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Injector: Administration of contrast and flushing media in conjunction with computed tomography (CT) scanning of the body with an optional interface to a CT scanner
EDA: The Extravasation Detection Accessory is indicated for the detection of extravasations of contrast media during CT using a power injector.

The EmpowerCT and EmpowerCTA Injector Systems have been modified for a software change only specific to the Empower Remote Control. They have been modified to add an optional calculator for glomerular filtration rate (GFR). This optional calculator is used as an additional screening tool for the use of a CT contrast injection in conjunction with a CT scan. This calculator does not affect the safety or efficacy of the device. Nor does it affect the indications for use of the system.

The provided document describes a Special 510(k) submission for a software change to the EmpowerCT and EmpowerCTA Injector Systems, specifically adding an optional calculator for glomerular filtration rate (GFR). The core functionality of the injector systems (contrast and flushing media administration in CT scanning) remains unchanged.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state "acceptance criteria" in a separate section for the GFR calculator. Instead, it focuses on demonstrating substantial equivalence to the predicate device, highlighting that the core injector performance metrics remain the same. The "Performance (Injector)" table compares the proposed device with the currently marketed device. Since the modification is only a software change for an optional GFR calculator, and "This calculator does not affect the safety or efficacy of the device. Nor does it affect the indications for use of the system," the implied acceptance criterion for the injector system performance is:

• The performance of the injector system (flow rate, delivery volume, maximum pressure) must be identical to the predicate widely marketed device.

For the GFR calculator itself: The document states, "This calculator does not affect the safety or efficacy of the device. Nor does it affect the indications for use of the system." This suggests that a specific clinical validation study for the GFR calculator's accuracy or impact on patient outcomes was not required for this 510(k) submission, as it's presented as an "optional calculator" that is an "additional screening tool" without affecting the device's fundamental function, safety, or efficacy. Therefore, there are no reported performance metrics for the GFR calculator and no specific acceptance criteria cited for it. The primary acceptance criterion for the overall device's performance is its equivalence to the predicate.

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

• The document describes a software modification to an existing injector system (adding a GFR calculator). It explicitly states that the modification "does not affect the safety or efficacy of the device. Nor does it affect the indications for use of the system."
• There is no mention of a clinical test set or data for the GFR calculator or the injector system itself in the provided text. The submission relies on comparative data to predicate devices and likely non-clinical (e.g., software verification and validation, electrical safety, EMC testing, etc.) testing, which is not detailed in this summary for the GFR calculator. The core injector performance described above is based on the established performance of the predicate devices.

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

• Not applicable. There is no mention of a test set requiring expert-established ground truth within this summary.

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

• Not applicable. There is no mention of a test set or adjudication process within this summary.

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 system with an optional GFR calculator, not an AI-assisted diagnostic imaging tool that would typically undergo an MRMC study.

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

• While the GFR calculator is an "algorithm only," the summary does not include any standalone performance study data (e.g., accuracy against a gold standard for GFR calculation) in terms of its output. The submission focuses on its nature as an "optional calculator" that does not impact the device's fundamental safety or efficacy.

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

• Not applicable. The document does not describe studies that would require establishing a ground truth of this nature. The GFR calculator would typically use standard clinical formulas, but no validation against a ground truth for its accuracy is discussed here.

8. The sample size for the training set:

• Not applicable. There is no mention of a training set, as the GFR calculator is likely based on established medical formulas, not a machine learning model trained on a dataset.

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

• Not applicable. See point 8.

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EmpowerMR: Vascular administration of contrast media and flushing media in conjunction with magnetic resonance (MR) imaging.

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I am sorry, but the provided text only contains an FDA 510(k) clearance letter for the "E-Z-EM EmpowerMR Injector System and Fastload MR Syringe Pack." It describes the device's indications for use and states that it has been found substantially equivalent to a predicate device.

However, the document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications as requested in your prompt. Therefore, I cannot generate the detailed response you are looking for based solely on this document.

