(164 days)
The one megahertz ultrasound/peristaltic irrigation pump combination system, trade name Silberg T.P.S. (Tissue Preparation System), provides a method for the subcutaneous infusion and ultrasonic dispersion of tumescent fluid. It is not indicated for the administration of parenteral fluids, infusion of drugs, or for any life-sustaining purpose.
The Silberg Tissue Preparation System, Model ME 800, consists of a 1 MHz ultrasonic generator, 10 cm2 ultrasonic applicator, peristaltic pump irrigation unit. foot switch, hollow cannula, system cart, IV pole with saline solution bag and irrigation tubing set.
The provided text does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria. The document is a 510(k) summary statement for a medical device (Silberg's Vein Preparation System Model ME 800) which primarily focuses on establishing substantial equivalence to predicate devices, rather than presenting detailed performance studies against defined acceptance criteria.
Therefore, I cannot fulfill the request to provide:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set or data provenance.
- Number of experts or their qualifications for ground truth.
- Adjudication method.
- MRMC comparative effectiveness study results.
- Standalone performance results.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
The document discusses the device's components and its intended use, stating that the ultrasound portion is functionally and electrically the same as a predicate device (Sonicator 716, ME 716) and the peristaltic irrigation pump system is the same as another predicate device (Barnant pump system used by KMI Kolster Methods, Inc. "Irrigation or Infusion Pump 'K' Pump"). This comparison of technological characteristics is the basis for the 510(k) clearance, implying that the device is considered safe and effective because its components are substantially equivalent to already approved devices. It does not detail new performance studies conducted for the ME 800 itself with specific acceptance criteria.
§ 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).