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The Syringe with Handi-Fil is part of the contrast delivery system which is designed to mject radiopaque contrast media and/or salıne into the vascular system for Angiographic or CT procedures as prescribed by qualified healthcare professionals

The proposed device is a disposable, single-use syringe, used to deliver radiographic contrast media and/or salme into a patient's vascular system for the purpose of obtaming enhanced diagnostic images The Syringe with Handi-Fil is plastic and consists of the same components as the predicate device The configuration is equivalent to other syringes already marketed by Mallinckrodt The synnge is provided to the customer packaged and sterilized. This submission covers the following devices: 150 ml syringe with Handı-Fil, 200 ml syringe with Handı-Fil.

I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance tables, study designs (sample sizes, data provenance, expert panels, adjudication methods, MRMC studies, standalone studies), or ground truth establishment. The document is a 510(k) summary for a medical device (Syringe with Handi-Fil) establishing substantial equivalence to a predicate device. It focuses on device description, intended use, and a comparison of features, not on the results of a performance study.

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The Optistar Elite Injection System is a contrast delivery system and is designed to inject MR contrast media and flushing solutions into a patient's vascular system to obtain diagnostic images when used with Magnetic Resonance Imaging equipment.

The Optistar Elite is a delivery system designed to inject image enhancing MR contrast media and flushing solutions into the vascular system for the purpose of obtaining enhanced diagnostic images. The Optistar Elite consists of 4 main components and syringes, just like the predicate device: Power Head, Console, Power Control, and Power Supply. Syringes accommodated include Mallinokrodt Optimark pre-filled syringes (10 ml, 15 ml, 20 ml, 30 ml), Mallinckrodt pre-filled saline syringes (50ml and 125 ml), and empty disposable 60 ml Mallinckrodt syringes.

The provided document is a 510(k) Summary for the Optistar Elite Injection System, which is a premarket notification to the FDA for a medical device. This type of document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone comprehensive study with detailed acceptance criteria and performance reports in the format requested.

Therefore, much of the requested information regarding detailed acceptance criteria, sample sizes for test/training sets, number and qualifications of experts for ground truth, adjudication methods, MRMC studies, or specific effect sizes from AI assistance is not present in this document. This is because the context is not a clinical trial or performance study designed to prove device efficacy against predetermined statistical thresholds for acceptance. Instead, it's about demonstrating that the new device is as safe and effective as a previously cleared device.

However, I can extract the available information to address as much of your request as possible.

Description of Acceptance Criteria and Study Findings for the Optistar Elite Injection System

The Optistar Elite Injection System's acceptance criteria and demonstrated performance are primarily evaluated through comparison to a predicate device (Optistar MR Injection System, K984088) to establish substantial equivalence. The performance testing largely focuses on verification steps against recognized standards and confirming that the new features are conveniences that do not negatively impact safety or effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

As explicit, quantifiable "acceptance criteria" are not formally presented in the same way a clinical trial would define them, the table below reflects the comparison of features and capabilities between the Optistar Elite and its predicate device. "Reported Device Performance" here refers to the capabilities and specifications listed for the Optistar Elite. The "Acceptance Criteria" implicitly are that these features are equivalent or improved without compromising safety or fundamental function compared to the predicate, especially within the expanded MR environment.

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

The document does not detail specific "test set" sample sizes in the context of clinical data for performance evaluation. The verification and validation activities mentioned are primarily engineering and software testing.

For the MR environment testing:

• Data Provenance: The Optistar LE injector (mechanically and electrically equivalent to Optistar Elite) was tested "with a variety of MR scanners from various manufacturers." The document does not specify the country of origin of this data or if it was retrospective or prospective, but the context implies prospective engineering and compatibility testing.
• Sample Size: The number of scanners or tests performed is not quantified beyond "a variety."

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

This information is not provided in the document. The testing described is technical verification and validation, not a clinical study requiring expert ground truth for diagnostic accuracy.

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

This information is not provided in the document, as it is not a clinical study based on expert interpretation of diagnostic images.

