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The Uroan DIR-4U Rigidometer measures penile axial rigidity.

The DIR-4U Rigidometer consists of an instrument and attached sensor that measures penile axial rigidity. It has been designed, so that men can use this instrument in the privacy of their homes to measure their penile axial rigidity.

Here's a breakdown of the acceptance criteria and study information for the Uroan DIR-4U Rigidometer, based on the provided text:

Acceptance Criteria and Device Performance

The provided text for K061676 does not explicitly state quantitative acceptance criteria for the Uroan DIR-4U Rigidometer. Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (Uroan Model DIR-101C Rigidometer). The supporting information mentions "Bench, biocompatibility and clinical testing supported the substantial equivalency of the DIR-4U Rigidometer," but does not provide specific performance metrics or thresholds.

Therefore, the table below reflects that the primary "acceptance criterion" was substantial equivalence to the predicate, and the "reported device performance" is that it met this criterion as determined by the FDA.

Study Details

Based on the provided text, detailed information regarding sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance is not included. The document is a 510(k) summary and FDA clearance letter, which typically provides high-level information rather than granular study methodology.

Here's what can be inferred or explicitly stated from the text:

1. Sample size used for the test set and the data provenance:

   • Sample Size: Not specified.
   • Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The document mentions "clinical testing," but no details.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not specified.

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

   • Not specified.

4. 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:

   • No indication of an MRMC study. This device is described as a direct measurement tool (penile axial rigidity monitor) rather than an AI-assisted diagnostic or interpretive system. Therefore, the concept of "human readers improving with AI assistance" is not relevant to this type of device.

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

   • The device is a physical instrument that measures penile axial rigidity and uses indicator lights to show the result. It operates as a "standalone" device in the sense that it doesn't require human interpretation of complex outputs; it directly displays a measured value via indicator lights. However, the term "standalone algorithm performance" typically refers to AI/software performance. Since this is a hardware measurement device, this question is not directly applicable in the typical AI context. The document indicates it "measures penile axial rigidity" and "uses indicator lights to indicate the measured axial rigidity," which implies its performance is intrinsic to its measurement capability.

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

   • Not specified. Given it's a measurement device for "penile axial rigidity," the ground truth would likely be established through a gold-standard physical measurement technique, but this is not detailed.

7. The sample size for the training set:

   • Not applicable as this is a physical measurement device, not an AI/machine learning algorithm that requires a "training set."

8. How the ground truth for the training set was established:

   • Not applicable for the same reason as above.

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The Plethora Solutions Sexual Assessment Monitor (SAM) is intended for use as a diagnostic tool for use in the quantifiable assessment and monitoring of penile tumescence and ejaculatory latency.

The Plethora Solutions Sexual Assessment Monitor (SAM) is intended for use as a diagnostic tool for use in the quantifiable assessment and monitoring of penile tumescence and ejaculatory latency. The Sexual Assessment Monitor (SAM) includes the following components: SAM application software, device control box, vibrator with integral 3m lead, serial port communications cable, 0.5m sensor lead adapter, device charger.

Here's a summary of the acceptance criteria and the study information for the Plethora Solutions Sexual Assessment Monitor (SAM) based on the provided document:

This device (SAM) is seeking substantial equivalence to predicate devices and does not present specific new acceptance criteria or a comparative effectiveness study against a human reader with AI assistance. Instead, it relies on demonstrating similar performance to existing devices, documented safety standards, and clinical utility.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: The document mentions "findings from three studies" and "3 full clinical study reports referenced" by Dinsmore WW, Ralph DJ, Kell P et al. However, the exact sample sizes for these studies are not provided in this summary.
• Data Provenance: The studies are clinical studies, implying prospective data collection. The document does not explicitly state the country of origin for the clinical data, but the manufacturer is based in the UK, suggesting some data may be from the UK or Europe given CE Mark approval.

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

• The document does not specify the number of experts or their qualifications used to establish ground truth in the clinical studies. It refers to the findings as "documented by Dinsmore WW, Ralph DJ, Kell P et al," which are likely medical professionals involved in the research.

4. Adjudication Method for the Test Set

• The document does not mention any specific adjudication method (e.g., 2+1, 3+1) for the ground truth establishment in the clinical studies.

