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The THD Anopress device must be used exclusively to assess the average sphincter tone due to the pressure exerted by the muscles in the anal canal on the specially designed THD Probes. THD Anopress must only be used by appropriately trained medical staff.

Furthermore, the THD SensyProbe enables evaluation of rectal sensitivity and capacity and the ano-rectal inhibitory reflex through connection to a syringe and filling of the balloon on the probe with air.

The THD Anopress with THD SensyProbe is intended to be used in adults only.

THD Anopress with THD SensyProbe is a handheld, portable anorectal manometry device for its use on patients requiring anorectal pressure studies and evaluation of functional rectal and pelvic diseases.

The subject device consists of two main components:

• . THD Anopress: This is the main unit with a keyboard for the selection of input command for pressure measurement and display for the visualization of detected pressure parameters in real time;
• . THD Probes, grouped in THD PressProbe and THD SensyProbe
  • THD PressProbe is non-sterile disposable probe to be connected via the dedicated Luer-Lock connector to the THD Anopress. The probe is charged with air by the pump contained into the THD Anopress main unit and then is introduced into the anal canal of patient for the detection of pressure.
  • THD SensyProbe keeps the same characteristics of the THD PressProbe but it is additionally featured with a balloon positioned on the top of the introducer that is designed to be filled with air by the mean of a second inflation line and a Luer-Lock connection with a syringe. The inflation of the balloon with air allows the evaluation of the sensation thresholds of the lower rectum and to assess and trigger what is known as Recto Anal Inhibitory Reflex (RAIR).

THD Anopress may be used in conjunction with a PC for data storage (not provided with THD Anopress). For this purpose, the PC requires installation of a dedicated program (Anopress SW) and the insertion of the Bluetooth Dongle accessory into the USB port. The Bluetooth dongle as well as Anopress SW are optionally provided by THD SpA.

THD PressProbe membrane has a diameter varying from 14,4 mm (empty membrane) to 16,6 mm (membrane inflated to 150 mmHg).

THD PressProbe is inflated to 150 mmHg, then it is inserted in the anal canal so that the sphincter exerts a compression on the membrane until 390 mmHg.

THD SensyProbe membrane has the same diameter and performances as the THD PressProbe. The additional balloon positioned on the top of the introducer reaches a diameter of 70 mm when inflated with 200 ml of air. The allowed maximum inflation volume for distal end balloon is 180 ml of air.

The provided text describes the THD Anopress with THD SensyProbe, a device for anorectal manometry and evaluation of rectal sensitivity. However, it does not contain acceptance criteria for the device's performance nor a study that explicitly demonstrates the device meets these criteria.

Instead, the document focuses on:

• Substantial Equivalence: The primary goal of this 510(k) summary is to demonstrate that the THD Anopress with THD SensyProbe is substantially equivalent to previously cleared predicate devices (THD Anopress K161785 and Medspira Mcompass K120088).
• Performance Data (Non-Clinical): It mentions non-clinical tests that were performed or referenced from the predicate device (K161785) to ensure safety and basic functionality. These include biocompatibility, electrical safety, EMC, software verification, and mechanical performance tests.
• Clinical Literature: It lists clinical literature used to support the indications for use, not a specific study proving the device meets quantifiable performance metrics.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance or information about sample sizes, expert ground truth, adjudication, MRMC studies, or standalone performance for a specific performance evaluation study of this device meeting its own acceptance criteria.

Here's a breakdown of what is provided regarding performance and studies, in relation to your questions:

1. A table of acceptance criteria and the reported device performance

• Not provided. The document does not specify quantitative acceptance criteria (e.g., specific accuracy thresholds for pressure measurements, sensitivity, or specificity for detecting conditions). It broadly states that "Obtained results demonstrate compliance to the standards" or "The performances and the accuracy obtained are comparable with the predicate devices for all the products tested." This indicates compliance with established standards and comparability to predicates, but not a pre-defined set of performance criteria for this specific device.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not provided. The non-clinical tests mentioned do not detail sample sizes of devices or test conditions beyond "different THD Anopress and different THD PressProbe" for functional performance. No clinical test set data is presented.

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. No clinical test set with expert-established ground truth is described in this document.

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

• Not applicable. No clinical test set with adjudication is described.

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 device for physiological parameters, not an AI-assisted diagnostic tool involving human readers.

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

• No standalone performance data for a diagnostic algorithm is presented. The device itself is a standalone measurement system. The document does not describe an "algorithm only" performance for a diagnostic task.

