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The Fecobionics Anorectal System is for use on patients requiring anorectal pressure studies and testing of defecatory function. The Fecobionics System must only be used by appropriately trained clinicians. The Fecobionics System enables evaluation of rectal volume and shape, rectoanal inhibitory reflex, anal diameter during defecatory push pressure, and anorectal angle changes. The Fecobionics device is only intended to be used in adult patients.

The Fecobionics Anorectal System (Fecobionics System) is a portable anorectal manometry device for use on patients requiring anorectal pressure studies and evaluation of defecatory function. The Fecobionics System consists of three main components: AR-100 Probe, DH-100 Data Hub, and Fecotracker App (installed on a provided PC-based laptop). The AR-100 Probe is a single-use, non-sterile disposable, battery-powered probe designed to be inserted manually into the rectum and wirelessly transmit data to the external Data Hub, which wirelessly sends the data to the PC with the Fecotracker App. The system provides clinicians with real-time manometric data and geometric mapping information in a single examination. The probe features a balloon designed to be filled with saline by means of a detachable fill tube and a Luer-Lock connection with a syringe. The inflation of the balloon allows the evaluation of sensation thresholds of the lower rectum and assesses and triggers Recto Anal Inhibitory Reflex (RAIR). To mimic the defecation process, the wireless probe is designed to be defecated as an untethered free distensible mass. In total, the Fecobionics System enables the evaluation of rectal sensitivity, rectal volume, and shape, recto anal inhibitory reflex, anal diameter during defecation, defecatory push pressure, and anorectal angle changes. The AR-100 Probe is 10cm long, and its interior bendable core is 10mm in diameter. When inflated with the allowed maximum saline inflation volume (100 mL), the balloon reaches a diameter of up to 5cm.

Here's an analysis of the acceptance criteria and study proving the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly state quantitative acceptance criteria for device performance beyond the successful completion of various tests. Instead, the acceptance criteria are largely implied by meeting the requirements of recognized standards and demonstrating "no difference," "comparable," or "high correlation" with the predicate device or expected results.

2. Sample Size Used for the Test Set and Data Provenance

The only explicitly mentioned test set with a sample size is the clinical study:

• Sample Size: 10 patients
• Data Provenance: The document states it was a "nonsignificant risk (NSR), observational, randomized clinical study." This implies a prospective study design. The country of origin of the data is not specified.

For the other performance tests (Biocompatibility, Electrical Safety, EMC, Software V&V, Functional Performance, Mechanical and Performance), the sample sizes are not explicitly stated. The provenance for these is "Preclinical and clinical tests" and "verification bench testing," implying laboratory or engineering testing.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

This information is not provided in the document. For the clinical study, it mentions "appropriately trained clinicians" are required to use the device, but it doesn't specify how many or their qualifications for establishing ground truth or evaluating the data. Given the comparative nature of the clinical study (comparing sensory measurements between the Fecobionics system and the predicate), it's likely the clinicians involved acted as evaluators, but their number and specific qualifications are not detailed.

4. Adjudication Method for the Test Set

This information is not provided in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

• No, an MRMC comparative effectiveness study was not done. The device described is a diagnostic tool (anorectal manometry system) for measuring physiological parameters, not an AI-assisted interpretation or diagnostic aid for human readers. It provides data for clinicians to interpret, but it doesn't mention an AI component that assists human reading.
• Therefore, there is no effect size related to human readers improving with AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• The document implies the device provides raw data and measurements to clinicians ("The Fecobionics System provides clinicians with real-time manometric data and geometric mapping information in a single examination"), rather than producing an automated diagnosis or interpretation. Thus, the concept of "standalone algorithm performance" as typically applied to AI diagnostics is not directly applicable here. The device itself is a measurement system.
• The "functional performance accuracy verification" and "mechanical and performance tests" can be considered standalone performance tests of the device's measurement capabilities. The clinical study, while involving patients and comparison, still focuses on the device's ability to accurately measure sensory parameters.

7. The Type of Ground Truth Used

For the clinical study:

• The ground truth for sensory measurements was established by comparison to the predicate device. The study looked for "high correlation... between the sensation levels and the volume data with the two technologies," implying the predicate device served as the reference for acceptable sensory measurement.

For the other performance tests:

• Engineering specifications and recognized standards served as the ground truth. For example, IEC 60601-1 for electrical safety, ISO 10993 for biocompatibility, and internal design requirements for mechanical and functional performance.

