(258 days)
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.
| Acceptance Criteria (Inferred from testing) | Reported Device Performance (Summary) |
|---|---|
| Biocompatibility | Compliance with ISO 10993-1, ISO 10993-5, ISO 10993-10 |
| Electrical Safety | Compliance with IEC 60601-1 |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2 |
| Software Verification & Validation | Compliance with IEC 62304 |
| Functional Performance & Accuracy | Comparable to the predicate device (K120088) for strain, squeeze, and resting pressures in simulated use conditions |
| Mechanical Performance (New & Aged) | No significant differences between new and aged samples; comparable to the predicate device where applicable |
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.
§ 876.1725 Gastrointestinal motility monitoring system.
(a)
Identification. A gastrointestinal motility monitoring system is a device used to measure peristalic activity or pressure in the stomach or esophagus by means of a probe with transducers that is introduced through the mouth into the gastrointestinal tract. The device may include signal conditioning, amplifying, and recording equipment. This generic type of device includes the esophageal motility monitor and tube, the gastrointestinal motility (electrical) system, and certain accessories, such as a pressure transducer, amplifier, and external recorder.(b)
Classification. Class II (performance standards).