(289 days)
The KleinTouch Pump is an infiltration pump used to cause a flow of fluid from an IV bag into a patient in a manner controlled manually by a health care professional. The KleinTouch pump is not intended to be used as an IV infusion pump.
Device Functionality: The KleinTouch Pump is an electrically or battery operated, manually controlled, peristaltic pump using three rollers to create pumping action in a section of sterile tubing.
Scientific Concept(s): The KTP is designed to specifically function with sterile single use only Klein Touch Tubing (KT20). Tubing must be primed before use. Please refer to the KT20 Instructions for Use for further details.
Physical And Performance Characteristics: Device Design Display: Color Graphic LCD Dual Foot Switches With Hose - Air Activated Dimensions: 11" x 10 ¾" x 5" Weight: 8.4 lbs.
Components Used: Motor Fluid Pathway Materials Silicone Inlet Hospital Power Cord Hospital Grade Plugs Barcode Reader Base, Plastic Battery Instrument Foam PCBA - Power Board PCBA, Main Circuit Board Pump, Peristaltic, 3-Roller, Fixed Clamp Switch, Rocker, Lighted
Physical Properties: The Pump is intended for use in combination with the KT20 tubing. The peristaltic pump using three rollers will create pumping action in KTP20 tubing set specifically designed for the KleinTouch Pump
The provided text describes the 510(k) Notification for the HK Surgical KleinTouch Pump and Tubing Set. However, it does not contain specific acceptance criteria tables or detailed study results that typically outline performance metrics for AI/ML-based medical devices. The document focuses on regulatory compliance, intended use, and general safety testing for an infusion pump, which is a physical device, not an AI/ML algorithm.
Therefore, it is not possible to extract the requested information regarding acceptance criteria and a study proving device performance in the context of AI/ML, as the document describes a traditional medical device (an infiltration pump).
Here's an analysis of what can be extracted and why other parts of your request cannot be fulfilled:
1. A table of acceptance criteria and the reported device performance:
- Cannot be provided. The document lists general performance testing categories (UL Standards, EMC, Biocompatibility, Sterilization, Human Factors) but does not provide specific quantitative acceptance criteria or reported performance values for these tests. For example, it states "Performance testing demonstrates the KleinTouch Pump meets the specifications" but doesn't detail what those specifications are or the exact results obtained.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Cannot be provided. This information is relevant for studies involving data-driven devices or algorithms. The KleinTouch Pump is a physical device, and its testing involves physical and electrical safety standards, biocompatibility, and human factors, not data samples in the context of AI/ML.
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):
- Cannot be provided. "Ground truth" in the context of expert consensus is typically for evaluating diagnostic or predictive AI/ML models. For a physical pump, testing involves adherence to engineering standards and safety protocols by qualified testing labs (MET LABS is mentioned), not expert consensus on medical image interpretation or similar. The "Human Factors evaluation" implies expert observation, but no specific numbers or qualifications are given for that.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Cannot be provided. Adjudication methods are specific to scenarios where multiple experts might disagree on ground truth, which is not applicable to the testing described for this device.
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:
- Cannot be provided. MRMC studies are for evaluating diagnostic accuracy, particularly with AI assistance, which is not relevant to a physical infiltration pump.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Cannot be provided. This device is a physical pump, not an algorithm. Therefore, "standalone" performance in the AI/ML sense is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Cannot be provided. The "ground truth" for this device's performance is adherence to established international and national safety and performance standards (e.g., UL 2601-1, IEC/EN 60601-1, ISO10993-1, ISO11135). The testing verifies that the device meets these engineering and safety requirements.
8. The sample size for the training set:
- Cannot be provided. The device is not an AI/ML model, so there is no "training set."
9. How the ground truth for the training set was established:
- Cannot be provided. As there is no training set, this question is not applicable.
In summary: The provided text is a 510(k) summary for a physical medical device (an infiltration pump) and details its design, intended use, and compliance with various established safety and performance standards. It does not describe an AI/ML device or studies involving data-driven performance metrics, ground truth establishment, or human-AI interaction.
§ 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).