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The Nipro Hypodermic Needle is intended for use to inject fluids into or withdraw fluids from parts of the body below the surface of the skin.

The subject devices can be classified as single use hypodermic needles as described in 21 CFR 880.5570. Needle sizes include 16-30 Gauge, lengths of ½ to 1 ½ inches, and regular or short bevels.

I'm sorry, but this document does not contain the information requested. The document is a 510(k) premarket notification for Nipro Disposable Needles, and it primarily focuses on establishing substantial equivalence to a predicate device. It does not include details on formal acceptance criteria, device performance studies, sample sizes for test or training sets, ground truth establishment, or multi-reader multi-case studies as described in your request.

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The Nipro® Hypodermic Needle is intended to be used to inject fluids into or withdraw fluids from parts of the body below the surface of the skin.

The devices that we intend to market are hypodermic needles as described in 21 CFR 880.5570. Two types of hypodermic needles will be available: types L (long) and S (short). Type L hypodermic needles are 11/2 to 11/2 inches long and Type S needles 74 to 1 inch long.

I am sorry but the provided text does not contain detailed information about acceptance criteria, study methodologies, or performance results for the Nipro Hypodermic Needle. The documents provided relate to its 510(k) premarket notification and substantial equivalence to a predicate device, which focuses on regulatory approval rather than a detailed performance study as you described.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets or their data provenance.
• Number and qualifications of experts for ground truth.
• Adjudication methods.
• MRMC comparative effectiveness study results.
• Standalone performance details.
• Ground truth type.
• Training set sample size or ground truth establishment for the training set.

The document primarily states that the Nipro Hypodermic Needle is "similar in design, technical, performance, and biological characteristics" to a legally marketed predicate device (K944355) and is intended for injecting or withdrawing fluids under the skin. It does not provide the specific study details you are asking for.

Ask a specific question about this device