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

An MRMC study was not done, nor is there any mention of AI assistance in this medical device. The device is a power injector for contrast media, not an image analysis or diagnostic aid involving AI.

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

This concept is not applicable to this device. The Optistar Elite Injection System is a physical contrast delivery system that requires a human operator for programming and initiation. There is no "algorithm only" performance that stands alone in the way an AI diagnostic algorithm might.

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

For the software verification, "Validation testing was performed by customers on production equivalent units in simulated clinical conditions." This suggests user feedback and internal performance metrics against "defined customer needs" and "intended use" serve as a form of "ground truth" for software functionality and usability, rather than clinical ground truth like pathology for diagnostic accuracy.

For hardware performance (e.g., in the MR environment), the "ground truth" was that "the injector performed as specified, delivering accurate volume, flow and pressures" and "did not interfere with the operation of the MR systems." This implies measurement against engineering specifications and non-interference as the ground truth.

8. The sample size for the training set

This information is not applicable and therefore not provided. The device does not employ machine learning or AI that would necessitate a "training set" in the conventional sense. Software verification involved unit, integration, exploratory, and system-level testing, which are standard software development practices, not AI model training.

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

This information is not applicable and therefore not provided, as there is no training set for machine learning for this device.

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The OptiVantage DH Injector System with Enhanced Communication is a contrast delivery system and is designed to inject radiopaque contrast media into a patient's vascular system to obtain diagnostic images when used with computed tomography (i.e. "CT") equipment.

The OptiVantage DH Injector System with Enhanced Communication delivers radiographic contrast media and/or saline at a controlled flow rate and volume into a patient's vascular system for the purpose of obtaining enhanced diagnostic images. The OptiVantage DH Injector System with Enhanced Communication consists of 4 main components, just like the predicate device:

• Power Head- Contains two electromechanical syringe drive systems, the syringe holding mechanisms, the main microprocessor, control electronics, control keypad for programming and initiating injection protocols, a status display, and two purge/retract manual knobs. The OptiVantage uses a drive system that is similar to existing Mallinckrodt injectors in the marketplace. It uses a motor and gearbox coupled to a ball screw. The ball screw drives a ram that attaches to the syringe plunger in order to fill or expel the contents of the syringe.
• Power Supply- The power supply converts the line voltage to the working voltage for the power head and console (approximately 24-vdc).
• Console Communicates with the Power Head to program and initiate injection protocols, displays the injection status, and displays a timer.
• Syringes The OptiVantage DH Injector System with Enhanced Communication accommodates the Syringes - The Oper rainage styles as well as a 200 ml front loading empty syringe. These Minimonrol. I 22 million place on the market and are currently used with the predicate device.

The provided text is a 510(k) summary for the OptiVantage DH Injector System with Enhanced Communication. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria, a study proving device performance against those criteria, or details regarding sample sizes, ground truth establishment, or expert involvement for a performance study.

The document is a submission to the FDA for market clearance, focusing on demonstrating that the new device is substantially equivalent to a previously cleared predicate device (K042744). The comparison table highlights features that are identical between the new device and the predicate. The "enhancement" mentioned is an additional layer of enforcement for existing safety features, rather than a new performance characteristic requiring a new clinical performance study with acceptance criteria.

Therefore, many of the requested details about performance studies, data provenance, expert ground truth, etc., are not present in this 510(k) summary document.

Here's a breakdown of what is and is not available in the provided text:

1. Table of acceptance criteria and reported device performance:

• Not available. The document does not specify quantitative acceptance criteria (e.g., specific thresholds for flow rate accuracy or pressure limits) against which a study's results would be measured. It rather lists specifications and features that are identical to the predicate device.

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

• Not available. No performance study or test set is described.

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

• Not available. Not applicable as no performance study with ground truth establishment is described.

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

• Not available. Not applicable.

5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs. without AI assistance:

• Not applicable. This device is a power injector for contrast media, not an AI-assisted diagnostic tool for human readers.

