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The ASCPO Needle is intended for use in the subcutaneous injection of fluid for medical purpose. The ASCPO Needle is compatible for use with standard luer slip and luer lock syringes. Additionally, after withdrawal of the needle from the body, the attached needle safety sheath can be automatically activated to cover the needle and locked immediately after use to minimize risk of accidental needlestick.

The ASCPO Needle is a single lumen needle intended to inject fluids subcutaneously. 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.

The ASCPO Needle is intended for use in the subcutaneous injection of fluid for medical purpose. The ASCPO Needle is compatible for use with standard luer-slip and luer-lock syringes. Additionally, after withdrawal of the needle from the body, the needle safety sheath can be automatically activated to cover the needle and locked immediately after use to minimize risk of accidental needlestick.

The provided document describes the acceptance criteria and the study that proves the CCBIO ASCPO Needle meets these criteria, primarily focusing on its safety and performance aspects for its 510(k) submission (K214004) to the FDA.

Here's an analysis based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily based on compliance with various international standards and internal specifications, rather than numerical performance metrics for a diagnostic algorithm. The device performance is reported as meeting these standards.

2. Sample Size for Test Set and Data Provenance

• Test Set Sample Size:
  • Simulated Clinical Use Study: 500 simulated injections.
  • Human Factor Study: Not explicitly stated as a numerical 'sample size' for a test set, but it states "5 enrolled qualified evaluators." This implies the "sample" here refers to the number of users testing the device.
• Data Provenance: Not explicitly stated (e.g., country of origin). The document mentions "510(k) summary... prepared at June 06, 2017" and the submitter's address is in Tainan, Taiwan. The studies are described as "non-clinical tests verification activities" and "Clinical Test Validation Activities." It's unclear if these were truly "clinical" studies in humans through a prospective trial, or simply simulated/human factor lab studies. Given the device type (a needle), it's highly likely these are laboratory-based validation tests and human factor assessments rather than large-scale patient-based clinical trials often associated with "clinical test validation" for other device types. The "Simulated Clinical Use Study" strongly suggests a laboratory simulation rather than real patient data.

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

This device validation does not involve establishing "ground truth" in the way an AI diagnostic algorithm would (e.g., through radiologists' consensus on images). Instead, the "ground truth" for a medical device like a needle is adherence to established engineering, material, and safety standards.

• For the Human Factor Study, "5 enrolled qualified evaluators" were used. Their specific qualifications (e.g., healthcare professionals, engineers, lay users) are not detailed beyond "qualified evaluators." They completed "TDICT SIP Evaluation Forms."

4. Adjudication Method for the Test Set

Not applicable in the context of this device's validation. Adjudication methods like "2+1" or "3+1" are typically used for establishing ground truth in diagnostic imaging studies where expert readers independently review data, and conflicts are resolved by additional readers or consensus. This validation focuses on objective performance against engineering standards and user feedback, not diagnostic accuracy.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and Effect Size

No, an MRMC comparative effectiveness study was not performed. This type of study is specific to evaluating the impact of AI on human reader performance in diagnostic tasks and is not relevant for a medical device like a hypodermic needle. The human factor study assessed usability and safety features.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done

Not applicable. This is a physical medical device (a hypodermic needle), not a diagnostic algorithm or AI system. Its "performance" is inherent to its design, materials, and mechanical function, which were tested against defined standards independently (e.g., ISO standards).

7. The Type of Ground Truth Used

The "ground truth" for this medical device is the compliance with established international and FDA-recognized standards and internal specifications. For example:

• Engineering standards: ISO 23908 (sharp injury protection), ISO 7864 (hypodermic needles), ISO 9626 (needle tubing), ISO 80369-7 (small-bore connectors).
• Safety standards: ISO 10993 series (biocompatibility), ISO 11135 (sterilization), FDA guidance on SIP features.
• Objective measurements: Failure rates in simulated use, physical properties (e.g., bond strength, penetration force, leakage).
• User feedback: From qualified evaluators in the Human Factor Study.

8. The Sample Size for the Training Set

Not applicable. This document describes the validation of a physical medical device, not a machine learning model. Therefore, 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 this type of device.

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