Search Results

The ConceptoMed Luer-Jack device is a sterile syringe without needle intended for single use by health care professionals for general purpose aspiration of fluids immediately after filling. The device is intended to be used only in combination with female 6% Luer connectors.

The LuerJack is a five-piece, single use syringe without needle, with a male 6% (Luer) connector in 3 ml, 5 ml, 10ml, 20 ml Luer Slip and 10 ml Luer Lock syringe sizes. The device includes a three-piece slip syringe (the Reference Device) with a barrel with graduated volume scale, a stopper and a plunger rod. Onto the barrel is a single-handed hub release system in two pieces monunted. The hub release system provides a single-handed connector release system for all Subject Devices and the additional locking function for the LuerJack Lock syringe.

The LuerJack is used as a general syringe except when disconnecting from a compatible female 6% (Luer) connector. The LuerJack is delivered sterilized by irradiation) in a syringe only configuration. The LuerJack is used as a general syringe except when disconnecting from a compatible female 6% (Luer) connector. For disconnection of an attached connector, the hub release system mounted onto the barrel is used.

This document describes the Luer-Jack Slip/Lock syringe, a medical device, and the testing conducted to demonstrate its substantial equivalence to predicate devices. It is not an AI/ML powered device, therefore, some of the requested information (like number of experts, AI effect size, training set) is not applicable.

Here's the breakdown of the acceptance criteria and the study as presented in the document:

1. Table of acceptance criteria and reported device performance:

2. Sample size used for the test set and the data provenance:

The document mentions "Design Verification tests were performed based on the risk analysis." However, it does not specify the exact sample sizes used for each individual test. It also does not provide information on the data provenance (e.g., country of origin, retrospective or prospective) beyond stating that "Design Verification tests were performed." Given this is a physical medical device, not an AI/ML algorithm, the concept of "data provenance" as typically applied to algorithms is not directly relevant here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable as the device is a physical medical device, not an AI/ML system requiring expert-established ground truth. The "ground truth" for these performance tests is defined by the objective standards themselves (e.g., ISO, EN ISO standards).

4. Adjudication method for the test set:

This information is not applicable as the device is a physical medical device, not an AI/ML system requiring adjudication of expert opinions. The performance is measured against established technical standards.

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:

This information is not applicable as the device is a physical medical device and not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This information is not applicable as the device is a physical medical device, not an algorithm.

7. The type of ground truth used:

The ground truth for this device's performance is based on objective technical standards and regulatory requirements, primarily the ISO and EN ISO standards mentioned in the acceptance criteria. For example, "Per ISO 7886-1:1997" defines the ground truth for the sustaining force.

8. The sample size for the training set:

This information is not applicable as this is a physical medical device, not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established:

This information is not applicable as this is a physical medical device, not an AI/ML algorithm.

Ask a specific question about this device