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The non-contact forehead thermometer is an electronic thermometer using an infrared detector (thermopile detector) to detect body temperature from forehead center in people of all ages.

The thermometer (Mode: TH48FE, TH09F, THD2FE) are electronic thermometer using an IR sensor to measure infrared energy radiated from the forehead. This energy is collected through the lens and converted to an oral temperature value. The thermometer consists of an IR sensor with a built-in ambient temperature sensor, Application-Specific Integrated Circuitry including software, LCD display, buttons, and batteries.

The provided text describes a 510(k) premarket notification for a non-contact forehead thermometer. While it discusses the device's accuracy and clinical validation, it does not detail a study that proves the device meets complex acceptance criteria for an AI/ML-driven medical device, as typically outlined for such systems. The acceptance criteria and study described are for a traditional medical device (a thermometer), focusing on its accuracy and safety standards rather than AI performance metrics.

Therefore, for AI/ML specific criteria like MRMC studies, ground truth establishment for AI training/testing, or separate human-in-the-loop vs. standalone AI performance, the provided document does not contain this information. The questions will be addressed based on the information available in the document, and limitations will be noted where information is absent.

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

The device in question is a Non-contact Forehead Thermometer (Models TH48FE, TH09F, THD2FE), which is a traditional electronic medical device, not an AI/ML system. Therefore, the "acceptance criteria" and "study" described in the document relate to the performance of a thermometer, primarily its accuracy and compliance with relevant standards, rather than the complex AI/ML evaluation metrics (like sensitivity, specificity, MRMC studies, etc.) typically associated with AI-driven devices.

Here's a breakdown of the requested information based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

For a non-contact forehead thermometer, the primary performance criterion is accuracy.

Note: The document implies these are "acceptance criteria" by stating the device "met all design specifications" and "complied with" or "meet" the standards.

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

• Sample Size for Clinical Accuracy Validation (Test Set): 113 subjects.
• Data Provenance: Not explicitly stated, but the submission is from a Taiwan-based manufacturer (Radiant Innovation Inc.). It also doesn't specify if the clinical trial was retrospective or prospective, but clinical accuracy validation trials per ISO standards are typically prospective.

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

The document does not specify the number or qualifications of experts used to establish ground truth for the thermometer's clinical accuracy. For thermometer testing, "ground truth" typically refers to core body temperature measured by a highly accurate reference method (e.g., rectal thermometer in a controlled setting) against which the test device's readings are compared. This usually involves clinical staff following a standardized protocol rather than a panel of "experts" as in AI image interpretation.

4. Adjudication method for the test set

Not applicable/not specified. For simple temperature measurement, "adjudication" in the sense of resolving disagreements between multiple readers (as in AI image analysis) is not relevant. The ground truth would be established by the reference standard measurement.

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 standalone non-AI thermometer. There is no AI component or human-in-the-loop aspect for which an MRMC study would be performed.

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

This device is a "standalone" device in the sense that it provides a temperature reading without human interpretation beyond reading the display. Its "algorithm" is the internal software that converts IR signals to an oral temperature value. The document states:

• "Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Content of Premarket Submissions for Device Software Functions"."
• "The software for this device was considered as a "Basic" documentation level."

This confirms that the device's internal software/algorithm performance was validated.

7. The type of ground truth used

The ground truth for the clinical accuracy validation would be a reference body temperature measurement, typically obtained using a highly accurate clinical thermometer (e.g., a rectal thermometer) under controlled clinical conditions, as per the methodology outlined in ISO 80601-2-56 for clinical accuracy validation of medical thermometers. This is implicit in "Clinical Accuracy Validation."

8. The sample size for the training set

Not applicable. This is a traditional medical device, not an AI/ML device that requires a "training set" for model development. The internal software/firmware is developed and verified, not "trained" on data in the AI sense.

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

Not applicable, as there is no "training set" for this type of device.

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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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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 THD Revolution is intended to be used for the surgical treatment of hemorrhoidal disease. This treatment is based on the Doppler-guided Transanal Haemorrhoidal Dearterialization technique.

