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2 Way SoftSimplastic Catheters:

Indicated where routine transurethral drainage of the bladder is required either postoperatively or for patients with conditions requiring transurethral urine drainage.

3 Way SoftSimplastic Catheters:

Indicated where routine transurethral drainage of the bladder is required either postoperatively, for patients with conditions requiring transurethral urine drainage and for patients requiring bladder irrigation.

The Rusch SoftSimplastic Foley Catheter is a balloon retention type catheter and is single use, disposable and sterile. The catheters are made of transparent PVC. They have a 2 lumen or 3 lumen shaft with proximal funnel, inflation valve and a distal retaining balloon made of latex. Balloon capacity is in ml and the shaft size in French gauge (Fr.) as indicated on the funnel of each individual catheter.

The provided text describes a 510(k) premarket notification for a medical device, the Rusch SoftSimplastic Foley Catheter, not an AI/ML medical device. Therefore, the information required to answer the prompt regarding acceptance criteria and studies for an AI/ML device (e.g., sample size for test/training sets, expert qualifications, ground truth establishment, MRMC studies) is not present in the document.

The document focuses on demonstrating substantial equivalence to a predicate device (Rusch Simplastic Foley Catheters) based on:

• Intended Use: Similar indications for use for bladder drainage and irrigation.
• Technological Characteristics: Similar balloon retention type, materials (PVC), sizes, lumens, sterilization method, single-use, and radiopacity. The key differences highlighted are a change in PVC plasticizer, extended shelf life, and slightly different size ranges.
• Non-Clinical Performance Testing: This includes:
  • Biocompatibility testing (e.g., cytotoxicity, sensitization, systemic toxicity, implantation) according to ISO 10993 standards.
  • Bench performance testing (e.g., visual inspections, strength, connector security, balloon safety, flow rate, kink stability, tensile force, radiopacity) according to ISO 20696, ASTM F623, and ASTM F640 standards.
  • Sterilization and Packaging validation according to ISO 11135-1, ISO 10993-7, ISO 11607, ASTM D4169, ASTM F1886, ASTM F88, EN 868-5, and ASTM F2096.

The document explicitly states: "Differences in technological characteristics between the subject and predicate devices do not raise different questions of safety and effectiveness." and "Performance test results demonstrate that the subject device is as safe and effective as the predicate device."

Therefore, I cannot provide the requested information regarding acceptance criteria and studies for an AI/ML device based on the provided text. The document pertains to a traditional medical device demonstrating substantial equivalence through non-clinical bench and biocompatibility testing, not an AI/ML algorithm requiring clinical performance studies against defined ground truth with human reader involvement.

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