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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.

Device Description

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.

AI/ML Overview

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.

Feature	Acceptance Criteria (Implied by Predicate - CT 8000)	Reported Device Performance (ELPH)
Multi-phasic Injections	4 phases per protocol	Single phase
Protocol Storage	12 protocols	1 protocol
X-ray Scan Delay Timer	99 seconds	Manual, 20 minutes
Syringe Sizes	Mallinckrodt 125-ml; Liebel-Flarsheim 200-ml	Mallinckrodt 125-ml; 130-ml (L-F # 600172)
Syringe Drive System	Electromechanical	Electromechanical
Syringe Heater	Yes	No
Syringe Fill Rate	2 to 15-ml/sec	1 to 8-ml/sec
Flow Rate	0.1 to 8-ml/sec	0.1 to 6-ml/sec
Max Pressure Limit	300 psi	250 psi
Pressure Limit Control	User settable	Automatic based on flow rate
Flushing System	Manual	Manual; Automatic with interface option
Remote Start	Yes	Yes
Display Technology	LCD	LED
Program Memory	Yes	Yes
Number of Control Panel Buttons	8	5
Post Injection Readout	Yes	Yes
Printer Option	Yes	No
Interface	Relays & Optical Couplings	Relays & Optical Couplings
Safety Stop Mechanism	Electrical Stop when injection parameters are out of spec.	Electrical Stop when injection parameters are out of spec.
Remote Control	Yes	Yes
Fill/Expel Control	Push buttons on Power Head and Manual Knob	Purge/Retract trigger
Programming Injections	Buttons on Console	Buttons on Console and Powerhead
Volume Remaining Display	Display on Powerhead and Console	Display on Powerhead and Console
Materials	Plastic and metal	Plastic and metal
Anatomical Injection Site	Injection into venous system	Injection into venous system
Function and Purpose	Injection of X-ray contrast agents for enhanced diagnostic CT imaging	Injection of X-ray contrast agents and flushing solutions for enhancing diagnostic imaging
Target Population	Humans	Humans
Sterility (Syringe)	Injectors not sterile, Syringes/Disposables sterile	Injectors not sterile, Syringes/Disposables sterile

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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