8. The Sample Size for the Training Set

• The document does not mention a training set in the context of an AI/ML algorithm. This indicates the device is not based on a machine learning model that requires a distinct training phase. The functional and clinical testing described are for verification and validation of a hardware and software system.

9. How the Ground Truth for the Training Set Was Established

• As there is no mention of a training set or AI/ML algorithm, this question is not applicable.

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RED is used to evaluate the neuromuscular function of the patient's ability to expel its contents from the rectum and as a qualitative test for rectal hypersensitivity. RED helps identify patients with rectal hypersensitivity who experience desire or urge-to-defecate at lower volumes of distension. RED is intended to be used in a clinical setting by trained health care providers in adult populations.

RED has been designed to duplicate test performance of traditional balloon expulsion test (BET) and manual sensation testing devices without needing electronics or software. The RED catheter consists of an open-cell foam ball encased inside of a balloon, coupled to a hollow catheter. The insertion end of the device has a rounded tip for comfortable insertion through the anus. Once inserted and opened, the catheter normalizes to atmospheric pressure which allows the foam to passively and safely expand to its original size. The volume of air it displaces when inflated in room air is 52ml. This passive expansion provides the same function as filling an empty balloon with water or air. When expanded, the volume of material inside the patient's rectum is perceived by the patient similar to how patients perceive stool, and this may trigger the desire to defecate. This is measured by asking patients the questions on perceived desire to defecate according to the London Classification that define the evaluation of rectal sensation. After the sensation evaluation, while in the seated or left lateral decubitus position, the patient is instructed to attempt to expel the device in a set amount of time. If the patient is unable to expel the device, the practitioner may gently remove the balloon manually.

The acceptance criteria and study proving the device meets these criteria are described below:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: 60 adults
• Data Provenance: Prospective clinical trial. The country of origin is not explicitly stated in the provided text.

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

The document does not explicitly state the number of experts or their qualifications used to establish the ground truth for the clinical trial. However, it mentions that patients with functional constipation were "defined by Rome IV criteria," which are internationally recognized diagnostic criteria established by experts in gastroenterology. The evaluation for rectified hypersensitivity also involved "querying on the patient perception to defecate," suggesting reliance on patient self-report interpreted within clinical guidelines.

4. Adjudication method for the test set:

The document does not explicitly describe an adjudication method (e.g., 2+1, 3+1). The "ground truth" for functional constipation was based on Rome IV criteria, and rectal hypersensitivity was determined by patient perception to defecate when the RED device was distended. This suggests reliance on established diagnostic criteria and patient report rather than an expert adjudication process for image or data interpretation.

5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance:

A multi-reader, multi-case (MRMC) comparative effectiveness study was not conducted. The RED device is described as operating without electronics or software, and is not an AI-assisted device. The study focused on the device's standalone performance and its comparison to traditional methods in terms of accessibility and ease of use.

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

Yes, a standalone performance study was done for the device in the context of its intended use. The RED device itself is a mechanical device, and its "standalone performance" refers to its ability to perform the balloon expulsion test and facilitate the qualitative assessment of rectal hypersensitivity as described, without additional electronic or software components. The clinical trial evaluated its performance in these applications.

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

• For functional constipation: Expert consensus-based diagnostic criteria (Rome IV criteria).
• For rectal hypersensitivity: Primarily patient perception/self-report regarding the desire or urge-to-defecate at lower volumes of distension, interpreted qualitatively.

8. The sample size for the training set:

The provided text describes a clinical trial for performance evaluation, not a machine learning model, therefore, there is no "training set" in the context of an algorithm.

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

As there is no machine learning model or training set, this question is not applicable.

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The Solar anorectal manometry catheter is a non-sterile, single patient use catheter for use on patient requiring anorectal manometry testing.

The Solar™ Anorectal Manometry Catheter is a high-resolution anorectal manometry (HRAM) catheter. It is a diagnostic device used to assess the function of anal and rectum muscles. The device consists of 10 air-charged sensing balloons which can sense pressures during anorectal manometry, along with a distal balloon used for the assessment of recto anal inhibitory reflex (RAIR). The catheter is disposable and non-sterile. Through manual insertion in the device assesses pressures within the anorectal anatomy as well as assessing sensation and reflexes. This product is non-sterile, single patient use catheter intended for use with a reusable Solar™ Anometry Charger on patients requiring lower gastrointestinal pressure measurements.

The provided text does not contain information about acceptance criteria for an AI/ML device or a study proving that such a device meets acceptance criteria. The document is an FDA 510(k) clearance letter for a Solar™ Anorectal Manometry Catheter, which is a medical device for measuring gastrointestinal motility, not an AI/ML product.

Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth for an AI/ML device from this document.

The document focuses on:

• The regulatory clearance of the catheter.
• Comparisons of the new catheter’s design and technology to a predicate device.
• Non-clinical bench performance testing (visual, dimensional, functional, destructive, biocompatibility, bioburden, transit simulation) for the catheter and its charger. These tests aim to demonstrate substantial equivalence to the predicate device, not the performance of an AI/ML algorithm.
• Usability assessment according to EN IEC 62366-1 for the device.

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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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The mcompass Biofeedback Anorectal Manometry System is for use on patients requiring anorectal pressure studies and biofeedback therapy.

The mcompass Biofeedback Anorectal Manometry System is a manometry system for the measurement of anorectal pressures. It provides visual feedback (biofeedback) of the muscle action allowing the patient to modulate the activity of the anorectal muscles, thereby reeducating the pelvic floor muscles. It is used in a clinical setting and consists of a non-sterile disposable catheter (2-channel or 5-channel), a previously cleared reusable RMD FOB (and related battery charger), and software that resides on a tablet PC and that collects, records and displays the pressure data. Air-charged balloons are used to measure contractile pressures of the anorectal canal and simulate a range of bowel fullness levels, in addition to measuring locational pressure at the distal tip of the catheter. During the clinical procedure, the distal end of the catheter is inserted in the anus/rectum of the patient. The proximal end of the catheter is connected via an integrated cable to the handheld RMD FOB which transmits real-time pressure data wirelessly to the mcompass software on the PC

The provided text describes a 510(k) premarket notification for the mcompass Biofeedback Anorectal Manometry System (K143031). It focuses on demonstrating substantial equivalence to a predicate device (mcompass Anorectal Manometry System, K120088) rather than detailing specific acceptance criteria and a study to prove they are met in the same way one might for a novel AI device.

Therefore, the requested information, particularly regarding AI-specific criteria, sample sizes for test/training sets, expert adjudication methods, and MRMC studies, is not present in this document. This document pertains to the regulatory clearance of a physical medical device.

However, I can extract the information that is present regarding performance data and validation:

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

Since this is a 510(k) submission for substantial equivalence to an existing device, a direct "acceptance criteria" table with numerical performance targets similar to a novel AI algorithm's sensitivity/specificity is not explicitly stated. Instead, the "performance data" section focuses on demonstrating that the new device meets various safety and functional standards, and that its technological differences do not raise new questions of safety or effectiveness compared to the predicate.

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The mcompass Anorectal Manometry System is for use on patients requiring anorectal pressure studies.

The mcompass device is a manometry system for the measurement of anorectal pressures. It is used in a clinical setting and consists of a non-sterile disposable catheter, a reusable RMD FOB, and software that resides on a tablet PC that collects, records and displays data. During the clinical procedure, the distal end of the catheter is inserted in the anus/rectum of the patient. The proximal end of the catheter is connected via an integrated cable to the handheld RMD FOB which transmits real-time pressure data wirelessly to the mcompass software on the PC. Pressures are measured via four small, air-charged, radial balloons evenly spaced around the distal circumference of the catheter and a fifth larger balloon, positioned near the distal tip. The four small balloons measure radial contractile pressures of the anorectal canal while the most distal balloon is used to simulate a range of bowel fullness levels, in addition to measuring locational pressure.

The Medspira mcompass™ Anorectal Manometry System did not report specific acceptance criteria or detailed study results in the provided document. The submission is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting full clinical trial data with predefined acceptance criteria.

The information provided describes the device, its intended use, predicate devices, and the types of testing performed to ensure its functional and performance requirements.

Here's a breakdown of the available information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria:
Specific quantitative acceptance criteria (e.g., accuracy thresholds, sensitivity/specificity targets) for the device's clinical performance are not explicitly stated in the provided document. The submission focuses on compliance with general functional, safety, and performance requirements through various standards.

Reported Device Performance:
The document states that "representative samples of the device underwent mechanical, electrical, and biocompatibility testing in accordance with the applicable industry standards." However, the quantitative results or specific performance metrics from these tests (e.g., exact pressure measurement accuracies, reliability figures) are not provided. The conclusion is simply that the device design "met its functional and performance requirements" and is "substantially equivalent" to predicate devices.

2. Sample Size for Test Set and Data Provenance

No information regarding a "test set" in the context of clinical performance or algorithm evaluation is provided. The functional and safety testing mentioned likely refers to laboratory-based engineering and safety tests rather than a clinical study test set for assessing diagnostic or prognostic performance. Therefore, sample size for a test set and data provenance (country of origin, retrospective/prospective) are not applicable or not reported.

