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Y-Connector hemostasis valve is intended to minimize blood loss during the introduction, withdrawal and use of devices that have an outer diameter of 8F catheter during diagnostic and interventional procedures.

The Insertion Tool facilitates introduction of a guidewire through the Y-Connector and into the guiding catheter.

The Torque Device attaches to guidewires and provides a handle to assist in manipulation of the guidewire.

The Y-connector kit is single use disposable device. It including Y connector, Insertion tool and torque device. It is mainly use for PTCA or PTA procedures to create the entrance and minimize blood loss when intervention device are inserted into the human vascular system.

The Y connector with a rotating luer lock, a sidearm and a hemostasis valve that is designed to provide a port for interventional system. The seal of hemostasis valve can be opened by pushing the switch cap, and closed by releasing switch cap.

The insertion tool is used to facilitate placement of a guide wire tip through the Y connector.

The torque device is designed to hold the guide wire and provide a handle for manipulating, so the doctor can control the guide wire to the right position.

The provided text describes a 510(k) premarket notification for a medical device called the "Y-connector Kit." This submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than a de novo clinical study proving novel performance criteria. Therefore, the information regarding acceptance criteria and a study proving device meeting those criteria will be based on the substantial equivalence claims and bench testing performed.

Here's an analysis of the provided text:

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

The document does not explicitly present a table of acceptance criteria with corresponding performance data in a quantitative manner as one might find in a clinical trial. Instead, it describes compliance with design specifications and recognized standards. The "acceptance criteria" are implied by the standards and performance characteristics of the predicate device.

Implied Acceptance Criteria and Reported Device Performance:

Study that Proves the Device Meets Acceptance Criteria:

The document describes "Bench tests were conducted to verify that the proposed device met all device specification as were substantially equivalent (SE) to the predicate device." It also mentions "Biocompatibility testing and reference standards."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the sample sizes for the bench tests. It only states that "Bench tests were conducted."

• Sample size: Not specified.
• Data provenance: The tests were conducted internally by Shanghai Kindly Medical Instruments Co., Ltd. (China). The data is presumably prospective (i.e., designed specifically for this submission).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This type of information (experts, their qualifications, and ground truth establishment) is typically relevant for clinical studies, especially those involving subjective interpretation (e.g., imaging diagnosis). Since this submission primarily relies on bench testing and substantial equivalence, there is no mention of experts establishing a ground truth for a test set in the context of clinical performance. The "ground truth" for the bench tests would be the established engineering and biological standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable for a submission based on bench testing and substantial equivalence, which does not involve subjective human interpretation of clinical data requiring 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

Not applicable. This is a medical device submission for a physical y-connector kit, not an AI software/algorithm, and no MRMC study was performed or needed.

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

Not applicable. This is a medical device submission for a physical y-connector kit, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the bench tests, the "ground truth" would be the established scientific and engineering principles codified in the referenced ISO standards (ISO 594-1, ISO 594-2, ISO 10993 series) and the functional performance characteristics of the predicate device. For biocompatibility, the ground truth is defined by the acceptable levels of biological response as outlined in the ISO 10993 standards.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI/machine learning model that requires a training set.

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

Not applicable, as there is no training set for a physical medical device.

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