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The 27G x 3/4" Thin Wall 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.

The 27G x 3/4" Thin Wall K-Pack II Needles are sterile hypodermic single lumen needles, for single use consisting of a stainless steel tube that is sharpened at one end and at the other end joined to a female luer connector (hub) made of polypropylene designed to be connected with a male connector (nozzle) of a piston syringe.

Here's a breakdown of the acceptance criteria and the study information for the K-Pack II Needle - 27G x ¾" Thin Wall, based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

The device passed all validation activities as indicated by the submission of the 510(k), which implies that the reported device performance met the specified acceptance criteria. The summary states: "All necessary verification and validation tests have been performed by testing the 27G x ½" Thin Wall K-Pack II Needles in accordance with EN ISO 7864 (1995)."

Study Details

The provided document describes a submission for a hypodermic single lumen needle. This is a physical medical device, not an AI/software device. Therefore, many of the typical questions related to AI studies (e.g., sample size for AI test sets, data provenance, expert ground truth, MRMC studies, standalone AI performance, training set details) are not applicable to this 510(k) submission.

The "study" in this context refers to the verification and validation (V&V) testing performed on the physical needle device itself.

1. Sample size used for the test set and the data provenance:

   • Sample Size: Not explicitly stated in the provided summary. Device manufacturers typically perform V&V testing on a statistically significant number of samples, but the exact count is not detailed here.
   • Data Provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable in the context of physical product testing. The testing was conducted by Terumo Europe N.V., presumably in their facilities or by contracted labs.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable. The "ground truth" for a physical device like a needle is based on objective measurements and established engineering/medical device standards (e.g., EN ISO 7864 for hypodermic needles, ISO 594 for luer fittings). There isn't a "ground truth" established by human experts in the way it applies to AI diagnostic outputs.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not applicable. Adjudication methods are relevant for subjective interpretations, typically in AI or clinical study contexts. For physical device testing, results are typically objective measurements against a standard.

4. 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 a physical hypodermic needle, not an AI software device.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Not applicable. This is a physical hypodermic needle, not an AI algorithm. The device's performance is inherently "standalone" in the sense that its physical properties are tested directly.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The "ground truth" (or more accurately, the reference standard) for this device is based on international and national standards for medical devices, specifically:
     • EN ISO 7864 (1995): "Sterile hypodermic needles for single use"
     • ISO 6009: "Hypodermic needles for single use - Colour coding for identification"
     • ISO 594-1 and ISO 594-2: "Conical fittings with a 6 % (Luer) taper for syringes, needles, and certain other medical equipment"
     • EN ISO 11135-1: "Sterilization of Health Care Products - Ethylene oxide"
     • EN 556-1: "Sterilization of Medical Devices - Requirements for medical devices to be designated "STERILE""
     • EN ISO 10993-7: "Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals'"
       The biological evaluation also references FDA General Program Memorandum #G95-1 (5/1/95): Use of International Standard ISO-10993-1.

7. The sample size for the training set:

   • Not applicable. This is a physical device, not an AI model, so there is no "training set."

8. How the ground truth for the training set was established:

   • Not applicable. See point 7.

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