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The iTind System is intended for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men age 50 and above.

The iTind System is a prescription temporary implantable transprostatic tissue retractor system and consists of the iTind System and a Retrieval Kit. The iTind System consists of an implant and a delivery system. The iTind implant is pre-mounted on a dedicated guide wire. The iTind implant is made of nitinol super elastic shape memory alloy (SMA), and biocompatible material widely used in the manufacture of medical devices. When in its folded configuration, the device is inserted through a sheath and deployed within the bladder neck and prostatic urethra where it assumes its expanded configuration at a maximum diameter of 33 mm and a length of 50 mm. When in expanded configuration, the struts of the iTind implant exert radial force outwardly on the bladder neck and prostatic urethra to push obstructive tissue away from the urinary path. The implant is designed to cover the entire length of the prostatic urethra, from the bladder neck to a point proximal to the external urinary sphincter. The iTind implant is left in position for 5–7 days. The device is subsequently removed using a sheath. The deployment and removal of the iTind implant should follow the Instructions For Use supplied by Medi-Tate and should only be attempted after the operator has been appropriately trained. The device is compatible with commercially available cystoscopes at least 19Fr in diameter.

I apologize, but the provided text from the FDA 510(k) clearance letter and summary for the Medi-Tate iTind System does not contain the information requested regarding acceptance criteria and a study proving a device meets those criteria, especially in the context of an AI/algorithm-driven device performance study.

The document describes the iTind System as a physical medical device for treating BPH symptoms. It outlines:

• Device Name: iTind System
• Regulation Number: 21 CFR § 876.5510
• Regulation Name: Temporarily-placed Urethral Opening System for Symptoms of Benign Prostatic Hyperplasia
• Regulatory Class: II
• Product Code: OKA
• Indications for Use: Treatment of symptoms due to urinary outflow obstruction secondary to BPH in men age 50 and above.
• Device Description: A temporary implant made of nitinol that exerts radial force to open the prostatic urethra.
• Performance Data: This section lists various ISO and ASTM standards for biological evaluation, packaging, and sterilization (e.g., biocompatibility, sterility, shelf-life testing). These are typical for hardware medical devices.

The document fundamentally lacks any mention of artificial intelligence (AI), algorithms, software performance, or comparative effectiveness studies involving human readers and AI assistance. Therefore, I cannot generate the table or answer the specific questions related to AI device performance, such as:

• Acceptance criteria for AI performance (e.g., sensitivity, specificity, AUC)
• Sample size for AI test sets
• Data provenance for AI studies
• Number of experts for AI ground truth
• Adjudication methods for AI ground truth
• MRMC studies for AI
• Standalone AI performance
• Ground truth type for AI (pathology, outcomes, expert consensus)
• Training set size and ground truth establishment for AI.

The information in the provided text pertains to the safety and efficacy of a physical implantable device, demonstrated through adherence to recognized medical device standards and comparison to a predicate device, not through AI performance metrics or clinical study designs involving AI.

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The iTind System is intended for the treatment of symptoms due to urinary outflow obstruction secondary to benign prostatic hyperplasia (BPH) in men age 50 and above.

The iTind System consists of the iTind implant, delivery system, and retrieval kit. The iTind implant is made of nitinol and pre-mounted on a dedicated guide wire. In its folded configuration, the implant is inserted through a cystoscope sheath and deployed within the bladder neck and prostatic urethra where it assumes its expanded configuration. When expanded, the struts of the implant exert radial force on the bladder neck and prostatic urethra, pushing obstructive tissue away from the urinary path. The implant is designed to cover the entire length of the prostatic urethra, from the bladder neck to a point proximal to the external urinary sphincter. It is left in position for 5-7 days and subsequently removed using a Foley catheter. The delivery system is used to advance the iTind implant into the bladder through a standard cystoscope. The retrieval kit (snare) is used to remove the iTind implant by inserting it through a Foley catheter and tying the retrieval suture to the snare loop.

Here's a breakdown of the iTind System's acceptance criteria and the supporting studies, based on the provided text:

Acceptance Criteria and Reported Device Performance

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