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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

Study Information

2. Sample Size Used for the Test Set and Data Provenance:

• Clinical Studies (Effectiveness & Safety):
  • MT-01 (Feasibility): 32 iTind subjects enrolled (31 completed 12-month FU), 31 completed 36-month follow-up. Data Provenance: OUS (Outside US), prospective.
  • MT-02 (Single-arm, safety/efficacy): 81 iTind subjects enrolled (70 completed 6-month FU; 67 completed 12-month FU). Data Provenance: OUS (Outside US), prospective.
  • MT-03 (Pivotal Study): 185 subjects randomized (128 iTind, 57 Sham) into the Intent-to-Treat (ITT) population. 175 actually treated (118 iTind, 57 Sham). 81 iTind subjects completed 12-month follow-up. Data Provenance: US/OUS (International), prospective.
• Bench/Non-Clinical Studies:
  • Crimping, Radial Force, Tensile Force at Break, Deployment, Dimensions: 30 systems for each test, based on ISO 2859-1 for 90% reliability and 95% confidence.
  • Corrosion Testing: 8 "final device configurations".
  • Biocompatibility, Sterility, Shelf Life, MR Compatibility: Sample sizes not explicitly stated beyond "samples" or standard testing protocols.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

• For the clinical studies (MT-01, MT-02, MT-03), the ground truth for effectiveness (IPSS, QoL, PFR, PVR, SHIM/IIEF) and safety (AEs/SAEs) was established by clinical assessments and patient-reported outcomes. This inherently involves the interpretations and diagnoses of the clinicians treating the patients in the multi-center international studies. Specific numbers and detailed qualifications of these individual clinicians (e.g., "radiologist with 10 years of experience") are not provided in the text. However, the MT-03 study was a "randomized, controlled, efficacy-assessor-blinded, multi-center, international prospective study," implying adherence to rigorous clinical study protocols and standard medical expertise.

4. Adjudication Method for the Test Set:

• The text does not explicitly detail an "adjudication method" in the sense of an independent panel reviewing individual cases for ground truth establishment.
• For the MT-03 pivotal study, it was an "efficacy-assessor-blinded" study, meaning the personnel assessing the effectiveness endpoints were unaware of the treatment arm (iTind vs. Sham). This helps prevent bias in efficacy measurement.
• Adverse Events (AEs) and Serious Adverse Events (SAEs) were reported and classified during the clinical trials, with some being "deemed possibly related" or "not related" to the device, implying a process of review and categorization by investigators.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No, an MRMC comparative effectiveness study was not done.
• The clinical studies described (MT-01, MT-02, MT-03) are trials comparing the iTind device to either baseline or a sham control (MT-03), and then comparing the results of the iTind MT-03 study with published data from the UroLift device (L.I.F.T. study). These are not MRMC studies in the context of image interpretation or diagnostic accuracy where multiple readers evaluate cases with and without AI assistance to measure reader improvement. The iTind System is a therapeutic device, not a diagnostic imaging AI.

6. Standalone (Algorithm Only Without Human-in-the Loop Performance) Study:

• Not applicable. The iTind System is a physical medical device (implant, delivery system, retrieval kit) used in a procedure by trained clinicians. It is not an algorithm or AI system that operates standalone to produce diagnostic or prognostic outputs. The performance studies are of the device itself and its clinical impact with human intervention.

7. Type of Ground Truth Used:

• Clinical Outcomes / Patient-Reported Outcomes:
  • Effectiveness: International Prostate Symptom Score (IPSS), Quality of Life (QoL) scores, maximal urinary peak flow (Qmax), post-void residual urine volume (PVR), Sexual Health Inventory for Men (SHIM), International Index of Erectile Function (IIEF). These are directly measured physiological parameters or standardized questionnaires completed by patients.
  • Safety: Incidence of adverse events (AEs) and serious adverse events (SAEs), as reported by patients and recorded by clinicians.
• Bench/Engineering Standards: For non-clinical tests, the "ground truth" or acceptance criteria are defined by established engineering standards (e.g., ISO, ASTM, USP) and specific, quantifiable physical parameters (e.g., force measurements, dimensional changes, visual inspection against a "gold standard picture").

8. Sample Size for the Training Set:

• Not applicable. The iTind System is a device, not an AI/machine learning algorithm that requires a "training set" in the computational sense. The "training" here refers to the iterative design and testing of the physical device to meet specifications.

9. How the Ground Truth for the Training Set Was Established:

• Not applicable. As above, there is no AI "training set." The performance and safety characteristics of the device were established through a combination of engineering design, bench testing (against established physical and medical standards), and extensive clinical trials with human subjects.

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