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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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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 consisting of a 0.25 mL graduated barrel, plunger, plunger stopper, needle, needle shield, and plunger cap. The needle is a 31-gauge needle, 5/16in in length, which is permanently attached to the syringe body. It is intended for use by health care 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. The StaClear syringe is suitable for ophthalmic use.

Here's a breakdown of the acceptance criteria and study information for the StaClear Syringe, based on the provided document:

Acceptance Criteria and Device Performance

Study Information

The document describes non-clinical bench testing and biocompatibility testing. It does not describe a study comparing human readers with and without AI assistance, nor does it describe a standalone algorithm-only performance study.

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

• The document does not explicitly state numerical sample sizes for each test. For example, it lists "Cleanliness" as a test performed but does not quantify how many units were tested.
• The data provenance is not specified beyond being "non-clinical bench testing" and "TriboFilm's design control system," implying internal testing by the manufacturer. No country of origin for test data is mentioned.

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 device is a medical product (syringe), and the evaluation involved bench testing and biocompatibility assessment, not interpretation of medical images or diagnostic tasks. As such, "ground truth" was established by adherence to recognized testing standards and methods, not expert consensus in a clinical diagnostic sense.

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

• Not applicable for this type of device and testing. The tests performed are objective, quantitative measurements against established standards.

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 device is a syringe, not an AI-powered diagnostic tool.

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

• No, a standalone algorithm-only performance study was not done. This device does not involve an algorithm.

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

• The "ground truth" for evaluating the StaClear Syringe against its acceptance criteria was based on:
  • International and National Standards: e.g., ISO 7886-1, ISO 7864, ISO 9626, ISO 10993 series, ASTM F756, USP , USP . These standards define acceptable performance limits and test methodologies.
  • Objective Measurements: Laboratory and material testing results.
  • Biological Endpoints: Observed responses in biocompatibility tests (e.g., absence of cell lysis, irritation, toxicity).

8. The sample size for the training set

• Not applicable. This device does not use machine learning or AI, so there is no training set.

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

• Not applicable. As there is no training set, this question is irrelevant.

Ask a specific question about this device