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

• No, an MRMC comparative effectiveness study was not done in the context of human readers improving with AI vs. without AI assistance. This device is a standalone diagnostic tool, not an AI-assisted interpretation system for human readers.

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

• Yes, a standalone study was effectively done. The device itself is designed to provide quantifiable assessment and monitoring, acting as a standalone diagnostic tool. The clinical studies referred to in the submission would have evaluated the device's performance in this standalone capacity.

7. The Type of Ground Truth Used

• The type of ground truth used would likely be clinical assessment and measurement from the studies by Dinsmore et al. For "penile tumescence," this could involve direct physiological measurements. For "ejaculatory latency," this would involve timed observations. The studies themselves would define their specific "ground truth" methods.

8. The Sample Size for the Training Set

• The document does not provide any information regarding a training set sample size. Given the nature of the device (a monitor with software, but not explicitly stated as an AI/machine learning model in the typical sense), it's possible that a separate "training set" for an algorithm, as commonly understood in AI, may not be applicable or explicitly mentioned in this context. The software would have been developed and validated, but details about distinct training data are absent.

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

• As no training set is explicitly mentioned or detailed in the document, information on how its ground truth was established is not available.

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The PrefTest Professional Suite™ is used to measure penile tumescence in response to visual and auditory stimuli. Penile Tumescence data can later be combined with other standardized psychological testing procedures to assist clinicians with their assessment and treatment of sexual offenders.

Limestone Technologies Penile Plethysmograph is based on a circumference measurement using a strain gauge transducer which measure penile tumescence in millimeters. PrefTest Professional Suite™ computer software is used to store, tabulate, display and print out the acquired data from a personal computer or lap top.

This 510(k) summary for the PrefTest Professional Suite™ indicates that its clearance was based on substantial equivalence to a predicate device, the MONARCH 21 Penile Plethysmograph (K033126), rather than on specific quantitative acceptance criteria or a detailed clinical study demonstrating its performance against such criteria.

Here's a breakdown of the available information based on your requested categories:

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

Based on the provided text, there are no explicit quantitative acceptance criteria or a table of performance metrics. The document states:

• "Testing for the PrefTest Professional Suite™ software included software validation."
• "A risk analysis performed according to ISO 14971: 2000 was conducted."
• "Testimonials and published literature supports the safety and effectiveness of this technology."

This suggests that the device's performance was assessed through software validation and risk analysis, and its safety and effectiveness were supported by existing evidence for the technology rather than a new comparative study with specific acceptance thresholds.

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

Not applicable. The submission does not describe a clinical test set with a specific sample size.

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. There is no mention of an expert panel or ground truth establishment for a specific test set.

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

Not applicable. There is no mention of an adjudication process for a test set.

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 measurement instrument (penile plethysmograph) and associated software, not an AI-assisted diagnostic tool that would typically involve a multi-reader multi-case study with human readers.

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

This concept doesn't directly apply. The device's function is to measure penile tumescence, store, tabulate, display, and print data. Its "performance" would likely relate to the accuracy and reliability of its measurements, and the proper functioning of its software. The text indicates "software validation" was performed, which is a form of standalone testing for the software's functionality, but no specific performance metrics are provided.

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

The document does not detail specific ground truth for performance testing. For a measurement device, the "ground truth" for validation would typically involve comparing its measurements against a known standard or a reference measurement system. The text mentions "software validation" and "risk analysis," which imply internal testing and adherence to standards, but no external ground truth against which the device's measurements were compared.

8. The sample size for the training set

Not applicable. This device is not an AI/ML model that would typically have a "training set" in the context of machine learning.

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

Not applicable, as there is no training set for an AI/ML model.

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The MONARCH 21 system's intended use is to measure sexual response to visual and auditory stimuli in male sexual offenders as an important part of evaluating individual treatment need and determining risk for recidivism.

MONARCH 21 Penile Plethysmograph consists of attached sensors, which measure penile tumescence. A laptop computer is used to store, tabulate, display and print out the acquired data.

