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The meso-relle needles are intended to inject fluids intradermally.

The meso-relle® needles are single lumen needle intended to inject fluids intradermally. 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. Needles have different length, which make them suitable to inject fluids intradermally. The meso-relle are not intended for injection in the bloodstream. The devices do not contact the central nervous system. The meso-relle® needles are suitable for administration of fluids intradermally. Each needle is provided with a protective cap (cover is rigid and not colored. The dimensions are suitable to accommodate the corresponding needle and vary according to the dimensions of the needle. The meso-relle® needles are disposable single use devices, sold sterilized by ethylene oxide.

The provided document describes the acceptance criteria and the study conducted for the meso-relle needles (AAL34, AAL36, AM30G), a hypodermic single lumen needle intended to inject fluids intradermally.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present acceptance criteria in a dedicated table format with corresponding numerical performance values. Instead, it states that the meso-relle needles were tested according to specific ISO standards and "met the acceptance criteria." The device's performance is reported indirectly by stating its compliance with these standards and demonstrating substantial equivalence to predicate devices.

However, based on the non-clinical performance data section and the comparison table, we can infer the acceptance criteria are met by conforming to the specified ISO standards and achieving substantial equivalence to the predicate devices in terms of materials, design, and functional characteristics.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size used for each non-clinical performance test. It mentions that "tests were performed on the final finished device," suggesting a representative sample was used for each test (biocompatibility, sterility, functional testing).

The data provenance is retrospective, as the tests were conducted on the finished devices to demonstrate compliance with existing standards and equivalence to already marketed predicate devices. The country of origin of the data is not explicitly stated, but the manufacturer (Biotekne S.r.l.) and contact person (Enrico Bisson) are located in ITALY.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not applicable to this type of device and study. The ground truth for hypodermic needles is established by compliance with international engineering and medical device standards (e.g., ISO standards for materials, sterility, and functional performance) and comparison to established predicate devices, not by expert consensus on clinical images or outcomes.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation of medical data (e.g., radiology images) where there may be disagreement among experts. This study focuses on objective engineering and performance testing.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance, which is not the focus of this device (a hypodermic needle).

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No, a standalone algorithm performance study was not done. This device is a physical medical instrument, not an AI algorithm.

7. Type of Ground Truth Used

The ground truth used for this device is based on:

• International Standards: Compliance with ISO 10993-1 (Biocompatibility), AAMI / ANSI / ISO 11135-1:2007 and UNI EN ISO 10993-7:2008 (Sterility), ISO 7864:2016 (Hypodermic Needles), ISO 9626:2016 (Stainless Steel Needle Tubing), and ISO 594-1:1986 (Luer Taper Fittings).
• Performance of Predicate Devices: The established safe and effective performance of the legally marketed predicate devices (K110606, MV Intradermic Needles and K051783, Artsana Hypodermic Needles). The subject device demonstrates "substantial equivalence" to these predicates.

8. Sample Size for the Training Set

This information is not applicable. There is no "training set" in the context of validating a physical medical device like a hypodermic needle. Training sets are used for machine learning algorithms.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reason as in point 8.

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