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The PreludeSYNC is a compression device used to assist in gaining hemostasis of arterial percutaneous access sites.

The PreludeSYNC™ Radial Compression Device is a sterile, single use disposable device used to assist in gaining and maintaining hemostasis of the radial and ulnar artery following catheterization procedures. It consists of a soft wristband with a secure hook and loop fastener and a clear curved backer plate that provides optimal visualization of the puncture site and ease of placement. The inflatable bulb delivers adjustable compression of the puncture site. A check valve and tubing allow for easy inflation and deflation with the accompanying 20ml syringe inflator. PreludeSYNC is available in a variety of graphic designs and in two band sizes: regular (24cm) and long (29cm).

This document is a 510(k) Summary for the PreludeSYNC™ Radial Compression Device. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific performance acceptance criteria for a novel AI or diagnostic system.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set details) are not applicable to this type of regulatory submission and device. This document primarily outlines bench testing and biocompatibility testing conducted to ensure safety and function in comparison to a predicate, not to establish diagnostic accuracy or human performance improvement.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria for each test and then report the exact performance. Instead, it lists the types of performance and biocompatibility tests conducted, implying that the device "meets the requirements" as part of the substantial equivalence determination.

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

• Sample Size: Not specified for individual tests. The testing methodology is outlined by referencing various ISO and ASTM standards (e.g., ISO 594-1, ISO 594-2, ISO 2233:2001, ISO 11607-1:2006, ASTM D4169-09, ASTM F1980-11, ISO 11135:2014, ISO 10993-1:2009, ISO 10993-5:2009, ISO 10993-7:2008, ISO 10993-10:2010, ISO 10993-11:2006). These standards would dictate the sample sizes for the specific tests, but the document itself does not report these numbers directly.
• Data Provenance: Not applicable in the context of clinical data. This is bench and biocompatibility testing of a physical device.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Not applicable. Ground truth, in the sense of expert review for diagnostic accuracy, is not relevant for this type of device and testing. The "ground truth" for the performance tests would be the measurement against established engineering or material specifications, and for biocompatibility, the results of standardized biological assays.

4. Adjudication Method for the Test Set

• Not applicable. No expert adjudication process is described for these types of engineering and biocompatibility tests.

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

• No. This is a physical medical device (radial compression device), not an AI or diagnostic imaging system. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or performed.

6. Standalone (Algorithm Only) Performance Study

• No. This is a physical medical device, not an algorithm or software. "Standalone performance" in this context refers to the device's physical function and safety, without human-in-the-loop, which is addressed by the bench and biocompatibility testing.

7. Type of Ground Truth Used

• The "ground truth" for these tests are:
  • Engineering Specifications: For dimensions, tensile strength, leak tests, burst tests, etc.
  • Material Science Standards: For absorbency, transparency, ink adherence.
  • Biological Assay Results: For cytotoxicity, sensitization, irritation, and systemic toxicity, as defined by the ISO 10993 series of standards.
  • Functional Objectives: For simulated use, ensuring the device performs its intended mechanical function.

8. Sample Size for the Training Set

• Not applicable. This device does not involve machine learning or AI, so there is no "training set."

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

• Not applicable. There is no training set.

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