The Vaginal Tactile Imager obtains a high resolution mapping of pressures and assesses the strength of pelvic floor muscles within the vagina. It is used in a medical setting to acquire the pressures and store the corresponding data. It also provides visualization, analysis tools and information. The real time data as well the analysis information can then be viewed with an intention of assisting in the diagnosis and evaluation. The device is intended for use by physicians, surgeons and medically trained personnel.

Device Description

The Vaginal Tactile Imager (VTI) obtains a high resolution mapping of pressures and assesses the strength of pelvic floor muscles within the vagina. It is used in a medical clinical setting to sense the pressure along the vagina and store the corresponding data. The VTI also provides analysis information. The real time data as well the analysis information can then be viewed by a physician as a tool for diagnosis and analysis.

During the clinical procedure, the probe is inserted in the vagina for measurement of pressures on the vaginal wall at rest and pelvic floor muscle contractile pressures. Real time data is sampled from each sensing element via the VTI interface electronics and made available to the VTI software during each sample period. The software displays the data in real time to support the clinical procedure. The software also supports operational utility functions such as providing the user with an interface for operating the pressure calibration system. It obtains the probe sensor and calibration chamber data during the calibration process and determines the correction factors to be used in subsequent data collection.

The VTI supports physician data analysis by means of a playback function, which replays a stored session using previously recorded data instead of the real time data. The VTI also indicates measured parameters such as high pressure zone location and size, resting pressures, muscle contraction pressures and calculated pressure gradients.

AI/ML Overview

The provided text describes the Vaginal Tactile Imager (VTI), a device intended to obtain a high-resolution mapping of pressures and assess the strength of pelvic floor muscles within the vagina. However, the document does not explicitly state acceptance criteria or a detailed study proving the device meets specific quantitative performance acceptance criteria.

The document primarily focuses on regulatory approval (510(k)) based on substantial equivalence to predicate devices, and outlines general performance testing and clinical studies to demonstrate safety and functionality.

Based on the provided information, here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly provided in the document. The text describes "performance testing" and "clinical studies" but does not define quantitative acceptance criteria or provide specific numerical performance results.

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

Sample Size for Clinical Studies (Test Set): "Twenty-two women provided data from 32 procedures with the device." This refers to a "feasibility study evaluating the final version of the subjects."
Data Provenance: The document does not explicitly state the country of origin. It mentions "Advanced Tactile Imaging, Inc." with an address in Trenton, NJ, USA, which implies the studies were likely conducted in the USA. The studies were described as "clinical studies," and one specifically as a "feasibility study," suggesting a prospective nature.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not provided in the document. The document mentions the device is intended for use by "physicians, surgeons and medically trained personnel" and that analysis information can be viewed by a "physician," but it does not specify how ground truth for the clinical studies (e.g., diagnosis of pelvic floor disorders) was established or by how many experts of what qualifications.

4. Adjudication Method for the Test Set

This information is not provided in the document.

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

This information is not provided in the document. The clinical studies mentioned focused on safety, comfort, and the device's ability to perform its core functions (tactile imaging, recording muscle contractions), not on comparing human reader performance with and without AI assistance.

6. Standalone (Algorithm Only) Performance Study

The document describes the VTI as a device that "obtains a high resolution mapping of pressures and assesses the strength of pelvic floor muscles... It also provides visualization, analysis tools and information." The data and analysis information ""can then be viewed with an intention of assisting in the diagnosis and evaluation." This strongly implies that the device is a tool for clinicians, not a standalone diagnostic algorithm. Therefore, a standalone (algorithm only) performance study as typically understood for AI deployments in diagnostics was likely not performed or applicable for this device as presented. The device itself is the "algorithm" that processes and displays pressure data.

7. Type of Ground Truth Used

The document mentions two groups of women in the feasibility study: "(1) those with no evidence of pelvic floor disorder and no prior pelvic surgery and (2) those with stage 1 or 2 pelvic organ prolapse." This implies that clinical diagnosis (e.g., by a physician based on clinical examination) was used to categorize these groups, which would serve as the ground truth for evaluating the device's ability to provide relevant information in these populations. There is no mention of pathology or outcomes data as ground truth.

8. Sample Size for the Training Set

This information is not provided in the document. The document describes "various prototypes" being used in clinical studies, but it does not detail any specific training set for a machine learning model, as the VTI itself is described as an imaging and analysis tool, not necessarily an AI-driven diagnostic algorithm in the contemporary sense. Calibration processes are mentioned, but not a separate "training set" for a diagnostic algorithm.