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The EmpowerCTA Injector system is intended for the vascular administration of contrast and flushing media and the EmpowerCT Injector system is intended for vascular administration of contrast. Both injector systems are used in conjunction with computed tomography (CT) scanning of the body with an optional interface to a CT scanner.

The EmpowerCT and EmpowerCTA Injector Systems are currently marketed as injection systems that use one or two consumable syringe(s) to displace contrast media and flushing media (EmpowerCTA only) to the patient. A motor driven linear actuator mechanism controls displacement of the syringe piston.

The currently marketed injector systems consist of four components. These include the Injector, Remote Control, EDA and Power Supply.

Consistent with currently marketed devices, the proposed device will allow the user to administer the contrast media to the patient by specifying the following variables at the remote control.

Volume- Volume is selectable from 1 ml to 200 ml in 1 ml increments.
Flow Rate- Flow rates are selectable from 0.1 to 10 ml/sec in increments of 0.1ml/sec.
Pressure- Maximum syringe pressure is selectable from 40-300 psi in increments of 1 psi

The provided text is a 510(k) summary for a medical device (EmpowerCT/EmpowerCTA Injector System) and focuses on comparing the modified device to its predicate devices for substantial equivalence. It does not contain information about acceptance criteria or a study proving that the device meets those criteria, as typically found in clinical trial reports or validation studies.

Here's a breakdown of what can be extracted and what is missing based on your request:

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

The document provides performance specifications for the injector systems, which can be considered acceptance criteria based on their current marketing status and regulatory approval. However, it does not explicitly present these as "acceptance criteria" against which a new study's results are being compared to prove the device meets them. Instead, it describes "Proposed Devices" and "Currently marketed devices" with identical performance specifications, indicating that the modification (connectivity) does not alter these core performance aspects.

Missing Information (Not Available in the Provided Text):

The document describes a special 510(k) submission for a device modification (adding scanner connectivity) to a previously cleared device. It establishes substantial equivalence by demonstrating that the performance characteristics of the modified device are identical to the predicate device, except for the new connectivity feature. It does not present a new study with explicit acceptance criteria and corresponding results proving the device meets those criteria for the entire device system in the context of this submission. The focus is on the impact of the modification.

Therefore, the following points cannot be answered from the provided text:

• Sample sized used for the test set and the data provenance
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts
• Adjudication method
• 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
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
• The type of ground truth used
• The sample size for the training set
• How the ground truth for the training set was established

Summary of what is present:

The document is a regulatory submission demonstrating substantial equivalence for a modification to an existing device. It highlights that the core performance parameters (flow rate, volume, pressure) remain the same as the predicate devices, and the modification is primarily related to connectivity. Therefore, it relies on the previously established performance of the predicate devices rather than presenting new studies to re-prove these fundamental aspects.

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The E-Z-EM ENDOSCOPIC CO2 REGULATOR is designed to use CO2 as a distention media in the gastrointestinal tract when used in conjunction with a gastrointestinal endoscope.

The ENDOSCOPIC CO2 REGULATOR allows the physician to modulate and control the CO2 to the patient in an identical manner to that being done currently with room air which is supplied by an air pump in the Light Source of the Endoscopic equipment.

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This document is a 510(k) clearance letter from the FDA for the E-Z-EM Endoscopic CO2 Regulator. It is not a study report and therefore does not contain the information requested in your prompt regarding acceptance criteria, device performance, or details of a study.

The document primarily states that the device is substantially equivalent to legally marketed predicate devices and can therefore be marketed. It includes the indications for use but no technical specifications or performance data from a study.

Therefore, I cannot provide the requested table and study details based on the provided text.

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The Empower Transfer Set is intended to deliver fluid (contrast media or saline) from a container into a CT power Injector syringe.

The Empower Transfer Set is a disposable set used to transfer contrast media or saline from a container that can be spiked to a CT power Injector syringe.

This document is a 510(k) summary for the E-Z-EM Empower Transfer Set, seeking clearance for a medical device. It does not contain information about studies or acceptance criteria for device performance in the way a clinical or AI performance study would.

