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The Doyle Extractor is a needle extractor intended for use as an accessory to IV administration sets. Specifically, the Doyle Extractor is intended for use during the removal of right-angle needles from implanted IV ports.

The Doyle Extractor is a needle extractor intended for use as an accessory to IV administration sets. Specifically, the Doyle Extractor is intended for use during the removal of right-angle needles from implanted IV ports. It is manufactured from polypropylene and provides a suitable leverage for extraction of right-angle needles from the skin and implanted IV port. The device contains a slot on the top blade to secure the IV tubing prior to removal of the needle.

This document describes a medical device, the Doyle Extractor, a needle extractor intended for use as an accessory to IV administration sets for removing right-angle needles from implanted IV ports. However, the provided text is a 510(k) summary (a premarket notification for medical devices in the US) and does not contain the detailed information required to fulfill all aspects of your request regarding acceptance criteria and a study proving device performance.

Specifically, the document states: "Testing was designed to determine the force required to withdraw a right-angle needle from the skin and injection port, as well as to determine that the material and design characteristics of the device were adequate to meet\provide that required force. Testing results confirmed the suitability of the device material and design for its intended use."

This is a high-level summary and does not provide quantitative acceptance criteria, detailed study methodology, sample sizes, expert qualifications, or ground truth information.

Therefore, I cannot populate the table or answer most of your detailed questions directly from the provided text.

Here's an attempt to address as much as possible based on the limited information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample size: Not specified.
• Data provenance: Not specified (e.g., country of origin, retrospective/prospective). It likely refers to internal testing conducted by Safetech International Inc.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not specified. The testing described appears to be a performance test of the device's mechanical capabilities, rather than a clinical study requiring human expert ground truth for interpretation (like image analysis).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable/Not specified. This typically refers to adjudication of clinical readings or interpretations, which does not seem to be the nature of the described "device testing."

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No. This is not an AI-powered device, and no MRMC study is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This device is a manual tool, not an algorithm. The "device testing" described is likely a standalone performance test of the physical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• Based on the description ("determine the force required to withdraw a right-angle needle from the skin and injection port, as well as to determine that the material and design characteristics of the device were adequate"), the ground truth would likely be established by physical measurements and engineering specifications. For example:
  • Force Measurement: A load cell or similar force gauge would measure the force required to extract a needle from a test medium simulating skin and an implanted port.
  • Material Strength/Design Adequacy: Mechanical testing (e.g., stress tests, fatigue tests) comparing the device's performance against predefined engineering limits or industry standards for polypropylene and similar devices.

8. The sample size for the training set

• Not applicable. This is not a machine learning/AI device, so there is no "training set."

9. How the ground truth for the training set was established

• Not applicable.

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