(189 days)
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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510(k) SUMMARY
Applicant's Name, Address, Phone, Fax, Contact Person, Email, Date Prepared
Limestone Technologies Inc. Jamie Brown, President 556 O'Connor Drive Kingston, Ontario K7P 1N3 Canada Phone: (613) 634-2594 Fax: (613) 634-4098 Email: brownjs@limestonetech.com
APR 2 6 2006
PG. 1 VE 2
September 29, 2005 Date Prepared:
Device Name, Common/Generic Name and Classification Name
| Proprietary Name: | PrefTest Professional Suite TM |
|---|---|
| Common/Usual Name: | Penile Plethysmograph |
| Classification Name: | Monitor, Penile Tumescence |
| Predicate Device | |
| Device Name: | MONARCH 21 Penile Plethysmograph (K033126) |
Description of the Device
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.
Intended Use of the Device
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.
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Technological Summary between PrefTest Professional Suite and its predicate device
PrefTest Professional Suite™ has the same intended use and function as its' predicate device.
Performance Test Results
Testing for the PrefTest Professional Suite™ software included software validation. A risk analysis performed according to ISO 14971: 2000 was conducted.
Clinical Test Results
Testimonials and published literature supports the safety and effectiveness of this technology.
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Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
APR 2 6 2006
Limestone Technologies, Inc. % Ms. Nancy Ruth Associate Director, Regulatory Services CanReg, Inc. 4 Innovation Drive Dundas, L9H 7P3 CANADA
Re: K052929
Trade/Device Name: PrefTest Professional Suite™ Regulation Number: None Regulatory Class: Unclassified Product Code: LIL Dated: March 31, 2006 Received: April 3, 2006
Dear Ms. Ruth:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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, the enactment date of 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 controls provisions of the Act include 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 Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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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 marketed predicate 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.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 (301) 443-6597 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): Ko52929
Device Name: PrefTest Professional Suite™
Indications For Use: 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.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE.CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Laura Garcia
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number K052129
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