The technique consists of locating and ligating the terminal branches of the superior haemorrhoidal artery using the THD Revolution device and the compatible single-use THD kits.

THD Revolution and its accessories may exclusively be used by specialist physicians for ligation of the terminal branches of the superior haemorroidal artery in hospital facilities (or suitable aseptic outpatient facilities). Furthermore, by using the optic fiber accessory of the THD Revolution, it can be used in modality "Light Source", to support the different THD diagnostic devices.

Identically to the predicate devices K090009, K081429 e K070815, the THD Revolution is a 8 MHz continuous wave (CW) Doppler detector with a loudspeaker and a light source.

Further, as the predicate device, the THD Revolution doppler is used with dedicated accessories (optical fiber and pneumatic foot pedal) and a dedicated kit containing a proctoscope, needle holder, knot tightener, sutures, doppler probe and Surgy proctoscope in order to allow the surgical operation through the Transanal Hemorroidal Dearterialization (THD) technique.

The provided document is a 510(k) Summary for the THD Revolution device. It describes the device, its intended use, and its equivalence to previously cleared predicate devices. It also details performance testing, but it does not contain typical "acceptance criteria" and "reported device performance" in the format of a table as might be found in a study for a new AI/software device. This is due to the nature of the device (a nonfetal ultrasonic monitor with a light source used for surgical treatment) and the type of submission (a 510(k) for substantial equivalence to existing devices, not a de novo submission for a novel device).

Therefore, I will extract the closest relevant information from the document to construct the answer, particularly from "2.8 Performance data", highlighting the differences and similarities with predicate devices which serve as the basis for substantial equivalence.

Here's a breakdown of the requested information based on the provided text:

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

The document does not specify formal, quantitative acceptance criteria for the THD Revolution as a new, standalone device, nor does it present "reported device performance" against such criteria in a typical tabular format. Instead, it demonstrates substantial equivalence to predicate devices by showing that the THD Revolution's performance is either the same as or improved upon the predicate devices without raising new safety questions.

The "performance data" section focuses on:

• Compliance with recognized standards.
• Acoustic signal quality, specifically addressing the improved clarity due to DSP technology.
• Light source efficacy and photobiological safety.
• Clinical effectiveness in treating hemorrhoidal disease, extending to Grade IV.

Here's an attempt to synthesize the information into a table format, focusing on the comparisons made:

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

The document primarily relies on two clinical studies for surgical efficacy:

• Study 1: Giorndano P, et al. Colorectal Dis. 2014 May;16(5):373-6.

  • Sample Size: 31 patients.
  • Data Provenance: Not explicitly stated, but authors' names and journal suggest potential European origin. The abstract mentions "Colorectal Dis." which is a UK-based journal.
  • Retrospective/Prospective: Not explicitly stated, but typical for such intervention studies, it would likely be prospective observation or a clinical trial. The text says "were operated," which could imply retrospective data collection on outcomes, but the context of proving effectiveness for Grade IV hemorrhoids often means dedicated follow-up.

• Study 2: Morrett R.S. Crujano General. Vol 34 Num 2; 2012.

  • Sample Size: 250 patients (including 21 patients with Grade IV hemorrhoids).
  • Data Provenance: "Crujano General" is likely "Cirujano General," a Spanish-language journal for general surgeons, suggesting data from a Spanish-speaking country (e.g., Mexico, Spain, Latin America).
  • Retrospective/Prospective: Not explicitly stated. Similar to Study 1, "were operated" suggests observation of outcomes post-procedure.

For technical performance (acoustic output, signal quality, luminous efficacy), the "tests were conducted" using the THD Revolution and predicate devices. No sample size of devices or specific data provenance is mentioned beyond "a THD Revolution prototype representative of the standard THD SpA production."

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)

This section is not applicable in the context of this device and submission. The performance of the THD Revolution is evaluated based on its physical/electrical characteristics and clinical outcomes (e.g., recurrence, pain, satisfaction) as reported in surgical studies, rather than by human expert interpretation of output (like in imaging AI). The "ground truth" for surgical efficacy is the patient's clinical outcome after the procedure, as assessed by the operating physician and patient reporting.

