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It is intended for use by health care professionals for puncture, drainage and fluid collection of the anterior chamber of the eye. Its operation is manual. The Disposable Aqueous Humor Collector is single use only. The Disposable Aqueous Humor Collector is suitable for ophthalmic use.

Disposable aqueous humor collector is composed of a liquid collecting needle sheath, a liquid collecting needle, a needle seat, a liquid collecting needle rubber sheath, a rubber plug, a liquid collecting tube, a cylinder body, a rubber ring, push rod and buckle structure.
Models: SnovoDAHC I-50, SnovoDAHC II-50, SnovoDAHC II-50-27, SnovoDAHC II-100-27
Volume: 50μL, 100μL
Needle Gauge: 25G, 27G

The provided FDA 510(k) clearance letter and summary for the "Disposable Aqueous Humor Collector" does not contain acceptance criteria or a detailed study description of device performance, beyond general statements about compliance with ISO standards and a brief mention of an OUS study.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (StaClear Syringe) by comparing specifications and stating that differences do not raise new safety or effectiveness concerns, supported by various non-clinical tests (biocompatibility, sterility, bench functional performance).

Therefore, I cannot fulfill the request to provide the acceptance criteria and the study that proves the device meets them based solely on the provided text. The document refers to testing being performed, but does not present the specific acceptance criteria or the detailed results of those tests.

However, I can extract the information that is present and highlight what is missing based on your request:

Missing Information: The provided document states that "required testing was conducted to validate the cumulative modifications made to the subject devices" and that "Substantial Equivalence is being supported with full performance testing," including bench functional performance tests. It also mentions "An outside of the United States (OUS) study was performed demonstrating the effectiveness of the subject device to collect 50 uL of liquid with the 50 uL model." However, it does not detail the specific acceptance criteria for these tests, nor does it provide a full study report with reported device performance against those criteria.

Here is what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified for any of the tests.
• Data Provenance: The document mentions "An outside of the United States (OUS) study." This indicates a prospective clinical study conducted outside the US. No further details on the country of origin are provided. Bench and biocompatibility testing locations are not specified.

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

• Not Applicable. This device is a medical instrument (collector/syringe) for fluid collection, not an AI/diagnostic device that typically requires expert-established ground truth for its performance evaluation (e.g., image interpretation). Its performance is evaluated through physical and chemical property testing (e.g., volume accuracy, needle strength, sterility).

4. Adjudication Method for the Test Set

• Not Applicable. As noted above, this type of device does not involve expert adjudication for ground truth establishment.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No. An MRMC study is typically for evaluating the performance of diagnostic devices, especially those involving human interpretation of data (e.g., radiology images) with and without AI assistance. This device is a manual fluid collector, so such a study is not relevant.

6. If a Standalone Performance Study Was Done

• Yes, implicitly. The bench functional performance tests (ISO 7886-1, ISO 9626, ISO 7864), biocompatibility tests, sterility tests, and the OUS study (which demonstrated effectiveness to collect 50 µL) all represent standalone performance evaluations of the device itself, without human interpretation as a variable.

7. The Type of Ground Truth Used

• Metrological and Biological Standards: The ground truth for this device's performance is established by reference to international standards (e.g., ISO for syringes and needles), specific quantitative measurements (e.g., needle force, volume, heavy metal limits, SAL for sterility), and established biocompatibility principles (ISO 10993 series). In the case of the OUS study, the "ground truth" for liquid collection would be the actual measured volume collected by the device.

8. The Sample Size for the Training Set

• Not Applicable. This is a hardware medical device, not an AI/software device that requires a training set.

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

• Not Applicable. As it's not an AI/software device, a training set and its associated ground truth are not relevant.

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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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