THD Procto Software System by THD SpA

· In endoanal ultrasound (EAUS), in order to help evaluate pelvic floor disorders by processing and recording images of tissue structures in the pelvic region with the aid of a dedicated ultrasound probe. This is done by inserting the probe into the anal canal, acquiring the ultrasound signal and letting the software process the image.

· In Anoscopy exams in order to record images and videos of the anorectal channel, which are acquired through a dedicated video camera that provides images with a resolution greater than 1.1 MPx through USB protocol

Device Description

The THD Procto Software System, is a diagnostic system intended to be used to investigate pelvic floor disorders, and specifically the THD Procto Software together with its accessories (endoanal probe and video camera), is able to be applied for:

Endoanal ultrasound (→ trans-rectal ultrasound / echography) -
-Anoscopy exams,

During Endoanal Ultrasound the THD Procto Software System processes and records images of tissue structures in the pelvic region with the aid of a dedicated ultrasound probe; Durinq Anoscopy exams the THD Procto Software System records and displays images of the anorectal channel with the aid of a dedicated video camera;

The THD Procto Software consists of three macro modules or sub-parts, each one with its own function, as described below:

Medical Report (Launcher) module, which contains the functions for the management of . the patient database and of the Exams database. Patients and Exams databases support the operation of the remaining macro modules (Endoanal Ultrasound Module and Anoscopy Exams Module) that are listed below
. Endoanal Ultrasound Module, which manages:
- The acquisition of the ultrasound signal from the probe and its processing to o transform it into a two-dimensional echographic image / video
- Any image / video processing (application of notes, zoom, measurements, etc.) in o real-time (during the exam) or post-processing,
- The examination report (medical history, comments, conclusions) and the printing O
Anoscopy Exams module, which manages:
- Capturing images and video from the video camera via standard USB protocol. o Images are then recorded and displayed on the computer screen
- Any image / video processing (application of notes, zoom, measurements, etc.) in O real-time (during the exam) or post-processing
- The examination report (medical history, comments, conclusions) and the printing o

AI/ML Overview

Here's a breakdown of the acceptance criteria and study details for the THD Procto Software System, based on the provided document. Please note that the document is a 510(k) summary, which focuses on substantial equivalence to predicate devices rather than detailed performance studies typical for novel AI/ML devices. Therefore, some information, particularly regarding specific performance metrics and AI/ML evaluation methodologies, is not present. The device appears to be primarily an imaging and diagnostic system with software for processing and recording, not an AI/ML diagnostic algorithm that would have specific performance metrics like sensitivity, specificity, or AUC.

Acceptance Criteria and Device Performance

The provided document (a 510(k) summary) doesn't explicitly state quantitative acceptance criteria in the typical sense of a pre-defined performance threshold for an AI/ML algorithm (e.g., "sensitivity must be >X%"). Instead, the "acceptance" in this context is based on demonstrating substantial equivalence to predicate devices for its intended use as an ultrasonic pulsed echo imaging system and for anoscopy exams.

Therefore, the "reported device performance" is largely demonstrated through a comparison of technological characteristics and intended uses with legally marketed predicate devices, rather than through specific performance metrics like accuracy, sensitivity, or specificity.

Table of Acceptance Criteria and Reported Device Performance (based on Substantial Equivalence)

Since the device is cleared via 510(k) substantial equivalence, the "acceptance criteria" revolve around demonstrating that the device is as safe and effective as the predicate. The "reported device performance" is the assertion of meeting these equivalence points.

Feature / Criterion (Implicitly Accepted for Substantial Equivalence)	THD Procto Software System Performance (Claimed)
Primary Indication for Use (EAUS)	Helps evaluate pelvic floor disorders by processing and recording images of tissue structures in the pelvic region with a dedicated ultrasound probe inserted into the anal canal. (Equivalent to predicate's use for investigating pelvic floor disorders via endoanal ultrasound).
Secondary Indication for Use (Anoscopy)	Records images and videos of the anorectal channel acquired through a dedicated video camera (resolution > 1.1 MPx via USB protocol). (This specific anoscopy functionality is a feature of the applicant device, but the overall function of imaging and recording is implicitly accepted as safe and effective within the broader context of diagnostic imaging).
Safety and Effectiveness	The device is considered substantially equivalent to the predicate devices, implying comparable safety and effectiveness for its stated indications. No specific safety/effectiveness metrics are provided in this summary. Instead, equivalence is demonstrated through similar technological principles, fundamental scientific technology, and intended use.
Technical Specifications (e.g., Measurement Functions)	Provides 2D measurement: distances, area, and angle measurement. (Comparable to predicate device's 2D measurement functions).
Software Platform	Commercial off-the-shelf operating system (Windows). (Comparable to predicate device's use of Commercial off-the-shelf operating system (Windows)).
Configuration	Standalone software, USB Endoanal probe, and camera. (Comparable to predicate's standalone software and dedicated pelvic floor probes).