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

• Not applicable for clinical ground truth. For the non-clinical performance tests, the "ground truth" would be established calibration standards and engineering specifications.

8. The sample size for the training set

• Not applicable. This document describes a medical device, not an AI/ML model with a discreet training set.

9. How the ground truth for the training set was established

• Not applicable. As above, no training set for an AI/ML model is described.

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The THD Anopress device must be used exclusively to assess the average sphincter tone due to the pressure exerted by the muscles in the anal canal on the specially designed THD Press Probe. THD Anopress may only be used by appropriately trained medical staff.

THD Anopress is a handheld, portable anorectal manometry device for measuring anal pressure, and especially the average sphincter tone, at the bedside on adult patients population.

The subject device consists of two main components:

• THD Anopress: This is the main unit with a keyboard for the selection of input command for pressure measurement and display for the visualization of detected pressure parameters in real time;
• THD Press Probe: This is a non-sterile disposable probe to be connected via the dedicated Luer-Lock connector to the THD Anopress. The probe is charged with air by the pump contained into the THD Anopress main unit and then is introduced into the anal canal of patient for the detection of pressure.

THD Anopress may be used in conjunction with a PC for data storage (not provided with THD Anopress). For this purpose, the PC requires installation of a dedicated program (Anopress SW) and the insertion of the Bluetooth Dongle accessory into the USB port. The Bluetooth dongle as well as Anopress SW are optionally provided by THD SpA

THD PressProbe membrane has a diameter varying from 14,4 mm (empty membrane) to 16,6 mm (membrane inflated to 150 mmHg).

THD Press Probe is inflated to 150 mmHg, then it is inserted in the anal so that the sphincter exerts a compression on the membrane until 390mmHg.

The provided text describes the THD ANOPRESS device, categorized as a Gastrointestinal Motility Monitoring System (Class II, 21 CFR 876.1725; KLA). The device is intended to assess the average sphincter tone due to the pressure exerted by the muscles in the anal canal.

Based on the provided document, here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of "acceptance criteria" for performance in the typical sense of numerical thresholds for sensitivity, specificity, accuracy, etc., as one might find for diagnostic algorithms. Instead, the performance evaluation for this device is based on showing compliance with established standards and comparable performance to a predicate device. The "acceptance criteria" can be inferred as meeting these standards and demonstrating comparability.

2. Sample size used for the test set and the data provenance

The document does not describe a "test set" in the context of an AI/algorithm-based device using data for performance evaluation. The "tests" performed are primarily engineering and bench testing on the device itself and its components. Therefore, information on sample size and data provenance (country of origin, retrospective/prospective) for a data-driven test set is not applicable to this submission. The "samples" referred to are physical units of the THD Anopress and THD Press Probe for mechanical and functional testing.

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

This information is not applicable as the submission does not involve a data-driven "test set" requiring expert-established ground truth. The device is a measurement system, and its performance is evaluated against physical standards and comparison to a predicate, not against a clinical "ground truth" established by experts on a dataset.

4. Adjudication method for the test set

This information is not applicable for the reasons stated above.

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

An MRMC comparative effectiveness study is not applicable to this device. The THD ANOPRESS is a direct measurement device, not an AI or imaging system that assists human readers in interpretation. The document explicitly states "No clinical tests were performed on the subject device."

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

This concept is not applicable. The THD ANOPRESS is a hardware device with embedded software for measuring anal pressure, not an AI algorithm that performs a standalone diagnosis or analysis. Its performance is inherent to its functional design as a measurement tool.

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

The "ground truth" for this device's performance evaluation lies in the established technical standards (e.g., IEC, ISO) for medical devices and the performance characteristics of the legally marketed predicate device (Medspira Mcompass, K120088). The device is assessed based on its ability to accurately measure pressure in simulated conditions, its compliance with safety and compatibility standards, and its comparability to the predicate's known performance for parameters like resting pressure, squeeze pressure, etc.

8. The sample size for the training set

This information is not applicable. The THD ANOPRESS is not an AI/machine learning device that requires a "training set" to learn from data.

9. How the ground truth for the training set was established

This information is not applicable for the reasons stated above.

In summary:

The submission for the THD ANOPRESS focuses on demonstrating substantial equivalence to a predicate device through engineering and bench testing, compliance with relevant international standards, and functional comparison. It is explicitly stated that "No clinical tests were performed on the subject device." This type of submission does not involve AI or machine learning, and therefore, many of the requested elements pertaining to data sets, expert review, and algorithm performance are not relevant or present in the document.

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