3. Number of Experts and Qualifications for Ground Truth

No information regarding a clinical study involving human experts to establish ground truth is provided. The device is a measurement system, and its "ground truth" would typically relate to the accuracy of its physical measurements against known standards, which is addressed by the functional and performance testing mentioned.

4. Adjudication Method

As no clinical study with human interpretation or expert-based ground truth is described, adjudication methods are not applicable or not reported.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC study is mentioned. This device is a measurement system, not an AI-assisted diagnostic tool that would typically involve human readers interpreting output.

6. Standalone (Algorithm Only) Performance Study

The document does not describe an "algorithm only" performance study in the context of AI. The device includes software that "collects, records and displays data," implying a user interface for clinicians. The performance described relates to the accuracy of pressure measurements by the system as a whole.

7. Type of Ground Truth Used

For the functional and performance testing mentioned:

• Physical standards/calibrations: The "ground truth" for pressure measurements would be established through calibrated pressure sources and other physical reference standards used during the mechanical and electrical testing.
• Industry standards: Biocompatibility testing relies on established biological evaluation standards (ISO 10993 series).

8. Sample Size for Training Set

The document does not describe the use of machine learning algorithms requiring a "training set" in the context of AI. The software primarily handles data collection, recording, and display. Therefore, sample size for a training set is not applicable or not reported.

9. How Ground Truth for Training Set Was Established

As no training set for a machine learning algorithm is mentioned, this information is not applicable or not reported.

In summary: The provided document is a 510(k) summary for a medical device that measures anorectal pressures. It demonstrates substantial equivalence through compliance with safety and performance standards rather than presenting detailed clinical performance data with specific acceptance criteria, clinical study designs, or AI-specific evaluation metrics. The "study" referenced refers to laboratory-based functional, electrical, and biocompatibility testing against recognized industry standards.

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The SarMed Single Use Esophageal Manometry Catheters and Ano-Rectal Manometry Catheters are intended for Manometry analysis of Gastro-Intestinal and Ano-Rectal Tract.

The SarMed Single Use Esophageal Manometry Catheters and Ano-Rectal Manometry Catheters are indicated for patients where Gastro-Intestinal and Ano-Rectal tracts pressure measurements are required, such as for detection of GI tract disorders. The products are to be used by a trained physician.

The SarMed Single Use Esophageal Manometry and Ano-Rectal Manometry Catheters are available in some different configurations, respect to number of lumen and number of tubes. They are designed to be connected to a manometric infusion pump and allow, by the way of a defined number of holes, the measurement of pressure on the Gastro-Intestinal and Ano-Rectal Tract.

This document is a 510(k) Premarket Notification for SarMed Single Use Esophageal Manometry Catheters and Single Use Ano-Rectal Manometry Catheters. It describes the device, its intended use, indications for use, and a comparison to predicate devices. It does not contain acceptance criteria or a study demonstrating device performance against specific metrics.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets them from the provided text. The document focuses on establishing substantial equivalence to legally marketed predicate devices, rather than presenting de novo performance study results with specific performance metrics.

Specifically, the document states:

• "The SarMed Single Use Esophageal Manometry Catheters and Ano-Rectal Manometry Catheters has been tested for biocompatibility and meets the requirements of ISO 10993-1 schemes, for the intended use of the devices." (Page 1)
• "The catheters in object are technologically equivalent to the predicate devices above listed, both in physical than in design characteristics." (Page 1)
• The FDA letter confirms "substantial equivalence (for the indications for use stated in the enclosure) to legally marketed predicate devices." (Page 2)

This indicates that the submission relies on demonstrating similarity to existing devices and meeting a general biocompatibility standard, not on a new clinical or performance study with defined acceptance criteria and detailed performance metrics.

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The Mediplus Single Use Anorectal GI Manometry Catheter is intended for waterperfused manometry of the anorectal GI tract.

The Mediplus Single Use Anorectal GI Manometry catheter is indicated for use when measurements of gastrointestinal tract pressures are needed to assist in the diagnosis of suspected colonic and anorectal disorders. The product is for use by a trained physician.

Mediplus Single Use Anorectal GI Manometry Catheters are designed for the monitoring of anorectal canal pressure. They are designed to be used with a manometric infusion pump. The major structure of the Mediplus Anorectal GJ Manometry Catheter is a multilumen PVC tube.

