Dual-Safety Pen Needle by Promisemed Hangzhou Meditech Co., Ltd.

The Dual Safety Pen Needle is intended for use with pen injector devices for subcutaneous injection of insulin. The product has two safety shields which lock in place after use (patient-end) and upon removal of the needle from the pen (pen connector-end). The lock shields help reduce the occurrence of needle sticks from both ends of the needle.

Device Description

The device is a pen needle with shields at both the patient end and the pen connector end which are intended to reduce risk of needle stick before and after injections. The patient end mechanism shields the needle before and after an injection, and a second mechanism passively covers the pen connector needle following removal from the patient end shield indicates the needle has fully penetrated the skin. A second shield covers the pen connector needle when it is removed from the pen.

AI/ML Overview

This looks like a 510(k) summary for a medical device called "Dual Safety Pen Needle" (K191853). It describes the device, its intended use, a comparison to a predicate device, and summaries of non-clinical and clinical tests.

Here's an analysis of the acceptance criteria and study information, organized as requested:

1. Table of Acceptance Criteria and Reported Device Performance

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

Sample Size for Clinical Simulated Use Test Set: A total of 500 samples were tested.
Data Provenance: The document does not explicitly state the country of origin for the clinical study data. It implies an internal study ("internal protocol and test results") but no specific geographic location for the conduct of the test is mentioned. The study appears to be prospective as it involves the evaluation of the device by participants.

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

Number of Experts: 8 participants were selected to evaluate the subject device.
Qualifications of Experts: These participants included endocrine doctors and nurses who provide training to patients in the use of pen needles for insulin injection. No specific years of experience are mentioned.

4. Adjudication Method for the Test Set

The document describes a usability/simulated use study where participants evaluated the device. The "ground truth" here is the effectiveness of the safety mechanism as observed during use. The study reported "zero failures." This suggests a direct observation and categorical outcome (success/failure) rather than an adjudication process requiring multiple expert opinions on a subjective measure. Therefore, no formal adjudication method (like 2+1, 3+1) is described, as the outcome appears to be objectively observed during the simulated use.

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

No, a MRMC comparative effectiveness study was not done. The document describes a usability/simulated use test for the safety mechanism and various bench tests for physical and biological properties. It does not mention a comparative effectiveness study involving human readers (or users) comparing performance with and without AI assistance, as AI is not a component of this device.

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

Not applicable. This device is a physical medical instrument (pen needle), not an AI algorithm. Therefore, a standalone algorithm performance study is not relevant.

7. Type of Ground Truth Used

For the Clinical Simulated Use testing, the ground truth appears to be observed effectiveness/failure of the safety mechanism during actual handling by trained users. The outcome was "zero failures" across 500 samples, indicating the mechanism worked as intended.
For the Non-Clinical tests (e.g., sterilization, biocompatibility, product functionality, sharps injury protection, packaging), the ground truth is established by compliance with recognized international standards (ISO, ASTM, USP) and manufacturer's internal protocols, which are based on objective measurements and test methods defined by these standards.

8. Sample Size for the Training Set

Not applicable. This device is a physical medical instrument, not a machine learning model, so there is no "training set."

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

Not applicable. As there is no training set for a machine learning model, this question is not relevant.

Summary

Regulation Number and Section

§ 880.5570 Hypodermic single lumen needle.

(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. 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 or an intravascular administration set.(b)
Classification. Class II (performance standards).

Acceptance Criteria Category	Specific Criteria/Standard	Reported Device Performance
Product Functionality	Meets criteria specified in ISO 11608-2 (Pen-injectors - Part 2: Needles)	Device meets criteria specified in ISO 11608-2 after sterilization.
Shelf Life	Sterile devices meet criteria specified in ISO 11608-2 after accelerated aging.	Product is labeled with an expiry date of 5 years.
Biocompatibility: Cytotoxicity	Meets cytotoxicity requirements of ISO 10993-5 (Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity)	Device meets cytotoxicity requirements of ISO 10993-5.
Biocompatibility: Sensitization	Meets sensitization requirements of ISO 10993-10 (Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization)	Device meets sensitization requirements of ISO 10993-10.
Biocompatibility: Intracutaneous Reactivity	Meets intracutaneous reactivity requirements of ISO 10993-10 (Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization)	Device meets intracutaneous reactivity requirements of ISO 10993-10.
Biocompatibility: Hemocompatibility	Meets hemocompatibility requirements of both ISO 10993-4 (Biological evaluation of medical devices Part 4: Selection of tests for interactions with blood) and ASTM F756 (Standard Practice for Assessment of Hemolytic Properties of Materials)	Device meets hemocompatibility requirements of both ISO 10993-4 and ASTM F756.
Biocompatibility: Systemic Toxicity	Meets systemic toxicity requirements of ISO 10993-11:2006(R)2010 (Biological evaluation of medical devices - Part 11: Tests for systemic toxicity)	Device meets system toxicity requirements of ISO 10993-11:2006(R)2010.
Sharps Injury Protection: Activation Force	Meets safety mechanism activation requirements as per ISO 23908 and internal protocol. Force to activate the sharps injury prevention feature is 1N to 5N for both ends.	Device meets safety mechanism activation requirements as per ISO 23908. Force to activate the sharps injury prevention feature is 1N to 5N for both ends of the Dual Safety Pen Needle.
Sharps Injury Protection: Override/Unlocking Force	Meets safety overriding/unlocking force after activation requirements as per ISO 23908 and internal protocol. Force required to override the sharps injury prevention feature greater than 20N for both ends.	Device meets safety overriding/unlocking force after activation requirements as per ISO 23908. Force required to override the sharps injury prevention feature greater than 20N for both ends of the Dual Safety Pen Needle.
Sterilization	Sterility Assurance Level (SAL) of 10^-6 validated in accordance with ISO 11135:2014 for Ethylene Oxide.	SAL of 10^-6 has been validated in accordance with the requirements of ISO 11135:2014 for Ethylene Oxide.
LAL Pyrogen Testing	Meets endotoxin requirements of USP39_NF34 Bacterial Endotoxins Test.	Device meets endotoxin requirements of USP39_NF34 Bacterial Endotoxins Test.
Packaging: Shipping	Meets requirements of ISTA 3A.	Shipping package meets requirements of ISTA 3A.
Packaging: Unit Functionality	Meets acceptance criteria specified in ASTM F1929-98 (2004) for dye penetration and peel strength after EO sterilization.	Unit package functionality meets acceptance criteria specified in ASTM F1929-98 (2004) for dye penetration and peel strength after EO sterilization.
Packaging: Microbial Barrier	Provides a seal having a microbial barrier that meets log reduction value (LRV) requirements of ASTM F1608-16.	Unit package provides a seal having a microbial barrier that meets LRV requirements of ASTM F1608-16.
Clinical Simulated Use Effectiveness	Posterior safety protective mechanism of the Dual Safety Pen Needle is effective (zero failures).	Evaluations resulted in zero failures of each of the Dual Safety Pen Needle.