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

This is not applicable. The clinical studies cited concern surgical outcomes, not diagnostic interpretations requiring adjudication.

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

This is not applicable. The THD Revolution is a surgical device, not an AI software intended to assist human readers in interpretation. There are no "readers" involved in this use case, and thus no MRMC study or AI assistance effect size.

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

This is not applicable. The THD Revolution is a hardware device (an ultrasonic monitor with a light source) used by a surgeon. It does not operate as a standalone algorithm in the sense of AI or software. Its operation is always "human-in-the-loop" as it requires a specialist physician to use it for diagnosis and surgery.

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

For the clinical effectiveness data:

• Outcomes data: The primary ground truth for clinical efficacy is the patient's clinical outcome (e.g., resolution of hemorrhoids, absence of intra-operative complications, recurrence rates, post-operative pain levels, patient satisfaction). This is determined by the treating physicians' assessments and patient self-reports.

For the technical performance data (acoustic output, luminous efficacy, safety):

• Objective measurements and international standards: Ground truth is established by objective measurements using calibrated equipment (e.g., illuminance meter) and compliance with recognized international standards (e.g., IEC 60601-1, IEC 60601-2-37, IEC 60601-1-2, IEC 62471).

8. The sample size for the training set

This is not applicable. The THD Revolution is a hardware device. It does not use Machine Learning or AI models that require a "training set" of data.

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

This is not applicable, as there is no training set for this device.

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The THD N-Ano Anoscopes, are intended for physician use to examine the anal sphincter, anus, rectum to perform various diagnostic and therapeutic procedures.

The disposable, not sterile THD N-ano anoscope is a disposable, not sterile anoscope with an integrated LED light source. The device is designed for the examination o the anal sphincter, anus, rectum to perform various diagnostic and therapeutic procedures. The light source is integrated on the handle. Differently than predicate devices (Family of THD disposable Anoscopes, Proctoscopes, Rectoscopes and Light-scope - K103647) disposable, not sterile THD N-ano Anoscope does not have any accessory and is available only "not sterile"

The provided text describes a 510(k) summary for the THD N-ANO ANOSCOPE, which is a medical device. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with acceptance criteria for device performance in a clinical or diagnostic setting. Therefore, most of the requested information regarding acceptance criteria, study design, expert involvement, and ground truth establishment is not present in the provided text.

The document highlights modifications made to the THD N-ANO ANOSCOPE compared to its predicate device (THD S.p.A. Family of THD disposable Anoscopes, Proctoscopes, Rectoscopes and Light-scope, K103647). The review process involves design control activities, risk analysis, and a declaration of conformity, aiming to ensure that the modifications do not adversely affect the safety and performance of the device.

Here's a breakdown of the information that can be extracted or deduced from your input:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria for device performance in terms of diagnostic accuracy or clinical outcomes. Instead, the "acceptance criteria" are implied to be substantial equivalence to the predicate device, meaning the modified device performs as safely and effectively as the original device.

The reported "performance" relates to the design and materials of the device, rather than diagnostic metrics.

• LED light source block eliminated (due to handle modification).
• Cover of LED light source circuit made of ABS Terluran (vs. ABS Lustran in predicate).
• Dimensions are "not more critical than dimensions of predicate devices" (Length: 105mm vs. 90mm/130mm, Diameter: 21.7mm vs. 22.1mm/26.1mm/15.1mm).
• White polypropylene tip on introducer eliminated. |
  | Intended Use Equivalence | The THD N-Ano Anoscope is indicated for the same intended use: "to examine the anal sphincter, anus, rectum to perform various diagnostic and therapeutic procedures." |
  | Materials Equivalence | Manufactured with the same materials and the same process as the predicate family of devices. |

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

Not applicable. The document does not describe a test set or clinical study to evaluate diagnostic performance. The evaluation is focused on engineering and design changes and their impact on substantial equivalence.

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

Not applicable. No ground truth for a test set is established in this document as it's not a clinical performance study.