The catheters are designed with variations of the configuration of the channels (depending on the model and application). The catheter facilitates the measurement of pressure at a fixed number of points along the anorectal gastrointestinal tract when correctly installed to water perfusion manometry transducer equipment. Measurement is accomplished by perfusion of water through each catheter lumen. Each column of water transmits pressure to a transducer. The equipment terminates in a pressure transducer and 3-way tap.

The provided text describes a 510(k) premarket notification for the "Mediplus Single Use Anorectal Manometry Catheter." This document focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific performance acceptance criteria.

While the document states that the device has been tested for biocompatibility and meets the requirements of ISO 10993 and USFDA 510(k) Memorandum - # K951 for the intended use, it does not provide a table of acceptance criteria for specific performance metrics (e.g., pressure accuracy, flow rates, durability) or a study report detailing how those criteria were met.

Therefore, many of the requested details about performance studies, sample sizes, ground truth establishment, and expert involvement are not available in the provided text.

Based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Not provided. The document states testing was done for biocompatibility and 510(k) memorandum requirements, but does not specify sample sizes or data provenance for these tests. This is a 510(k) submission, which primarily focuses on substantial equivalence rather than detailed clinical performance studies often submitted for PMAs.

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

• Not applicable/Not provided. The type of testing mentioned (biocompatibility, technological equivalence) does not typically involve expert review for ground truth in the same way clinical diagnostic device studies would.

4. Adjudication method for the test set:

• Not applicable/Not provided.

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 an anorectal manometry catheter, not an AI-powered diagnostic imaging device. No MRMC study was done.

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

• Not applicable. This is a medical device, not a standalone AI algorithm. It is used by a "trained physician."

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

• For biocompatibility, the ground truth would be established by validated test methods and standards (e.g., ISO 10993).
• For technological characteristics, the ground truth is the specifications and materials of the predicate device.
• No other ground truth relevant to clinical performance is discussed.

8. The sample size for the training set:

• Not applicable/Not provided. There is no mention of a "training set" as this is not an AI/machine learning device.

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

• Not applicable/Not provided.

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The Medtronic Single Use Esophageal Manometric Catheter is intended for water-perfused manometry of the GI tract.

The Medtronic Single Use Anorectal Manometric Catheter is intended for water-perfused manometry of the rectal and anal canal.

The Medtronic Single Use Esophageal Manometric Catheter is intended for water-perfused manometry of the GI tract. The Medtronic Single Use Anorectal Manometric Catheter are intended for water-perfused manometry of the rectal and anal tract.

These catheters consist of a multi-lumen PVC tube connected to multiple PVC capillary tubes. The capillary tubes connect to pressure transducers of an infusion system that perfuses each lumen of the catheter with water. Pressure measurements are made at side holes in the multi-lumen PVC tube along the gastro-intestinal tract. A silicone balloon is attached to the end of the catheter body of the anorectal model.

The provided text describes a 510(k) premarket notification for Medtronic Single Use Esophageal Manometric Catheter and Medtronic Single Use Anorectal Manometric Catheter. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting new clinical study data with specific acceptance criteria and performance metrics for a novel AI device.

Therefore, the document does not contain the detailed information requested regarding:

1. A table of acceptance criteria and reported device performance.
2. Sample size and data provenance for a test set.
3. Number and qualifications of experts for ground truth establishment.
4. Adjudication method for a test set.
5. MRMC comparative effectiveness study results.
6. Standalone algorithm performance.
7. Type of ground truth used (e.g., pathology, outcomes data).
8. Sample size for the training set.
9. How ground truth for the training set was established.

Instead, the document states:

• No applicable mandatory performance standards or special controls exist for this device. This indicates that the device is not subject to specific quantifiable performance targets set by regulatory bodies.
• In-vitro testing was performed to support substantial equivalence to the predicate devices. This implies that the testing focused on demonstrating that the device performs similarly to existing, cleared devices, rather than meeting novel performance criteria.
• The results of this testing indicate that the Medtronic Single Use Esophageal Manometric Catheter and Medtronic Single Use Anorectal Manometric Catheter meet all of the design and performance requirements. While this broadly states the device meets "requirements," it does not specify what those requirements are or provide quantitative performance metrics.

In summary, this 510(k) submission does not include the type of detailed performance study and acceptance criteria specific to an AI/ML device that would typically be described in the requested format. Its purpose is to demonstrate substantial equivalence to predicate devices through biocompatibility and in-vitro functional testing, not to quantify diagnostic or clinical accuracy against a defined ground truth using a clinical study.

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