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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 PRESS DUO elite is intended to be used for injecting contrast media and common flushing solution into the vascular system in Angiographic and Computed Tomography (CT) procedures whereas the PRESS DUO elite AG is intended to be used for injecting contrast media and common flushing solution into the vascular system for Angiographic procedures only.

The main components of the PRESS DUO elite and PRESS DUO elite AG are the Console, Powerhead and Main Control Unit. The basic confiqurations of the PRESS DUO elite and PRESS DUO elite AG are a pedestal, ceiling mount or table mount configuration. With any configuration, the three main components are most often contained in the angiographic suite and normally near the patient. The parameters of the injection, such as volume, flow rate and pressure are programmed by the graphical user interface with touchscreen input. The system is designed to deliver a variety of injection protocols. It can deliver single or multiple phase injections. The Console is powered via 24 volts DC which is derived from a remote AC to DC converter (like that used with laptop computers) and communicates with Main Control Unit communications interface cable. After the injection protocol has been set, the Powerhead performs the injection by driving the lead screw ram. The ram pushes the push-rod of the syringe which expels fluid from the barrel of the syringe. The only difference between the PRESS DUO elite and PRESS DUO elite AG is the availability of the CT Mode. The PRESS DUO elite provides both an Angiographic Mode and CT Mode of operation whereas the PRESS DUO elite AG has the CT Mode of operation turned off in the software and cannot be turned on by the user. All other software, hardware and mechanical aspects of the PRESS DUO elite and PRESS DUO elite AG are identical.

The provided text describes the Nemoto Kyorindo Co., Ltd.'s PRESS DUO elite and PRESS DUO elite AG contrast delivery systems and their clearance through the FDA 510(k) process. This is a medical device, and the information available focuses on demonstrating substantial equivalence to predicate devices and performance testing to meet specifications, rather than clinical efficacy studies often associated with AI/ML devices. Therefore, many of the requested points related to AI/ML studies (like MRMC studies, training/test set sample sizes with ground truth, expert opinions for ground truth, etc.) are not applicable here.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The submission claims the device met specifications, but specific quantitative acceptance criteria for each measurement are not explicitly listed as numerical targets. Instead, the document states that tests verified the device's ability to "accurately achieve these the substantial equivalence claims" and that "all pressure readings were within the allowable specifications," "flow rate measured within the allowable ranges of the specification," and "successfully delivered the volumes within the allowable specifications."

The table below summarizes the claimed performance relative to the specifications mentioned in the "SUMMARY OF PERFORMANCE TESTING" section. It's important to note that the specific numerical thresholds for "allowable specifications" are not provided in this document.

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

• Sample Size: "a single unit of the justification for testing only a single unit is based upon our long history of the PRESS DUO in the Japanese market."
• Data Provenance: The justification references "our long history of the PRESS DUO in the Japanese market for approximately 5 years," implying previous market experience. The testing itself was performed on a prototype, but the location of this specific performance testing is not explicitly stated, although the company is based in Tokyo, Japan. The mention of "prototype device" suggests the testing was likely prospective for this specific submission, even if drawing on prior experience.

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

• Not applicable. This is a contrast delivery system, not an AI/ML device requiring expert ground truth for image or clinical interpretation. Performance testing involved direct measurement of physical parameters like volume, flow rate, and pressure.

4. Adjudication method for the test set

• Not applicable. As above, this is performance testing of a physical device, not an AI/ML diagnostic or prognostic tool requiring adjudication of clinical interpretations.

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 for injecting contrast media, not an AI-assisted diagnostic or prognostic tool.

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

• Not applicable. This is a medical device, not an algorithm. The performance testing was for the device itself.

7. The type of ground truth used

• The ground truth for the performance testing was based on direct physical measurements of the device's output (flow rate, volume, pressure, manual speeds) compared against pre-defined engineering specifications. This is a form of engineering ground truth.

