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The Plastic LOR Syringe is intended for use in conjunction with an epidural needle, to verify the needle tip placement in the epidural space by the loss of Resistance technique, it will be filled with air and/or saline during use. The loss of Resistance Syringe is not intended for injection or aspiration. The syringe will be sold sterile individually packaged, and as part of a sterile kit.

The Plastic LOR syringe is a piston syringe of three pieces. It consists of barrel, plunger and piston. The barrel is available with Luer slip, NRFit lock, NRFit Slip male connector. The Plastic LOR syringe is provided in combinations of four connectors and four syringe capacities (5ml, 7ml, 10ml, 20ml). The device is a sterile finished disposable device, supplied sterile to the end user and non-sterile will be supplied to Anesthetic Conduction Kit manufacturers to be sterile and packaged into kit. The Plastic LOR syringe is a single use device which will be supplied as sterile individually packaged and the non-sterile bulk packed. The sterilized by Ethylene Oxide Gas to achieve a SAL of 10° and supplied sterility maintenance package which could maintain the sterility of the device during the s helf life of five years.

This document is a 510(k) Summary for a Plastic LOR Syringe. The purpose of this summary is to demonstrate that the device is substantially equivalent to legally marketed predicate devices.

Here's the breakdown of the acceptance criteria and the study information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily derived from various ISO and ASTM standards for syringes, neuraxial, and Luer connectors, as well as biocompatibility and sterilization standards. The reported device performance indicates compliance with these standards.

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

The document does not specify the exact sample sizes for each non-clinical test (e.g., how many syringes were tested for fluid leakage, or how many samples for biocompatibility tests). It simply states that "Non clinical tests were conducted to verify that the proposed device met all design specifications."

The data provenance is from non-clinical tests conducted by Jiangsu Caina Medical Co., Ltd. (the manufacturer). The country of origin of the testing data is presumably China, where the manufacturer is located. The tests are retrospective in the sense that they were performed to support the 510(k) submission for an already developed device.

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 this is a non-clinical submission for a physical medical device (syringe), not an AI/software device that requires expert-established ground truth for a test set. The "ground truth" here is compliance with established international and national standards.

4. Adjudication method for the test set

This information is not applicable for the same reasons as point 3. Testing against standards does not typically involve adjudication in the way AI/software studies do.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This is a 510(k) submission for a physical medical device (Plastic LOR Syringe), which does not involve human readers or AI assistance.

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

No, a standalone algorithm performance study was not done. This device is a physical medical instrument, not an algorithm.

7. The type of ground truth used

The "ground truth" for this submission is compliance with recognized consensus standards (ISO, ASTM, USP) for medical devices, materials, and sterilization, as well as the demonstration of substantial equivalence to predicate devices based on these tests.

8. The sample size for the training set

This information is not applicable as this is a physical medical device. There is no AI model or "training set" involved in its development or regulatory submission.

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

This information is not applicable as there is no training set for this type of device.

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