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The Streamline® Viscoelastic Injector is intended to deliver small amounts of viscoelastic fluid during Ophthalmic Surgery.

The Streamline® Surgical System is a single-use disposable cannula for use during ophthalmic surgical procedures to deliver small amounts of viscoelastic fluid.

The Streamline® Viscoelastic Injector is a single use disposable device designed to deliver small amounts of viscoelastic fluid.

The device consists of a single-use disposable device comprised of a surgical grade stainless steel cannula and a polymer handset, actuator button and priming port (Figure 1). The cannula is comprised of a long thin neck with an outer sleeve at its tip and allows access through a minimum 1.8 mm clear corneal incision. The cannula is long enough to reach across the eye 180 degrees from the clear corneal incision.

The device outer sleeve is transparent which allows the dispensing cannula with a clearly identifiable color to be visible at 12X magnification.

The priming port allows interfacing with commonly used viscoelastic containers used during priming and filling of the device.

The actuator button is located at the top of the handset and is colored for easy identification and incorporates a slight depression giving the user a tactile feel and correct finger placement. Each actuation of the actuator button causes an internal mechanical cam to rotate causing a snap action which rapidly retracts the outer sleeve at the device's distal tip. This action allows the cannula to dispense viscoelastic fluid through opposing side outlets located at an acute angle from the perpendicular plane of tip (Figure 2).

The length of the gear assembly allows for up to eight (8) total activations of the device. Each activation of the delivers approximately 7 µL of OVD and approximately 56 µL of OVD for the total maximum 8 activations allowed by the device. Once all activations are completed the gear assembly will have reached the end of travel and cannot be reset. Additionally, activation of the actuator button causes the priming port to disengage from the fluid pathway, to prevent re-priming of the device. This prevents the device from further priming preventing re-use.

Materials used to manufacture the Streamline® Viscoelastic Injector are of medical grade quality and no toxic substances are used in the manufacturing process. The materials used in the Streamline® Viscoelastic Injector were selected from materials safe for use in a clinical setting. These materials include stainless steel, polycarbonate, ABS polymer and silicone.

The provided document is a 510(k) premarket notification for the Streamline® Viscoelastic Injector. It details the device's technical characteristics, intended use, and provides a comparison to a predicate device. It also lists performance testing conducted to demonstrate conformance to design specifications and applicable standards.

However, the document does not contain specific acceptance criteria values or detailed results of a study that directly proves the device meets those criteria in a quantitative sense as typically presented with metrics like sensitivity, specificity, or F1-score. The "Performance Testing" section describes what types of tests were performed but does not provide the numerical acceptance criteria or the reported performance outcomes beyond qualitative statements (e.g., "assuring cannula integrity", "Qualitatively verify activation").

Furthermore, the document does not describe a study involving human readers or comparative effectiveness studies (MRMC) as it is a medical device for injecting viscoelastic fluid, not an AI/imaging diagnostic device.

Here's an attempt to answer your questions based only on the provided document, highlighting where information is unavailable:

1. Table of Acceptance Criteria and Reported Device Performance

As noted above, specific numerical acceptance criteria and reported performance values (e.g., precise strength values, exact force measurements, or quantitative pass/fail rates for functional tests) are not detailed in this document. The document lists the types of tests performed to ensure the device meets design specifications and conformance to standards.

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

The document does not specify exact numerical sample sizes for most of the performance tests (e.g., "100% of units during sample build" is mentioned for drivetrain motion, but no number of units is given). For Human Factors Engineering, "15 surgeons" were used.

Data provenance (e.g., country of origin, retrospective/prospective) is not stated. These tests are likely laboratory-based functional and material tests.

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 in the context of this device and the provided document. The ground truth for functional engineering tests, material science tests, and biological safety is established by adherence to recognized international and national standards, and by engineering specifications, rather than expert consensus on diagnostic interpretations. The "experts" involved would be the engineers, test technicians, and possibly medical professionals (for cadaver evaluation and human factors) conducting these specific tests. For the Human Factors Engineering evaluation, 15 surgeons were used. Their specific qualifications beyond being "surgeons" are not detailed.

4. Adjudication method for the test set

This is not applicable as the tests described are primarily objective engineering and material science evaluations against predefined mechanical, biological, and material specifications, not subjective assessments requiring adjudication.

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 type of study is relevant for diagnostic imaging or AI-assisted diagnostic tools, not for a surgical instrument like the Streamline® Viscoelastic Injector.

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

No, this is not applicable. The Streamline® Viscoelastic Injector is a manually operated surgical device, not an algorithm.

7. The type of ground truth used

The ground truth for the performance testing is based on:

• Established engineering specifications (e.g., required force for actuation, dispensed volume).
• Compliance with recognized international and national standards (e.g., ISO 10993 series for biocompatibility, ISO 80369-7 for Luer fittings, ISO 9626 for cannulas, ASTM standards for packaging).
• Qualitative assessment by trained personnel during functional checks (e.g., visual verification of drivetrain motion, qualitative verification on cadaver eyes).

8. The sample size for the training set

This is not applicable. The Streamline® Viscoelastic Injector is a mechanical surgical device, not an AI or machine learning model that requires a training set.

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

This is not applicable for the reasons stated in point 8.

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