(69 days)
To inject fluids into, or withdraw fluids from parts of the body below the surface of the skin.
TSK STERIJEKT is a sterile Hypodermic Single Lumen Needle, packaged individually for single patient use. It consists of a stainless steel beveled cannula bonded to a plastic hub. Sizes include 14G-31G and various lengths. The needle is intended to fit any luer lock or luer slip syringe tip.
This document describes a 510(k) summary for the TSK STERIJEKT Premium Disposable Hypodermic Needle. The information provided is for a traditional medical device (hypodermic needle) and not an AI/ML powered device. Therefore, many of the requested categories in your prompt relating to AI/ML studies (e.g., sample size for test/training sets, data provenance, ground truth establishment, MRMC studies, standalone performance) are not applicable to this submission.
Here's an attempt to answer the applicable parts of your request based on the provided text, while labeling the non-applicable sections.
Acceptance Criteria and Device Performance for TSK STERIJEKT Premium Disposable Hypodermic Needle
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Protector Removal | Meets Specification | Meets Specification |
| Needle Bond Strength | Meets Specification | Meets Specification |
| Sensitization | Pass | Pass |
| Intracutaneous | Pass | Pass |
| Hemolysis | Pass | Pass |
| Systemic Toxicity | Pass | Pass |
| LAL Pyrogen Test | Pass | Pass |
| Cytotoxicity | Pass | Pass |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified in the provided 510(k) summary. The summary only lists the tests performed and their outcomes ("Meets Specification" or "Pass").
- Data Provenance: Not specified in the provided 510(k) summary. The manufacturer is "Tochigi Seiko KK, Japan." It is implied the tests were conducted by or on behalf of the manufacturer, but specific details about the origin (e.g., country) of the data from these tests are not provided. The study type (retrospective/prospective) is not applicable or specified for these types of device performance tests.
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 for this type of medical device. Ground truth, in the context of AI/ML, refers to a definitively correct answer established by experts. For a hypodermic needle, "ground truth" is determined by established physical, chemical, and biological testing standards and specifications, not expert consensus on interpretations. The "experts" would be the scientists and engineers conducting and analyzing these standard tests.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods like 2+1 or 3+1 are used in AI/ML studies to resolve disagreements among human readers when establishing ground truth. For the physical and biological tests of a hypodermic needle, the outcome is typically an objective pass/fail against a predefined specification, not a subjective interpretation requiring adjudication.
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 device is a hypodermic needle, not an AI/ML diagnostic or assistive tool. An MRMC study comparing human readers with and without AI assistance is irrelevant to its evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a hypodermic needle, not an algorithm. Standalone performance refers to an AI algorithm's performance without human intervention.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Standardized Test Specifications/Reference Methods: For physical tests (Protector Removal, Needle Bond Strength), the "ground truth" is defined by adherence to engineering specifications and performance limits. For biological tests (Sensitization, Intracutaneous, Hemolysis, Systemic Toxicity, LAL Pyrogen Test, Cytotoxicity), the "ground truth" is determined by meeting the requirements of established biocompatibility and sterility standards (e.g., ISO 10993 series and pharmacopeial standards), which dictate acceptable biological responses.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device, so 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, so there is no "training set" and thus no ground truth established for one.
§ 880.5570 Hypodermic single lumen needle.
(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).