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The Surflo Winged Infusion Set is indicated for venipuncture and intravenous administration of fluids for up to 24 hours using compatible/appropriate disposable infusion devices for medical purposes. It may be used for any patient population with consideration given to patient size.

The Surflo Winged Infusion Set consists of a protector, needle, wing, tubing, connector, and connector cap. The connector is 6% female Luer. It is primarily made from medical grade PVC (the whole device uses TOTM as plasticizer instead of DEHP) and medical grade stainless steel. The Surflo Winged Infusion Set is operated manually. The device is intended to be used by trained healthcare professionals in a healthcare facility. The Surflo Winged Infusion Set is available in different gauge sizes and tubing lengths. The Surflo Winged Infusion Set is a disposable device intended for single use only. The device is packaged and sterilized by ethylene oxide gas.

This document is a 510(k) Premarket Notification for the Surflo Winged Infusion Set, seeking substantial equivalence to a legally marketed predicate device. As such, it describes performance testing conducted to demonstrate product safety and effectiveness, rather than a study proving a device meets acceptance criteria for an AI/ML product. Therefore, several points in your requested output, such as those related to AI/ML specific criteria (e.g., sample size for training set, number of experts for ground truth establishment, MRMC study, standalone performance) are not applicable to this type of medical device submission.

However, I can extract and present the relevant information regarding acceptance criteria and performance testing for this traditional medical device:

Acceptance Criteria and Device Performance for Surflo Winged Infusion Set

The Surflo Winged Infusion Set underwent non-clinical performance testing to ensure it met predetermined specifications, conformed to applicable ISO and non-ISO standards, and demonstrated substantial equivalence to its predicate device.

1. Table of Acceptance Criteria (Standard Compliance) and Reported Device Performance

For tests conducted against specific standards, the document implies that compliance with the standard is the acceptance criterion. For additional performance tests, the acceptance criterion was "Meets acceptance criteria," established based on the predicate device's performance.

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

The document does not explicitly state the sample sizes used for each performance test. It only mentions that "Performance testing was conducted to ensure the Surflo Winged Infusion Set met the predetermined specifications." The data provenance is implied to be from the manufacturer's internal testing facilities in Hangzhou, China, as it is manufactured by "Terumo Medical Products (Hangzhou) Co., Ltd." The testing is described as non-clinical, implying a prospective testing approach conducted specifically for this 510(k) submission.

3. Number of Experts Used and Qualifications

Not applicable. This is a non-clinical performance test for a traditional medical device, not a study requiring expert readers for ground truth establishment.

4. Adjudication Method for the Test Set

Not applicable. This is a non-clinical performance test for a traditional medical device, not a study requiring adjudication of expert readings.

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

Not applicable. This is a non-clinical performance test for a traditional medical device, not a study evaluating human reader performance with or without AI assistance.

6. Standalone Performance (Algorithm Only)

Not applicable. This is a traditional medical device, not an AI/ML algorithm.

7. Type of Ground Truth Used

The "ground truth" for the performance tests were adherence to established industry standards (ISO, JIS, GB) and internal company specifications derived from the predicate device's performance.

8. Sample Size for the Training Set

Not applicable. This is a traditional medical device, not an AI/ML product requiring a training set.

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

Not applicable. This is a traditional medical device, not an AI/ML product requiring a training set.

Additional Test Information:

• Biocompatibility: Tests were conducted on non-aged and accelerated-aged devices according to ISO 10993-1, with results demonstrating biocompatibility throughout the product's shelf life.
• Sterilization: The device is sterilized to a Sterility Assurance Level (SAL) of 10^-6, validated in accordance with ISO 11135:2014.
• Clinical Tests: The 510(k) submission states that it "does not include data from clinical tests."

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RADIFOCUS Torque Device is intended to facilitate guidewire manipulation during interventional procedures.

RADIFOCUS Torque Device is a supportive device intended to facilitate guide wire manipulation during interventional procedures. This product consists of a cap that screws onto the main body of the device (handle) to apply a clamping force on the guide wire. The cap is made of polypropylene and the handle is made of polyoxymethylene. The torque device can be used for the guide wires with diameters of 0.010" to 0.038". RADIFOCUS Torque Device is sterilized with ethylene oxide.

The provided text describes a 510(k) submission for the RADIFOCUS Torque Device, a medical device intended to facilitate guidewire manipulation. It specifically states that no clinical tests were performed or deemed necessary for this submission. The evaluation relies on non-clinical performance testing and comparison to a predicate device.

Therefore, the requested information regarding acceptance criteria and a study proving device performance cannot be fully provided in the context of a clinical study with human subjects, given that no such study was conducted or required.

However, based on the provided text, I can infer the "acceptance criteria" and "study" refers to the non-clinical performance testing conducted.

Here's the breakdown of what can be extracted from the provided text regarding the non-clinical performance testing:

1. A table of acceptance criteria and the reported device performance:

The document states: "The RADIFOCUS Torque Device tested met the predetermined acceptance criteria." While the specific numerical or qualitative acceptance criteria for each test are not detailed, the results are uniformly positive.

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

• Sample size: Not specified. The document only mentions "Performance testing was conducted."
• Data provenance: Not specified. It's implied to be internal testing by the manufacturer (Terumo Medical Products (Hangzhou) Co., Ltd.) given the context of a 510(k) submission and the lack of external study details. The testing is retrospective in the sense that it was conducted before the submission.

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

• This is not applicable as there was no clinical study involving human subjects or expert assessment of clinical outcomes. The "ground truth" for the non-clinical performance tests would be the established engineering specifications and measurement standards.

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

• This is not applicable for non-clinical performance testing of a medical device. Adjudication methods are typically used in clinical studies for interpretation of imaging or clinical events.

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:

• This is not applicable. The device is a physical torque device, not an AI-assisted diagnostic tool. No MRMC study was mentioned or implied.

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

• This is not applicable as the device is not an algorithm or AI. The performance testing was for the physical device.

7. The type of ground truth used:

• For the non-clinical tests, the "ground truth" was established by predetermined specifications and engineering standards for mechanical performance (e.g., strength, dimensions, torque).

8. The sample size for the training set:

• This is not applicable as there was no AI/algorithm that required a training set. This is a physical medical device.

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

• This is not applicable for the same reason as above.

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