(178 days)
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
| Acceptance Criteria Category | Specific Test/Evaluation | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|---|
| Material/Physical Properties | Cleanliness | ISO 7886-1:2017, ISO 7864:2016, ISO 9626:2016 | Met applicable requirements |
| Acidity and Alkalinity | ISO 7886-1:2017, ISO 7864:2016, ISO 9626:2016 | Met applicable requirements | |
| Extractable Metals | Exhaustive extraction, limits ≤ 0.2 µg/device (intraocular lenses) | Met applicable requirements | |
| Lubricant | ISO 7886-1:2017, ISO 7864:2016 | Met applicable requirements | |
| Tolerance on Graduations | ISO 7886-1:2017 | Met applicable requirements | |
| Stopper Detachment | ISO 7886-1:2017 | Met applicable requirements | |
| Dead Space | ISO 7886-1:2017 | Met applicable requirements | |
| Air and Liquid Leakage Past Plunger | ISO 7886-1:2017 | Met applicable requirements | |
| Plunger Force | ISO 7886-1:2017 | Met applicable requirements | |
| Fit of Stopper | ISO 7886-1:2017 | Met applicable requirements | |
| Tolerance on Length (needle) | ISO 7864:2016 | Met applicable requirements | |
| Tube Defects (needle) | ISO 7864:2016 | Met applicable requirements | |
| Point Defects (needle) | ISO 7864:2016 | Met applicable requirements | |
| Needle Penetration Force | ISO 7864:2016 | Met applicable requirements | |
| Bond between Tube and Hub | ISO 7864:2016 | Met applicable requirements | |
| Patency of Lumen | ISO 7864:2016 | Met applicable requirements | |
| Materials (needle) | ISO 9626:2016 | Met applicable requirements | |
| Surface Finish (needle) | ISO 9626:2016 | Met applicable requirements | |
| Size designation (needle) | ISO 9626:2016 | Met applicable requirements | |
| Dimensions (needle) | ISO 9626:2016 | Met applicable requirements | |
| Stiffness (needle) | ISO 9626:2016 | Met applicable requirements | |
| Resistance to Breakage (needle) | ISO 9626:2016 | Met applicable requirements | |
| Resistance to Corrosion (needle) | ISO 9626:2016 | Met applicable requirements | |
| Particulate Matter | Particulate Matter in Injections | USP | Met applicable requirements |
| Particulate Matter in Ophthalmic Solutions | USP | Met applicable requirements | |
| Biocompatibility | Cytotoxicity (cell lysis/toxicity) | ISO 10993-5 | No evidence of causing cell lysis or toxicity |
| Sensitization (skin) | ISO 10993-10 | Not considered a sensitizer | |
| Irritation, Ocular | ISO 10993-15 | Not considered irritants to the ocular tissue of the rabbit | |
| Irritation, Intravitreal Injection | Intravitreal Injection Irritation testing | Not considered inflammatory to intraocular tissues of the rabbit | |
| Intracutaneous Reactivity | ISO 10993-15 | No intracutaneous reactivity (no erythema and edema) | |
| Acute Systemic Toxicity | ISO 10993-11 | No mortality or evidence of systemic toxicity | |
| Pyrogenicity | ISO 10993-11 | Not considered pyrogenic | |
| Hemolysis | ASTM F756, ISO 10993-4 | Not considered hemolytic | |
| Chemical Characterization / Toxicological Risk Assessment | ISO 10993-1, ISO 10993-2, ISO 10993-4, ISO 10993-5, ISO 10993-10, ISO 10993-11, ISO 10993-12, ISO 10993-17, ISO 10993-18 | Acceptable level of risk of systemic exposure to extractable compounds |
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.
§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).