8. The sample size for the training set

• Not applicable. This device does not involve a training set in the context of AI/ML or statistical modeling. The "long history of the PRESS DUO in the Japanese market for approximately 5 years" provides historical data and experience, but not a "training set" in the computational sense.

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

• Not applicable, as there is no training set in the AI/ML context.

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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 REMPRESS is an intravascular injection system intended for the administration of contrast media or normal saline used in conjunction with angiographic imaging procedures.

The main components of the REMPRESS are the Console, Powerhead and Main Control Unit. The configurations of the REMPRESS are a pedestal or table mount configuration. The three main components are possible in the angiographic suite and normally in close proximity to the patient. The parameters of the injection, such as volume, flow rate and pressure are programmed by the operator via the graphical user interface with touchscreen input. The Console is powered via 24 volts DC which is derived from a remote AC to DC converter (similar to that integrated in a laptop computer). The Console communicates with Main Control Unit communications interface cable. After the injection protocol has been set, the Powerhead performs the injection via the contribution of the lead screw ram. The ram pushes the push-rod of the syringe which expels fluid from the barrel of the syringe.

The provided text describes the Nemoto Kyorindo Co., Ltd. REMPRESS Contrast Delivery System and details its technical characteristics in comparison to predicate devices, along with some information about performance testing. However, it does not contain a detailed study proving device acceptance criteria in the format requested. Specifically, the document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a full clinical or performance study with detailed acceptance criteria and validation results as a standalone study might.

Here's a breakdown of the available information and what is missing from the provided text based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document implicitly defines "acceptance criteria" by stating that performance testing was completed to verify the new device's ability to perform within its "specificated" parameters, aligning with the substantial equivalence chart. It claims the system "successfully delivered the volumes within the allowable specifications" and that measured pressures and speeds "were within the allowable specifications." However, the specific numerical limits or ranges for these "allowable specifications" are not explicitly stated as acceptance criteria.

The following table summarizes what can be inferred for "acceptance criteria" from the provided text and the general performance statements:

What's Missing:

• Specific quantitative acceptance criteria (e.g., "Volume must be within ±X% of programmed volume," "Flow rate must be within Y ml/s," "Pressure must be within Z PSI"). The text only refers to "allowable specifications" without defining them.

2. Sample Size for the Test Set and Data Provenance

Missing. The document mentions "During testing" for volume, flow rate, pressure, and manual control speeds, but it does not specify the sample size for any of these tests (e.g., number of injections, number of devices tested). It also does not state the data provenance (e.g., country of origin, retrospective or prospective).

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not Applicable (or Missing). This information is typically relevant for studies involving qualitative assessments or diagnoses (e.g., medical imaging interpretation). For a device like a contrast injector, "ground truth" is established through direct physical measurements of objective technical parameters (volume, flow rate, pressure, speed) using calibrated equipment. It does not involve human expert interpretation in the same way.

4. Adjudication Method for the Test Set

Not Applicable. As "ground truth" is established by direct measurement of physical parameters, there is no expert adjudication process in this context.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. The provided text describes performance testing for a medical device (contrast injector), which focuses on engineering specifications and physical performance. MRMC studies are typically used for diagnostic devices where human readers interpret medical images. This document does not describe such a study.

6. Standalone Performance Study

Yes, implied. The "SUMMARY OF PERFORMANCE TESTING" section describes tests conducted on the REMPRESS device itself to verify its performance against "specificated parameters." This constitutes standalone testing of the algorithm (or, in this case, the device's operational capabilities) as it evaluates the device's output independently, not in conjunction with human performance.

7. Type of Ground Truth Used

The ground truth for the performance testing of the REMPRESS device was established through objective physical measurements using instruments to assess parameters like:

• Fluid volume delivered (compared to programmed volume).
• Flow rate (calculated from recorded volume and injection time).
• Pressure (monitored during injections).
• Manual (ram) control speeds.

8. Sample Size for the Training Set

Not applicable (or Missing). The REMPRESS is a mechanical/electronic device, not an AI/machine learning algorithm that requires a "training set" in the conventional sense. Performance testing validates the device's operational parameters rather than training a model.

