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The Vitrelect® Needle is intended for use with a luer-tip syringe for the administration of drugs. The VitreJect® Needle is indicated for intravitreal use.

The OcuSafe® Needle is intended for use with a luer-tip syringe for the administration of drugs. The OcuSafe® Needle is indicated for intravitreal use.

The VitreJect® / OcuSafe® Needles are designed to provide a means of fluid injection and aspiration. The devices are single-lumen needles intended for use with a luer-tip syringe. The VitreJect® Needle has a spring-actuated, non-removable sliding cap that protects the needle prior and during its use. The OcuSafe® Needle has a removable cap that is removed prior to the needle's use. They are intended for use by health care professionals for administration of drugs. Their operation is manual. The VitreJect®/OcuSafe® Needles are single use only, non-toxic, nonpyrogenic, and sterilized by ethylene oxide gas. The VitreJect®/OcuSafe® Needles are suitable for ophthalmic use.

The provided document is a 510(k) Premarket Notification for a medical device (VitreJect® Needle; OcuSafe® Needle), which primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a clinical study of AI/device performance requiring human reader studies and expert adjudication. Therefore, much of the requested information (e.g., sample size for test/training sets, number of experts, MRMC studies, ground truth establishment methods for AI) is not applicable to this type of regulatory submission.

The document discusses non-clinical testing to confirm the safety and effectiveness of the device. The acceptance criteria are based on meeting established standards and demonstrating biocompatibility and performance similar to the predicate device.

Here's an attempt to answer your questions based on the available information, noting where information is not present or applicable:

Acceptance Criteria and Study for VitreJect® Needle / OcuSafe® Needle (K230959)

This 510(k) submission primarily relies on demonstrating substantial equivalence to a legally marketed predicate device (SteriCap® Mini Needle and Standard Needle, K212805) through comparison of technological characteristics and non-clinical performance testing, rather than a clinical trial involving human readers or AI.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this type of device are generally met by demonstrating compliance with recognized standards and proving that the device performs as intended and is biocompatible. The "reported device performance" is essentially the passing of these tests.

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

• Sample Size: The document does not specify exact sample sizes for the non-clinical tests (e.g., how many needles were tested for dimension, strength, or biocompatibility). These are typically determined by relevant industry standards and statistical methods for device testing.
• Data Provenance: The data is generated from non-clinical laboratory testing performed by OcuJect, LLC (or their designated testing facilities) to support the regulatory submission. It is not patient data. It is retrospective in the sense that the testing was completed prior to the submission, but it is not from a real-world clinical patient population. The country of origin of the testing is not specified, but it would be expected to comply with US FDA requirements.

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

• This question is not applicable as the "test set" here refers to physical devices undergoing non-clinical performance and biocompatibility assessments, not a dataset requiring expert human interpretation or ground truth labeling in the context of AI or diagnostic studies.

4. Adjudication Method for the Test Set

• This question is not applicable as there is no human interpretation or ground truth establishment requiring adjudication for this type of device testing.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI/imaging diagnostic devices, not for a hypodermic needle.

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

• Not applicable. This device is a physical hypodermic needle, not an algorithm or AI system.

7. The Type of Ground Truth Used

• Not applicable in the conventional sense of ground truth for AI/diagnostic studies. For this device, the "ground truth" is defined by compliance with established international and US standards (e.g., ISO, USP, ASTM) for medical device performance, safety, and biocompatibility. The "truth" is whether the physical properties and biological interactions of the needle meet these predefined, objectively measurable criteria.

8. The Sample Size for the Training Set

• Not applicable. This document describes a physical medical device, not an AI or machine learning model that requires a training set.

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

• Not applicable. As there is no AI or machine learning model, there is no training set or ground truth in this context.

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