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The steerable guiding sheath, Destino Reach is intended for the introduction of diagnostic and therapeutic devices into the human vasculature, including but not limited to intracardiac, renal or other peripheral placements. Do not use this device for neural placements.

The Destino Reach Steerable Guiding Sheath is a percutaneous steerable sheath designed to facilitate the intracardiac, renal and peripheral placement of diagnostic and therapeutic devices. The device features an adjustable tip through use of a rotating collar that allows the physician to perform a bi-deflection at the distal tip section of the sheath. The sheath has a hemostatic valve, sideport with stopcock, radiopaque distal tip, contains side flush portholes and is deflectable by rotating the collar incorporated into the handle. The dilator has depth markings and locks onto the sheath. The dilator has a tapered distal tip and an inner lumen recommended for use with 0.035" to 0.038" guidewire and/or transseptal needle.

This document describes the Destino Reach, Steerable Guiding Sheath and does not contain information about an AI/ML powered device. Therefore, it does not provide the specific details requested regarding acceptance criteria and a study proving device performance in the context of AI/ML.

The provided document is a 510(k) summary for a medical device (a steerable guiding sheath) that demonstrates substantial equivalence to predicate devices based on design, manufacturing materials, intended use, principles of operation, and technical characteristics. It details traditional medical device testing and regulatory information.

Based on the provided text, I cannot answer the following questions as they pertain to AI/ML device evaluation:

1. A table of acceptance criteria and the reported device performance: The document lists standards followed for traditional medical devices (e.g., risk management, sterilization, biocompatibility), but not acceptance criteria for an AI/ML specific performance.
2. Sample size used for the test set and the data provenance: Not applicable to a non-AI/ML device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable in the context of AI/ML.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

What the document does provide regarding device performance and testing:

The "DEVICE PERFORMANCE" section on page 5 and "TESTING" section on page 6 outline the types of evaluations performed for this traditional medical device:

• Standards followed:

  • BS EN ISO 14971:2012, Medical devices - Application of risk management to medical devices
  • AAMI/ANSI/ISO 11135: 2014, Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices.
  • AAMI/ANSI/ISO 10993-7:2008, Cor. 2009, Biological evaluation of medical devices, Part 7, Ethylene oxide sterilization residuals.
  • ISO 10555-1 2013, Intravascular catheters- Sterile and single use catheters, Part 1, General requirements. (Note: Requirements for flow rate and power injections not followed as this does not apply to an introducer.)
  • ISO 11070: 1998, Sterile single-use intravascular catheter introducers. (Note: Requirements for needles do not apply since the product is not packaged with a needle).

• Testing Conducted:

  • Functional system testing
  • Risk analysis
  • Biocompatibility
  • Packaging/transportation qualification

The claim is that "Based on this testing, we have determined that the device performs as well as the legally marketed predicate devices identified in this summary." This implies that the device met the performance characteristics expected for its class and intended use, as demonstrated by adherence to recognized standards and specific internal verification and validation tests. However, the exact acceptance criteria thresholds for each test and the specific results are not detailed in this summary.

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