9. How Ground Truth for the Training Set Was Established

Not applicable. As a non-AI device, there is no "training set" for which ground truth would be established.

In summary: The provided document is a 510(k) summary, which aims to demonstrate substantial equivalence through technical comparisons and a high-level summary of performance testing. It lacks the granular detail of a full study report that would typically include specific acceptance criteria, comprehensive methodology (including sample sizes and data provenance), and detailed results. The device's "performance is deemed acceptable and substantially equivalent to the predicate devices" based on the unspecified "allowable specifications."

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The contrast delivery system Sonic Shot GX is an intravascular injection system intended for the administration of MRI contrast media and normal saline solution used in conjunction with magnetic resonance imaging (MRI).

The contrast delivery system Sonic Shot GX is an intravascular injection system intended for the administration of MRI contrast media and saline used in conjunction with MRI.

The main components of the Sonic Shot GX are the Console, Powerhead and Main Control Unit. The Console resides in the control room or the MR suite, while the Main Unit and Powerhead reside in the scanning room alongside the MR scanning device and the patient. The parameters of the injection, such as volume, flow rate and pressure are programmed by the operator via the graphical user interface with touchscreen input. The Console is powered via 24 volts DC which is derived from a remote AC to DC converter (similar to that used with laptop computers) and communicates with Main Control Unit via a fiber-optic interface. The communication link is used to communicate the user set injection parameters to the Main Control and Powerhead located in the MR suite.

After the injection protocol has been set, the Powerhead performs the injection by driving one or two lead screw rams. The rams push the syringe which expels fluid from the barrel of the syringe.

The provided document describes a contrast delivery system (Sonic Shot GX) and primarily focuses on its substantial equivalence to predicate devices, rather than a detailed study report for meeting acceptance criteria of an AI/ML powered medical device. Therefore, much of the requested information (like sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, and ground truth for AI models) is not applicable or not present in the provided text, as the device is a hardware injector, not an AI system.

However, I can extract information related to the performance testing done to verify the system meets its specifications.

Here's a breakdown of the available information:

1. Acceptance Criteria and Reported Device Performance

The "Summary of Performance Testing" section describes that the device must be capable of achieving "specification parameters for the system as outlined in the substantial equivalence chart." The "Performed Testing" section describes how the device meets those specifications.

Note: The document refers to "allowable specifications" and "allowable ranges," implying specific numerical thresholds, but these thresholds are not explicitly stated in the provided text.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not specified. The document states "During testing" or "Over the range of volumes programmed" but does not provide specific numbers of tests or injections performed.
• Data Provenance: Not specified, but given the manufacturer is Nemoto Kyorindo Co., Ltd. in Japan, it is highly likely the testing was conducted in Japan. The testing described is prospective, as it involves actively performing injections and measuring parameters.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This information is not applicable as the device is a contrast delivery system (hardware), not an AI/ML-driven diagnostic or interpretative device that requires expert-established ground truth for its performance. The "ground truth" here is the physical measurement of fluid dynamics and pressure, compared against engineered specifications.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as above. The performance evaluation relies on objective physical measurements against engineering specifications, not subjective expert judgment requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This information is not applicable. The Sonic Shot GX is a hardware device for injecting contrast media, not a system that assists human readers in interpreting medical images. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This information is not applicable. The Sonic Shot GX is a mechanical injector. Its performance is measured as a standalone system (it delivers fluid autonomously once programmed), but it does not have an "algorithm-only" performance in the context of AI/ML or image interpretation. Its performance is its standalone mechanical and electronic function.

7. The Type of Ground Truth Used

The "ground truth" for the performance testing of the Sonic Shot GX involves objective physical measurements of:

• Delivered volume
• Measured flow rate
• Actual pressure
• Drip mode increments and intervals
• Manual control speeds

These measurements are compared against the engineering specifications defined for the device.

