and validation tests" and "verification and validation testing conducted under design control requirements" but does not describe any specific studies (clinical or non-clinical) in detail. It primarily relies on demonstrating substantial equivalence to a previously cleared predicate device (V.A.C.® Abdominal Dressing, K022011) rather than presenting a performance study against specific acceptance criteria.
Therefore, most of the requested information cannot be extracted from this 510(k) summary. Here's what can be inferred or explicitly stated from the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | "Equivalent to the predicate in terms of technology and performance requirements for its intended use." |
| "Assure performance and conformance to design specifications." | "Evaluated under a number of design verification and validation tests." |
The document does not provide specific quantifiable acceptance criteria or performance metrics.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size: Not specified.
- Data provenance: Not specified. The document mentions "design verification and validation tests," implying laboratory or engineering tests, but no details of human subject data (clinical data) are given or implied beyond the comparison to a predicate device.
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)
- Not applicable/Not specified, as no human subject test set or ground truth establishment by experts is detailed in this 510(k) summary. The evaluation focuses on "design control requirements" and technological equivalence.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not specified, as no human subject test set requiring adjudication is detailed.
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 device is a wound dressing, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a wound dressing, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable. For this device submission, the "ground truth" for "performance" is primarily defined by its adherence to design specifications and its equivalence to the predicate device through engineering and performance testing. There's no clinical trial data presented with a ground truth established by medical experts or pathology in this summary.
8. The sample size for the training set
- Not applicable/Not specified. There is no mention of "training sets" as this is not an AI/ML device.
9. How the ground truth for the training set was established
- Not applicable/Not specified, as there is no training set mentioned.
§ 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.