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The Adapters with X-Coating are intended to be used to interconnect tubing and other devices within a circuit during extracorporeal bypass procedures.

The adapters are intended for use in procedures lasting up to 6-hours in duration.

The blood-contacting surfaces of the adapters are coated with X-Coating, which is a biocompatible coating that reduces the adhesion of platelets to the surfaces.

Device Description

The Adapters with X-Coating are of various designs (Male luer lock adapters, Female luer lock adapters, Needle/Slip adapters, Straight adapters, Y-adapters), each of which provide for the flow of blood and extracorporeal fluids through the bypass circuit. Each adapter is molded from polycarbonate or acrylic resin. The blood-contacting surfaces of the adapters are coated with X-Coating, which is a biocompatible coating that reduces the adhesion of platelets to the surfaces.

AI/ML Overview

The provided document is a 510(k) summary for a medical device (Adapters with X-Coating) seeking substantial equivalence to a predicate device. This type of submission does not typically involve complex AI algorithms or extensive clinical trials with human readers. Instead, it focuses on demonstrating that the new device performs similarly to an already legally marketed device through engineering and bench testing.

Therefore, many of the requested categories for AI/MRMC studies, expert ground truth, and training data will not be applicable.

Here's the information extracted from the document:

Acceptance Criteria and Device Performance

The core of this submission is demonstrating "substantial equivalence." The acceptance criteria are implicitly defined by showing that the Adapters with X-Coating perform equivalently to the uncoated predicate adapters in key areas.

Acceptance Criteria Category	Specific Criteria	Reported Device Performance	Comments
Intended Use	To interconnect tubing and other devices in extracorporeal bypass procedures for up to 6 hours.	Same as predicate device.	Demonstrates equivalence.
Principles of Operation & Technology	Provide connection for blood/extracorporeal fluid flow within a bypass circuit.	Same as predicate device.	Demonstrates equivalence.
Design and Materials	Similar designs (luer lock, needle/slip, straight, Y-adapters) and molded from polycarbonate or acrylic resin.	Same as predicate device, with the addition of the X-Coating polymer.	The coating is the primary differentiator, and its biocompatibility and performance are addressed.
Performance	- Dimensional/Visual Analysis	No clinically significant performance differences compared to uncoated adapters.	Demonstrated through various tests.
	- Leakage and Mechanical Integrity Testing	No clinically significant performance differences compared to uncoated adapters.	Demonstrated through various tests.
	- Pull Force Testing (Against Tubing)	No clinically significant performance differences compared to uncoated adapters.	Demonstrated through various tests.
	- 6-hour Circulation Testing (Damage & Thrombus formation - Visual)	No clinically significant performance differences compared to uncoated adapters.	Specifically addresses the 6-hour use duration and the X-Coating's effect on thrombus.
Sterilization	Sterility Assurance Level (SAL) of 10⁻⁶	Validated in accordance with AAMI guidelines.	Standard for sterilized medical devices.
Ethylene Oxide Residues	Not to exceed maximum residue limits.	Will not exceed maximum residue limits.	Addresses potential toxicity from sterilization.
Biocompatibility	Blood-contacting materials must be biocompatible (ISO 10993). In-vivo animal study for coating material.	Blood-contacting materials found to be biocompatible. No adverse conditions noted in in-vivo animal study.	Critical for a blood-contacting device. The animal study specifically evaluates the X-Coating.

Study Details (Applicable Sections)

Given this is a 510(k) for a physical medical device, not an AI algorithm, most of the AI-specific questions are not applicable.

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated as a single "test set" in the context of an AI model. Performance evaluations (Dimensional/Visual Analysis, Leakage and Mechanical Integrity Testing, Pull Force Testing, 6-hour Circulation Testing) were conducted. The sample sizes for each of these engineering tests are not detailed in the summary but would be part of the full 510(k) submission.
- Data Provenance: The studies were conducted by Terumo Cardiovascular Systems Corporation. No information is provided regarding country of origin for any human data (as there isn't any directly involved in performance validation) nor whether they were retrospective or prospective studies (as these are bench/engineering tests).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. Ground truth, in the context of AI, refers to expert-labeled data. For this device, "ground truth" for the performance evaluations would be objective measurements and observations (e.g., specific pull force values, absence of leaks, visual assessment of damage/thrombus). The expertise would be in conducting the tests and interpreting the results, rather than establishing a "ground truth" label.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. Adjudication methods are typically used when multiple human experts are labeling data for AI ground truth. For engineering tests, results are typically objective or interpreted by a single qualified individual, or a team agrees on a finding based on established protocols.
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:
- Not Applicable. This is not an AI-assisted device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is not an AI algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's performance relies on objective engineering measurements, visual inspection criteria, and biocompatibility testing standards (ISO 10993). For the 6-hour circulation test, "thrombus formation (visual)" would rely on trained observers. The animal study for the coating also provides in-vivo objective data on biological response.
The sample size for the training set:
- Not Applicable. This device does not use an AI training set.
How the ground truth for the training set was established:
- Not Applicable. This device does not use an AI training set.