Therefore, I cannot extract the requested information as it is not present in the provided text. The document focuses on regulatory compliance, device description, and comparison to a predicate device, not on analytical or clinical performance studies with specific acceptance criteria and detailed study designs.

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CT Injector: Administration of contrast and flushing media in conjunction with computed tomography (CT) scanning of the body.
EDA: The Extravasation Detection Accessory is indicated for the detection of extravasations of contrast media during CT using a power injector.

The EmpowerCTA Injector System is an injection system that uses one or two consumable syringe(s) to displace contrast media and flushing media to the patient. A motor driven linear actuator controls displacement of the syringe piston. This method of contrast injection is consistent with predicate devices from E-Z-EM for over 12 years. This new version of the EmpowerCT Injector family addresses the addition of a second syringe for the device for purposes of displacing flushing media.

This document is a 510(k) premarket notification for the E-Z-EM EmpowerCTA Injector System with Optional EDA. It demonstrates substantial equivalence to a predicate device, the E-Z-EM EmpowerCT Injector System (K011160). It is not a study report for an AI/ML device evaluating acceptance criteria through a clinical trial with human readers or AI standalone performance. Therefore, most of the requested information regarding acceptance criteria, study design, and AI performance metrics is not applicable.

However, I can extract information related to the device's technical specifications and how its performance is compared to the predicate device to establish substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) for a device modification and not an AI/ML device with clinical performance endpoints, "acceptance criteria" here refers to the performance specifications demonstrating substantial equivalence to the predicate device. The document explicitly outlines the performance characteristics of the proposed device and compares them to the predicate.

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 applicable as this is a 510(k) submission for a medical device injector system, not an AI/ML diagnostic or prognostic device that typically relies on clinical test sets with patient data. The "testing" referred to here is primarily engineering verification and validation against technical specifications and predicate device performance, not a clinical study on a patient population.

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. Ground truth, in the context of clinical expert consensus for image interpretation or diagnosis, is not relevant for this device's 510(k) submission. The device performs automated contrast injection and extravasation detection, not diagnostic interpretation.

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

This is not applicable for the reasons stated above.

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. This document describes an automated medical device (contrast injector), not an AI-assisted diagnostic or treatment planning tool that would involve human readers.

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

This concept is not applicable in the AI/ML sense. The device itself operates "standalone" in its function of injecting contrast and detecting extravasation, but it is not an algorithm making diagnostic decisions. It performs physical and electronic functions. Performance is confirmed through engineering tests, not a "standalone algorithm" evaluation against ground truth in a clinical dataset.

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

For this device, "ground truth" would relate to the accurate measurement of physical parameters like flow rate, volume, pressure, and bio-impedance, as well as the reliable detection of simulated extravasation events in a laboratory setting. This would be established by controlled experimental setups and validated measurement equipment, rather than clinical expert consensus or pathology. The document implies that the device's performance characteristics match those of the predicate, which would have undergone similar engineering validation.

8. The sample size for the training set

This is not applicable. The device is not an AI/ML model that undergoes "training" on a dataset in the traditional sense. It is a control system with specific algorithms for injection and detection, likely developed through engineering design, mathematical modeling, and empirical testing.

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

This is not applicable as there is no "training set" in the context of AI/ML for this device.

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The E-Z-EM PROTOCO2L COLON Insufflator administers and regulates carbon dioxide (CO2) as a distention media to the colon during CT Colonography (CTC or Virtual Colonoscopy) and conventional Colonoscopy.

The EZEM PROTOCO>L with performance improvements, as with the predicate device is an insufflation system that is used in conjunction with a consumable and is intended to displace and regulate carbon dioxide (CO2) as a distention media to a patient's colon for purposes of CT Colonography and conventional colonoscopy. As with the predicate, the PROTOCO2L system with performance improvements consists of 3 components. These are the insufflator, consumable and accessory cart.

