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The extriCARE 2400 Negative Pressure Wound Therapy Pump System is a portable, battery powered pump intended to generate negative pressure or suction to remove wound exudates, infectious material, and tissue debris from the wound bed which may promote wound healing.

The system consists of a vacuum pump, canister, and tubing. In operation, the device is attached via the tubing to a Negative Pressure Wound bandage. Maximum pressure and mode selection are digitally programmable. The extriCARE pump can be sold alone or as a part of the extriCARE 2400 system with extriCARE bandages. The extriCARE bandages are an all-in-one wound dressing, with no wound packing required.

The provided text describes the extriCARE 2400 Negative Pressure Wound Therapy System and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study proving that a device meets specific acceptance criteria related to AI or a diagnostic performance claim.

Instead, the document focuses on:

• Device Description and Intended Use: Explaining what the extriCARE 2400 system is and what it's designed to do (generate negative pressure to remove wound exudates, infectious material, and tissue debris).
• Substantial Equivalence: Arguing that the device is technologically similar to existing predicate devices (NPD 1000, MobIVAC W.C., Renasys Gauze Dressing Kit).
• Performance Testing: Listing functional and mechanical tests (e.g., vacuum pressure calibration, flow rate, alarm verification, battery verification, exudate removal, bandage tests like peel strength, shear adhesion, leakage), and compliance with EMC and electrical safety standards (IEC 60601-1-2, UL 60601-1). These are engineering performance tests, not diagnostic accuracy studies.
• Biocompatibility Testing: Reporting results for tests on the bandage (Guinea Pig Maximization Sensitization, Cytotoxicity, Intracutaneous Irritation) to ensure it's safe for body contact.

Therefore, I cannot fulfill your request for the detailed information about acceptance criteria and a study proving a device meets them, especially regarding diagnostic accuracy, AI performance, or MRMC studies, as this information is not present in the provided text.

Specifically, the following points from your request cannot be answered from the provided document:

1. A table of acceptance criteria and the reported device performance: While performance tests are listed, the acceptance criteria for these tests (e.g., "vacuum pressure must be within X% of target") are not explicitly stated, nor are the detailed quantitative results ("reported device performance") beyond "successfully passed" or "did not elicit sensitization/non-cytotoxic/non-irritant" for biocompatibility tests.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not mentioned.
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 as this is not a diagnostic device or AI study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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