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The Euclid™ Tier 1 Mini Access System is designed to provide the medical practitioner with the capability to accurately and reliably insert a guidewire into a vessel. The device consists of (1) the Euclid™ Tier 1 Mini Base Kit containing the sterile disposable device assembly consisting of a needle (18/21 Gauge) and guidewire (0.18" diameter x 40 cm length), a Euclid™ Ultrasound Imaging Screen Overlay, and IFU; and (2) the Euclid™ Tier 1 Mini Transducer Adapter Kit which contains a Euclid™ Transducer Adapter and IFU.

AI/ML Overview

Here's the breakdown of the acceptance criteria and study information for the Houston Medical Robotics, Inc. Euclid™ Tier 1 Mini Access System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Test/Study	Acceptance Criteria	Reported Device Performance
Functional Verification	Expected to perform reliably at functional extremes (5mm and 60mm guidewire insertion).	Benchtop testing (guidewire insertion) demonstrated performance at functional extremes (5mm and 60mm).
Shipping Integrity	Device and packaging integrity maintained after simulated shipping; guidewire insertion at functional extremes successful; pouch seal strength and dye penetration maintained.	Simulated shipping conditions followed by device and packaging inspection, guidewire insertion in benchtop model to functional extremes (5mm and 60mm), pouch seal strength testing, and dye penetration testing all met acceptance criteria.
Accelerated Aging	Device function (guidewire insertion) maintained after accelerated aging; pouch seal strength and dye penetration maintained.	Aging to 6 months followed by functional testing (guidewire insertions to 5mm and 60mm), pouch seal strength testing, and dye penetration testing all met acceptance criteria.
Animal Validation	Successful guidewire insertion in an animal model by end-user.	Guidewire insertion in animal model by end-user was successful.
Biocompatibility Testing	Materials meet ISO 10993 standards for systemic toxicity, intracutaneous toxicity, implantation, cytotoxicity, hemolysis, pyrogenicity, and sensitization.	Materials tested per ISO 10993, including: Systemic Toxicity, Intracutaneous Toxicity, Implantation, Cytotoxicity, Hemolysis, Pyrogenicity, and Sensitization, all met acceptance criteria.

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

The provided text does not explicitly state the sample sizes for the benchtop tests (Functional Verification, Shipping Integrity, Accelerated Aging) nor for the Animal Validation. It mentions these tests were conducted, and acceptance criteria were met, but not the number of units tested.

The data provenance is retrospective for the tests mentioned, as they were conducted as part of the 510(k) submission process to demonstrate equivalence. The location of the animal study (country of origin) is not specified.

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

This information is not provided in the document. The studies listed (benchtop tests, animal model) do not inherently require "experts" to establish a ground truth in the way a diagnostic imaging study would. Performance was assessed against predefined functional and safety criteria. In the animal model, the "end user" performed the insertion, but their specific qualifications or how "ground truth" (e.g., successful access) was formally established beyond direct observation are not detailed.

4. Adjudication Method for the Test Set

This information is not provided and is not applicable to the types of performance tests described. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where multiple readers interpret results and discrepancies need to be resolved. The studies here are bench and animal model performance tests.

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

No. This device is a mechanical access system, not an AI-powered diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant and was not performed.

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

No. This device is a medical instrument and does not feature an "algorithm only" component in the sense of AI or software for diagnosis or analysis. Its performance is always physical and directly involves a human operator.

7. The Type of Ground Truth Used

For Functional Verification, Shipping Integrity, and Accelerated Aging: The ground truth was based on pre-defined engineering specifications and quantifiable performance metrics (e.g., successful guidewire insertion within specific depth ranges, maintaining pouch seal strength, passing dye penetration tests).
For Animal Validation: The ground truth was successful guidewire insertion into the target anatomical location by the end-user, likely confirmed by visual inspection or subsequent procedures within the animal model.
For Biocompatibility Testing: The ground truth was adherence to ISO 10993 standards, which involves established laboratory testing protocols and reference materials to determine biological safety.

8. The Sample Size for the Training Set

This information is not applicable as this is a hardware device submission, not a software or AI algorithm that requires a training set.

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

This information is not applicable for the same reason as above; there is no training set for this type of device.

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