(158 days)
Used for remote afterloading of a radiation source. To be used with the Varian VariSource Remote High Dose Rate Afterloader system, supplied by Varian Oncology Systems of Palo Alto, California.
The VRAC High Dose Rate (HDR) Remote Afterloading Catheter is a 4.6 French , 150cm 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 Varian VariSource Remote High Dose Rate Afterloader manufactured by Varian Oncology Systems, Palo Alto, California.
Here's an analysis of the provided text regarding the acceptance criteria and study for the HDR Applicator Catheter:
Lack of Specific AI/Machine Learning Information:
It's important to note that the provided text is a 510(k) Premarket Notification document from 1998. This predates the widespread use of AI/Machine Learning in medical devices for diagnostic or interpretive purposes as we understand it today. Therefore, the document does not discuss AI/ML specific acceptance criteria, studies, or performance metrics like sensitivity, specificity, AUC, human-in-the-loop performance, or the other AI/ML-centric points you've requested.
The document focuses on the physical and functional safety and effectiveness of a medical device (a catheter) through traditional engineering and biocompatibility testing, with the primary goal of demonstrating substantial equivalence to existing predicate devices.
Interpretation based on the provided text:
Given the context, I will provide the information requested where applicable, interpreting "acceptance criteria" and "study" in the traditional sense of medical device validation for this older, non-AI device. For items related to AI/ML or human interpretation, I will explicitly state that the information is not present in the provided document.
Acceptance Criteria and Study for the HDR Applicator Catheter
The VRAC High Dose Rate (HDR) Remote Afterloading Catheter's acceptance criteria and the studies proving it meets these criteria are centered around its physical integrity, functionality, and biocompatibility. The primary goal of the submission was to demonstrate substantial equivalence to legally marketed predicate devices, meaning its performance characteristics are similar enough not to raise new questions of safety or effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Evaluation | Reported Device Performance (Summary) |
|---|---|---|
| Functional Performance | Co-Efficient of Friction Comparison/Simulated Use | Assured reliable design and performance under specified parameters. Details not provided, but implies the catheter can be inserted and operated as intended without excessive friction or damage. |
| Physical Integrity | Tensile Strength | Assured reliable design and performance under specified parameters. Details not provided, but implies appropriate strength for intended use without breakage. |
| Safety - Fluid Barrier | Ingress of Fluids | Assured reliable design and performance under specified parameters. Details not provided, but implies the catheter prevents fluid ingress into critical areas during use. |
| Safety - Biocompatibility | Biocompatibility | Assured reliability. Details not provided, but implies the materials are safe for patient contact and do not cause adverse biological reactions. |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify the exact sample sizes (N numbers) for each individual test (Co-Efficient of Friction, Tensile Strength, Ingress of Fluids, Biocompatibility). The tests are typically performed on a statistically relevant number of device units according to internal quality procedures and industry standards for medical device testing, but these numbers are not detailed in this 510(k) summary.
The data provenance is from internal testing conducted by COOK INCORPORATED, the device manufacturer. The tests described are laboratory-based, non-clinical evaluations. There is no mention of human clinical data or geographical origin of such data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This question is not applicable to the provided document. The "ground truth" for these types of engineering and biocompatibility tests is established through objective measurements against predetermined specifications and adherence to recognized testing standards (e.g., ISO for biocompatibility). There are no "experts" establishing a ground truth in the context of diagnostic interpretation or clinical outcomes for this submission.
4. Adjudication Method for the Test Set
This question is not applicable to the provided document. Adjudication methods like 2+1 or 3+1 refer to agreement among human readers or experts, typically for image interpretation or clinical decision-making, which is not part of this device's validation. The testing described involves objective, measurable physical and chemical properties.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The provided information pertains to the physical and functional characteristics of a medical catheter, not to an AI-assisted diagnostic or interpretive device. The concept of "AI assistance" or "human reader improvement with AI" is not relevant to this 1998 medical device submission.
6. If a Standalone (i.e. algorithm only, without human-in-the-loop performance) Was Done
No, a standalone (algorithm only) performance study was not done. This device is a physical catheter, not an algorithm. Its performance is evaluated through material science, engineering, and biocompatibility testing.
7. The Type of Ground Truth Used
The "ground truth" for the tests described is based on:
- Engineering Specifications: Predetermined performance limits and tolerances for parameters like tensile strength and coefficient of friction.
- Industry Standards: Compliance with established standards for medical device materials and safety (e.g., ISO standards for biocompatibility).
- Predicate Device Characteristics: The performance of the predicate devices implicitly sets a benchmark for acceptable performance.
This is not expert consensus, pathology, or outcomes data in the clinical sense.
8. The Sample Size for the Training Set
This question is not applicable. There is no "training set" as this device is not an AI/Machine Learning algorithm.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable. There is no "training set" or "ground truth" establishment in the context of AI/ML for this device.
§ 892.5700 Remote controlled radionuclide applicator system.
(a)
Identification. A remote controlled radionuclide applicator system is an electromechanical or pneumatic device intended to enable an operator to apply, by remote control, a radionuclide source into the body or to the surface of the body for radiation therapy. This generic type of device may include patient and equipment supports, component parts, treatment planning computer programs, and accessories.(b)
Classification. Class II.