It is not possible to extract the requested information from the provided text. The document "K955849" describes a medical device called the "DIB Infusor" and its intended use, manufacturing, and prior testing/clinical experience. However, it does not contain the specific details about "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the format requested.

The provided text discusses:

Standards and Intended Use: States the DIB Infusor uses biocompatible materials and will conform to the AMMI Draft Infusion Device Standard. Its intended use is similar to other legally marketed elastomeric infusion pumps.
Manufacturing and Testing Procedures: Mentions manufacturing in a clean room, GMP regulations, and 100% testing of silicone balloons to an internal pressure.
Prior In-Vitro Tests and Clinical Experience: Lists several studies and clinical uses, but these documents are only referenced as "attached" and their content is not provided.

To answer your request, detailed study reports with acceptance criteria, performance metrics, sample sizes, ground truth establishment, and expert qualifications would be needed. This information is not present in the given "SUMMARY of SAFETY and EFFECTIVENESS" document.

Summary

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K955849

AUG = 5 1996

ATTACHMENT G

SUMMARY of SAFETY and EFFECTIVENESS for the DIB INFUSOR

I. Standards and Intended Use

The DIB Infusors utilize all biocompatible materials, including a medical grade silicone shaft and silicone balloon. The DIB Infusor will conform to the AMMI Draft Infusion Device Standard. The intended use of the DIB Infusor is similar to that of other legally marketed elastomeric infusion pumps.

II. Manufacturing and Testing Procedures

All manufacturing operations are performed in a class 10,000 clean room in accordance with GMP regulations. The silicone balloons are 100% tested to an internal pressure of 110+5 mmhg. Normal clinical operating pressure has been measured at approximately 70 mmhg. Full traceability of production lots will be maintained.

III. Prior In-Vitro Tests and Clinical Experience

A.) In-Vitro Tests: A Disposable Drug Infusion Balloon Catheter: A Laboratory Evaluation, Y. Susuki, M.D., et al, Department of Anesthesia, The Hospital for Sick Children and the University of Toronto, Toronto, Canada M5G-1X8 (attached).

Dept of Biomedical Engineering. Univ of Utah, flow study on DIB model 10010

B) Clinical Experience: legally marketed DIB pumps have been used clinically in the USA for obstetrical analgesia, post operative pain, chronic pain and intravenous infusions.

Clinical Experience (outside the USA):

Continuous Epidural Block with a Micro-Infusion Balloon (DIB Catheter) and Patient Controlled Analgesia, Michihiro Murozono, M.D., et al. Department of Anesthesiology, Tokyo Medical School, Tokyo, Japan (attached)
Management of Postoperative Pain Relief, Hioko Hirota, M.D.,et al, Department of Anesthesiology, Tokyo Toshima Hospital, Tokyo, Japan (attached)
Ramsey Hunt Syndrome (Hunt's Neuralgia) and Continuous Infusion of Cervical Epidural Anesthesia Haruma Ikebe, M.D., et al. Department of Anesthesiology, Ooita Medical College, Tokyo, Japan (attached)

(These publications are attached to the original Premarket Notification under FDA

file K930404)

Regulation Number and Section

§ 880.5725 Infusion pump.

(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).