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510(k) Data Aggregation
(227 days)
ABTHERA OPEN ABDOMEN NEGATIVE PRESSURE THERAPY SYSTEM
The ABThera Open Abdomen Negative Pressure Therapy System 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 in open abdominal wounds with exposed viscera including, but not limited to, abdominal compartment syndrome. The intended care setting is a closely monitored area within the acute care hospital, such as the ICU. The abdominal dressing will most often be applied in the operating theater.
The therapy system consists of a therapy unit which delivers negative pressure through a tubing set to the dressing which is placed into the open abdomen. Controls within the therapy unit monitor delivery of negative pressure and provide safety alarms. The dressing manifolds negative pressure from the therapy unit and protects abdominal contents. A canister collects wound fluids removed under negative pressure.
The document describes the ABThera Open Abdomen Negative Pressure Therapy System. Here's an analysis of the provided information concerning acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance | Study that Proves Device Meets Criteria |
|---|---|---|---|
| Functional Equivalence | Delivery of negative pressure | Equivalent to predicate devices | Laboratory tests with ABThera, V.A.C. ATS, InfoV.A.C., and V.A.C.Ulta Negative Pressure Therapy Units |
| Fluid removal | Equivalent to predicate devices | Laboratory tests with ABThera, V.A.C. ATS, InfoV.A.C., and V.A.C.Ulta Negative Pressure Therapy Units | |
| Safety and Use Information | Updated labeling to provide new safety and use information | Labeling has been updated to provide new safety and use information. | This is a documentation update, not a performance test. The acceptance criterion is the existence and correctness of the updated labeling. |
2. Sample Size Used for the Test Set and Data Provenance
The provided text only mentions "laboratory tests" for functional equivalence. It does not specify a sample size for the test set or the data provenance (e.g., country of origin, retrospective/prospective). This type of information is typically not included in a 510(k) summary for this kind of device.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable to the provided document. The device in question is a medical therapy system (Negative Pressure Wound Therapy System), not an AI/imaging diagnostic device that would require expert consensus for ground truth. The evaluation focused on the physical performance of the system against predicate devices.
4. Adjudication Method for the Test Set
This information is not applicable for the same reasons as point 3.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study was not done as this is not an AI/imaging diagnostic device intended to be used by human readers for interpretation.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
A standalone study in the context of AI algorithms was not done. The "standalone" performance here would refer to the device's ability to maintain negative pressure and remove fluid, which was evaluated in laboratory tests without direct human intervention in the continuous therapy delivery, but the evaluation itself was conducted by human operators.
7. Type of Ground Truth Used
The ground truth used for the functional equivalence tests was the performance of legally marketed predicate devices. The new device's performance (negative pressure delivery and fluid removal) was compared against these established devices in laboratory settings to demonstrate equivalence.
8. Sample Size for the Training Set
This information is not applicable as this device does not involve a "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as this device does not involve a "training set."
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