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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 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 an adequate resolution and their subsequent processing.
• In anorectal manometry examinations, in order to view on a two-dimensional Pressure/Time graph the acquisition of the mean pressure signal transmitted by the THD Anopress device and subsequent processing (examination report and report printing)
• Follow the clinical history, possible follow-ups of a patients

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 and devices (endoanal probe, video camera and THD Anopress), is able to be applied for:

• -Endoanal ultrasound (→ trans-rectal ultrasound / echography)
• Anoscopy exams
• -Manometry 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; During Anoscopy exams the THD Procto Software System records and displays images of the anorectal channel with the aid of a dedicated video camero;
  During Manometry exams the THD Procto Software System allows the visualization and storage of patient data and examination results (anorectal manometry pressure values) as measured by THD Anopress device.
  The different modules and associated hardware devices cannot interfere with each other neither can work simultaneously.

The provided text is a 510(k) Pre-Market Notification for the THD Procto Software System. It focuses on administrative changes and design control activities related to the addition of a new "Manometry Module" to an already cleared software system. This type of submission (Special 510(k)) indicates that the device modification does not raise new questions of substantial equivalence.

Crucially, the document does not contain the detailed performance study results, acceptance criteria, or information about the ground truth establishment, expert review, or sample sizes for a clinical performance study related to an AI/ML component. The "Performance Data" section ([8]) states that "Non clinical tests performed on the subject device. The software has been tested and validated according to the requirements of IEC 62304." and mentions "an integration test on the modified device."

Therefore, I cannot extract the requested information regarding acceptance criteria and the study that proves the device meets them, specifically relating to AI/ML performance, because such data is not present in this 510(k) document. This submission primarily focuses on the integration and functional verification of a new module.

Based on the provided text, the requested information cannot be found.
The document is a regulatory submission describing a software modification (addition of a manometry module) to an existing device, and it relies on non-clinical testing and conformity to standards like IEC 62304. It does not detail clinical performance studies for AI/ML components with human-in-the-loop performance, expert consensus on ground truth, or specific acceptance criteria for diagnostic accuracy.

The relevant section on "Performance Data" ([8]) explicitly states:

• "Non clinical tests performed on the subject device."
• "The software has been tested and validated according to the requirements of IEC 62304."
• "an integration test on the modified device has been performed in order to check the correct integration of the THD Procto Software... with the THD Anopress device, verifying that the additional Manometry Module performs the expected functions and dialogues correctly with the THD Anopress device."

This indicates fundamental functional and integration testing, not a clinical performance study with the metrics and details requested (e.g., AUC, sensitivity, specificity, expert consensus, MRMC studies, etc.).

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The THD Procto Software 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 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

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

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.

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.

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