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It is intended to inject fluids into or withdraw fluids from the body for medical purposes.

Verifine Safety Syringe with Fixed Needle is a sterile device consisting of a calibrated barrel with plunger and a fixed needle at the distal end. It is made of plastic and silicone materials. It includes an attached needle with a safety mechanism. The protective shield covers the needle. After injection, the shield is permanently locked in place by pushing axially until a click is heard, reducing risk of needle sticks and rendering the device unusable. This is a single-use device.

The provided text is a 510(k) summary for the "Verifine Safety Syringe with Fixed Needle." This document primarily focuses on demonstrating substantial equivalence to a predicate device through conformity to recognized standards and bench testing. It does not contain information about a study that would involve acceptance criteria related to a statistical performance metric of a device, especially not an AI/ML powered device, assessed against a ground truth established by experts.

Here's why the requested information cannot be extracted from this document:

• Device Type: The device is a "Verifine Safety Syringe with Fixed Needle," a hardware medical device (a physical syringe with a safety mechanism). It is not an AI/ML powered device.
• "Study that proves the device meets the acceptance criteria": The document describes performance testing (bench testing) to show compliance with various ISO standards (e.g., ISO 7886-1 for syringes, ISO 23908 for sharps injury protection, ISO 10993 for biocompatibility) and packaging tests. These are engineering and material compliance tests, not clinical studies or performance studies involving human-in-the-loop or standalone AI performance evaluation.
• "Acceptance criteria": The "acceptance criteria" for a physical device like a syringe are typically defined by these ISO standards (e.g., specific force required to activate safety, leakage rates, sterility levels, biocompatibility results like "no cytotoxicity"). These are quantitative engineering specifications rather than diagnostic performance metrics.

Therefore, I cannot provide the requested table and details because the device and the testing described in the document do not align with the nature of the questions, which are highly specific to the evaluation of AI/ML-powered medical devices.

To answer your request based on the provided document:

The acceptance criteria are implicitly met by demonstrating compliance with the referenced ISO standards. For example, for biocompatibility, the acceptance criteria would be "no evidence of cytotoxicity," "no evidence of skin irritation," etc. For sharps injury protection, the acceptance criteria would be that the device functions as intended to prevent sharps injury according to ISO 23908.

Since the information is not present in the provided text, I cannot fill out the requested table or answer points 2-9.

What the document does provide regarding performance testing:

• Bench Testing: The device underwent bench testing to verify performance characteristics against the predicate device.
• Standards Followed:
  • ISO 7886-1:2017 (Sterile hypodermic syringes for single use Part 1: Syringes for manual use)
  • S ISO 9626:2016 (Stainless steel needle tubing for the manufacture of medical devices)
  • ISO 7864:2016 (Sterile hypodermic needles for single use)
  • ISO 23908:2011 (Sharps injury protection)
  • USP Bacterial Endotoxin Test
• Biocompatibility Testing (per ISO 10993-1, -5, -10, -11, -4, -7, USP42-NF37, USP):
  • Cytotoxicity: No cytotoxicity
  • Skin Irritation: No evidence of skin irritation
  • Skin Sensitization: No evidence of sensitization
  • Acute Systemic Toxicity: No systemic toxicity
  • Hemolysis: No evidence of hemolysis
  • Pyrogen: Non pyrogenic
  • USP Particulate matter
• Sterility, Shipping, and Shelf-Life Testing:
  • ISO 11135:2014 (Ethylene oxide sterilization)
  • ASTM D4169-16 (Simulated transport)
  • ASTM F88/F88-15 (Seal strength)
  • ASTM F1929-15 (Dye penetration)
  • USP38-NF33 C71 (Sterility test)
  • ASTM F1980-16 (Accelerated aging for shelf life of 5 years)

In summary, the document details engineering and material testing to ensure the safety and effectiveness of a physical syringe, not the performance of an AI/ML algorithm.

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