Study Details (Based on the 510(k) Summary)

It's crucial to understand that a 510(k) summary is not a detailed scientific study report. It summarizes the basis for substantial equivalence to a predicate device. Therefore, explicit information about a "study" in the typical clinical trial sense, especially for AI/ML performance, is not present for this device. The information provided below is a reconstruction based on typical 510(k) submission practices rather than an explicit description of a performance study within the document.

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

Not explicitly stated. For a 510(k) submission based on substantial equivalence of an imaging system rather than a diagnostic AI algorithm, there isn't typically a "test set" in the sense of a dataset used for performance evaluation against ground truth. Equivalence is primarily based on technical characteristics, rather than performance on a clinical dataset.
The document implies that the device works by acquiring and processing real-time ultrasound signals and camera inputs, suggesting its function is akin to a medical device instrument rather than a standalone AI diagnostic tool evaluated on a pre-defined test set.

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

Not applicable/Not stated. Given the nature of a 510(k) for an imaging system, ground truth establishment by experts for a "test set" is not detailed in this summary. The device's function is to provide images and measurements, not to interpret them autonomously.

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

Not applicable/Not stated. No test set or associated adjudication method is mentioned in this 510(k) summary.

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 evidence. This document does not describe an MRMC study. The THD Procto Software System appears to be an imaging and measurement software rather than an AI-assisted diagnostic tool that would typically undergo such a study.

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

No evidence. The document describes a system involving a human operator (inserting probes, acquiring signals, using the software for processing and recording). There is no mention of a standalone algorithm or its performance.

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

Not applicable/Not stated. The document does not describe performance evaluation against a specific type of ground truth in the context of an AI/ML diagnostic claim. The device aims to visually present anatomical structures and allow for measurements, for which the "ground truth" is typically the real-time anatomical structures themselves as visualized by the medical professional.

7. The sample size for the training set:

Not applicable/Not stated. The document does not describe a training set, suggesting this device is not based on a machine learning model that requires a training set. It appears to be a functional image acquisition, processing, and recording software.

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

Not applicable/Not stated. As no training set is mentioned, ground truth establishment for it is not discussed.

Summary

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January 26, 2020

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. Food & Drug Administration".

THD SpA % Filippo Bastia CEO Via dell'Industria, 1 Correggio (RE) 42015 ITALY

Re: K193512

Trade/Device Name: THD Procto Software System Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: Class II Product Code: IYO, ITX, OUG, FWG Dated: December 16, 2019 Received: December 18, 2019

Dear Filippo Bastia:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K193512

Device Name THD Procto Software System

Indications for Use (Describe) The THD Procto Software is a software that can be used:

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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1. General Information
  Submitter :

THD SpA Via dell'Industria 1 Correggio (RE) 42015, Italy Tel. +39 0522 634311 Fax +39 0522 634371

Establishment Registration Number: 3006680097

Contact:

Filippo Bastia Via dell'Industria 1 Correggio (RE) 42015, Italy Tel. +39 0522 634311 Fax +39 0522 634371 Email: requlatory@thdlab.com

Summary Preparation Date:

December 19, 2019

1. Name & Classification

Device Name:	THD Procto Software System
Classification names	Regulation Name	Product Code
Ultrasound Pulsed Echo Imaging System	892.1560	IYO
Diagnostic ultrasonic transducer	892.1570	ITX
Surgical camera and accessories	878.4160	FWG
Medical Device data system	880.6310	OUG

CLASS:

1. Predicate Devices
  The THD Procto Software System is substantially equivalent to the following device:

Applicant	Device name	510(k) Number
Halo MedicalTechnologies	CatalySt, MidCRYSTL, HALOUltrasound System	K140899Predicate device
Interson Corporation	Interson USB UltrasoundSystem	K163443Reference device

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1. Device Description
  The THD Procto Software System, is a diagnostic system intended to be used to investigate pelvic floor disorders, and specifically the THD Procto Software together with its accessories (endoanal probe and video camera), is able to be applied for:
Endoanal ultrasound (→ trans-rectal ultrasound / echography) -
-Anoscopy exams,

anorectal channel with the aid of a dedicated video camera;

The THD Procto Software consists of three macro modules or sub-parts, each one with its own function, as described below:

Medical Report (Launcher) module, which contains the functions for the management of . the patient database and of the Exams database. Patients and Exams databases support the operation of the remaining macro modules (Endoanal Ultrasound Module and Anoscopy Exams Module) that are listed below
. Endoanal Ultrasound Module, which manages:
- The acquisition of the ultrasound signal from the probe and its processing to o transform it into a two-dimensional echographic image / video
- Any image / video processing (application of notes, zoom, measurements, etc.) in o real-time (during the exam) or post-processing,
- The examination report (medical history, comments, conclusions) and the printing O
Anoscopy Exams module, which manages:
- Capturing images and video from the video camera via standard USB protocol. o Images are then recorded and displayed on the computer screen
- Any image / video processing (application of notes, zoom, measurements, etc.) in O real-time (during the exam) or post-processing
- The examination report (medical history, comments, conclusions) and the printing o
1. Indications for Use

The THD Procto Software System is a software that can be used:

• In endoanal ultrasound (EAUS), in order to help evaluate pelvic floor disorders by processing and recording images of tissue structures in the pelvic reqion with the aid of a dedicated ultrasound probe. This is done by inserting the probe into the anal canal, acquiring the ultrasound signal and letting the software process the image.

• In Anoscopy exams in order to record images and videos of the anorectal channel, which are acquired through a dedicated video camera that provides images with a resolution greater than 1.1 MPx through USB protocol

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6. Comparison of technological characteristics with the predicate devices

	Proposed Device	Predicate device	Reference device
Product Name	THD Procto SoftwareSystem	CatalySt, MidCRYSTL, HALOUltrasound System	Interson USB UltrasoundSystem
Manufacturer	THD Spa	Halo Medical Technologies	Interson Corporation
510(K) No.	/	K140899	K163443
Classification
• Regulation Name	Ultrasound Pulsed Echo ImagingSystem	Ultrasound Pulsed Echo ImagingSystem	Ultrasonic pulsed doppler imagingsystem
• Regulation Number	21 CFR 892.156021 CFR 892.157021 CFR 878.416021 CFR 880.6310	21 CFR 892.156021 CFR 892.1570	21 CFR 892.1550
• Regulatory Class	II	II	II
• Product Code	IYO	IYO	IYN,
• Subsequent ProductCode	ITX, FWG, OUG	ITX	IYO, ITX
Intended use
• Indications for use	The THD Procto Software System isa software that can be used:• In endoanal ultrasound (EAUS), inorder to help evaluate pelvic floordisorders by processing andrecording images of tissuestructures in the pelvic region withthe aid of a dedicated ultrasoundprobe. This is done by inserting theprobe into the anal canal, acquiringthe ultrasound signal and letting thesoftware process the image.• In Anoscopy exams in order torecord images and videos of theanorectal channel, which areacquired through a dedicated videocamera that provides images with aresolution greater than 1.1 MPxthrough USB protocol	"Catalyst" is a diagnostic ultrasoundsystem designed to be used forinvestigating disorders of the pelvicfloor.An ultrasonographic crystal withinthe probe records images of theorgan, muscle, and tissue structuresof the pelvic region.MidCRYSTL and HALO probes allowfor ultrasonography ofthe following:1) on the surface of the perineumnand/or abdomen,2) endocavity, by inserting theendovaginal probe into the vagina,and3) endocavity, by inserting theendoanal probe into the anal canal.	The Interson USB UltrasoundSystem is intended for diagnosticultrasound imaging in B, colorDoppler, or Combined (B + Color)modes. It is indicated for diagnosticultrasound imaging and fluid flowanalysis in the followingapplications:• Fetal/Obstetric• Abdominal• Pediatric• Small Organ• Musculo-skeletal(conventional)• Musculo-skeletal (superficial)• Urology• Gynecology• Pelvic Floor• Neuro-muscular• Peripheral VesselThe system is intended for use byhealthcare professionals
• Anatomical site	Anal canal	Perineum and/or abdomen, vagina,anal canal	Every area in which ultrasonography isrequired - it include anal canal usingthe proper probe
Features
• Configuration of thesystem	Standalone software,USB Endoanal probe and camera	Standalone software andUSB dedicated pelvic floor probes	Standalone software andUSB dedicated probes for differentapplications
• Software platform	Commercial off-the-shelf operating system(Windows)	Commercial off-the-shelf operating system(Windows)	Commercial off-the-shelf operating system(Windows)
• Measurement function	2D measurement: distances,area and angle measurement	2D measuredistances and calculate angles	2D measurement andarea measurement
• Commercial package	THD Proctostation or THD Proctomobile	"Catalyst" diagnostic ultrasoundsystem	Unknown

Regulation Number and Section

§ 892.1560 Ultrasonic pulsed echo imaging system.

(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.