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The Standard Catheter Set is indicated for use to provide access to tumor sites for treatment of any case where high dose rate irradiation is an accepted clinical practice.

The Standard Catheter Set (AL1311XXXX) is designed as an applicator for intraluminal Brachytherapy. The Standard Catheters are 4.7 French (1.6 mm in diameter) PTFE (Polytetrafluroethalene) catheters, which are supplied in nominal lengths of 100cm and 150cm with either a metal tip or plastic tip. The catheters can be readily inserted into small lumen. The metal tip catheter is sealed at the distal end with a small tungsten pluq for easy visualization under fluoroscopy. The distal end of the plastic catheter is tightly sealed to prevent body fluids from entering the lumen or extension of the source wire beyond the tip. The catheters are shipped with a pin plug in the open end to keep the lumen clean and to keep the opening round. The applicator acts to guide the radioactive source to the correct location or locations for treatment.

The provided document describes a 510(k) premarket notification for the "Standard Catheter Set" by Varian Medical Systems, Inc. This submission focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical performance data.

Here's a breakdown of the acceptance criteria and study information, based on the provided text:

Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" in a quantitative sense for clinical or algorithm performance. Instead, it details various non-clinical tests conducted to support substantial equivalence and safety. The acceptance criteria are implicitly met by successfully passing these tests, indicating the device performs as intended and is safe.

Specific quantitative thresholds for "acceptance" (e.g., maximum allowable cytotoxic response, specific log reduction in microbial load) are not detailed in this summary document but would have been part of the full test reports referenced. The general statement is that the results support the safety and effectiveness and that the device performs as well as or better than the predicate device.

Study Details

The provided document describes the evaluation of a medical device (Standard Catheter Set), not an AI algorithm. Therefore, many of the typical AI-specific questions are not applicable.

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: Not applicable. The studies described are non-clinical, involving physical device testing (biocompatibility, sterilization, mechanical properties) rather than a "test set" of patient data for an algorithm.
   • Data Provenance: Not applicable in the context of patient data. The tests were performed in a laboratory/testing environment on device samples.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable as there is no "test set" of patient data requiring expert ground truth or an AI algorithm being evaluated. The evaluations were performed by laboratories/personnel competent in the specific types of non-clinical tests (e.g., biocompatibility specialists, sterilization validation experts).

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not applicable. This is not a study involving human reader interpretation or annotation of data.

4. 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. This is a medical device (catheter) submission, not an AI or software product.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • No. This is a medical device (catheter) submission, not an AI or software product. The document explicitly states: "This item is not applicable to the subject device; the device does not contain or consist of software/firmware." (page 9)

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   • Not applicable in the context of an AI algorithm. For non-clinical tests, "ground truth" would correspond to established scientific principles, regulatory standards (e.g., ISO 10993-1 for biocompatibility), and established test methods, with results assessed against predefined acceptance criteria from these standards.

7. The sample size for the training set:

   • Not applicable. This is not an AI or software product.

8. How the ground truth for the training set was established:

   • Not applicable. This is not an AI or software product.

In summary, the provided information pertains to the premarket notification of a physical medical device (Standard Catheter Set) and its equivalence to a predicate device, focusing on non-clinical performance data to establish safety and effectiveness. It does not involve AI or clinical performance studies with patient data, hence many of the requested AI-specific details are not applicable.

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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

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.

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