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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.

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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.

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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.

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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 indicated for patients with severe knee pain and disability due to:

• Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
• Collagen disorders and/or avascular necrosis of the femoral condyle.
• Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy.
• Moderate valgus, varus, or flexion deformities.
• The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery.
  This device is indicated for cemented use only.

The proposed device is part of the NexGen system of semiconstrained, nonlinked knee prostheses.

The provided text is for a 510(k) premarket notification for a medical device, the NexGen® Prolong™ All-Poly Patella. This document concerns the substantial equivalence of the device to a predicate device, not a study proving it meets specific acceptance criteria in the way one might expect for a novel diagnostic device.

Here's an analysis based on the provided text, addressing your points:

1. A table of acceptance criteria and the reported device performance

The provided text does not list specific acceptance criteria or quantitative performance metrics for the NexGen® Prolong™ All-Poly Patella. Instead, it relies on the concept of substantial equivalence to a predicate device.

The "performance" criteria are essentially that the device is "safe and effective and is substantially equivalent to the predicate device."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document explicitly states: "Performance testing completed as part of the design assurance process demonstrated that this device is safe and effective and is substantially equivalent to the predicate device."

However, no specific sample size for a test set is mentioned, nor is the provenance of any data (e.g., country of origin, retrospective/prospective). The assessment appears to be based on non-clinical performance (design assurance testing) and direct comparison to the predicate device, rather than a clinical trial with a defined patient sample.

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)

Not applicable. This submission is not based on a study requiring expert-established ground truth for a test set (e.g., interpreting medical images). It's a device modification where substantial equivalence is claimed through non-clinical testing and comparison to an established predicate.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. As there's no clinical test set with human interpretation requiring ground truth establishment, no adjudication method was used.

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

Not applicable. This device is a total knee prosthesis, not an AI-assisted diagnostic tool. Therefore, MRMC studies and AI assistance are not relevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable. This device is a physical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not explicitly stated in terms of "ground truth" for a clinical study. The determination of safety and effectiveness for substantial equivalence was based on:

• Non-Clinical Performance: "Performance testing completed as part of the design assurance process." The "ground truth" here would be engineering specifications, material properties, and biomechanical testing standards met during design assurance.
• Comparison to Predicate Device: The predicate device itself (Zimmer NexGen Knee System, K933785) provides the "ground truth" for established safety and effectiveness.

8. The sample size for the training set

Not applicable. This device is a physical knee prosthesis, not a machine learning model that requires a training set.

9. How the ground truth for the training set was established

Not applicable. As above, no training set for an algorithm was used.

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Prolong is used to administer a patient conduction, regional, or local anesthesia. ProBloc is used in performance of regional anesthesia block.

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This document does not contain information about acceptance criteria, device performance, or a study proving that the device meets acceptance criteria. The document is a 510(k) substantial equivalence determination letter from the FDA for a device named "ProBloc" and "Prolong," which are anesthesia conduction needles. It states that the FDA has determined the device is substantially equivalent to legally marketed predicate devices for the indications for use stated.

Therefore, I cannot provide the requested information.

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This device is indicated for patients with severe knee pain and disability due to:

• Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
• Collagen disorders, and/or avascular necrosis of the femoral condyle.
• Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy
• Moderate valgus, varus, or flexion deformities.
• The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery.
  The device is indicated for use when both cruciate ligaments have been excised.
  The device is intended for use as part of a cemented or uncemented knee prosthesis.

The NexGen LPS-Flex Prolong articular surfaces are part of the NexGen system of semiconstrained,

The provided document describes a 510(k) premarket notification for a medical device, specifically NexGen® Complete Knee Solution LPS-Flex Prolong™ Highly Crosslinked Polyethylene Articular Surfaces. The document focuses on demonstrating substantial equivalence to predicate devices rather than a de novo study with explicit acceptance criteria and performance data.

Therefore, many of the requested categories (2-9) are not directly applicable or explicitly stated in this type of submission which primarily relies on equivalence to devices already on the market.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission is a 510(k), which asserts substantial equivalence to predicate devices rather than establishing new performance acceptance criteria and showing performance against them in a de novo study. The "Performance Data" section explicitly states "Non-Clinical Performance and Conclusions: Performance testing completed as part of the design assurance process demonstrated that this device is safe and effective and substantially equivalent to the predicate device. Clinical Performance and Conclusions: Clinical data and conclusions were not needed for this device."

Therefore, a table of explicit acceptance criteria and reported device performance, as one would see in a de novo study, is not provided in this type of submission. The 'acceptance criterion' for a 510(k) is demonstrating substantial equivalence to a legally marketed predicate. The 'performance' is therefore inherently linked to the performance of the predicate device.

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

Not applicable. No dedicated "test set" or clinical study with a prospectively collected sample size is described as clinical data was not needed. The non-clinical performance refers to design assurance testing, which would typically involve laboratory testing, not a clinical test set. The provenance of such non-clinical data would be internal lab reports.

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

Not applicable. As clinical data and a test set requiring ground truth establishment by experts were not needed or presented, this information is not provided.

4. Adjudication Method for the Test Set

Not applicable. No test set requiring expert adjudication is described.

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

Not applicable. No clinical study, let alone an MRMC study comparing human readers with or without AI assistance, was performed or presented for this 510(k) submission.

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

Not applicable. This device is a physical knee prosthesis component, not an algorithm or AI. Therefore, a standalone performance study in the context of an algorithm's performance is not relevant.

7. Type of Ground Truth Used

Not applicable, as no external "ground truth" for a clinical assessment was required. The "truth" in this context is established through engineering and material science testing that demonstrates the physical properties and performance characteristics (e.g., wear, strength) of the device are equivalent to the predicate.

8. Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

Not applicable. As this is not an AI/ML device, there is no training set or ground truth in that context.

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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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