4. Adjudication Method for the Test Set

Not applicable. No test set or expert adjudication is described for clinical performance evaluation.

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

No. The document does not mention any MRMC study or an assessment of human reader improvement with or without AI assistance. This device is a physical instrument, not an AI or diagnostic software.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No. This is not an algorithm or AI-driven device, so a standalone performance study in that context is not relevant.

7. Type of Ground Truth Used

Not applicable in the context of diagnostic performance. The "ground truth" here is the predicate device and its established safety and efficacy, to which the modified device is compared through design and material analysis.

8. Sample Size for the Training Set

Not applicable. No training set is mentioned as this is not an AI or machine learning device.

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

Not applicable.

Summary of the Document's Focus:

This 510(k) summary is for a medical device (anoscope) where the manufacturer is seeking FDA clearance based on substantial equivalence to a previously cleared predicate device. The changes described are primarily related to mechanical design (handle, LED light source integration, dimensions) and material of a component. The "study" referenced implicitly is the design control process, risk analysis, and material compatibility assessment to demonstrate that these modifications do not alter the fundamental safety or effectiveness of the device compared to the predicate. It is not a clinical trial evaluating diagnostic accuracy or a performance study of AI.

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The family of disposable, sterile and not sterile THD Anoscope, Proctoscope, Rectoscope and Light-scope is intended for physician use to examine the anal sphincter, anus, rectum, and to perform various diagnostic and therapeutic procedures by using additional accessories.

The Family of disposable, sterile and not sterile THD Anoscope, Proctoscope, Rectoscope and Light-scope are disposable, sterile rectoscopes, proctoscope and anoscopes with a light source which can be external or integrated on the handle. The devices are designed for the examination and treatment of anus (anoscopes) and the examination of rectum (proctoscopes and rectoscopes). The devices consist of plastic anoscopes, proctoscopes for diagnostic or therapeutic use. The Family of disposable, sterile and not sterile THD Anoscope, Proctoscope, Rectoscope and Light-scope is made by two categories of devices: Diagnostic Anoscopes, Proctoscopes and Rectoscopes and Surgical Proctoscopes. The Family of disposable, sterile and not sterile THD Anoscope, Proctoscope, Rectoscope and Light-scope includes both models which require the external light source and models which not require the external light source. In the latter case the light source is integrated on the handle. The external light source is provided as an accessory of the device family and it can be the THD Shining Light and the THD pen light.

The manufacturer, THD S.p.A., submitted a 510(k) premarket notification for a "Family of disposable, sterile and not sterile THD Anoscope, Proctoscope, Rectoscope and Light-scope". This submission is for device modifications to an already approved product family (K103647). The modifications include the availability of THD Light-scope devices in sterile condition and changes to the handle materials (ABS Terluran and ABS Novodur replacing ABS Lustran).

The document does not describe a study involving AI, human readers, or a test set in the traditional sense of diagnostic or clinical performance studies. Instead, the provided text details design verification tests to ensure the updated device's safety and effectiveness due to manufacturing material and sterilization changes.

Here's an analysis based on the provided text, focusing on the acceptance criteria and the "study" (design verification tests) that proves the device meets them, as much as possible given the context of a medical device modification submission:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size for the Test Set and Data Provenance

The document does not detail specific sample sizes for these design verification tests. The tests are related to material changes and sterilization processes, so "test set" here refers to the samples of the modified devices subjected to validation. The data provenance is internal to THD S.p.A., an Italian company, performing design verification tests for a 510(k) submission to the FDA. These would be prospective tests performed on the modified devices.

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

For these types of engineering and sterilization validation tests, "experts" typically refers to qualified engineers, microbiologists, and materials scientists involved in the testing and evaluation process. The document does not specify the number or qualifications of these experts. The "ground truth" for these tests is established by industry standards, regulatory requirements, and validated test methodologies for sterilization efficacy and material biocompatibility/durability.