The MONARCH 21 Penile Plethysmograph's acceptance criteria and the study proving it meets these criteria are described below:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state numerical acceptance criteria for the MONARCH 21 Penile Plethysmograph. Instead, it focuses on demonstrating substantial equivalence to a predicate device (CAT-600 Penile Plethysmograph, K936115) through functional testing. The "acceptance criterion" in this context is implicitly the successful mimicry of the predicate device's examination results, ensuring that differences do not diminish safety and effectiveness.

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

The study described is a non-clinical, in-vitro validation for functional equivalence, not a clinical study involving human subjects or patient data.

• Sample Size: Not applicable. The "test set" consists of a precision machined aluminum calibration cone and "secondary agents" for in-vitro testing. No human data or patient samples were used.
• Data Provenance: Not applicable. The data is generated from laboratory testing of the device components (sensors, system functionality) using physical calibration tools and simulated values.

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

Not applicable. This was a non-clinical engineering and functional validation study. Ground truth was established by physical measurements and comparison to known values, not expert consensus.

4. Adjudication Method for the Test Set

Not applicable. As a non-clinical, in-vitro validation, there was no need for expert adjudication. The comparison was against expected physical measurements and the performance of the predicate device.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Affect Size of How Much Human Readers Improve with AI vs Without AI Assistance

No. An MRMC comparative effectiveness study was not done. The MONARCH 21 is a device to measure sexual response, not an AI-assisted diagnostic tool for human readers. It provides data for human interpretation but does not involve AI or "human readers" in the context of diagnostic image or signal interpretation.

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

Yes, in essence. The "non-clinical test results" section describes standalone testing of the device's components and system functionality. This involved measuring the penile sensors' range of values using a calibration cone and testing secondary agents with simulated values. This testing assessed the device's intrinsic mechanical and electrical performance without human interpretation as part of the assessment.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, Etc.)

The ground truth used was based on physical measurement standards and simulated equivalent values.

• For sensor calibration: Known circumferences of a precision machined aluminum calibration cone.
• For secondary agents: Simulated equivalent values, implying comparison against predefined or calculated values.
• Overall: The performance of the predicate device (CAT-600 Penile Plethysmograph) served as a benchmark for demonstrating substantial equivalence.

8. The Sample Size for the Training Set

Not applicable. The MONARCH 21 is a medical measurement device, not an AI or machine learning algorithm that requires a "training set."

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

Not applicable, as there is no training set for this type of device.

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The VISER™ penile tumescence monitor is a noninvasive monitoring device used to measure intracavernosal pressure (ICP) and blood flow in the penis. This monitoring assists the physician in the diagnosis of erectile dysfunction. VISERTM is a prescriptive device to be used under the direction of a physician or other authorized health care professional.

Not Found

This document is a 510(k) clearance letter for the VISER™ Penile Tumescence Monitor. It indicates that the device has been found substantially equivalent to a legally marketed predicate device.

The provided text does not include details about acceptance criteria, device performance from a study, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, types of ground truth, or training set information. These details are typically found in the 510(k) submission itself, which is not fully included here.

The letter explicitly states:

• "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..."

This means the FDA did not require a new clinical study to establish safety and effectiveness, but rather determined that the new device is as safe and effective as a device already on the market. Therefore, the detailed study information requested is not present in this clearance letter.

Without the actual 510(k) submission, it's impossible to answer the specific questions about acceptance criteria and study details.

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The NEVA™ System is an device to measure and record penile erectile events nocturnally.
Measure and record penile erectile events nocturnally.

The UroMetrics NEVA system consists of three disposable electrodes sets, a portable battery powered recorder, a host interface, cables and a computer program. Two of the three electrode sets are placed on the penis so that one electrode set is on the glans terminating just proximal to the glans, one set is at the base of the penis terminating a fixed distance from the base of the penis. The third electrode is attached to the patient's hip. The wires from the electrodes terminate in a phone connector which plugs into the portable NEVA recorder.

The electrodes and the recorder are used by the patient to monitor nocturnal tumescence for up to three nights. The host interface and the computer program are used to prepare (initialize) the recorder for use and to download the data from the recorder for display and analysis on a physician's computer.

