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The Luer Lock Syringe with Exchangeable Needle is used to inject medicines and vaccines into, or withdraw fluids from. the body.

The Luer Lock Syringe with Safety Needle is used to inject fluids into, or withdraw fluids from, the body. The safety mechanism covers the needle after use. In the activated position, the protective arm guards against accidental needle stick during normal handling and disposal of the used needle/syringe combination.

The Luer Lock Syringe with Blunt Fill Needle is used for aspiration from multi-dose medicine vials.

The Luer Lock Syringe with Exchangeable Needle is a sterile, single-use, standard 3-piece piston syringe with a detachable pre-attached needle.

The Luer Lock with Safety Needle is a syringe and needle combination with the safety needle. It contains a mechanism that covers the needle point after use. In the activated position, the needle cover guards against accidental needle stick during normal handling and disposal of the used needle/syringe combination. The Safety needle can be pre-attached or aside the syringe.

The Luer Lock Syringe with Blunt Fill Needle is a sterile, single-use, standard 3-piece piston syringe with a detachable pre-attached needle. It is used for aspiration from multi-dose medicine vials.

The proposed devices are offered in various gauge sizes and length.

The proposed devices are available in EO sterilized to achieve a Sterility Assurance Level (SAL) of 10-6.

The device is for medical professionals use only and for prescription use only.

• Luer Lock Syringe with Safety Needle (Syringe range: 1ml, 3ml, 5ml,10ml; Needle range: 20G, 21G, 23G, 25G; Needle length from 5/8" to 1 1/2"). The Safety needle can be pre-attached or aside the syringe.

• Luer Lock Syringe with Exchangeable Needle (Syringe range: 3ml, 5ml, 10ml, Needle range: 20G, 21G, 22G, 23G, 25G; Needle length from 5/8" to 1 1/2").

• Luer Lock Syringe with Blunt Fill Needle (Syringe range: 3ml, 5ml, 10ml, Needle: 18G, Needle length:1 1/2").

The provided text describes a 510(k) premarket notification for a medical device, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove acceptance criteria in the typical sense of algorithm performance. The device referenced is a "Luer Lock Syringe with Safety Needle: Luer Lock Syringe with Exchangeable Needle; Luer Lock Syringe with Blunt Fill Needle."

Therefore, most of the requested information (sample size, data provenance, expert ground truth, adjudication method, MRMC studies, standalone performance, training set details) is not applicable as this is a physical medical device clearance, not an AI/algorithm-driven device.

However, I can extract the acceptance criteria (standards the device complies with) and the reported device performance (test results indicating compliance).

Here's the information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria is a series of non-clinical performance tests detailed in the "8. Performance Data" section. These tests were conducted on representative samples of the proposed devices to demonstrate compliance with the listed international and ASTM standards and USP monographs.

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

• Sample Size: Not explicitly stated for each test. The document mentions "representative samples" were used.
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). As these are bench tests and biocompatibility assessments for a physical device, the concept of "country of origin of data" in the AI sense is less relevant. The studies were non-clinical performance and biocompatibility tests conducted to industry standards.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• Not Applicable. This is a clearance for a physical medical device, not an AI/algorithm-driven device requiring expert consensus for ground truth. The "ground truth" here is compliance with established performance standards for syringes and needles.

4. Adjudication Method for the Test Set:

• Not Applicable. As above, this is for a physical device. Test results are typically objective measurements against a standard, not subjective expert adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No. This type of study is relevant for AI/imaging algorithms, not for physical syringes and needles. The document explicitly states: "No data from human clinical studies have been included to support the substantial equivalence of the proposed device."

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study:

• Not Applicable. This is a physical device; there is no embedded algorithm.

7. Type of Ground Truth Used:

• The "ground truth" for this device is compliance with internationally recognized scientific and engineering standards and biological safety standards as listed (e.g., ISO 7886-1, ISO 10993 series, ASTM, USP). The tests performed (e.g., cytotoxicity, pyrogenicity, seal strength, fluid dynamic performance) provide objective measurements against these predefined standards.

8. Sample Size for the Training Set:

• Not Applicable. This is a physical device, not an AI/ML model that requires a training set.

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

• Not Applicable. (See point 8).

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