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

The StaClear Syringe is a single-use piston syringe intended for use by healthcare professionals for general-purpose fluid aspiration/injection. Its operation is manual. The StaClear Syringe is single use only, non-toxic, non-pyrogenic, and sterilized by ethylene oxide gas. It uses standard syringe components with a low-particulate gas plasma crosslinked silicone coating called TriboLink-Si. The StaClear Syringe is suitable for ophthalmic use.

The StaClear Syringe is offered in the following configurations:

• SC250AN – Consisting of a 0.25 mL graduated barrel, plunger, plunger stopper, needle, needle shield, and plunger cap.
• SC250LS – Consisting of a 0.25 mL graduated barrel with an ISO 80369-7-compliant luer-slip connector, plunger, and plunger stopper.
• SC250LL – Consisting of a 0.25 mL graduated barrel with an ISO 80369-7-compliant luer-lock connector, plunger, and plunger stopper.

The provided document is an FDA 510(k) clearance letter for the StaClear Syringe, which is a medical device, not an AI/ML algorithm. Therefore, many of the requested fields, such as "number of experts used to establish the ground truth," "adjudication method," "MRMC comparative effectiveness study," "standalone algorithm performance," "type of ground truth," and information about training sets, are not applicable to this type of device and therefore not present in the document.

The document primarily focuses on demonstrating substantial equivalence to a predicate device through adherence to established performance standards for syringes.

Here's the information that can be extracted from the provided text regarding acceptance criteria and performance:

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

The document lists various ISO and USP standards as the basis for performance evaluation. The "Acceptance Criteria" are implied to be compliance with these standards, and the "Reported Device Performance" is stated as "Identical" or "Compliant" with these standards.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the sample sizes used for testing each attribute. The data provenance (country of origin, retrospective/prospective) is also not provided. The testing is described as "non-clinical testing" and "performance testing performed as per the design control system," suggesting in-house, prospective testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This is a physical medical device, not an AI/ML algorithm requiring expert ground truth for image interpretation or diagnosis. The "ground truth" for the device's performance is objective measurements against established engineering and biocompatibility standards.

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

Not applicable. This is a physical medical device, not an AI/ML algorithm requiring adjudication of interpretations.

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 is a physical medical device and does not involve AI assistance for human readers.

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. The "standalone" performance refers to the device's adherence to specified standards in direct testing.

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

The "ground truth" for this device's performance is adherence to recognized international and national standards for medical devices, specifically:

• ISO standards (e.g., ISO 7886-1, ISO 7864, ISO 9626, ISO 80369-7, ISO 10993-1, ISO 11607-1) which define performance characteristics, materials, and testing methodologies.
• USP standards (e.g., USP , USP , USP , USP ) which define testing for particulate matter, sterility, and endotoxins.
• ASTM standards (e.g., ASTM D4169, ASTM F1980) for packaging and accelerated aging.

These standards provide objective, measurable criteria.

8. The sample size for the training set

Not applicable. This is a physical medical device and does not involve a training set as would an AI/ML algorithm.

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

Not applicable. This is a physical medical device and does not involve a training set.

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