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

• Not available. No standalone performance study is mentioned. The device's performance is implicit in its specifications, which are deemed substantially equivalent to the predicate device.

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

• Not available. Not applicable.

8. The sample size for the training set:

• Not available. Not applicable as no machine learning algorithm development is described.

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

• Not available. Not applicable.

What can be extracted from the document related to "performance" and "criteria":

The document relies on substantial equivalence to a predicate device (OptiVantage DH Power Injection System, K042744). The "acceptance criteria" are implicitly that the new device performs identically or acceptably compared to the predicate for all relevant functions.

Reported Device Performance (based on comparison to predicate):

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The OptiVantage DH Injection System is a contrast delivery system and is designed to inject radiopaque contrast media into a patient's vascular system to obtain diagnostic images when used with computed tomography (i.e. "CT") equipment.

The OptiVantage DH Injection System delivers radiographic contrast media and/or saline at a controlled flow rate and volume into a patient's vascular system for the purpose of obtaining enhanced diagnostic images. The OptiVantage is made up of the following major components:

• Power Head- Contains two electromechanical syringe drive systems, the syringe holding mechanisms, the main microprocessor, control electronics, control keypad for programming and initiating injection protocols, a status display, and two purge/retract manual knpbs. The OptiVantage uses a drive system that is similar to existing Mallinetcrodt injectors. 11he marketplace. It uses a motor and gearbox coupled to a ball screw. The ball screw drines a ram that attaches to the syringe plunger in order to fill or expel the contents of the syringe.
• Power Supply- The power supply converts the line voltage to the working voltage for the power . head and console (approximately 24-vdc).
• Console Communicates with the Power Head to program and initiate injection protocols, . displays the injection status, and displays a timer.
• Syringes The OptiVantage Injection System accommodates the Mallinckrodt 125-ml pre-filled . syringe styles and pre-filled saline syringes as well as a 200 ml front loading empty syringe. These syringes are commonplace on the market.

The provided document is a 510(k) summary for a medical device called the "OptiVantage DH Injection System." It describes the device, its intended use, and compares it to a predicate device to establish substantial equivalence.

However, this document does NOT contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria related to clinical performance, diagnostic accuracy, or similar aspects that would typically involve statistical metrics (like sensitivity, specificity, AUC) and expert review.

Instead, the document focuses on design and functional equivalence to a predicate device. The "features" table (sections 8 and 9) compares technical specifications and functionalities of the new device against the predicate. The "study" referenced implicitly in this context is the comparison to the predicate device itself, aiming to demonstrate that the new device performs similarly or offers enhancements without raising new questions of safety or effectiveness.

Therefore, many of the requested fields cannot be directly answered from the provided text because such information is not present. Here's a breakdown of what can and cannot be extracted:

1. Table of Acceptance Criteria and Reported Device Performance:

Based on the provided document, there are no explicit "acceptance criteria" in the sense of performance metrics (e.g., sensitivity, specificity, accuracy) for a diagnostic output or clinical outcome. The document focuses on demonstrating substantial equivalence to a predicate device by comparing technical features. The "acceptance criteria" can be inferred as matching or improving upon the predicate device's functional specifications without introducing new safety/effectiveness concerns.

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

• Not applicable. This document describes a 510(k) submission based on substantial equivalence to a predicate device, focusing on design and functional comparisons. It does not refer to a clinical study with a test set of data points or patients.

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. As above, no clinical test set or ground truth establishment by experts is mentioned. The ground truth for this submission is implicitly the established safety and effectiveness of the predicate device based on its design and performance.

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

• Not applicable. 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. This device is a power injector, not an AI-powered diagnostic tool. Therefore, no MRMC study or AI assistance is relevant.

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

• Not applicable. This device is hardware with software control; it's not an algorithm meant for standalone performance in the diagnostic sense. Its operation is "standalone" in that it performs its injection function without continuous human intervention during the injection process itself, once programmed. However, this is not the typical meaning of "standalone" in the context of diagnostic algorithms.

