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The contrast delivery system Dual Shot Alpha 7 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).

The contrast delivery system ~ Dual Shot Alpha 7 is an angiographic injector that is used in conjunction with Computed Tomography, and is intended for use by doctors, radiology technologists and other licensed medical practitioners. This device is designed to be used in conjunction with various injection methods of contrast media and saline, and utilized with multi-slice CT scanners. The Dual Shot Alpha 7 has two driving mechanisms to deliver contrast media and/or saline, each side A and B respectively are capable of utilizing either a 100mL or 200mL size syringe. Syringes are connected to the patient via an intravascular catheter. The Dual Shot Alpha 7 consists following components; Injector Powerhead, Console, and optional Hand Switch.

The medical device, "Contrast Delivery System - Dual Shot Alpha 7" by Nemoto Kyorindo Co., Ltd., is an angiographic injector intended for the administration of ionic and non-ionic contrast media and saline in conjunction with computed X-ray tomography (CT).

Here's an analysis of its acceptance criteria and the study proving it meets them:

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

The provided document describes the "Special 510(k) SUMMARY" for the Dual Shot Alpha 7, which establishes substantial equivalence to a predicate device (Dual Shot Alpha K062168 and K071691). The study proving the device meets acceptance criteria is a compliance study with recognized international and European standards for medical devices, rather than a clinical effectiveness study.

The document states: "The contrast delivery system Dual Shot Alpha 7 has been tested in conformance with the following recognized standards, and is substantially equivalent to the predicate device Dual Shot Alpha." This implies that a series of tests and evaluations were conducted to demonstrate the device's adherence to the specified standards listed in the table above.

Key Information Requirements and Their Details:

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

   • This information is not provided in the summary. The "test set" here refers to the performance of the physical device against engineering and safety standards. Details on the specific number of devices tested, samples of injection cycles, or environmental testing conditions are not disclosed.
   • The data provenance is not specified beyond the manufacturer being based in Saitama, Japan.

2. 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 is not applicable to this submission. The "ground truth" in this context is the adherence to engineering specifications and safety standards, which would be verified by internal testing personnel, qualified engineers, and potentially third-party testing labs, not medical experts establishing diagnostic ground truth from images.

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

   • This information is not applicable to this type of device and submission. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies for diagnostic accuracy, where multiple readers evaluate medical images against a consensus or pathological truth. This submission focuses on engineering and regulatory compliance.

4. If a multi-reader multicase (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, an MRMC comparative effectiveness study was not done. This device is a contrast delivery system (an angiographic injector), not an AI-powered diagnostic tool. Therefore, the concept of human readers improving with AI assistance is not relevant.

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

   • No, a standalone algorithm performance study was not done. This device is a hardware system with embedded software, not a standalone algorithm for image analysis or diagnosis. Its performance is evaluated in terms of its mechanical, electrical, and software compliance, not "algorithm-only" performance as understood in AI/ML medical devices.

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

   • The "ground truth" for this device's performance directly relates to its adherence to the specified recognized standards (EN 60601-1, EN 60601-1-2, EN 60601-1-6, EN 62304, EN 62366, EN 1041, EN ISO13485, EN ISO14971). This "ground truth" is established through objective measurements, calibration, and engineering tests to verify parameters like flow rate accuracy, pressure limits, software functionality, electrical safety, usability engineering principles, and risk management processes. It is based on predefined technical specifications and regulatory requirements, not medical diagnostic outcomes.

7. The sample size for the training set:

   • This information is not provided and is not applicable in the context of this device. The phrase "training set" is typically used for machine learning models. The software in this device would have undergone traditional software development lifecycle verification and validation, not machine learning model training.

8. How the ground truth for the training set was established:

   • This information is not applicable as there is no "training set" in the machine learning sense for this device. The software development process would involve requirements definition, design specification, implementation, and rigorous testing against those specifications, which serve as the "ground truth" for software functionality.

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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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