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Promisemed X-safety pen needle is intended for use with needle based injector for the injection of drugs.

X-Safety Pen Needle is a single-use, double-ended, sterile needles for needlebased injection systems (NISs) that fulfil the specifications of ISO 11608-1. This device is constructed as a double-ended, stainless steel needle of various sizes that is with a threaded plastic hub. The device includes needle shielding safety features (at both patient-end and cartridge-end or at patient-end only) to reduce the risk of needle stick injury and its container can be provided as short or long type. It is packaged in a sealed sterility barrier, and the needle is lubricated. This is a single-use device and delivered sterilization process is validated according to EN ISO 11135. Sterilization process undergoes routine control.

The Promisemed X-Safety Pen Needle is a single-use, double-ended, sterile needle intended for use with needle-based injection systems for drug injection. The device performance was assessed through various bench tests compliant with ISO, ASTM, and USP standards.

The acceptance criteria and reported device performance are summarized in the table below:

Table_1: Acceptance Criteria and Reported Device Performance

Study Details:

1. Sample Size and Data Provenance: The document does not specify exact sample sizes for each test. However, it indicates that testing was conducted on the "final, packaged, and sterile devices," implying a representative sample. The data provenance is from Promisemed Hangzhou Meditech Co., Ltd. in China, as they are the manufacturer and submitter of the 510(k). The studies appear to be prospective bench studies performed by the manufacturer or their designated testing facilities to demonstrate compliance with international and national standards.

2. Number of Experts and Qualifications for Ground Truth: Not applicable. These are bench performance tests evaluating physical, chemical, and biological properties according to standardized protocols, not human-interpreted diagnostic results. Thus, no medical experts were involved in establishing ground truth for these types of tests. The "ground truth" is defined by the objective pass/fail criteria of the scientific standards themselves.

3. Adjudication Method for Test Set: Not applicable. As these are objective bench tests with predefined pass/fail criteria from international standards, there is no need for expert adjudication.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No, an MRMC comparative effectiveness study was not performed. This type of study is relevant for diagnostic devices that involve human interpretation of results, not for the performance of a hypodermic needle.

5. Standalone Performance: Yes, the described studies represent the standalone performance of the device (Promisemed X-Safety Pen Needle) against established technical and safety standards. There is no human-in-the-loop performance component in these specific evaluations.

6. Type of Ground Truth Used: The ground truth for these tests is based on objective, standardized criteria established by international and national organizations (e.g., ISO, ASTM, USP). For instance, for material composition, the ground truth is the chemical specification of 304 Stainless steel; for cytotoxicity, it's the absence of cytotoxic effects as defined by ISO 10993-5; for sterility, it's achieving a Sterility Assurance Level (SAL) of 10^-6.

7. Sample Size for Training Set: Not applicable. This device is a medical instrument (pen needle), not an AI algorithm. Therefore, there is no "training set" in the context of machine learning.

8. How Ground Truth for Training Set Was Established: Not applicable, as there is no training set for this device.

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