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

• The "ground truth" for this 510(k) pertains to the safety and effectiveness profile of the predicate device (CT9000ADV / OptiBolus Injection System, K031339). The new device demonstrates substantial equivalence by showing that its design, materials, and operational parameters are either identical or offer improvements that do not introduce new risks, aligning with the already-cleared predicate.

8. The sample size for the training set:

• Not applicable. This device does not use machine learning or AI models that require a training set.

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

• Not applicable. As above, there is no training set for this device.

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The CT9000ADV is designed to inject a radiopaque contrast media into a patient's vascular system, which enhances diagnostic images obtained with computed tomography (i.e. "CT"). Each injection is accomplished with a motor-driven syringe mechanism with microprocessor control of the flow rate, volume and timing.

The CT9000ADV / OptiBolus Injection System delivers radiographic contrast media at a controlled flow rate and volume into a patient's vascular system for the purpose of obtaining enhanced diagnostic images. The OptiBolus feature is used to enable an exponential decaying flow rate injection that will optimize the contrast usage and provide an extended period of uniform enhancement. The OptiBolus feature can be turned on or off by the user for any given injection protocol.

The major components of the system are:

1. Power Head- The CT 9000ADV / OptiBolus Powerhead is contained in a sturdy metal case. The Powerhead contains the operator interfaces for viewing injection information, controlling the fill and expel operation, starting and stopping an injections for enabled and injecting states and the interface for connection of the various syringes. The Powerhead communicates its gathered information to the Power Pack.
2. Power Pack- Contains the power supply and main microprocessor. The power supply converts the line voltage to the working voltage for the powerhead and console (approximately 24-vdc). The main processor provides a centralized control system for all system functions. The Powerhead and Console each contain a remote microprocessor that is used to control their localized functions.
3. Console- Communicates with the Power Pack to program and initiate injection protocols, displays the injection status, and displays an iniection timer. The Console provides the means for the operator to enable, disable and view an OptiBolus injection. The Console display provides a simulated display that represents the OptiBolus injection as it progresses.
4. Syringes- The CT9000ADV / OptiBolus Injection System accommodates the Mallinckrodt 125-ml pre-filled syringe styles. It is also accommodates the Liebel-Flarsheim 200-ml syringe. These syringes are commonplace on the market.

The provided text describes a Special 510(k) Summary for the CT9000ADV/OptiBolus Injection System. This document focuses on demonstrating substantial equivalence to a predicate device, the CT 8000 Digital Injection System, rather than presenting a study with acceptance criteria and device performance results in the context of diagnostic accuracy or clinical outcomes.

The "study" described herein is essentially a comparison and verification effort to ensure the new device functions similarly and safely to the predicate device, especially regarding its core function of injecting contrast media. The key difference highlighted is the "OptiBolus" feature for bolus shaping.

Here's an analysis based on the provided text, addressing your questions where possible:

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

The document does not explicitly state "acceptance criteria" in a quantitative, performance-metric sense often seen in diagnostic AI/image analysis studies. Instead, the acceptance is based on demonstrating substantial equivalence to the predicate device, the CT 8000 Digital Injection System, through a comparison of features and functional specifications. The "reported device performance" is essentially that the new device meets or matches the predicate device's capabilities, with the addition of the OptiBolus feature.

Here's a table summarizing the comparison, which serves as the "performance" relative to the predicate:

The primary "new performance" of the CT9000ADV/OptiBolus is its ability to perform a "bolus shaping injection" with an exponential decaying flow rate, which the predicate device did not explicitly offer. The document implies this feature functions as designed due to the overall substantial equivalence and safety of the system.

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

This type of information is not applicable to this 510(k) submission. This is a submission for an injection system, not a diagnostic algorithm or AI device that processes medical images. There is no "test set" of patient data in the sense of accuracy studies for image interpretation. The "testing" would involve engineering verification and validation of the device's mechanical and software functions. The document does not provide details on the specific sample sizes used for internal engineering tests (e.g., number of injections performed, number of devices tested), nor the provenance of such test 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)

This is not applicable. As this is an injection system, not an interpretive diagnostic device, there is no "ground truth" to be established by medical experts in the context of interpreting images or diagnosing conditions. Medical experts (e.g., radiologists) use the output of such devices (enhanced CT images) for diagnosis, but their role is not to establish "ground truth" for the device's function as an injector. The "ground truth" for an injector would be its mechanical and software precision and safety, verified through engineering tests.

