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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.

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

The Luer-Jack Slip 10ml is a five-piece, single use syringe without needle, with a 6% (Luer) male slip connector. The device includes a three-piece syringe with a plastic barrel with graduated scale, a stopper and a plastic plunger rod. Upon the barrel is a single-handed needle hub release system in two pieces. The Luer-Jack is used as a general syringe except when disconnecting from a compatible female 6% (Luer) connector. For disconnection the hub release system mounted upon the barrel is used. The Luer-Jack will be delivered sterilized by irradiation) in a hard blister pack (the Steri-Tilt™).

The provided text describes the acceptance criteria and the summary of performance testing for the ConceptoMed Luer-Jack Slip 10ml device, a sterile syringe, in comparison to a predicate device (BD Single use, Hypodermic Syringe).

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Designed with connectors with 6% female Luer fittings | "PASS" |
   | Catch mechanism | Functional catch mechanism | "PASS" |
   | Usability | | "PASS" on all criteria |
   | One-hand handling and usability of blister | A Use of gloves during handling
   B Use in combination with a PVC | "PASS" |
   | Regulatory | -----------------------------|
   | Standard for syringes | Conformance to EN ISO 7886-1:1993 | "PASS" |
   | Biocompatibility | Conformance to EN ISO 10993-1:2009/AC:2010 | "PASS" |
   | Packaging safe for sterilization | 1) Existence of Packaging and labelling specification. Compliance with Packforsk Std-40-101 2001 Transport tests (including air transportation)

2. Packaging material intended for irradiation sterilization | "PASS" |
   | Lifetime and reliability | | "PASS" on all criteria |
   | Shelf life | Shelf life of 4 years | "PASS" |
   | Mechanical requirements | | "PASS" on all criteria |
   | Drop test | No damage of the packages, and full functionality of device | "PASS" |
   | Press fit test | Withstand a pulling force of 20 N | "PASS" |
   | Mechanical strength | a) Full function of the Lever after 15 full cycles
   b) A mechanical report shall conclude sufficient mechanical strength | "PASS" |
   | No interference when connected | Functionality after 70N push force | "PASS" |
   | Surface contact | Ability to use with a PVC | "PASS" |
   | Functionality | | "PASS" on all criteria |
   | Transparency of Lever and Collar | Visual control of graduation lines | "PASS" |

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the specific sample sizes used for each performance test. It broadly states that "Design Verification tests were performed based on the risk analysis." The data provenance (e.g., country of origin, retrospective/prospective) is also not specified for these tests.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not provided in the document. The testing appears to be primarily laboratory-based engineering and compliance testing rather than clinical studies requiring expert ground truth establishment in the traditional sense.

4. Adjudication Method for the Test Set

This information is not provided in the document. Given the nature of the tests (engineering and regulatory compliance), an adjudication method as typically used in clinical studies with human evaluators would not be applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or reported. This document pertains to the 510(k) clearance of a medical device (syringe), which typically relies on demonstrating substantial equivalence through technical and performance testing rather than comparative human efficacy studies. The comparison to the predicate device focuses on design, materials, and meeting established performance standards.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This question is not applicable. The Luer-Jack Slip 10ml is a physical syringe, not an artificial intelligence algorithm. Therefore, "standalone" performance in the context of AI does not apply. The performance tests are for the physical device itself.

7. The Type of Ground Truth Used

For the individual performance characteristics, the "ground truth" is defined by the acceptance criteria (e.g., "functional catch mechanism," "Shelf life of 4 years," "Withstand a pulling force of 20 N"). These are objective and measurable standards, not expert consensus, pathology, or outcomes data in a clinical sense.

8. The Sample Size for the Training Set

This question is not applicable. The Luer-Jack Slip 10ml is a physical syringe, not an artificial intelligence algorithm that requires a "training set." The development process involved design verification and testing against established standards.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable, as there is no "training set" in the context of this device.

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