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The 21G x 2" K-Pack II Needle being a Hypodermic Single Lumen Needle is a sterile medical device for single use, intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin.

Device Description

Comprised of a stainless steel tube that is sharpened at one end and at the other end joined to a female luer connector (hub) designed to be connected with a male connector (nozzle) of a piston syringe.

AI/ML Overview

Here's an analysis of the acceptance criteria and study information provided in the document:

Device: K-Pack II Needle - 21G x 2"
General Type of Device: Hypodermic Single Lumen Needle

Acceptance Criteria and Reported Device Performance

TEST	ACCEPTANCE CRITERIA	REPORTED DEVICE PERFORMANCE (Implied "Meets Criteria" since all tests were performed and the device was found substantially equivalent)
1. Cleanliness	Inspected by normal or corrected-to-normal vision without magnification under an illuminance of 300 lx to 700 lx, the surface of the hypodermic needle tube shall appear free from particles and extraneous matter. When examined under x2.5 magnification, the hub socket shall appear free from particles and extraneous matter.	Meets Criteria
2. Limits for acidity or alkalinity	$\triangle$ pH for K-Pack Needles extract solution is within 1 unit of the control fluid.	Meets Criteria
3. Limits for extractable metals	The extract solution of the 21G K-Pack II Needles has a content of extractable metals which is, when corrected for the metal content of the control fluid: $\Sigma$ Pb, Sn, Zn, Fe ≤ 5 mg/l; Cd < 0.1 mg/l	Meets Criteria
4. Size designation	Outside diameter and nominal length are expressed in mm (and G x ").	Meets Criteria
5. Colour coding	Hub and label are colour coded following ISO 6009.	Meets Criteria
6. Conical fitting	6% luer taper, compliant with requirements of ISO 594-1 and ISO 594-2.	Meets Criteria
7. Effective needle length	The effective length = nominal length + 1.5 mm/-2.5 mm	Meets Criteria
8. Lubricant	Needles are uniformly lubricated and the silicone is not visible as droplets on the outside surface of the needle, the quantity will not exceed 0.25 mg/cm2.	Meets Criteria
9. Needle point	The needle point of the 21G K-Pack II Needle is in the center of the bevel, is sharp and is free from extraneous matter, burr, edges and hooks.	Meets Criteria
10. Bonding strength between hub and cannula	The bonding strength between hub and cannula is ≥ 44N.	Meets Criteria
11. Patency of lumen	A stylet with a diameter of 0.40 mm is passing through the needle.	Meets Criteria
12. Flow rate	Tolerance on flow rate: between 80% and 125% of nominal value.	Meets Criteria

Additional Safety Information:

Sterilization: Assured by validated EtO method to SAL of 10^-6, compliant with EN ISO 11135-1 and EN 556-1.
Ethylene Oxide Residuals: In compliance with EN ISO 10993-7.
Biocompatibility: Blood contacting materials tested in accordance with FDA General Program Memorandum #G95-1 (ISO-10993-1).
Shelf Life: Established at 5 years.

Study Details

Sample size used for the test set and the data provenance:
- The document states, "All necessary verification and validation tests have been performed by testing the 21G x 2" K-Pack II Needles in accordance with EN ISO 7864 (1995)."
- Sample Size: Not explicitly stated. The details of "testing the 21G x 2" K-Pack II Needles" imply that multiple samples of the specified needle were used for each test criterion. It's a standard quality control and performance testing, not a clinical trial with human subjects.
- Data Provenance: The tests are implied to be conducted by the manufacturer, Terumo Europe N.V. (Belgium), under the guidelines of the European standard EN ISO 7864 (1995). No explicit mention of retrospective or prospective data in the context of clinical studies, as this is a device performance test.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This device is a hypodermic needle, and the tests performed are physical and chemical characteristic verification tests against international standards (e.g., ISO, EN ISO). There is no "ground truth" established by experts in the sense of clinical diagnoses or interpretations. The "ground truth" for these tests is the standard itself (e.g., ISO 7864 for needle characteristics, ISO 594-1/2 for luer taper).
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. See point 2. Adjudication methods are typically used in clinical studies for establishing ground truth from multiple expert reads, which is not relevant for the physical and chemical testing of a hypodermic needle.
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 physical medical instrument (hypodermic needle), not an AI-powered diagnostic or interpretive system. Therefore, an MRMC study or AI assistance is not relevant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. As stated in point 4, this is not an algorithm or AI-based device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's performance testing is adherence to established international standards for hypodermic needles. These standards define the acceptable physical dimensions, material properties, sterility, and functional characteristics. (e.g., EN ISO 7864, ISO 6009, ISO 594-1/2, ISO 11135-1, ISO 10993-7).
The sample size for the training set:
- Not applicable. This is not a machine learning or AI-driven device, so there is no concept of a "training set" for the device itself.
How the ground truth for the training set was established:
- Not applicable. See point 7.

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