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The compression device is used to assist patent hemostasis of the radial artery after a transradial procedure.

The TRAcelet™ compression device consists of a closure band and customized syringe. The device is used to assist in the hemostasis of the radial artery after a transradial percutaneous procedure.

The TRAcelet™ compression device is used to assist dUhYbh hemostasis of the radial artery after a transradial procedure.

Medtronic's TRAcelet™ compression device consists of a closure band and customized syringe. There are two different size closure bands regular (19.2cm) and large (25.2cm) comprised of the following technological characteristics:

• Frame
• Dial-Threaded Window Assembly
• Balloon Assembly
• Air Injection Port (Luer Check Valve Assembly
• Strap Assembly

The provided text describes a 510(k) premarket notification for the TRAcelet™ Compression Device. This submission primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing. No clinical study was performed to prove the device meets acceptance criteria. Therefore, many of the requested details related to clinical studies and human-in-the-loop performance are not applicable to this submission.

Here's a breakdown of the requested information based on the provided text:

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

The document lists various design verification tests (in-vitro bench testing) and biocompatibility tests. While it states that the device "meets the key safety and effectiveness requirements for its intended clinical use" and that "No new safety or effectiveness issues were raised during the testing," specific quantitative acceptance criteria and reported performance values are not provided in this summary. The tests performed include:

• Effective Strap Length
• Syringe to Anti-Lock Cap Tensile
• Balloon Rupture
• Side-Tube to Balloon Tensile
• Side-Tube to Check Valve Tensile
• Velcro to Lay flat Tubing Weld Tensile
• Rivet Joint Tensile Regular
• Initial Balloon Inflation Pressure
• Balloon Internal Pressure Over Time
• Dial Torque
• Dial Lock Disengagement Force
• Dial Removal Torque
• Dial to Threaded Window Shear Strength
• Cytotoxicity testing
• Sensitization testing
• Intracutaneous reactivity testing
• Acute systemic toxicity testing

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

The document states that "Design Verification (DV) testing was completed to demonstrate that the TRAcelet™ meets the key safety and effectiveness requirements for its intended clinical use. The Design Verification Testing included in-vitro bench testing on finished devices which were representative of commercial device."

• Sample Size: The exact sample size for each specific bench test is not specified.
• Data Provenance: The tests are described as "in-vitro bench testing" performed on "finished devices which were representative of commercial device." This indicates the data is from non-clinical laboratory testing rather than human subjects or real-world clinical use. There is no information on country of origin as it's not patient data.

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

This question is not applicable as no clinical study or human-in-the-loop evaluation was performed where experts would establish ground truth for a test set. The evaluation was based on engineering bench tests and biocompatibility assessments.

4. Adjudication method for the test set

This question is not applicable as no clinical study or human-in-the-loop evaluation was performed. The non-clinical tests would have pass/fail criteria based on engineering specifications rather than expert adjudication.

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 question is not applicable. The device is a physical compression device, not an AI-powered diagnostic or assistance tool. No MRMC study was conducted.

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

This question is not applicable. The device is a physical medical device, not an algorithm, and therefore does not have a "standalone" algorithmic performance.

7. The type of ground truth used

For the non-clinical bench testing, the "ground truth" would be the engineering specifications and performance requirements that the device was designed to meet, as well as the standards for biocompatibility (ISO 10993-1).

8. The sample size for the training set

This question is not applicable as no AI model was developed or described in this submission. Therefore, there is no training set in the context of machine learning.

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

This question is not applicable as there is no training set in the context of machine learning.

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