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100 mL/200 mL Syringe: The Disposable Syringe (Kit) (100 mL or 200 mL Syringe for the injection of contrast media orsaline for CT and MR imaging, for use on Nemoto injectors. 150 mL Syringe: The Disposable Syringe (Kit) (150 mL Syringe for the injection of contrast media or saline forangiography. for use on Nemoto injectors. J-Tube: J-Tube is to aid in transferring a media from its container (typically a vial or bottle) into the barrel of the Disposable Syringe (Kit). Extension Tubes: The Extension Tube is to provide a connection between the syringe barrel and the needle or catheter into the patient.

The "Disposable Syringe (Kit)" (Subject Device) is specifically designed for use with the Nemoto power injection systems marketed and sold in the USA using 510(k) references K133189, K071691, K173450, K092896, K091734. The Subject Device is a package provided to the end user that contains one or two plastic syringes, plastic tubing used for connecting syringe to needle or catheter (Extension Tubing) and a plastic J-shaped tube for transferring contrast media or physiological saline into the plastic syringe (J-Tube). The Subject Device, in accordance with the Indications for Use, may be used in conjunction with CT or MRI applications or in conjunction with angiographic applications. The key difference in the application as it relates to the Subject Device is the pressure required and the flow rates required for the Subject Device. The Subject Device when used for the CT and MRI applications must support a maximum pressure of 300PSI and a maximum flow rate of 10mL/second. The Subject Device when used for the angiographic applications must support a maximum pressure of 1200PSI and a maximum flow rate of 30ml/second. The maximum values related to the application are controlled by the Nemoto power injection system which are fully described in the aforementioned 510(k)s.

The provided text is a 510(k) summary for a medical device (Disposable Syringe (Kit)) and does not contain information about an AI/ML device. Therefore, the questions related to AI/ML device acceptance criteria and study details cannot be answered based on the provided input.

However, I can provide a summary of the non-clinical performance data presented for the Disposable Syringe (Kit), which demonstrates it meets its acceptance criteria based on established standards.

Non-Clinical Performance Data for Nemoto Disposable Syringe (Kit)

The Nemoto Disposable Syringe (Kit) underwent extensive non-clinical testing to demonstrate substantial equivalence to its predicate devices. The device passed numerous tests in accordance with internal requirements, national standards, and international standards.

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size for Test Set and Data Provenance:
The document does not specify the sample sizes used for each non-clinical test. The tests are general performance and materials tests, not based on patient data.

3. Number of Experts and Qualifications for Ground Truth:
Not applicable. These are non-clinical engineering and laboratory tests, not clinical studies requiring expert ground truth for interpretation.

4. Adjudication Method:
Not applicable. This is not a clinical study.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This is not an AI-assisted diagnostic device.

6. Standalone (Algorithm Only) Performance Study:
Not applicable. This is a physical medical device.

7. Type of Ground Truth Used:
For the non-clinical tests, the "ground truth" is defined by the specific parameters and thresholds set by the relevant ISO standards (e.g., ISO 10993, ISO 7886-1, ISO 8536-9, ISO 80369-7) and internal requirements. These standards specify acceptable limits for various properties like cytotoxicity, leakage, tensile strength, and dimensions.

8. Sample Size for Training Set:
Not applicable. This is a physical medical device, not an AI/ML system requiring a training set.

9. How Ground Truth for Training Set Was Established:
Not applicable.

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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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