The provided document describes a 510(k) submission for the PROTOCOL™ Insufflator with Performance Improvements. This submission focuses on comparing the improved device to its predicate device to demonstrate substantial equivalence, rather than a standalone study proving novel acceptance criteria.

Therefore, many of the requested elements (like sample size for test/training sets, data provenance, number/qualification of experts, adjudication methods, MRMC studies, specific ground truth types) are NOT applicable or NOT explicitly stated in this type of regulatory submission. The document primarily highlights modifications to existing performance specifications and confirms that the indications for use remain the same.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document presents a comparison of the proposed device's performance specifications against the predicate device's specifications. The improvements themselves serve as the "acceptance criteria" for the new design, aiming to meet or exceed previous performance in specific areas while maintaining core functionalities.

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

• Not explicitly stated. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device based on design, material, and performance specifications. It does not typically include detailed study results with sample sizes for specific tests conducted on the modified device, unless a new clinical trial was deemed necessary (which appears not to be the case here, as it's a "special 510(k)"). The performance improvements are described as design changes substantiated by technical data, likely bench testing or engineering verification rather than a clinical human subject study testing the acceptance criteria.
• Data provenance: Not specified, but likely from in-house engineering and bench testing.

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

• Not applicable/Not stated. This type of information would be relevant for studies evaluating a device's diagnostic accuracy or clinical effectiveness against a gold standard, often involving expert review of images or clinical outcomes. For modifications to an insufflator that primarily affect flow, pressure, and volume delivery mechanisms, the "ground truth" is established through physical measurements and engineering standards rather than expert consensus on diagnostic images.

4. Adjudication method for the test set

• Not applicable/Not stated. Adjudication methods like 2+1 or 3+1 are used in studies where multiple experts evaluate cases and a consensus is needed to establish ground truth or resolve discrepancies in interpretations (e.g., in diagnostic AI studies). This is not relevant for the type of engineering verification demonstrated in this 510(k) submission.

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

• No. This device is an insufflator, not an AI-powered diagnostic tool. MRMC studies are used to evaluate changes in human reader performance (e.g., radiologists) when assisted by AI. This is entirely outside the scope of this device and submission.

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

• Not applicable. This question pertains to AI algorithms. The PROTOCOL™ Insufflator is a medical device for physical CO2 delivery, not an algorithm.

7. The type of ground truth used

• For the performance specifications (flow rate, pressure relief, volume delivery logic, accuracy figures), the "ground truth" would be established through engineering measurements and calibration standards. This involves using validated equipment to measure CO2 flow, pressure, and volume output from the device under specified conditions and comparing these measurements against the defined performance specifications. Compliance with international safety and EMC standards (IEC/EN60601-1, IEC/EN 60601-1-2) would also be verified through standardized testing procedures.

8. The sample size for the training set

• Not applicable. There is no "training set" in the context of this device. Training sets are relevant for machine learning algorithms, which is not what this device is.

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

• Not applicable. As stated above, this device does not involve machine learning or training sets.

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The E-Z-EM PROTOCO₂L COLON Insufflator administers and regulates carbon dioxide (CC)) as a convention The E-Z-EM PROTOCOL COLON Insultiator administers and regaller one of the research and conventional Colonoscopy.

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This document is a 510(k) clearance letter from the FDA for the E-Z-EM PROTOCO2L COLON Insufflator, dated February 19, 2002. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The letter primarily states the substantial equivalence determination for the device.

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The device is indicated for the administration of ionic and nonionic compounds in conjunction with computed tomography scanning of the body.

The extravasation detecting electrode patch element of the device is indicated for contact with intact skin and single use only.

PercuPump II with EDA (Extravasation Detection Accessory)

This document is a 510(k) clearance letter from the FDA for a medical device (PercuPump II with EDA) and an "Indications for Use" statement. It does not contain information about acceptance criteria or a study proving the device meets those criteria. The provided text is solely administrative communication regarding regulatory clearance.

Therefore, I cannot extract the requested information from the provided input.

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