4. Adjudication Method for the Test Set

Not applicable in the context of these design verification tests. Adjudication methods like 2+1 or 3+1 are used for clinical trial endpoints or image interpretation by multiple readers. Here, the outcome of the tests (e.g., successful sterilization, material integrity) is determined by objective measurements against established criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This document describes a 510(k) submission for device modifications concerning materials and sterilization, not a diagnostic AI device requiring clinical performance or human reader studies.

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

No, a standalone algorithm performance study was not done. This device is a physical medical instrument (anoscope, proctoscope, rectoscope, light-scope), not an AI algorithm.

7. The Type of Ground Truth Used

The ground truth used for these design verification tests is based on:

• Sterilization Validation Standards: Demonstrating that the sterilization process achieves a specified sterility assurance level (SAL), typically accepted industry standards (e.g., ANSI/AAMI/ISO 11135 for ethylene oxide, or similar for other methods).
• Material Safety Standards: Demonstrating the biocompatibility and physical properties of the new handle materials meet safety and performance requirements, often referencing ISO standards (e.g., ISO 10993 for biocompatibility) and relevant engineering specifications.
• Packaging Integrity Tests: Ensuring the packaging maintains sterility and product integrity over the claimed shelf life, according to ISO and ASTM standards.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device, so there is no training set in that context.

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

Not applicable, as there is no training set for an AI algorithm. The "ground truth" for the device's technical validation (as described above in point 7) is established through adherence to recognized international and national standards for medical device manufacturing, sterilization, and materials.

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The family of THD disposable Anoscope, Proctoscope, Rectoscope and Light-scope is intended for physician use to examine the anal sphincter, anus, rectum, and, using additional accessories, to perform various diagnostic and therapeutic procedures.

The Family of THD disposable Anoscope, Proctoscope, Rectoscope and Light-scope are disposable not sterile rectoscopes, proctoscopes and anoscopes with a light source external or integrated on the handle. The devices are designed for the examination and treatment of the anal (anoscopes) and rectum (proctoscopes and rectoscopes) examination. The devices consist of transparent plastic anoscope, proctoscope or rectoscope for diagnostic or therapeutic use. The Family of THD disposable Anoscope, Proctoscope, Rectoscope and Light-scope is made by two categories of devices: Diagnostic Anoscopes, Proctocope and Rectoscope and Surgical Proctoscopes. The Family of THD disposable Anoscope, Proctoscope, Rectoscope and Light-scope include both models which require the external light source and models which not require the external light source, in this case the light source is integrated on the handle. The external light source is provided as accessory of the family and it can be the THD Shining Light and the THD pen light.

Here's an analysis of the provided text regarding the acceptance criteria and study for the THD disposable anoscopes, proctoscopes, rectoscopes, and light-scope:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). The tests performed are described as "Design verification and effectiveness test," "Safety and electromagnetic tests," and "Design verification." These descriptions typically refer to internal engineering and functional testing rather than clinical studies with human subjects.

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

The document does not mention using experts to establish ground truth for a test set. The tests appear to be related to the device's physical and functional properties, as opposed to diagnostic performance requiring expert interpretation.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method. This type of method is typically used in clinical trials where multiple readers interpret results to establish a consensus ground truth.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not performed or mentioned in the provided text. The submission is for device modifications to an already cleared predicate device, focusing on functional and safety aspects of the changes rather than clinical effectiveness comparisons.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This is a medical device (anescope, proctoscope, rectoscope) for direct observation and intervention, not an imaging or algorithmic diagnostic device. Therefore, a standalone (algorithm only) study is not applicable and was not performed.

7. Type of Ground Truth Used

The ground truth for the "tests performed" appears to be based on engineering specifications, safety standards, and functional requirements to ensure the device's "safety and effectiveness." It is not based on expert consensus, pathology, or outcomes data in the clinical sense for these verification tests.

8. Sample Size for the Training Set

The concept of a "training set" is not applicable to this device's verification and validation process described. Training sets are typically used for machine learning algorithms, which are not involved here.

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

Since there is no training set in the context of this device and its studies, the method for establishing its ground truth is not applicable.