The NEVA system indicates penile tumescence by monitoring changes in volume, length and area. Due to a variety of factors (patient position, etc.) the size of the penis can change its shape. An increase in length, by itself, may not indicate tumescence. Tumescence is generally indicated by an increase in volume, length and area. This is the primary reason the NEVA system displays volume, length and area throughout the test.

Impedance values which are used to determine penile volume, length and area are continuously recorded at one second intervals. The one second time base and the change in volume data allow a physician to determine the fill rate once periods of tumescence are identified.

The NEVA system determines changes in volume by measuring the impedance within the penis. A low powered alternating current is sent from the electrode on the glans to the ground electrode on the hip. The remaining electrodes are used to measure the impedance. The electrode set at the base of the penis includes electrodes which are separated by a fixed distance. As the cross-sectional area of the blood volume in the penis increases, there is a decrease in measured impedance in the base electrode set. These impedance changes are then converted to a volume reading by the host computer. With an increase in distance between the base electrode and the electrode posterior to the glans (penis length) there is an increase in the impedance between these electrodes. This change in impedance is converted to a length reading.

To begin a test, the NEVA recorder is plugged into a computer through the host interface to a host computer running the NEVA software. The computer and software will recognize the recorder and will display a menu which allows the physician to download previously recorded data or initialize the recorder for a new test. To begin a new test, the physician enters the patient's name and other information and initializes the recorder. All previous data are cleared and the patient information is saved to the recorder.

The NEVA software allows the physician the option of real time measurements while connected to the computer. This capability is useful to demonstrate the proper placement of the electrodes and to check for proper operation. Once the NEVA recorder is initialized and the patient is instructed in its use, the recorder and electrodes are sent home with the patient. The electrodes are designed for single use so a separate set of electrodes is needed for each night (sleep period) of the test.

The NEVA recorder is normally in standby mode until the electrodes are placed on the patient and the connector is plugged into the recorder. When the connector is removed the recorder returns to the standby mode. Patients should be instructed to plug in the electrodes at the beginning of the test and unplug the electrodes at the end of the test. The recorder can store data for a maximum of 36 hours, typically three sleep periods.

At the end of the test period, the NEVA recorder is plugged into a computer through the host interface to a host computer running the NEVA software. The computer and software will recognize the recorder and will display a menu which allows the physician to download the data.

The data are then downloaded to the computer and stored on the computer's hard drive. The impedance data are converted to volume, length and crosssectional area plots which are displayed graphically on the computer screen.

The software incorporates a number of features which facilitate the analysis and interpretation of the data by the physician.

The provided text does not contain specific acceptance criteria or detailed results of a study that directly proves the device meets specific performance criteria in a quantifiable manner (e.g., sensitivity, specificity, accuracy).

Instead, it mentions:

• "Performance testing raised no issues, and the 510(k) included Comparative Testing and Function and Beta Testing." This is a general statement indicating that testing was performed and found acceptable for regulatory submission, but it doesn't provide the criteria or the results.
• The NEVA™ System is being cleared based on its substantial equivalence to the RigiScan® Plus System (K941781). The argument for substantial equivalence is that the differences in technical specifications, physical appearance, and design "do not affect the relative safety and effectiveness." This implies that the NEVA™ System is expected to perform comparably to the predicate device, but no quantitative performance metrics for either device are presented here.

Therefore, many of the requested details cannot be extracted from this document.

Here's an attempt to answer the questions based on the limited information available:

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

   Acceptance Criteria	Reported Device Performance
   Not explicitly stated (implied to be comparable safety and effectiveness to predicate device)	"Performance testing raised no issues."

"Differences... do not affect the relative safety and effectiveness of the NEVA™ System." |

2. Sample size used for the test set and the data provenance: Not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not mentioned.

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 mentioned. This device is a measurement system, not an AI-assisted diagnostic tool for Human-in-the-loop performance improvement.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The document implies standalone testing was done as it states "Performance testing raised no issues," and the system outputs data for physician analysis. However, no specific standalone performance metrics (e.g., accuracy of tumescence detection) are provided.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not mentioned. For a penile tumescence monitor, ground truth would likely involve independent clinical assessment of erectile events or physiological measurements, but this is not specified.

8. The sample size for the training set: Not mentioned.

9. How the ground truth for the training set was established: Not mentioned.

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