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510(k) Data Aggregation
(80 days)
Used for remote afterloading of a radiation source. To be used with the GammaMed 12i Remote High Dose Rate Afterloader system, supplied by Frank Barker Associates of Tuwaco, New Jersey.
The GRAC High Dose Rate (HDR) Remote Afterloading Catheter is a 5.6 French , 129cm long, single lumen catheter. The distal end of the catheter is closed. The outside diameter of the shaft has placement markings to facilitate accurate pre-treatment positioning of the catheter. The catheter is compatible with the GammaMed 12i Remote High Dose Rate Afterloader supplied by Frank Barker Associates, of Tuwaco, New Jersey.
The provided text describes the 510(k) Premarket Notification for the GRAC High Dose Rate (HDR) Remote Afterloading Catheter. Based on the given information, here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Internal Friction Force | The device was subjected to testing for Internal Friction Force. The results "provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as a remote controlled radionuclide applicator." |
| Radiation Exposure | The device was subjected to testing for Radiation Exposure. The results "provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as a remote controlled radionuclide applicator." |
| Leak Test | The device was subjected to a Leak Test. The results "provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as a remote controlled radionuclide applicator." |
| Tensile Strength | The device was subjected to testing for Tensile Strength. The results "provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as a remote controlled radionuclide applicator." |
| Biocompatibility | The device was subjected to testing for Biocompatibility. The results "provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as a remote controlled radionuclide applicator." |
No specific quantitative or qualitative acceptance criteria thresholds are provided in the document. The document primarily states that the device 'was subjected to' these tests and the 'results provide reasonable assurance' of conformance.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature of the test data). It only lists the types of tests performed.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable as the tests conducted were physical and material property tests of the device, not an evaluation of diagnostic or treatment performance requiring expert interpretation or ground truth establishment in a clinical context.
4. Adjudication Method for the Test Set
This information is not applicable as the tests were physical and material property assessments of the device, not a clinical study requiring adjudication of expert opinions.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A multi-reader multi-case (MRMC) comparative effectiveness study was not performed, nor is it applicable to the type of device and testing described. This is a physical medical device (catheter) for remote afterloading, and the testing focused on its material properties and functional integrity, not on its diagnostic efficacy or the impact of AI on human reader performance.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
A standalone performance study in the context of an algorithm or AI is not applicable here. The device is a physical catheter, and the testing focuses on its physical and functional properties, not on an algorithm's performance.
7. Type of Ground Truth Used
The "ground truth" for the tests described would be the physical and chemical specifications and performance standards for medical device components, such as acceptable ranges for internal friction, leak rates, tensile strength, and established biocompatibility standards. These are determined by engineering and material science principles, not expert consensus or pathology in a clinical sense.
8. Sample Size for the Training Set
This information is not applicable as the device is a physical medical device undergoing direct testing, not an AI or algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as the device is a physical medical device and does not involve a training set for an algorithm.
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