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The Surguard™ Safety Syringe is a device intended for the manual aspiration of fluids, and for the injection of fluids into parts of the body below the surface of the skin. The syringe will also be used to withdraw medication from vials. This device is intended for insulin, allergy, or general use injections. Additionally, after withdrawing the needle from the patient, the safety feature can be manually activated to cover the needle to minimize the risk of accidental needlestick.

The Surguard Safety Syringe consists of a graduated hypodermic syringe barrel with a permanently affixed needle (also called cannula) and an integrated safety feature component, which is permanently attached at the top of the syringe barrel close to the needle. The safety feature component can swivel to allow users additional flexibility in positioning the syringe and bevel for use. The locking mechanisms are located within the body of the sheath and at the collar that attaches to the top of the syringe barrel.

The syringe portion is the same as Terumo's Insulin and Terumo's Allergy/General Syringe that are the subject of K882083 and K980796 respectively. No changes were made to the syringes other than a minor modification to outside of the barrel to allow for secure attachment of the safety feature.

The syringe is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The syringe will also be used to withdraw medication from vials. The syringe barrel will be graduated in insulin units for use with insulin or in cc/ml units for allergy or general use. The allergy/ general use syringe is offered with an intradermal bevel for intradermal injections and a regular bevel typically used for subcutaneous injections. The general use syringe has a regular bevel, which can be used for common injections such as intradermal, intramuscular, or subcutaneous. The insulin syringe will contain orange-colored needle cap and the allergy/general use syringe will contain a noncolored (white) cap.

The safety sheath is activated after syringe use and prior to disposal to minimize the possibility of sharps injury. The safety sheath is activated with a one-handed operation by pressing the sheath against a firm surface, thereby engaging the needle into the sheath. The user will visually confirm the needle is locked beneath the locking tab.

The provided document describes the predicate device information and does not contain detailed information regarding the acceptance criteria and study proving device meets the acceptance criteria for the TERUMO® SURGUARD™ Safety Syringe. The document states that the device is substantially equivalent to previously cleared devices (K822083, K980796, and K011925) based on intended use, design, technology/principles of operation, materials, and performance.

However, it does list performance tests conducted on the Surguard Safety Syringe. These tests would typically have associated acceptance criteria, but these specific criteria are not detailed in the provided text. The document only states that: "None of the data raises any new issues of safety and effectiveness." and "Additionally, a risk analysis was conducted and there were no new issues of safety and effectiveness."

Therefore, based on the provided text, I cannot complete a table of acceptance criteria and reported device performance, nor can I provide answers to most of the requested points, as the actual study details (sample sizes, ground truth, experts, etc.) for these specific performance tests are not included.

I can, however, extract the types of tests performed.

Summary based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance: This information is not provided in the document. The document lists the types of performance tests conducted but does not specify the acceptance criteria for each test or the quantitative results of those tests. It only states that "None of the data raises any new issues of safety and effectiveness."

2. Sample sizes used for the test set and the data provenance: Not specified for the performance tests. The document only mentions "The following tests were performed on the Surguard Safety Syringe," implying a test set was used, but details are absent.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified.

4. Adjudication method for the test set: Not specified.

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 device is a manual hypodermic syringe, not an AI-assisted diagnostic or therapeutic device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used: Not explicitly stated for each performance test. For biological evaluations, it states "The device's blood contacting materials were tested in accordance with the tests recommended in the FDA General Program Memorandum #G95-1 (5/1/95): Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part-1: Evaluation and Testing".
   For sterility, "The sterility of the device is assured using a sterilization method validated in accordance with ANSI/AAMI/ISO 11137-1994 Medical Devices - Validation and Routine Control of Radiation Sterilization. The Surguard Safety Syringe is sterilized to provide a Sterility Assurance Level (SAL) of 10-6." These standards set the "ground truth" for biocompatibility and sterility. For mechanical performance tests, the "ground truth" would be the engineering specifications for each parameter (e.g., a specific force range for activation).

8. The sample size for the training set: Not applicable and not specified. This is not an AI/machine learning device that requires a training set.

9. How the ground truth for the training set was established: Not applicable.

However, the document does list the performance tests conducted:

• Activation Force
• Deactivation Force
• Sheath Penetration Force
• Sheath Removal Force
• Collar Removal Force
• Sheath Swivel Force
• Hinge Integrity
• Residual Volume
• Simulated Use Study
• Biocompatibility Testing (ISO-10993)
• Sterility Validation (ANSI/AAMI/ISO 11137-1994)

The study proving the device meets the acceptance criteria is implicitly referred to as "The following tests were performed on the Surguard Safety Syringe," and the conclusion section states that based on these tests, the device is "substantially equivalent" to predicate devices, indicating that its performance met the necessary criteria for regulatory clearance. The exact details of these studies (methodologies, sample sizes, specific results, and criteria levels) are not present in this summary document.

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