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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.

Device Description

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.

AI/ML Overview

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

Acceptance Criteria (Inferred from Substantial Equivalence Claim)	Reported Device Performance (Summary from Submission)
Intended Clinical Use: Substantially equivalent to predicate devices.	The INTENDED CLINICAL USE for SAM is SUBSTANTIALLY EQUIVALENT to the predicate devices (Rigiscan System K841202, Rigiscan Plus Rigidity Assessment System K941781).
Anatomical Location & User: Used in the same anatomical location and by the same system users in the same clinical settings as predicate devices.	SAM and the 2 predicate devices are for use in the SAME ANATOMICAL LOCATION and BY the SAME SYSTEM USERs in the SAME CLINICAL SETTINGS.
Operational Features/Technological Characteristics: Same or similar to predicate devices.	The OPERATIONAL FEATURES/TECHNOLOGICAL CHARACTERISTICS of SAM are the SAME or SIMILAR to those offered by the predicate devices.
Safety Aspects: Same or very similar to predicate devices; no additional safety risk to patients or operators.	The SAFETY ASPECTS of SAM are the SAME or very SIMILAR to those offered by the predicate devices. SAM is as safe or safer than the two predicate devices and its characteristics present NO ADDITIONAL SAFETY RISK. SAM received CE MARK approval in 2005 with demonstrated compliance to EN 60601-1:1990 and EN 60601-1-2:2002.
Effectiveness: An effective diagnostic tool, at least as effective as predicate devices.	SAM has been observed to be an EFFECTIVE diagnostic tool (AS OR MORE EFFECTIVE THAN RIGISCAN DEVICE) in a clinical setting, as documented by Dinsmore WW, Ralph DJ, Kell P et al, Evaluation of the Sexual Assessment Monitor, a diagnostic device used to electronically quantify ejaculatory latency time: findings from three studies. BJU Inter. 2006;1-6, with further evidence from 3 full clinical study reports.

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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