(201 days)
TK Sterile Piston Syringes is intended for use by health care professionals for general purpose fluid aspirations injection.
The piston syringe is a device intended for medical purposes, consisting of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male Luer Slip / lock connector (nozzle) for attaching the female Luer connector (hub) of a hypodermic single lumen needle, or for attaching other devices with a female Luer. The syringe is sterilized by EtO gas and is labeled Non-Pyrogenic. The device is intended for single use only.
The provided text is a 510(k) summary for a medical device called "TK Sterile Piston Syringe without Needle." It outlines the device's characteristics and compares them to a legally marketed predicate device (U&U Sterile Piston Syringe without Needle) to establish substantial equivalence.
However, the provided document DOES NOT contain information about a study that uses an AI/ML algorithm or requires ground truth established by experts. It describes a conventional medical device (syringe) and its testing against established international standards for physical, chemical, and biological properties. Therefore, I cannot generate the requested table and study details related to acceptance criteria for an AI/ML device, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or specific ground truth methodologies in the context of an AI/ML study.
The document focuses on demonstrating that the new syringe complies with performance standards through non-clinical performance testing (e.g., liquid leakage, air leakage, conical fitting integrity), sterility testing, and biocompatibility testing.
Here's what I can extract and present based on the provided text, reinterpreting "acceptance criteria" in the context of a non-AI/ML medical device's performance testing:
Acceptance Criteria and Device Performance (for a non-AI/ML device)
The device, "TK Sterile Piston Syringe without Needle," is a conventional medical device. Its acceptance criteria are based on compliance with established international standards for syringes, rather than AI/ML performance metrics. The study described focuses on demonstrating equivalence to these standards and to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Element of Performance | Acceptance Criteria (Standard / Test) | Reported Device Performance |
|---|---|---|
| Functional Performance | ||
| General Requirements | ISO 7886-1:2017 Sterile Hypodermic syringes for single use - Part 1: Syringes for manual use, and ISO 80369-7:2016 Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications | Complies |
| Liquid Leakage | ISO 7886-1:2017 | Complies |
| Air Leakage | ISO 7886-1:2017 | Complies |
| Dead Space | ISO 7886-1:2017 | Complies |
| Nozzle Conical Fitting | ISO 80369-7:2016 | Complies |
| Leakage by Pressure | ISO 80369-7:2016 | Complies |
| Sub-atmospheric Air Leakage | ISO 80369-7:2016 | Complies |
| Stress Cracking | ISO 80369-7:2016 | Complies |
| Resistance to Separation | ISO 80369-7:2016 | Complies |
| Resistance to Unscrewing | ISO 80369-7:2016 | Complies |
| Resistance to Overriding | ISO 80369-7:2016 | Complies |
| Bonding Strength | ISO 80369-7:2016 | Complies |
| Sterility | USP and ISO 11135:2014, ISO 11607-1:2006, ISO 11607-2, ISO 10993-7:2008 | No microbial growth observed; in line with requirements. |
| Chemical Properties | ISO 7886-1 (limits for acidity/alkalinity, extractable metals) | Results conform to ISO 7886-1. |
| Biocompatibility | ISO 10993-1:2018; specific tests: Cytotoxicity (ISO 10993-5:2017), Sensitization (ISO 10993-10:2017), Irritation (ISO 10993-10:2017), Acute Systemic Toxicity (ISO 10993-11:2017), Pyrogenicity (ISO 10993-4:2017), Hemocompatibility (ISO 10993-4:2017), Particulate matter testing (USP) | The evaluation of the above testing items meets the requirements. |
| Labeling | 21 CFR Part 801 | Meets the requirements of 21 CFR Part 801. |
| Material Equivalence | Key materials: Barrel (PP), Plunger (PP), Piston (Polyisoprene Rubber); Lubricant (Dow corning 360 medical fluid silicone oil 0.02mg/cm²) to be equivalent or justify differences from predicate. | Barrel (PP) and Plunger (PP) are identical. Piston material changed from TPE (Rubber) to Polyisoprene Rubber, but equivalence is implicitly demonstrated by meeting performance and biocompatibility standards. Lubricant is identical. |
| Physical Appearance | Transparent and Clear Barrel, Legible Gradations. | Transparent and Clear, Legible. |
Regarding the AI/ML specific questions:
- Sample sizes used for the test set and the data provenance: Not applicable. This document is for a physical medical device, not an AI/ML algorithm. Testing involves physical samples of syringes.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a syringe's performance is established by objective physical, chemical, and biological measurements against established standards, not expert consensus on an AI's output.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods like those listed are used for human reader studies with AI, not for physical device testing.
- 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.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For this device, the "ground truth" for performance is defined by the objective pass/fail criteria of the various ISO and USP standards referenced (e.g., specific thresholds for fluid leakage, absence of microbial growth, acceptable levels for extractable metals, absence of adverse biological reactions).
- The sample size for the training set: Not applicable. This applies to AI/ML devices.
- How the ground truth for the training set was established: Not applicable. This applies to AI/ML devices.
Conclusion stated by the submitter:
"The TK Sterile Piston Syringe without Needle is substantially equivalent to the U&U Sterile Piston Syringe without Needle. The materials, performance, and operational features of both the subject device and the predicate device are substantially equivalent."
§ 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).