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The Contrast Delivery System – Dual Shot Alpha is an intravascular injection system intended for the administration of ionic and non-ionic contrast media and saline used in conjunction with computed X-ray tomography (CT).

Contrast Delivery System -- Dual Shot Alpha is an Angiographic injector that is used in conjunction with X-ray Computed tomography, and is intended for use by doctors, radiologic technologists and other licensed medical practitioners. This device is designed to correspond to the various injection methods of contrast media which were materialized with the appearance of multi-siice CT scanners. The Dual Shot Alpha has two driving parts to deliver contrast media and/or saline, one side is for 50mL, 100mL and 200mL, size syringes, and the other side for 100mL syringes capable for saline flush injection. Syringes are connected to the patient via an intravascular catheter. Dual Shot Alpha consists following components; Injector head, Console, Power Supply, and Options (Hand Switch).

This document is a 510(k) summary for the NEMOTO KYORINDO DUAL SHOT - CONTRAST DELIVERY SYSTEM (K062168). It focuses on demonstrating substantial equivalence to a predicate device, not on presenting novel performance data or clinical study results as would be typical for a new device requiring rigorous acceptance criteria and clinical trials.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes for test/training sets, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth types is largely not present in this type of submission. This document primarily addresses safety and effectiveness through adherence to recognized standards and comparison to a legally marketed predicate device.

Here's a breakdown of what can be extracted and what is absent:

1. Table of Acceptance Criteria and Reported Device Performance

Note: For this type of submission, "acceptance criteria" are implicitly met by demonstrating conformance to recognized standards and achieving substantial equivalence to the predicate device for all comparative features.

2. Sample size used for the test set and the data provenance

• Not Applicable / Not Provided: This document is a 510(k) premarket notification primarily demonstrating substantial equivalence through engineering comparisons and adherence to recognized standards. It does not describe a "test set" in the sense of clinical data or performance evaluation on patient samples. The "testing" refers to verification against engineering standards.
• Data Provenance: Not applicable as no clinical data or test set in that context is discussed.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not Applicable / Not Provided: No clinical test set requiring expert-established ground truth is mentioned. The ground truth for this device's safety and effectiveness is established by its conformance to international standards and its functional equivalence to a legally marketed predicate device.

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

• Not Applicable / Not Provided: No test set or adjudication process is described.

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 / Not Provided: This device is a contrast delivery system, not an AI-powered diagnostic tool. Therefore, an MRMC study related to human reader performance with or without AI assistance is entirely irrelevant and not performed.

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

• Not Applicable / Not Provided: This is a mechanical/electronic medical device for injecting contrast. It does not have an "algorithm only" performance or a human-in-the-loop component in the context of an AI device. Its performance is assessed by its mechanical and electronic functions meeting specified parameters and safety standards.

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

• Engineering Standards and Predicate Performance: For this device, the "ground truth" for its safety and effectiveness is primarily its adherence to recognized international safety and performance standards (IEC, ISO) and its documented functional equivalence to the legally marketed predicate device. There is no clinical "ground truth" (like pathology or outcomes data) presented for this type of submission.

8. The sample size for the training set

• Not Applicable / Not Provided: This device is not an AI/machine learning product; it does not have a "training set."

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

• Not Applicable / Not Provided: As there is no training set, this question is not applicable.

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