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

This is not applicable. There is no "test set" requiring adjudication by multiple experts in this context.

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

This is not applicable. MRMC studies are used for evaluating diagnostic performance of image interpretation systems, often comparing human readers with and without AI assistance. This document describes an imaging injection system, not an AI-based diagnostic algorithm or an image analysis tool.

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

This is not applicable. This is a hardware device with software control, not an algorithm meant to perform a diagnostic task independently. Its "performance" is inherently tied to its interaction with a human operator for programming and monitoring, and its output (contrast injection) is then utilized by other diagnostic devices.

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

For an injection system, "ground truth" would relate to the precision of its mechanical and software functions (e.g., accurately delivering programmed flow rates and volumes, maintaining pressure limits). This "ground truth" is typically established through:

• Engineering specifications and tests: The device is designed and tested to meet specific mechanical, electrical, and software performance criteria.
• Calibration: Ensuring the device's sensors and actuators are accurate.
• Verification and validation testing: Demonstrating that the device performs its intended functions safely and effectively under various conditions.

The document does not detail the specific test methods or "ground truth" establishment for these engineering aspects, as that level of detail is typically found in design control and testing documents, not in a 510(k) summary. However, it implicitly relies on the fact that the predicate device (CT 8000) was proven safe and effective through such methods. The new features (specifically OptiBolus) would have undergone similar internal verification.

8. The sample size for the training set

This is not applicable. There is no "training set" in the context of machine learning for this device. The software controls the injection based on pre-programmed algorithms and user inputs, not on learned patterns from a dataset.

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

This is not applicable for the same reasons as point 8.

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The ELPH Injection System is a contrast delivery system which is designed to inject radiopaque contrast media into a patient's vascular system to obtain diagnostic images when used with computed tomography (i.e. "CT") equipment.

The ELPH Injection System will deliver radiographic contrast media at a controlled flow rate and volume into a patient's vascular system for the purpose of obtaining enhanced diagnostic images. The ELPH is made up of the following major components: Power Head, Power Pack, Remote Console (Optional), Syringes.

The provided document is a 510(k) summary for the ELPH Injection System. It describes the device, its intended use, and argues for its substantial equivalence to a predicate device (CT 8000 Digital Injection System, later marketed as CT 9000ADV).

However, this document does not contain acceptance criteria or detailed study information that would typically be found in a performance evaluation or clinical study report. It is a regulatory submission focused on demonstrating equivalence rather than proving performance against specific criteria through a dedicated study.

Therefore, many of your requested points cannot be answered from the provided text. The document primarily focuses on a comparison of features between the new device and the predicate device to argue for substantial equivalence.

Here's how much can be extracted from the provided text based on your request:

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

The document does not explicitly state "acceptance criteria" for the ELPH Injection System in the way a performance study would. Instead, it compares the features and performance specifications of the ELPH system to its predicate device, the CT 8000 Digital Injection System. The "reported device performance" is essentially the listed specifications for the ELPH.

Note: The "acceptance criteria" here are implied by the performance of the predicate device. The submission makes a case that the ELPH system is "less expensive, smaller and less complicated to operate" and meets "only the ordinary needs," which sometimes results in lower specifications compared to the predicate, but is still considered substantially equivalent for its intended, more focused purpose.

2. 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 document. The document presents a comparison of device features and specifications, not data from a test set or provenance of 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)

This information is not provided in the document, as it does not detail a study involving expert assessment or ground truth establishment.

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

This information is not provided in the document.

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

This information is not provided in the document. The device is an injection system, not an AI-powered diagnostic tool.

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

This information is not provided in the document. The device is a hardware injection system and does not appear to involve algorithms in the context of diagnostic performance.

