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510(k) Data Aggregation
(85 days)
The MEDRAD Mark 7 Arterion Injection System is intended to be used specifically for the purposes of injecting contrast medium and common flushing solutions into humans for angiographic studies.
The MEDRAD Arterion Mark 7 is a software controlled medical device used to inject contrast agents from a 150ml disposable syringe. Commonly referred to as a powered injector it is designed to allow a user to fill a disposable syringe, and perform an injection with a preprogrammed volume and flow rate. The Arterion consists of three basic components or modules: a Power Unit, Display Control Unit (DCU), and an injector head.
This submission describes a medical device, the MEDRAD Mark 7 Arterion Injection System, which is a powered injector for contrast media. The provided document is a 510(k) summary and related FDA correspondence, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study report as would be found in a primary clinical trial or performance study report.
Based on the provided text, the device is an injection system, not an AI-powered diagnostic device, therefore, many of the requested categories related to AI performance metrics, ground truth, and expert evaluation are not directly applicable.
Here's an analysis of the provided information relative to your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria in a table format with corresponding performance results. Instead, it lists various types of performance data bench and laboratory testing that were performed to support substantial equivalence. The "performance" in this context refers to the device's operational characteristics and safety, not diagnostic accuracy.
| Category of Testing | Reported Performance (Type of Conclusion) |
|---|---|
| Biocompatibility of Disposables | Testing included Cytotoxicity (ISO 10993-5), Intracutaneous Reactivity (ISO 10993-10), Sensitization (ISO 10993-10), Acute Systemic Toxicity (ISO 10993-11), Material Mediated Pyrogen (ISO 10993-11), Physiochemical (ISO 10993-18), and Hemocompatibility. |
| Conclusion: Results provide assurance that the proposed device conforms to the requirements for its intended use and is substantially equivalent. | |
| Device Operational Characteristics | Performed to ensure the device functions as intended. |
| Conclusion: Results provide assurance that the proposed device conforms to the requirements for its intended use and is substantially equivalent. | |
| Fluid Delivery Testing | Performed to ensure accurate and consistent delivery of contrast and flushing solutions. |
| Conclusion: Results provide assurance that the proposed device conforms to the requirements for its intended use and is substantially equivalent. | |
| Human Factors Engineering | Performed to ensure safe and effective interaction between users and the device. |
| Conclusion: Results provide assurance that the proposed device conforms to the requirements for its intended use and is substantially equivalent. | |
| Electrical Design Element Testing | Performed to ensure electrical safety and performance. |
| Conclusion: Results provide assurance that the proposed device conforms to the requirements for its intended use and is substantially equivalent. | |
| Mechanical Design Element Testing | Performed to ensure mechanical integrity and performance. |
| Conclusion: Results provide assurance that the proposed device conforms to the requirements for its intended use and is substantially equivalent. | |
| Software Verification/Validation | Performed to ensure software functions correctly and reliably. |
| Conclusion: Results provide assurance that the proposed device conforms to the requirements for its intended use and is substantially equivalent. | |
| Overall Substantial Equivalence | The MEDRAD Mark 7 Arterion Injection System is considered substantially equivalent to the predicate devices based on similarities in functional design, materials, indication for use, fundamental technology, and principles of operation. |
2. Sample Size Used for the Test Set and Data Provenance
Given that this is a hardware device (injector) with software control, the "test set" does not refer to a set of medical images or patient data in the way it would for an AI diagnostic device. Instead, "testing" refers to various engineering and biocompatibility tests.
- The document does not specify sample sizes for any of the listed tests (e.g., how many disposable units were tested for biocompatibility, how many injection cycles were performed for fluid delivery testing, etc.).
- Data Provenance: The nature of these tests means they are typically performed in a controlled laboratory setting (bench testing) by the manufacturer. The document does not specify country of origin for the data or whether the tests were retrospective or prospective; these terms are less applicable to engineering verification and validation testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This question is not applicable. The device is not an AI diagnostic tool and does not generate "ground truth" through expert interpretation. The "ground truth" for its performance would be engineering specifications, established safety standards (like ISO 10993 for biocompatibility), and regulatory requirements.
4. Adjudication Method for the Test Set
This question is not applicable. There is no expert adjudication process for assessing the performance of this type of medical device in the context of this 510(k) summary. Performance is assessed against engineering specifications and regulatory standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
This question is not applicable. An MRMC study is relevant for AI diagnostic algorithms where human readers' performance is compared with and without AI assistance on a set of medical cases. This device is an injector, not a diagnostic imaging interpretation tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable. While the device has software, it is part of a complete injection system that requires human operation. "Standalone" performance in the AI context refers to an algorithm's diagnostic accuracy without human intervention, which is not relevant here. The software verification/validation ensures the software components function as designed within the system.
7. The Type of Ground Truth Used
For an injection system, "ground truth" refers to the established engineering specifications and safety standards that the device must meet.
- Engineering Specifications: E.g., precise fluid volume delivery, flow rate accuracy, pressure limits, mechanical durability, electrical safety parameters.
- Safety Standards: Such as those for biocompatibility (ISO 10993 series for disposables), electrical safety, and electromagnetic compatibility.
- The results of internal bench and laboratory testing are compared against these predetermined specifications and standards.
