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510(k) Data Aggregation
(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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