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The VitreJect Syringe is intended to inject fluids into, or withdraw fluids from, the body. The VitreJect Syringe is indicated for intracameral and intravitreal use.

The Vitrelect Syringe is designed to provide a means of fluid injection and aspiration. It is a luer-tip piston syringe consisting of a 1 mL hollow barrel with gradient markings and a plunger with an incorporated plunger stopper. The VitreJect Syringe barrel component is available in two configurations, a luer-slip or luer-lock tip, for the fitting of a compatible hypodermic needle. The VitreJect Syringe plunger is available in two configurations: standard dead space or low dead space. It is intended for manual use by health care professionals. The VitreJect Syringe is single use only, non-toxic, non-pyrogenic, and sterilized by ethylene oxide gas. The VitreJect Syringe is suitable for ophthalmic use.

This document is a 510(k) Premarket Notification for a medical device called the "VitreJect Syringe." It aims to demonstrate that the VitreJect Syringe is substantially equivalent to a legally marketed predicate device (StaClear Syringe, K200242).

This document describes non-clinical performance and biocompatibility testing for a medical device (syringe), not an AI/ML powered device. Therefore, many of the requested criteria related to AI/ML device testing (e.g., number of experts, adjudication methods, MRMC studies, training set details) are not applicable.

However, I can extract the relevant information regarding the device's acceptance criteria and the study that proves it meets them, based on the provided text.

1. A table of acceptance criteria and the reported device performance

The document doesn't present a single structured table explicitly labeled "Acceptance Criteria and Reported Performance" with quantitative thresholds for all tests. However, it lists a series of tests performed and states that the device "met the applicable requirements" or "met the established safety and performance characteristics." For some specific characteristics, it even provides the performance achieved.

Here's a summarized table based on the information provided:

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

The document does not specify the exact sample sizes (N numbers) used for each individual test. It generally states that "Performance testing was performed as per the design control system" and refers to ISO standards, which typically involve specific sample sizes.

• Sample Size: Not explicitly stated for each test.
• Data Provenance: The document does not specify the country of origin for the data. The tests are "non-clinical testing" (in vitro and in vivo studies) performed by the manufacturer (OcuJect, LLC). It's a regulatory submission, so the data is likely manufacturer-generated to support the device's claims. The studies were prospective in the sense that they were conducted specifically for this regulatory submission to demonstrate device performance.

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

This question is not applicable as the device is a physical medical device (syringe), not an AI/ML diagnostic tool. Ground truth in this context refers to the measured physical and biological properties of the device, established through standardized testing methodologies, not expert interpretation of medical images or data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This question is not applicable as the device is a physical medical device (syringe), not an AI/ML diagnostic tool. Adjudication methods are used in consensus labeling of data by human experts for AI models. The "ground truth" here is determined by direct measurement and standardized test results.

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 question is not applicable as the device is a physical medical device (syringe) and not an AI-powered diagnostic tool that assists human readers.

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

This question is not applicable as the device is a physical medical device (syringe) and does not involve an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this medical device is established through:

• Standardized Physical and Chemical Measurements: Performed according to ISO, USP, and ASTM standards (e.g., dead space volume, operational force, particulate matter counts, dimensional specifications).
• Biological Testing (In vitro and In vivo): Biocompatibility tests such as cytotoxicity, sensitization, irritation (intracutaneous, ocular, intravitreal, intraocular), systemic toxicity, pyrogenicity, and hemolysis.
• Chemical Characterization and Toxicological Risk Assessment: To identify extractables/leachables and assess their risk.

8. The sample size for the training set

This question is not applicable as the device is a physical medical device (syringe) and does not involve AI/ML requiring a training set.

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

This question is not applicable as the device is a physical medical device (syringe) and does not involve AI/ML requiring a training set.

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