8. The Sample Size for the Training Set
This question is not applicable. The device is not an AI/ML model that learns from a "training set" of data. Its functionality is based on predefined programming and mechanical/electrical design, not on learned patterns from a dataset.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable for the same reason as #8. There is no training set or associated ground truth for a device of this nature.
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(134 days)
The MEDRAD Intego™ PET Infusion System is intended to deliver accurate doses of 18F Fluorodeoxyglucose (FDG) radiopharmaceuticals and commonly used flushing solutions to patients during molecular imaging (nuclear medicine) diagnostic procedures. The MEDRAD Intego™ PET Infusion System is also intended to provide effective radiation shielding to medical personnel from Fluorine-18 (18F) radiation exposure during nuclear medicine diagnostic procedures.
The MEDRAD Intego PET Infusion System is a self-contained, shielded mobile cart. FDG is stored within a shielded chamber within the body of the MEDRAD Intego PET Infusion System in a bulk container until the time of the infusion. A multi-patient Source Administration Set (SAS) is installed within the shielded chamber at the same time a new bulk container of FDG is installed. Just prior to an infusion, the MEDRAD Intego PET Infusion System measures a dosage of FDG and a volume of saline flush in the dose calibrator. Once the correct radiation level is achieved, the dose of FDG / saline is injected into the patient via a disposable patient administration set.
The MEDRAD Intego™ PET Infusion System is intended to deliver accurate doses of $^{18}$F Fluorodeoxyglucose (FDG) radiopharmaceuticals and commonly used flushing solutions to patients during molecular imaging (nuclear medicine) diagnostic procedures, and to provide effective radiation shielding to medical personnel from Fluorine-18 ($^{18}$F) radiation exposure during nuclear medicine diagnostic procedures.
Here's a breakdown of the acceptance criteria and performance, along with details from the study:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| For a typical 15 mCi infusion per patient, $^{18}$F radiation exposure for medical personnel will be less than 6 mRem finger dose and 0.3 mRem whole body dose. | The document states, "For a typical 15 mCi infusion per patient, $^{18}$F radiation exposure for medical personnel will be less than 6 mRem finger dose and 0.3 mRem whole body dose." This implies the device is designed to meet and perform within these limits. The 510(k) summary does not provide specific numerical results from a performance study for radiation exposure, but rather states this as a performance requirement that the system meets. The FDA clearance suggests this requirement was deemed met. |
| Ability to deliver $^{18}$F radiopharmaceuticals within +/- 10% of the prescribed dose and within +/- 2% of the measured dose, excluding ionization chamber calibration factor. | The document states, "Ability to deliver $^{18}$F radiopharmaceuticals within +/- 10% of the prescribed dose and within +/- 2% of the measured dose, excluding ionization chamber calibration factor." This is stated as a performance requirement that the system meets. Similar to the radiation exposure, the exact numerical results from a performance study are not explicitly provided in the summary, but its inclusion as a met requirement in the 510(k) suggests testing confirmed this. |
| Flexibility to program the required dose either by activity only or by activity per patient weight. | The document describes this as a functional capability: "Flexibility to program the required dose either by activity only or by activity per patient weight." This is a design feature/functionality rather than a quantifiable performance metric that needs a numerical "reported performance" value. The device's design is assumed to incorporate this flexibility. |
| Capability to retain and print infusion history and dispensing records. | The document describes this as a functional capability: "Capability to retain and print infusion history and dispensing records." This is a design feature/functionality and not a quantifiable performance metric requiring a numerical "reported performance" value. The device is expected to have this capability built-in. |
Regarding the study that proves the device meets the acceptance criteria:
The provided 510(k) summary does not detail the specific studies, methodologies, or results that prove these acceptance criteria were met. Instead, it states them as "performance requirements" that the system "meets." In a 510(k) submission, the manufacturer is expected to have conducted these studies, and the FDA's clearance (as indicated by the letter) means they have accepted the manufacturer's data showing the device meets these performance specifications. However, the summary itself doesn't provide the study specifics.
Therefore, for the following points, based solely on the provided text, the answer is that this information is not detailed in the 510(k) summary.
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 510(k) summary. Performance testing for medical devices, particularly for dispensing accuracy and radiation shielding, typically involves laboratory evaluations and may include animal or simulated human studies, but the specifics are absent here.
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 for this type of device. The "ground truth" for an infusion system like this would be established through precise physical measurements (e.g., activity measurements using calibrated equipment, radiation dosimetry readings). It does not involve expert interpretation of images or clinical data.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable for this type of device. Adjudication methods are typically used in studies involving human interpretation or clinical endpoints that require consensus.
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 infusion system, 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 applicable. This device is a physical infusion system, not a standalone algorithm. Its performance is measured by its physical operation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the dose accuracy, the ground truth would be established by controlled measurements using highly calibrated reference instruments (e.g., dose calibrators, mass scales for volume) to verify the actual dispensed amount against the programmed/prescribed amount. For radiation shielding, the ground truth would be established by dosimetry measurements using calibrated radiation detectors to quantify exposure levels.
8. The sample size for the training set:
Not applicable. This device does not use machine learning or AI that requires a "training set." Its operation is based on established physical and engineering principles.
9. How the ground truth for the training set was established:
Not applicable, as there is no "training set" for this device.
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