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The inFlow Intraurethral Valve-Pump and Activator is a replaceable urinary prosthesis that is intended for use in female patients 18 years of age or older who have incomplete bladder emptying due to impaired detrusor contractility of neurologic origin, and who are capable of operating it in accordance with instructions or who have trained caregivers. The device must be replaced every 29 days (or less).

The inFlow Intraurethral Valve-Pump and Activator is a system that is designed for the management of impaired detrusor contractility in adult females, and consists of the following three components:

• inFlow device: This is the primary component of the system (Figure 1). The inFlow device is a temporary (≤ 29 days) urethral insert, consisting of a silicone (b)(4) TS/CCI which (b)(4) TS/CCl and an internal valve and pump mechanism. This insert is available in multiple shaft lengths selected based on the length of the female urethra. The distal end of the device has six flexible fins to retain the tip of the device at the bladder neck and minimize expulsion. The proximal end of the device has a flange that rests against the urethral meatus to prevent migration into the bladder. The inFlow device is labeled to be replaced every 29 days (or less). It is mounted on and inserted with the aid of a disposable "Introducer" , and is removed by manually pulling the proximal flange.
• Activator: The Activator is a battery-powered (b)(4) TS/CCI handheld remote control, which, when held close to the patient's pubic region and turned ON, magnetically actuates (rotates) the internal inFlow pump mechanism to transfer urine out of the bladder. After voiding, the Activator closes an internal magnetic valve to block urine flow. When not in use, a protective shield covers the Activator's magnet to minimize interference. This component only contacts the patient's hand.
• Sizing Device: To determine the proper inFlow device size to use in a given patient, the physician uses a separately-packaged Sizing Device. The Sizing Device is a single-use device that is inserted into the urethra to measure the distance between the bladder neck and urethral meatus. This component is constructed from a (b)(4) TS/CCl This component contacts the patient's intact urethra mucosa for a maximum of several minutes.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Bench Tests:

Clinical Study (Effectiveness):

2. Sample Sizes and Data Provenance

Bench Tests: Sample sizes were described as "justified" but specific numbers are redact (b)(4). The data provenance is internal laboratory testing ("These tests were conducted on final versions of the device (or final subassemblies).").

Clinical Study:

• Total enrolled: 273 female subjects at 18 sites (15 U.S., 2 Canada & 1 Israel).
• Original protocol: 88 subjects enrolled.
• Amended protocol: 185 subjects enrolled.
• Evaluable subjects for effectiveness analysis: 115 (those with PVR data for both baseline and treatment periods).
• Subjects completing the treatment phase: 77 (28 from original protocol, 49 from amended protocol).
• Subjects for secondary effectiveness (IQOL) analysis: 85 (evaluable subjects with both baseline and treatment IQOL data).
• Data Provenance: Prospective, single-arm, cross-over study conducted under IDE G970029, involving multiple clinical sites across the U.S., Canada, and Israel.

3. Number of Experts and Qualifications for Ground Truth (Clinical)

The text does not explicitly state the "number of experts" used to establish ground truth for the clinical study's objective measurements (like PVR or adverse events). These are typically quantitative measures or direct observations by clinical staff. For more subjective assessments like adverse event classification or quality of life questionnaires, the study design relies on standardized protocols and validated instruments (e.g., IQOL questionnaire validated by Wagner et al., 1996) rather than individual expert adjudication of ground truth for each case. The study was overseen by healthcare professionals at 18 clinical sites.

4. Adjudication Method for the Clinical Test Set

The document does not describe a formal "adjudication method" (like 2+1 or 3+1 reviewer consensus) for the clinical data collected. Clinical trial data, especially for objective endpoints like PVR and adverse events, are typically recorded directly by study personnel (physicians, nurses, coordinators) according to predefined protocols. Adverse events are often classified and reported based on investigator judgment and severity scales, then reviewed by ethics committees and the sponsor. The IQOL questionnaire is a self-reported measure.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly mentioned or described. The clinical study was a single-arm, cross-over study comparing the inFlow device to the standard of care (clean intermittent catheterization, CIC) within the same patients. It did not involve multiple human readers interpreting cases with and without AI assistance (the inFlow device is a medical device, not an AI diagnostic tool). Therefore, there is no effect size of how much human readers improve with AI vs. without AI assistance.

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

The device is not an AI algorithm in the context of diagnostic or interpretive software. It is a physical medical device. The "standalone" performance is assessed through the comprehensive bench testing (e.g., flow rate, endurance, magnetic field levels) and the primary effectiveness endpoint of the clinical study (PVR reduction), where its performance is measured directly. Human interaction is required for insertion/removal and activation, but its core function (pumping urine) is mechanical.

7. Type of Ground Truth Used (Clinical)

• Primary Effectiveness (PVR): The ground truth for bladder emptying effectiveness was the Post-Void Residual (PVR) urine volume, which is an objective, quantitative measurement typically obtained via ultrasound or catheterization. "Success" was defined as PVR < 50 cc or lower than with CIC.
• Secondary Effectiveness (IQOL): The ground truth for quality of life was patient-reported outcomes via the validated Incontinence-related Quality of Life questionnaire (IQOL).
• Safety: Ground truth for safety was based on observed and reported adverse events by clinical staff and subjects, along with objective findings from cystoscopy examinations.

8. Sample Size for the Training Set

The concept of a "training set" is not applicable here as the inFlow device is a physical medical device, not a machine learning model. Therefore, there is no AI algorithm training set. Its design and development involved engineering principles and iterative testing, not data-driven machine learning training.

9. How the Ground Truth for the Training Set was Established

As there is no training set for an AI algorithm (see point 8), this question is not applicable. The device's design and performance were established through non-clinical (bench) testing and a pivotal clinical study.

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