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The V.A.C. Open Abdomen Negative Pressure Therapy System is a specialty system 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 Open Abdominal Negative Pressure Therapy System is designed for the application of negative pressure therapy for temporary bridging of the abdominal wall for patients with an open abdominal wound due to trauma, abdominal surgery, infection and/or abdominal compartment syndrome. It is comprised of a negative pressure therapy unit, a canister and the currently cleared and marketed V.A.C.® Abdominal Dressing.

The provided text is a 510(k) summary for the "Open Abdomen Negative Pressure Therapy System." It outlines the product, its intended use, and comparability to predicate devices. However, it does not contain information about specific acceptance criteria or a detailed study proving the device meets those criteria, as typically found in clinical trials or performance studies with specific statistical outcomes.

The "Summary of nonclinical tests" section vaguely states: "The Open Abdomen Therapy unit was evaluated under a number of performance tests to assure performance and conformance to design specifications." This indicates that some testing was performed to ensure the device met design specifications, but no specifics are provided regarding what those specifications were, the acceptance criteria, or the results of those tests.

Therefore, the following information, based on the provided document, focuses on what is available and notes the absence of the requested detailed study information.

Here's an analysis of the provided text in relation to your request:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table of acceptance criteria or specific reported device performance metrics in the way one would expect from a clinical study or detailed performance report. It generally states that the device was evaluated to "assure performance and conformance to design specifications" and that testing "documents that the Open Abdomen Therapy System and the V.A.C.® ATS Therapy system with the V.A.C.® Abdominal dressing are equivalent in terms of technology and performance specifications for the delivery of negative pressure to the open abdomen."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The text refers to "nonclinical tests" but does not specify sample sizes or data provenance.

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 provided in the document. The submission focuses on device characteristics and equivalence, not clinical effectiveness studies requiring expert-established ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the document.

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 is not applicable to this device. The device is an Open Abdomen Negative Pressure Therapy System, not an AI-assisted diagnostic tool or system that would involve human readers interpreting AI output.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This is not applicable to this device. It is a physical medical device, not an algorithm. However, the device itself operates in a "standalone" manner in applying negative pressure, but its performance is measured by its physical function, not by an algorithm's output.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not provided in the document. Given that the submission focuses on equivalence to a predicate device and nonclinical (performance/conformance) tests, "ground truth" in the clinical sense of outcomes data or pathology is not detailed. The "ground truth" for the nonclinical tests would likely be established engineering specifications and physical measurements.

8. The sample size for the training set

This information is not provided in the document. As this is a physical device, a "training set" in the context of machine learning is not relevant. If "training set" refers to pre-production or design verification samples, that information is not disclosed.

9. How the ground truth for the training set was established

This information is not provided in the document. (See point 8 above regarding relevance).

In summary:

The provided 510(k) summary is for a physical medical device (Negative Pressure Therapy System) and focuses on establishing substantial equivalence to a predicate device based on technological characteristics and nonclinical performance tests. It does not include the detailed clinical study results, acceptance criteria tables, or specifics on ground truth establishment, expert involvement, or sample sizes typical for diagnostic AI devices or comparative clinical effectiveness studies. The document states that the device was evaluated through "performance tests to assure performance and conformance to design specifications" and concluded equivalence to its predicate, but it does not elaborate on the specifics of these tests or their acceptance criteria.

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