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The Nipro SafeTouch Needle is indicated for general purpose injection of fluid from vials, and to and from parts of the body below the surface of the skin. It includes a needle shield to prevent against accidental needlestick injuries. The needle is compatible with standard Luer-lock syringes.

The Nipro Syringe with SafeTouch Needle is indicated for general purpose injection of fluid from vials, and to and from parts of the body below the surface of the skin. It includes a needle shield to prevent against accidental needlestick injuries.

The Nipro SafeTouch Needle is a disposable hypodermic single lumen needle with attached safety device. The safety device is a needle shield that covers the needle post treatment eliminating accidental needlestick injuries. It is provided with and without a piston syringe.

The Nipro SafeTouch Needle is available in gauges of 18-30, lengths of ½". The needles are available individually or attached to a luer lock syringe in volumes of 1, 3, 5 and 10mL.

The device is sterile, single use only, non-toxic, and non-pyrogenic. It is sterilized by Ethylene Oxide gas and has a shelf-life of 5 years.

The provided text describes specific acceptance criteria and study details for the Nipro SafeTouch Needle and Nipro Syringe with SafeTouch Needle, but it does not describe a study proving the device meets acceptance criteria in the context of an AI/ML device. Instead, it outlines a 510(k) premarket notification for a traditional medical device, comparing it to a predicate device.

The document discusses non-clinical tests and a simulated clinical study, but these are for a physical medical device, not an AI/ML diagnostic or therapeutic system. Therefore, I cannot provide information on items such as multi-reader multi-case studies, standalone algorithm performance, ground truth establishment for AI training sets, or sample sizes for AI training sets, as these concepts are not relevant to the provided text.

However, I can extract the acceptance criteria and performance related to the physical medical device and the simulated clinical study.

Here's the information based on the provided text, focusing on the device's physical and functional properties:

Table of Acceptance Criteria and Reported Device Performance

Regarding the study proving the device meets acceptance criteria:

The document describes a series of non-clinical bench tests and a simulated clinical study for the physical device.

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

   • Simulated Clinical Study: 500 subject devices were evaluated. The provenance of the data (country of origin, retrospective/prospective) is not specified, but it's a prospective study since it's a simulated clinical evaluation of new devices.
   • Bench Testing: The document states "Bench testing was performed on the subject device and the predicate device" but does not specify the exact sample sizes for each type of bench testing.

2. 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):

   • Simulated Clinical Study: 10 "trained professionals" evaluated the devices. Their specific qualifications (e.g., nurses, doctors) or years of experience are not specified.
   • Predicate Device Comparison: The predicate device serves as a benchmark for comparison. Its "ground truth" (i.e., its established safety and efficacy) is derived from its prior 510(k) clearance (K162081).
   • Bench Testing: Standards (e.g., ISO, ASTM, USP) define the acceptance criteria and methods, and accredited labs conduct these tests. The "experts" in this context are the testing personnel skilled in performing the specified tests.

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

   • Simulated Clinical Study: The document states "There were no device failures, no user-related adverse events or safety device related adverse events." This implies a pass/fail assessment based on observed events, not an adjudication process requiring multiple expert opinions on a specific outcome (like in image interpretation).
   • Bench Testing: Adjudication is not typically applicable for these types of objective physical and chemical tests, where results are measured against defined criteria in standards.

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 document is for a physical medical device (needle/syringe with safety feature), not an AI/ML diagnostic or therapeutic system. Therefore, MRMC studies and concepts like "human readers improving with AI assistance" are not relevant.

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

   • Not Applicable. This document is for a physical medical device, not an AI/ML algorithm.

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

   • Simulated Clinical Study: User observation and event reporting (device failures, adverse events). The "ground truth" is the absence or presence of these events as observed by the trained professionals.
   • Bench Testing: Quantitative measurements (e.g., dimensional specifications, hemolytic index, bacterial endotoxin levels) and qualitative assessments (e.g., visual inspection, microbial growth) against predefined criteria in recognized standards (ISO, ASTM, USP).

7. The sample size for the training set:

   • Not Applicable. This document describes a physical medical device. There is no AI/ML "training set" in this context. The manufacturing and design process relies on engineering principles and quality control, not machine learning model training.

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

   • Not Applicable. As there is no AI/ML training set, this question is not relevant.

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