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510(k) Data Aggregation
(15 days)
The Quantum DiRex System provides diagnostic quality images to aid the physician with diagnosis. The DiRex can be used to perform radiographic exposures of the skeleton (including skull, spinal column and extremities), chest, abdomen and other body parts. The DiRex is not indicated for use in mammography.
The Quantum DiRex System is an integrated digital imaging system that combines the currently marketed Quantum Q-Rad Radiographic System with the currently marketed Agfa DX-S CR System (digitizer with NX workstation). The Quantum DiRex System is a combination of these previously cleared systems that have been combined and will be marketed as a single system.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Quantum DiRex System:
Based on the provided text, the Quantum DiRex System is an integrated digital imaging system that combines the Quantum Q-Rad Radiographic System with the Agfa DX-S CR System. The primary acceptance criteria for this submission revolve around demonstrating substantial equivalence to predicate devices and meeting pre-determined performance criteria.
Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Devices | "The Quantum DiRex System is substantially equivalent to the predicate devices and/or met pre-determined acceptance criteria." |
| Meet Pre-determined Performance Criteria | "Performance data demonstrated that the Quantum DiRex System... met pre-determined acceptance criteria." and "Performance testing was successfully completed on the proposed system in accordance with predetermined protocols based on the system design inputs." |
| Acceptable Risks | "The risks associated with use of the new device were found acceptable when evaluated by standardized risk/hazard analysis techniques." |
| Biocompatibility | "No biocompatibility testing was conducted... all patient-contacting materials... have been previously cleared for similar devices." (No new testing required as materials were pre-cleared) |
| Technological Characteristics Identity | "The technological characteristics are the same in the proposed and predicate devices." |
| Safety and Effectiveness Confirmation | "The Quantum DiRex System meets all the pre-determined acceptance criteria of the testing performed to confirm safety and effectiveness..." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify a sample size for any test set or data provenance. The descriptions are general statements about "performance data" and "performance testing."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not mention any expert review committee, experts used to establish ground truth, or their qualifications. The testing appears to be focused on technical performance and equivalence, rather than clinical efficacy studies requiring expert reader consensus on diagnostic images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not mention any adjudication method.
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, an MRMC comparative effectiveness study was not conducted. This submission is for a digital X-ray system, not an AI-powered diagnostic device, hence, there is no mention of human readers improving with AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not applicable as the device is a medical imaging system (hardware and associated software for image acquisition), not a standalone diagnostic algorithm. The performance described relates to the system's ability to produce diagnostic quality images, not an automated reading of those images.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The document does not explicitly state the type of ground truth used. Given the nature of the device (an imaging system, not a diagnostic algorithm), the "performance testing" likely involved evaluating image quality metrics, dose, system functionality, and compliance with pre-determined technical specifications (e.g., spatial resolution, contrast resolution, noise, consistency) rather than clinical ground truth diagnoses.
8. The sample size for the training set
The document does not mention a training set sample size. This is expected as the device is an imaging system, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
This question is not applicable as the device is an imaging system and not an AI/ML model requiring a training set with established ground truth.
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(55 days)
The GRIPPER PLUS™ Needle is indicated for the administration into or withdrawal of fluids from implanted ports. It is designed to help protect against exposure to bloodborne pathogens caused by accidental needlestick injuries.
The GRIPPER PLUS™ Needle is similar in design to the current GRIPPER® Needle, with the incorporation of a passive needle stick protection feature. The protection feature is made of a base and arm with a hinge on one end. As the needle is removed from a portal the hinge allows the needle to be pulled back and locked into the capture well in the base. There is an audible "click" when the needle is captured. The device is designed to help protect against exposure to bloodborne pathogens caused by accidental needlestick injuries. It does not protect against other routes of bloodborne pathogen transmission. The needle tip is fully protected after deployment of the needle stick protection feature and will not disengage with normal handling such that the needle tip becomes exposed.
The needle will be offered in various needle gauges and lengths, and with or without a slit-septum injection site cap.
The provided document describes the GRIPPER PLUS™ Needle, a medical device designed to protect against needlestick injuries. Below is an analysis of its acceptance criteria and the study used to demonstrate compliance.
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria for the GRIPPER PLUS™ Needle are primarily functional, focusing on the successful activation of the needle-stick protection feature and the biocompatibility of its components.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Needle-stick protection feature activation | Successfully activated during all attempts in simulated use testing. |
| Protection against exposure to bloodborne pathogens | Designed to help protect against exposure to bloodborne pathogens caused by accidental needlestick injuries. |
| Needle tip fully protected and will not disengage | Needle tip is fully protected after deployment and will not disengage with normal handling. |
| Function according to specifications | Functions according to specifications. |
| Biocompatibility of device components | Materials used in the device are biocompatible. |
| Acceptable for its intended use | Evaluated by healthcare professionals in simulated use and found acceptable for its intended use. |
2. Sample Size and Data Provenance for Test Set
- Sample Size: The document does not explicitly state a numerical sample size for the "simulated use test." Instead, it mentions that the device was "evaluated by health care professionals during a simulated use test."
- Data Provenance: The testing was "in-vitro testing and simulated use testing." The country of origin for the data is not explicitly stated, but the submission is to the U.S. FDA, suggesting the testing was conducted to U.S. standards. The study was retrospective in the sense that the testing was performed to support the 510(k) submission after the device's design.
3. Number of Experts and Qualifications for Ground Truth Establishment (Test Set)
- Number of Experts: The document states the device was "evaluated by health care professionals." It does not specify the exact number of professionals involved.
- Qualifications of Experts: The qualifications are broadly stated as "health care professionals." Specific expertise (e.g., years of experience, specific medical field) is not detailed.
4. Adjudication Method for the Test Set
The document does not describe a formal adjudication method (like 2+1 or 3+1 consensus). The assessment appears to be based on the direct observation and feedback from the "health care professionals" during the simulated use test, where the protection feature "successfully activated during all attempts."
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No multi-reader multi-case (MRMC) comparative effectiveness study was performed or cited. The document does not mention any comparison of human readers' performance with and without AI assistance, as AI is not a component of this device.
6. Standalone Performance Study
Yes, a standalone study was performed. The "functional testing" and "simulated use testing" evaluated the device's inherent performance. The key finding from this standalone testing was that the device's protection feature "successfully activated during all attempts."
7. Type of Ground Truth Used
The ground truth used for the acceptance criteria was primarily based on:
- Functional performance standards: The device's ability to activate its safety mechanism and protect the needle tip.
- Expert evaluation/observation: Healthcare professionals' assessment of the device's acceptability in simulated use.
- Biocompatibility testing: Laboratory results confirming material safety.
8. Sample Size for the Training Set
This device is a mechanical medical device, not an AI/machine learning algorithm. Therefore, there is no "training set" in the context of data used for algorithm development.
9. How Ground Truth for Training Set Was Established
Not applicable, as this is not an AI/machine learning device.
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