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Prolong is used as part of a climax control program for males who suffer from premature ejaculation. It is designed to increase the time between arousal and ejaculation through the use of the training sessions using the stimulating vibratory effects of the device on the penis as part of the "start-stop" technique. Prolong is intended to be available as an over-the-counter device.

The PROLONG™ device consists of the PROLONG™ vibrating device and a 4-ounce bottle of water-based lubricant. The lubricant was FDA cleared under K013086. The PROLONG™ vibrating device includes a white silicone body and a vibrator unit as shown in Figure 1. The vibrator unit comprises a 3-Volt coin (pancake) motor connected to a battery pack of two battery cells (Type PX625A) shrink wrapped together and an Acrylonitrile Butadiene Styrene (ABS) slide switch unit to activate the motor. The device should be disposed of at the end of the six week treatment.

Acceptance Criteria and Device Performance for PROLONG™

1. Table of Acceptance Criteria and Reported Device Performance

This device is not a diagnostic AI device, so the acceptance criteria are not in terms of traditional metrics like sensitivity, specificity, or accuracy. Instead, the acceptance criteria relate to safety, biocompatibility, and demonstrated effectiveness in improving time to ejaculation and patient satisfaction.

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

• Sample Size for Test Set: 33 subjects were enrolled in the clinical audit/evaluation. 23 subjects completed the full six-week treatment period and were included in the primary outcome analysis for time to ejaculation.
• Data Provenance: The data was collected from a single-site, prospective, open-label clinical audit/evaluation. The country of origin is not explicitly stated, but the contact information for Ergon Medical Ltd. is in the UK, and a European CE Mark is mentioned, suggesting the study likely took place in the UK or Europe.

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

This device does not involve a "ground truth" established by experts in the typical sense of a diagnostic AI device. The outcomes are self-reported (e.g., IELT/masturbation time recorded by subjects with a stopwatch, questionnaire scores for distress and satisfaction) or objective measurements (e.g., adverse events). Therefore, no experts were used to establish a ground truth in this context.

4. Adjudication Method for the Test Set

Not applicable. There was no expert adjudication process as the outcome measures were either objective measurements (e.g., stopwatch time, adverse events) or standardized questionnaire scores. Subjective satisfaction was rated by the subjects themselves on a Likert scale.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The study was a clinical audit/evaluation of the device's performance, not a comparison of human readers with and without AI assistance.

However, a comparison with Cognitive Behavioral Therapy (CBT) was presented, referencing a study by Zamar (2012) using Prolong in 58 subjects against men having CBT.

• Effect Size of human readers improvement with AI vs without AI assistance: Not applicable as this is not an MRMC study related to "human readers" and AI. The comparison was device vs. non-device therapy. The Zamar (2012) study showed a difference of 6 minutes and 12 seconds (6.2 minutes) in delayed time to ejaculation between the Prolong group and the CBT group. In the Prolong group, 61% of men delayed time to ejaculation from 0.8 minutes to 8.8 minutes on average. In the CBT group, 40% of men delayed time to ejaculation to 2.6 minutes on average.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, the clinical audit/evaluation assesses the standalone performance of the PROLONG™ device used by subjects as instructed. It measures the device's effectiveness and safety without human-in-the-loop (e.g., a clinician interpreting an AI output). The device itself is the intervention.

7. The Type of Ground Truth Used

The "ground truth" for the effectiveness of the PROLONG™ device was established through:

• Subject-reported outcomes:
  • Direct measurement: Intra-Vaginal Ejaculatory Latency Time (IELT) or masturbation time recorded by subjects using a stopwatch.
  • Standardized questionnaires: Scores from validated psychological inventories (Golombock Rust Inventory of Sexual Satisfaction (GRISS), Beck Anxiety Inventory (BAI), and Beck Depression Inventory (BDI-II)).
  • Subjective satisfaction: 10-point Likert satisfaction scale.
• Safety data: Reporting of adverse events by subjects.
• Bench testing: For biocompatibility, electrical safety, mechanical safety, and shelf life, the "ground truth" was established by adherence to recognized international and national standards (e.g., ISO, IEC, ANSI/AAMI).

8. The Sample Size for the Training Set

This device is not an AI/ML algorithm that requires a "training set" in the traditional sense. The device is a physical product, and its design and function are based on engineering principles and clinical research, not machine learning model training.

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

Not applicable, as there is no "training set" for this physical device.

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