(167 days)
The Sterile syringes for single use with/without needle are intended to be used for medical purposes to inject fluid into or withdraw fluid from body.
The Sterile Syringes for Single Use with/without Needle is a three-piece, sterile, single use hypodermic syringe with a 6% (Luer) male connector/lock fitting in various sizes. The syringe assembly consists of a lubricated polypropylene barrel with a graduated scale, a lubricated synthetic rubber stopper and a polypropylene plunger rod. The plunger rod is pulled back to aspirate fluids or depressed to inject or expel fluids.
The document describes the acceptance criteria and performance data for the "Sterile syringes for single use with/without needle," but it does not involve a study with a test set of data, ground truth, or expert consensus in the way that AI/ML device studies typically do. This is a traditional medical device (syringes) rather than an AI/ML diagnostic or prognostic tool.
Therefore, many of the requested fields are not applicable.
Here's the information extracted from the provided text, focusing on the available details:
1. Table of Acceptance Criteria and Reported Device Performance
The device's performance is demonstrated by compliance with various international standards and specific tests. The "acceptance criteria" are implied by the requirements of these standards.
| Test/Characteristic | Acceptance Criteria (Implied by standard compliance) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Meets requirements of ISO 10993-1:2018 for "External communication device - Blood path indirect" (contact duration | Testing performed and results imply compliance. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated. The document refers to "testing" and "evaluations" according to various standards, which would define the sample sizes for those specific tests.
- Data Provenance: Not explicitly stated, but the testing was conducted to comply with international standards (ISO, ASTM, USP), indicating standard laboratory and manufacturing quality control procedures. The manufacturer is Zhejiang Kangkang Medical-Devices CO., Ltd. in China, so likely some testing occurred there.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a physical medical device, not an AI/ML system requiring expert interpretation for ground truth.
4. Adjudication method for the test set
Not applicable. This does not involve adjudication of expert readings.
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 not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used
The "ground truth" for this device's performance is established by its adherence to the technical and safety specifications outlined in the referenced international standards (e.g., ISO, ASTM, USP). For instance, the ground truth for "sterilization" is the result of tests confirming a certain sterility assurance level; for "biocompatibility," it's the outcome of biological tests.
8. The sample size for the training set
Not applicable. This is not an AI/ML device; there is no "training set."
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.
§ 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).