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The 50 ml Terumo Syringes for administration of UV sensitive medicines are sterile hypodermic syringes for single use, intended for the aspiration of fluids and blood, or for the injection of fluids immediately after filling. Intended for manual use or for use with power driven syringe pumps. The opaque color of the barrel allows the administration of UV sensitive medicines.

The 50 ml Terumo Syringe for Administration of UV Sensitive Medicines is a hypodermic standard piston syringe for single use, with a 6 % luer lock tip, made of plastic material and a synthetic rubber gasket. The barrel of the syringes has an opaque color to avoid the transmission of UV light. The 6% luer lock tip allows the use with power driven syringe pumps.

The provided text describes a 510(k) summary for the "50 ml Terumo Syringe for Administration of UV Sensitive Medicines." This document focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study against specific acceptance criteria for algorithm performance.

Therefore, many of the requested elements for describing the acceptance criteria and the study that proves the device meets them, particularly those related to AI algorithm performance (like sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, standalone performance, and how ground truth for training was established), are not applicable to this type of medical device submission.

The "Performance" section explicitly states: "The 50 ml Terumo Syringe was tested in accordance with EN ISO 7886-1 (1997) and EN ISO 7886-2 (1997). Other testing included barrel transmission and UV protection of the opaque barrel." This indicates that the acceptance criteria are defined by these international standards for syringes and specific tests related to the UV-sensitive aspect of the device.

Here's a breakdown based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify sample sizes for the performance testing. The provenance of the data is implicit as it's a device manufactured by Terumo Europe N.V., suggesting the testing was conducted to European and international standards. It's a new device, so the testing would be prospective in nature, demonstrating compliance with specified standards.

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

Not applicable for a medical device like a syringe. Performance is measured against predefined engineering and biological standards, not expert interpretations of medical images or conditions.

4. Adjudication method for the test set

Not applicable. Performance is based on direct physical and chemical measurements against established standards.

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

Not applicable. This device is a physical syringe, not an AI algorithm.

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

Not applicable. This device is a physical syringe, not an AI algorithm.

7. The type of ground truth used

The "ground truth" for this device is defined by the requirements outlined in the referenced international standards (e.g., ISO, EN standards) and FDA biocompatibility guidelines. For example, for sterility, the ground truth is a sterility assurance level (SAL) of 10⁻⁶ as defined in EN 556-1. For biocompatibility, the ground truth is "biocompatible" as determined by tests recommended in FDA guidance and ISO 10993-1.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set.

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

Not applicable.

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The Terumo Syringe for administration of UV sensitive medicines is a sterile hypodermic syringe for single use, intended for the aspiration of fluids and blood, or for the injection of fluids immediately after filling. The opaque color of the barrel allows the administration of UV sensitive medicines.

The Terumo Syringe for administration of UV sensitive medicines is a hypodermic standard piston syringe, available in 20 ml volume, with an eccentric luer taper tip for single use, made of plastic material and a synthetic rubber gasket. The barrel of the syringe has an opaque color to avoid the transmission of UV light.

The provided text is a 510(k) Summary for a medical device (Terumo® Syringe for administration of UV sensitive medicines), not a study report. It describes the device, its intended use, and claims substantial equivalence to a predicate device.

Therefore, the document does not contain the detailed information necessary to complete the requested table and answer the study-specific questions.

Here's why and what information is available:

What the document does provide:

• Acceptance Criteria Mention: The document states, "The Terumo syringe was tested in accordance with EN ISO 7886-1 (1997). Other testing included barrel transmission and UV protection of the opaque barrel." This indicates that EN ISO 7886-1 (1997) standards and specific tests for barrel transmission and UV protection served as acceptance criteria. However, the specific quantitative criteria (e.g., minimum UV blockage percentage, specific values for plunger force, leakage, etc., as defined by the standard) and the results against those criteria are not provided in this summary.
• Device Performance Mention: It generally states, "None of the data raises any new issues of safety and effectiveness." and implicitly, "the opaque color of the barrel allows the administration of UV sensitive medicines," suggesting successful performance in UV protection. However, no specific metrics of performance (e.g., "99% UV blockage") are given.
• Intended Use: Clearly stated.
• Description & Materials: Clearly stated.
• Sterility Assurance: Methods used (EN 550, ISO 11135, SAL 10^-6, EN 556-1) and compliance with residual levels (ISO 10993-7) are mentioned.
• Biocompatibility: Confirmed by testing according to FDA G95-1 and ISO 10993-1.
• Expiration Dating: Established at 5 years.

Why the requested table and many questions cannot be answered from this text:

The 510(k) Summary is a high-level document to demonstrate substantial equivalence, not a detailed technical report of every study performed. The specifics of the "acceptance criteria" and "reported device performance" are summarized or referenced rather than explicitly detailed with quantitative data.

Therefore, I cannot fill out the table or answer questions about sample sizes, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details because this information is not present in the provided 510(k) summary.

In summary, the document states that performance testing was done against certain standards, but does not provide the results of that testing or the specific details of the study design.

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