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The THD Bandy is used to cut off the blood flow to hemorrhoidal tissue by means of a ligature or ring placed around the hemorrhoid base. The THD Bandy is to be used for exclusive use by medical personnel trained in a proctology procedures.

The THD Bandy is an hemorthoidal ligator intended for pinching off hemorrhoidal nodule. The device is to be used in combination with a suction device, mounted on the basis of the THD Bandy. The THD Bandy consists of a ligation unit, a pusher and a cone. The ligation unit consists of a cylindrical housing connected with a trigger for the release of the elastic band or of the ligature. The hemorrhoidal nodule, trapped on the distal portion of the device, receive an elastic ring or a ligature in order to cut off the blood flow. The pusher and the cylindrical cone are provided in order to assist in the loading of the bands.

The provided text does not contain information about acceptance criteria or a study that proves the device meets those criteria in the context of device performance metrics (e.g., sensitivity, specificity, accuracy) or comparative effectiveness. The available documents are a 510(k) summary and the FDA's clearance letter for the THD Bandy hemorrhoidal ligator.

Instead, the documents indicate that the device (THD Bandy) was determined to be "substantially equivalent" to predicate devices based on similarities in intended use, design characteristics, materials, and labeling information. The performance data section refers to compliance with international standards for biocompatibility (ISO 10993-1:2003), graphical symbols in labeling (CEN EN 980:1996+A1:1999+A2:2001), and risk management (ISO 14971:2007). These are general safety and procedural standards, not performance criteria for diagnostic or clinical effectiveness as one might expect for a study proving device performance in the sense of AI/reader studies.

Therefore, I cannot populate the requested table or provide information for points 2 through 9 based on the provided text. The device's "performance" in this context refers to its adherence to established safety and quality standards, and its equivalence to legally marketed predicate devices, rather than a clinical performance study with defined metrics.

Here's a breakdown of what can be extracted or deduced from the provided documents:

• Same intended use as predicate devices.
• Similar design characteristics to predicate devices.
• Similar materials to predicate devices.
• Compliant labeling information.
• Adherence to biocompatibility standards (ISO 10993-1:2003).
• Adherence to graphical symbol standards for labeling (CEN EN 980:1996+A1:1999+A2:2001).
• Adherence to risk management standards (ISO 14971:2007).

Reported Device Performance (from K093497):

• "The THD Bandy is substantially equivalent to the predicate devices."
• "The intended use of THD Bandy is the same as Sapimed LEM (K070881)."
• "Both THD Bandy and Sapimed LEM (K070881) are manufacture in plastic material, are designed with similar dimensions and are single use devices."
• "The THD Bandy is equivalent to the Sapimed LEM (K070881) and to the Haemoband Multi Ligator Device (K091519) and to the THD Disposable Anoscope/Proctoscope (K080132) concerning the labeling information."
• The device has "been developed and tested according to the following international standards": ISO 10993-1:2003, CEN EN 980:1996+A1:1999+A2:2001, ISO 14971:2007. |
  | 2 | Sample size used for the test set and data provenance | Not applicable. No "test set" in the context of clinical performance data is mentioned. The submission focuses on substantial equivalence and compliance with general standards. |
  | 3 | Number of experts used to establish ground truth and qualifications | Not applicable. No clinical ground truth establishment or expert review process (outside of FDA's regulatory review) is described in relation to performance data. |
  | 4 | Adjudication method for the test set | Not applicable. No test set requiring adjudication is mentioned. |
  | 5 | MRMC comparative effectiveness study and effect size | Not applicable. No MRMC study or AI assistance is mentioned. This device is a mechanical ligator, not an AI or diagnostic tool. |
  | 6 | Standalone (algorithm only) performance study | Not applicable. This is a medical device, not an algorithm. |
  | 7 | Type of ground truth used | Not applicable in the context of clinical performance metrics. The "ground truth" for substantial equivalence is the characteristics of the predicate devices and the relevant international standards. |
  | 8 | Sample size for the training set | Not applicable. No training set for an algorithm is mentioned. |
  | 9 | How ground truth for training set was established | Not applicable. No training set for an algorithm is mentioned. |

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