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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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The interestly and analogs'is vila lions For Ose. The 1977 her in and analgesia vila blockade of peripheral nerves.

Not Found

This document is a 510(k) clearance letter from the FDA for a medical device called the "Prolong Continuous Nerve Block Set." It indicates that the device has been determined to be substantially equivalent to legally marketed predicate devices.

However, this document does not contain any information about acceptance criteria, device performance, study designs, sample sizes, expert qualifications, ground truth establishment, or any other details related to a scientific study proving the device meets acceptance criteria.

The letter is a regulatory document confirming clearance, not a scientific publication detailing a study. Therefore, I cannot extract the requested information from the provided text.

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The intended use of the ProLong Centinuous Nerve Block set is for prolonged regional anesthesia and analgesia via blockade of peripheral nerves.

Not Found

The provided document is an FDA 510(k) clearance letter for the "ProLong Continuous Nerve Block Set." This type of document declares a device substantially equivalent to a predicate device and permits its marketing. It does not contain the detailed study information, acceptance criteria, or performance data that would typically be found in a clinical study report or a 510(k) summary, which is a separate document.

Therefore,Based on the provided FDA 510(k) clearance letter:

• 1. A table of acceptance criteria and the reported device performance: This information is not available in the provided document. The letter states the device is "substantially equivalent" to legally marketed predicate devices, implying that its performance is considered acceptable based on the predicate's established safety and effectiveness. However, specific acceptance criteria and performance metrics are not detailed here.

• 2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): This information is not available in the provided document.

• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): This information is not available in the provided document.

• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: This information is not available in the provided document.

• 5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: This information is not available in the provided document. The device is a medical instrument (nerve block set), not an AI-powered diagnostic or assistive tool, so an MRMC study related to AI assistance would not be applicable.

• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This information is not available in the provided document. As noted above, the device is an instrument, not an algorithm.

• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): This information is not available in the provided document. Given the nature of a nerve block set, ground truth would likely relate to the device's ability to deliver nerve blocks successfully and safely, assessed through clinical outcomes or direct observation, but specifics are not provided.

• 8. The sample size for the training set: This information is not available in the provided document. If a training set were relevant (e.g., for an AI device), its details would typically be in a separate technical study summary.

• 9. How the ground truth for the training set was established: This information is not available in the provided document.

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The ProLong-EX permits placement of catheters next to nerves and nerve plexus for continuous nerve block anesthesia or analgesia techniques. It is infileated for use up to 72 hours, and is for adult art paid.atric use.

Not Found

This is a 510(k) clearance letter for the ProLong-EX Continuous Nerve Block Set. It states that the device is substantially equivalent to legally marketed predicate devices. This type of regulatory submission typically does not include detailed performance studies with acceptance criteria, sample sizes, expert involvement, or training set information as would be found in a Premarket Approval (PMA) application or a de novo submission.

Therefore, based on the provided document, I cannot extract the information requested regarding acceptance criteria and the study proving the device meets them. The document primarily focuses on the regulatory approval process through substantial equivalence.

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This device is intended to reduce or relieve pain and restore function and motion to the knee joint. Total knee replacement is indicated for patients with severe knee pain and disability due to rheumatoid arthritis, osteoarthritis, primary and secondary traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral condyle or pseudogout, posttraumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy, moderate valgus, varus, or flexion deformities. This device may also be indicated in the salvage of previously failed surgical attempts if the knee can be satisfactorily balanced and stabilized at the time of surgery. This device is intended to be used as part of a cemented knee system.

These components are manufactured of machined Ultra-High Molecular-Weight (UHMWPE) polyethylene. Both the modified and predicate devices are crosslinked by exposure to electron-beam (e-beam) radiation.

Except for a minor modification to the patellar cutout, Prolong Highly Crosslinked Polyethylene Cruciate Retaining (CR) Articular Surface Components are identical to the predicate device. The modification does not change the intended use or the fundamental scientific technology. It is packaged and sterilized using the same materials and processes.

The provided document is a 510(k) premarket notification for a medical device: the Prolong™ Highly Crosslinked Polyethylene Cruciate Retaining (CR) Articular Surface Component. This document is related to a joint replacement component, not an AI/ML-driven device. Therefore, the information requested about acceptance criteria, study details, ground truth, and expert involvement (which are typical for AI/ML device evaluations) are not applicable to this submission.

Here's a breakdown of why the requested information cannot be provided from this document:

• Device Type: The device is a physical knee joint component made of Ultra-High Molecular-Weight (UHMWPE) polyethylene, crosslinked by electron-beam radiation.
• Regulatory Pathway: This is a 510(k) submission, demonstrating substantial equivalence to a predicate device (NexGen® Complete Knee Solution Crosslinked Polyethylene Cruciate Retaining (CR) Articular Surface Component, K003910).
• Performance Data: The document states, "Performance testing completed as part of the design assurance procedure demonstrated that this device is safe and effective and substantially equivalent to the predicate device." However, it does not provide details of this performance testing, acceptance criteria, or the specific results. The focus of the 510(k) summary is on comparing the new device to the predicate device and confirming the modification (minor change to the patellar cutout) does not alter intended use or fundamental scientific technology.

Therefore, I cannot populate the table or answer the specific questions related to AI/ML device evaluation criteria. The document simply confirms that performance testing was done and found the device substantially equivalent.

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