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

This information is not provided in the document, as it does not detail a study where ground truth would be established for evaluating diagnostic performance.

8. The sample size for the training set

This information is not provided in the document. The device is a hardware injection system and the submission does not mention a training set in the context of machine learning.

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

This information is not provided in the document.

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The Optistar MR Injector System is intended for injecting MR contrast agents and flushing solutions for the purpose of enhancing diagnostic imaging of humans.

The Optistar MR is a contrast delivery system that is designed to inject image enhancing contrast media into the vascular system of a human during an MRI (Magnetic Resonance Imaging) procedure. The main components of the Optistar MR system are the console, power pack, and powerhead. The console resides in the control room of the MR suite, while the power pack and powerhead remain in the scanning room with the patient. The parameters of the injection, such as volume and flow rate are programmed by the operator using a touch screen on the console. The console is powered by AC line voltage at 110 Volts at 60 Hz. The console communicates with the 24 VDC powerpack which in turn supplies power and the injection parameters to the powerhead. The powerhead performs the injections by driving one or two lead screw rams. The rams push the plunger of a syringe, which expels fluid from the barrel of the syringe.

Here's a breakdown of the acceptance criteria and the study details for the Optistar MR Injector System, based on the provided document:

Acceptance Criteria and Device Performance

The document states that performance testing was conducted to verify the Optistar MR Injector System's ability to achieve its specified parameters, as outlined in the substantial equivalence chart. The "substantial equivalence chart" itself effectively serves as the acceptance criteria for various parameters by comparing the new device to the predicate device. The performance testing section then reports that the device "successfully delivered" or "fell within the specified range" for these criteria.

Study Information

The document describes "Performance Testing" to verify the device's capabilities, primarily to support the claim of substantial equivalence to the predicate device (Medrad Spectris MR Injection System K935668).

1. Sample size used for the test set and the data provenance:

   • Sample Size: Not explicitly stated. The document mentions "Over the range of volumes programmed," "During the test injections," "In all cases," "Over the range of various drip mode parameters," and "The tested speeds." This suggests that a range of parameters and configurations were tested, but no specific number of injections or test cases is provided.
   • Data Provenance: The testing was performed internally by Liebel-Flarsheim. The location is Cincinnati, OH, USA, as indicated by the company address. This is a prospective validation of the device's technical specifications.

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

   • Not applicable as this is a performance validation of a medical device's physical functions (e.g., flow rate, volume delivery), not an diagnostic imaging study requiring expert interpretation of medical images. The "ground truth" for the test set was defined by the device's design specifications and accurately measured physical quantities (e.g., actual delivered volume, measured flow rate, actual pressure).

3. Adjudication method for the test set:

   • Not applicable. This was a physical performance test, not a subjective assessment requiring adjudication. Measurements were taken and compared against specifications.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done:

   • No, an MRMC study was not done. This study is a performance validation of the injector system's mechanical and software functions (flow, volume, pressure, etc.), not a diagnostic imaging study involving human readers and AI for image interpretation.

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

   • Yes, implicitly. The performance testing described is a standalone evaluation of the device's mechanical and software performance against its specifications, without a human operator's "performance" being part of the primary measured outcome (beyond programming the desired parameters). The device's ability to inject as programmed is the focus.

6. The type of ground truth used:

   • Defined Performance Specifications / Measured Physical Quantities: The ground truth was established by the design specifications of the device for parameters like volume, flow rate, pressure limits, and speeds. The "truth" for the comparison was then actual physical measurements taken during the tests (e.g., measured volume, calculated flow rate, physical pressure readings).

7. The sample size for the training set:

   • Not applicable. This is not a machine learning model, so there is no training set. The device operates based on programmed logic and physical mechanisms.

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

   • Not applicable, as there is no training set for this type of device validation.

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The Angiomat Illumena is designed to inject a radiopaque contrast medium into the vascular system for Angiographic or CT procedures as prescribed by qualified health care professionals.

