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.

Summary

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Image /page/0/Picture/0 description: The image shows handwritten text that appears to be a combination of alphanumeric characters. The text reads "K062042 p1 of 3". The handwriting is in black ink and is somewhat cursive in style. The text is likely a label or identifier for a document or page.

6 2006

Image /page/0/Picture/2 description: The image shows the logo for Plethora Solutions. The word "plethora" is written in a sans-serif font, with the word "SOLUTIONS" written in smaller letters underneath. To the right of the word "plethora" are three circles of varying sizes.

Lupus House 11-13 Macklin Street Covent Garden London WC2B 5NH

① +44 (0) 207 2698 630 ि +44 (0) 207 2428 518 ්‍රි) mail@piethomsolution:..co.ui:

2. 510(k) Premarket Notification Summary (Summary Prepared on July 18, 2006

A.	510(k) Owner:	Plethora Solutions LimitedOfficial FDA Correspondent: Miranda Tighe, ProjectManager for In-Licensed ProgrammesLupus House, 11-13 Macklin StreetCovent Garden, London, WC2B 5NHUnited Kingdom(T) +44 (0) 207 2698 630(F) +44 (0) 207 2428 518
		e-mail: miranda.tighe@plethorasolutions.co.uk

B.	Trade Name:	Sexual Assessment Monitor (SAM)
	Common Name:	Penile Tumescence/Ejaculatory Latency Monitor
	Product Code:	LIL (Unclassified)
	Advisory Committee:	Gastroenterology/Urology

C. Substantial Equivalence Predicate Device(s):

Manufacturer	Device Name	510-K Number	Decision Date
Dacomed Corporation	Rigiscan System	K841202	07/06/1984
Dacomed Corporation	Rigiscan Plus RigidityAssessment System	K941781	08/25/1994

Device Description: D.

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.

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K062042 pg2of3

device charger. .

E. Intended Use of Device:

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.

F. Substantial Equivalence Discussion

SAM is substantially equivalent to the identified predicate devices based on the following:

1. The INTENDED CLINICAL USE for the Plethora Sexual Assessment Monitor (SAM) is SUBSTANTIALLY EQUIVALENT to the predicate devices.
1. The Plethora Sexual Assessment Monitor (SAM) and the 2 predicate devices are both substantially equivalent Medical Device Systems FOR USE IN THE SAME ANATOMICAL LOCATION and BY the SAME SYSTEM USERs in the SAME CLINICAL SETTINGS.
1. The OPERATIONAL FEATURES/TECHNOLOGICAL CHARACTERISTICS of the Plethora Sexual Assessment Monitor are the SAME or SIMILAR to those offered by the predicate device.
1. The SAFETY ASPECTS of the Plethora Sexual Assessment Monitor (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 the technological characteristics of SAM and its intended clinical uses provide NO ADDITIONAL SAFETY RISK TO patients or System operators.
1. The Plethora Sexual Assessment Monitor (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

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K062042 pg3 of 3

quantify ejaculatory latency time: findings from three studies. BJU Inter. 2006;1-6 with further evidence provided in this submission from the 3 full clinical study reports referenced.

G. Bench and Clinical Testing Supporting Documentation

SAM received CE MARK approval in 2005 with demonstrated compliance to EN 60601-1:1990 and EN 60601-1-2:2002. Documentation from 3 prospective formal clinical studies including a peer-reviewed report of these clinical studies provides further clinical safety documentation of the Plethora Solutions Sexual Assessment Monitor in conjunction with the clinical efficacy of the device.

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Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

SEP -6 200%

Plethora Solutions Limited c/o Ms. Kimberly Doney Consultant 54 Forest Street LEXINGTON MA 02421

Re: K062042

Trade/Device Name: Plethora Solutions Sexual Assessment Monitor (SAM) Regulation Number: None Regulatory Class: Unclassified Product Code: LIL Dated: July 18, 2006 Received: July 19, 2006

Dear Ms. Doney:

We have reviewed your Section 510(k) premarket notification of intent to market the device wo have ro ro row a ve determined the device is substantially equivalent (for the indications for reservlied in the enclosure) to legally marketed predicate devices marketed in interstate commerce ass stated in the enerebare) for the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general therefore, maniel the deterroy cash one requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket n your do roo is chasilied (to such additional controls. Existing major regulations affecting your Apple vary, It the Joe of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Image /page/3/Picture/10 description: The image shows a circular logo with the text "1906-2006" at the top and "Centennial" at the bottom. The letters "FDA" are prominently displayed in the center of the logo. There are three stars below the word "Centennial". The logo is surrounded by a dotted circle.

Protecting and Promoting Public Health

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally prematicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

21 CFR 876.xxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 894.xxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150

or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director. Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): Original Premarket Notification KO62047 Device Name: Plethora Solutions Sexual Assessment Monitor (SAM) Indications for Use:

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.

Prescription Use _ X_ (Part 21 CFR 801 Subpart D)

NaveyC Brogdon

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number Ko 62042

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Regulation Number and Section

N/A