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The 3S INJECTOR - CT is an intravascular injection system intended for the administration of ionic and non-ionic contrast media used in conjunction with computed x-ray tomography (CT).
The 3S INJECTOR - CT is intended for the administration of contrast media into patients for diagnostic x-ray studies.

The Nemoto 3S Injector- CT is an auto injector system developed to meet the needs of physicians and provide accurate and steady injection rate, time, volume and enhanced safety. The 3S Injector - CT is an intravascular injection system intended for the administration of ionic and non-ionic contrast media used in conjunction with computed x-ray tomography (CT). The Injector system is composed of three main components: the master control and display unit, the injector head and a remote Control unit. The Iniector's master control unit uses function kevs and can store up to 20 protocols. The 3S INJECTOR - CT is designed for single- use, disposable svringes of 100ml and 200ml. The single-use svringes are manufactured of polypropylene, have the same intended use and perform similarly to those of predicate devices.

The provided text describes a 510(k) submission for the NEMOTO 3S INJECTOR- CT CONTRAST DELIVERY SYSTEM. This document focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study to prove acceptance criteria with specific performance metrics.

Therefore, many of the requested sections (e.g., acceptance criteria table with reported performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth details for training and test sets) cannot be extracted from this document, as it is not a clinical study report.

Here's a breakdown of what can be gleaned from the provided text regarding the closest relevant information:

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

The document does not provide a table of acceptance criteria with specific performance metrics or a study demonstrating direct adherence to such criteria. Instead, it states:

• "Laboratory testing reqarding the performance of the Nemoto 3S Injector- CT has been conducted to verify its safety, function and electromagnetic compatibility."
• "A biocompatibility assessment was performed on syringe materials following international standards with satisfactory results."

This indicates that internal testing was conducted, but no specific performance values or acceptance criteria are detailed.

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

Not applicable. This document refers to laboratory and biocompatibility testing, not a clinical study with a test set of patient data.

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)

Not applicable. This document describes pre-market notification for a medical device (an injector), which relies on laboratory testing and comparison to existing predicate devices, not on expert-adjudicated ground truth from a clinical dataset.

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

Not applicable. See #3.

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 device is an injector, not an AI or imaging diagnostic tool that would typically be subject to MRMC studies.

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

Not applicable. This is not an algorithm.

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

Not applicable. For a device like an injector, "ground truth" would relate to its engineering specifications, safety, and functionality (e.g., flow rate accuracy, pressure limits, material biocompatibility), which were assessed through laboratory and biocompatibility testing, not clinical ground truth from patient data.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable. See #8.

Summary of available information:

The document is a 510(k) summary for a medical device, the Nemoto 3S Injector- CT Contrast Delivery System. Its purpose is to demonstrate substantial equivalence to legally marketed predicate devices.

• Acceptance Criteria & Performance: The document states that "Laboratory testing regarding the performance of the Nemoto 3S Injector- CT has been conducted to verify its safety, function and electromagnetic compatibility." It also mentions a "biocompatibility assessment... following international standards with satisfactory results." However, no specific performance metrics or detailed acceptance criteria are provided in the summary.
• Study Type: The submission relies on laboratory testing and a comparison of technological characteristics to predicate devices (Medrad MCT, Medrad MCT Plus, CT 9000 Injector, PercuPump 1A) to establish substantial equivalence. It is not a clinical study involving human subjects or image interpretation.
• Predicate Device Comparison: The document includes a claim that "Unimachs Corp. believes the Nemoto 3S Injector- CT is substantially equivalent to the currently marketed angiographic systems use for delivery of contrast media," and states that characteristics were compared to these predicate devices. The FDA concurred with this determination.

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