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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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