The Angiomat Illumena is designed to inject a radiopaque contrast medium into the vascular system for Angiographic or CT procedures as prescribed by qualified health care professionals. The system is designed to be configured as cither an Angiographic injector or as a CT injector.

The system includes a microprocessor controlled DC servo motor which drives a lead serve ram against the piston of a single use syringe. The operation of the servo is programmed by the operator using a touch screen on an electroluments on display. The system is powered by AC line voltage at 100 Volts, 130 Volts, or 240 Volts. System power is less than 1500 Walls.

A typical Angiomat Illumena system includes a power pack, console, powerhead, syringe holder assembly, ac power cable assembly, start cable assembly, and console cable assembly. Other options include ECCG trigger systems, syringe heater, air detection and warning system, pedestal mounting system. wall/rack/ceiling mounting systems, interface cabling, powerhead and console extension cabling. Start switch variations, and printer system.

The system is designed to deliver contrast from either a prefilled syringe or an unfilled wringe which is filled at the start of the procedure. A reusable, sterilizable syringe is also available.

The system will interface with an X-ray system allowing either the start of injection initiated by the X-ray system or start of X-ray initiated by the injector.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Angiomat Illumena Injector:

Note: The provided document is a 510(k) summary for a medical device. This type of document focuses on demonstrating substantial equivalence to predicate devices rather than deeply detailed, statistically rigorous clinical trials common for novel devices or software. As such, some of the requested information (like specific sample sizes for test sets, the number of experts for ground truth, or MRMC studies) is not typically included in this type of submission and is therefore not present in the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by the device's ability to perform "to specification within ranges equivalent to the predicate devices with accuracy and precision superior to the predicate devices." The performance reported is that the device meets these specifications.

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

• Sample Size: Not explicitly stated in terms of number of injections or individual tests. The document refers to "a comprehensive set of tests" and "tests were performed using extremes of operating parameters."
• Data Provenance: The tests directly involve the physical device (Angiomat Illumena Injector) delivering water. This implies the data is prospective as it's generated during the testing phase of the new device. The country of origin for the testing is not specified, but given the company's address and the FDA 510(k) submission, it would likely be in the United States.

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

• Number of Experts: Not applicable. The "ground truth" for these performance tests is based on direct physical measurements using calibrated equipment (e.g., for volume, pressure, time) and comparison against the device's own specifications and programmed parameters. There are no human "experts" establishing a subjective ground truth for these engineering performance metrics.
• Qualifications of Experts: N/A.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. The "adjudication" is based on objective measurements from calibrated equipment compared against predefined specifications. These are not subjective assessments requiring multiple reviewers.

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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is an injector, not an imaging analysis or diagnostic AI tool. Its performance is measured by its mechanical and electronic accuracy in delivering contrast medium, not its impact on human reader interpretation of medical images.

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

• Standalone Performance: Yes, the described performance tests essentially are standalone performance tests. The device's ability to accurately deliver programmed flow, volume, and pressure is evaluated directly, without a human operator's influence on the measured output (beyond programming the device). The tests verify the device's inherent mechanical and electronic accuracy.

7. The Type of Ground Truth Used

• Type of Ground Truth: The ground truth used for these performance tests is objective physical measurement derived from calibrated reference equipment. For example:
  • For volume accuracy: Measured delivered volume using calibrated equipment.
  • For pressure accuracy: Measured back pressure using calibrated equipment.
  • For flow rate accuracy: Verification of algorithms, timing with measurement equipment, and measured delivered volume over time using calibrated equipment.

8. The Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This device is a hardware injector with embedded software for control, not a machine learning or AI algorithm that "trains" on data in the conventional sense. The "training" for such a system would involve engineering design, calibration, and iterative development rather than a dataset of clinical cases with established ground truth.

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

• Ground Truth for Training Set: Not applicable. As mentioned above, this is not an AI/ML device that uses a "training set" with ground truth in the typical sense. The "ground truth" for its development would be based on engineering specifications, physical laws, and performance requirements derived from its intended use and predicate devices.

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