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

Since no specific training set or explicit machine learning component for diagnosis is detailed, this information is not provided and likely not applicable in the context of this device's description. The "correction factors" for calibration are determined from "probe sensor and calibration chamber data" during a calibration process, which is distinct from establishing ground truth for a diagnostic algorithm's training.

Summary of Missing Information:

The core request for explicit acceptance criteria and corresponding numerical performance data from a specific study is not present. The document focuses on regulatory clearance via "substantial equivalence" and general safety and functionality rather than detailed quantitative performance metrics for a diagnostic claim.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a human figure in profile, with flowing lines representing the body and head.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 28, 2015

Advanced Tactile Imaging, Inc. Vladimir Egorov CEO 1459 Lower Ferry Road Trenton, NJ 08618

Re: K142355 Trade/Device Name: Vaginal Tactile Imager Regulation Number: 21 CFR 884.1425 Regulation Name: Perineometer Regulatory Class: II Product Code: HIR Dated: April 20, 2015 Received: April 27, 2015

Dear Vladimir Egorov,

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Joyce M. Whang -S

for Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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4. Indications for Use Statement

K142355 510(k) Number (if known):

Device Name: Vaginal Tactile Imager (VTI)

Indications for Use:

Prescription Use x (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

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510(k) Summary - K142355

5.1. IDENTIFICATION

Submission Date:	August 19, 2014
Applicant's/Owner's Name:	Advanced Tactile Imaging, Inc.1459 Lower Ferry RdTrenton, NJ 08618 USA
Contact Person:	Vladimir Egorov
Phone number:	609 333-2127
Fax number:	877 294-6259
Email:	vti@tactile-imaging.com
Device Common Name:	Perineometer
Device Trade/Proprietary Name:	Vaginal Tactile Imager
Device Class:	Class II
Classification Name:	Perineometer
Product Code:	HIR
Regulation Number:	884.1425

5.2. LEGALLY MARKETED DEVICES FOR SUBSTANTIAL EQUIVALENCE

K031169. Motility Visualization System (Sierra Scientific Instruments, Inc.)
K983052, Peritron Perineometer Model 9300V or 9300A (Cardio Design Pty. Ltd.)

5.3. DESCRIPTION

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5.4. INTENDED USE

The subject device has two intended uses - develop a pressure map of vagina including underlying muscles and measure the strength of the pelvic floor muscles. Each of the primary predicate devices serves as the predicate for one of the intended uses.

The subject device and the Motility Visualization System have the same intended use - develop a pressure map of a tubular structure and its underlying muscles. However, the subject device and the Motility Visualization System are intended for use in different anatomical areas, the vagina and the gastrointestinal tract, respectively.

The subject device and the Peritron Perineometer also have the same intended use - measure the strength of the pelvic floor muscles.

5.5. SUMMARY OF TECHNOLOGICAL CHARACTERISTICS

The Vaginal Tactile Imager has similar technological characteristics to the Motility Visualization System: however, the two devices differ with respect to the size of the number of pressure sensors, use of an accelerometer, ability to preheat, and inclusion of accelerometer. However, the differences in technological characteristics do not raise different questions of safety or effectiveness.

5.6. OVERVIEW OF THE PERFORMANCE DATA

The performance testing completed on the Vaginal Tactile Imager included the following:

Cleaning and high level disinfection validation of vaginal probe ●
Biocompatibility testing (cytotoxicity, sensitization, and irritation)
Electrical safety testing per AAMI/ANSI/IEC 60601-1
Electromagnetic compatibility testing per IEC 60601-1-2
Software verification and validation

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Four clinical studies were completed with various prototypes of the Vaginal Tactile Imager, including a feasibility study evaluating the final version of the subjects included two groups of women: (1) those with no evidence of pelvic floor disorder and no prior pelvic surgery and (2) those with stage 1 or 2 pelvic organ prolapse. Twenty-two women provided data from 32 procedures with the device. No adverse events were reported. The completed clinical studies demonstrated the following:

The VTI examination procedure is safe. ●
The VTI examination is more comfortable than manual palpation.
The VTI allows tactile imaging of the vagina, pelvic floor support structures and recoding of ● pelvic floor muscle contractions.

5.7. CONCLUSION

The Vaginal Tactile Imager is substantially equivalent to the proposed predicate devices.

Regulation Number and Section

§ 884.1425 Perineometer.

(a)
Identification. A perineometer is a device consisting of a fluid-filled sack for intravaginal use that is attached to an external manometer. The devices measure the strength of the perineal muscles by offering resistence to a patient's voluntary contractions of these muscles and is used to diagnose and to correct, through exercise, uninary incontinence or sexual dysfunction.(b)
Classification. Class II (performance standards).