(29 days)
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.).
§ 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.