Search Results
Found 1 results
510(k) Data Aggregation
(314 days)
KleenGel, LLC
The KleenGel hands-free dispenser is used to dispense lubricating gel for use by healthcare providers when performing pelvic and rectal exams and other procedures requiring lubricating gel.
The KleenGel Dispenser is a patented automatic dispenser designed to efficiently and hygienically dispense lubricating gel for use by health care providers when performing pelvic and rectal exams or other procedures requiring the use of lubricating gel. The KleenGel Dispenser has an Infrared Sensor for automatic dispensing of lubricating gel onto the providers fingers or on a medical instrument. The unit is designed to be placed on a counter top so it's easily accessible to healthcare providers in exam rooms. The device is battery operated, using four (4) AA (1.5V) batteries. Device also has an optional AC adapter. Sterile Lubricating Gel, (sold separately) is packaged in a 14 oz pre-filled disposable cartridge. Gel is dispensed in 3 volume selections, 1ml, 2ml or 3ml.
This document is a 510(k) Summary for the KleenGel Dispenser, a product intended to hygienically dispense lubricating gel in healthcare settings. It does not describe a study involving an AI algorithm or human readers. Therefore, I cannot extract the information required by your request about AI performance, human reader improvement with AI, or ground truth establishment relevant to AI.
However, I can provide information about the device's acceptance criteria and the non-clinical tests performed, based on the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Test | Reported Device Performance |
|---|---|
| Safety (Electrical) | Complies with UL61010-1 3rd edition (Safety Requirements for electrical equipment for measurement, control, and laboratory use. Part 1: General Requirements). |
| Software Functionality | "Software Validation Testing was performed to assure that the sensor and measurement features of the dispenser function as intended." |
| Volume Dispensing Accuracy | "The results from the Volume Dispensing Test Protocol demonstrated that the proper amounts of gel were dispensed for each setting each time the sensor was activated." |
| Leachable/Extractable Materials | Complies with USP 661. Results showed "any pharmaceutical preparation based on an aqueous and/or alcoholic matrix will not pick up any significant contamination when stored in these KleenGel Dispenser Cartridge materials." |
2. Sample sized used for the test set and the data provenance
The document does not specify the sample sizes for the "Volume Dispensing Test Protocol" or the "Leachable and Extractable testing." It refers to "bench testing" and "third-party labs" for electrical safety, indicating a controlled environment, but does not specify the provenance of the data in terms of country of origin or whether it was retrospective or prospective in the medical sense as these are non-clinical hardware/software tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This device is not an AI algorithm requiring expert ground truth for diagnostic or prognostic purposes. The "ground truth" for the tests performed relates to engineering specifications and safety standards (e.g., UL standards, USP standards, and the device's own design specifications for dispensing volumes).
4. Adjudication method for the test set
Not applicable. There was no clinical study requiring adjudication of expert opinions.
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. This document describes a medical device (a gel dispenser), not an AI algorithm for diagnostic interpretation by human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an AI algorithm. The device's "standalone" performance refers to its mechanical and software functionality, as detailed in the non-clinical tests. The software is integral to the dispenser's function (IR sensor activation, dispensing volume control), but it is not an AI for medical image analysis or diagnosis.
7. The type of ground truth used
The "ground truth" in this context refers to established engineering standards, safety requirements, and the device's design specifications:
- Electrical Safety: UL61010-1 3rd edition standard.
- Software Functionality: Whether the sensor and measurement features performed "as intended" (i.e., met design specifications).
- Volume Dispensing: Whether "proper amounts of gel were dispensed for each setting" (i.e., met pre-defined volume specifications).
- Leachable/Extractable: USP 661 standard for material biocompatibility/inertness.
8. The sample size for the training set
Not applicable. This is not an AI algorithm.
9. How the ground truth for the training set was established
Not applicable. This is not an AI algorithm.
Ask a specific question about this device
Page 1 of 1