8. The Sample Size for the Training Set

This information is not applicable. The Sonic Shot GX is not an AI/ML device that requires a training set. Its functionality is based on pre-programmed logic and mechanical engineering, not learned patterns from data.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reason as above.

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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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The Dual Shot – Contrast Delivery System 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).

DUAL SHOT - CONTRAST DELIVERY SYSTEM 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-slice CT scanners. The DUAL SHOT 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 50mL syringes capable for saline flush injection. Syringes are connected to the patient via an intravascular catheter. DUAL SHOT consists following components; Injector head, Console, Power Supply, Options (Hand Switch).

The Nemoto Kyorindo DUAL SHOT - CONTRAST DELIVERY SYSTEM is an intravascular injection system designed for administering ionic and non-ionic contrast media and saline during computed X-ray tomography (CT) procedures. The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than detailing extensive clinical trials or performance studies with specific statistical acceptance criteria for diagnostic accuracy.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document explicitly states: "No performance standards have been established for Angiographic injectors under section 514 of the FD&C Act." Therefore, there isn't a table of specific performance acceptance criteria. Instead, the device's acceptability is based on conformance to recognized safety and quality standards and demonstrating substantial equivalence to a predicate device through feature comparison.

The "reported device performance" in this context refers to the device meeting general safety and electrical standards, and its functional specifications being comparable to the predicate.

• IEC60601-1 (1988) Medical Electrical Equipment, Part 1: General Requirements for Safety
• IEC60601-1-1 (2000) Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems
• IEC60601-1-2 (2001) Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility -Requirements and tests
• IEC60601-1-4 (1996) Medical electrical equipment - Part 1-4: General requirements for safety - Collateral Standard: Programmable electrical medical systems |
  | Quality Management System: | Conformance to ISO13485 (2003) Medical devices - Quality management systems - Requirements for regulatory purposes |
  | Risk Management: | Conformance to ISO14971 (2000) Medical devices - Application of risk management to medical devices |
  | Functional Equivalence to Predicate Device: | The device's features (Intended Use, Syringe System, Flow Rate, Pressure Limit, etc.) were compared to the Stellant CT Injector System (K023183 and K033881) and found to be "the same or substantially equivalent materials and technology." Specific differences and similarities are listed in the comparison table, but these are for demonstrating equivalence, not for meeting pre-defined performance thresholds. |
  | Biocompatibility: | Not applicable/not performed as the device does not include a sterile syringe. |

2. Sample Size Used for the Test Set and Data Provenance:

The document does not describe a clinical study with a "test set" in the context of diagnostic accuracy or a similar performance metric. The "testing" referred to is against electrical, safety, and quality standards in a laboratory setting. Therefore, information about test set sample size, data provenance, or retrospective/prospective nature is not provided because such a study was not conducted or required for this type of submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

This information is also not applicable. As explained above, there isn't a "test set" for which ground truth would need to be established by experts for diagnostic or similar performance evaluation. The device's safety and functionality were assessed against engineering and electrical standards.

4. Adjudication Method for the Test Set:

Not applicable, as there was no test set requiring expert adjudication for performance evaluation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:

No, an MRMC comparative effectiveness study was not done. The document does not mention any studies evaluating human reader performance with or without AI assistance, as the device is an Angiographic injector, not an AI-powered diagnostic algorithm.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:

No, a standalone algorithm performance study was not done. The device is a physical medical device (an injector), not an algorithm or AI system.

7. The Type of Ground Truth Used:

The concept of "ground truth" as typically used in the context of diagnostic performance (e.g., pathology, outcomes data, expert consensus) is not directly applicable here. The "truth" for this device's evaluation largely refers to conformance to the specified engineering, safety, and quality standards (e.g., did it meet the described voltage tolerances, did it operate within specified flow rates, etc.).

8. The Sample Size for the Training Set:

Not applicable. The DUAL SHOT - CONTRAST DELIVERY SYSTEM is a hardware device, not a machine learning model, so there is no "training set."

9. How the Ground Truth for the Training Set was Established:

Not applicable. There is no training set for this device.

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