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The Atmo® Gas Capsule System measures whole gut and regional gut (stomach, small bowel, and colon) transit times. Measurements of gastrointestinal transit times are used for evaluating motility disorders.

Gastric Emptying Time (GET) is indicated for the evaluation of patients with suspected gastroparesis. Delayed gastric emptying is implicated in such disorders as idiopathic and diabetic gastroparesis and functional non-ulcer dyspepsia.

Colonic Transit Time (CTT) is indicated for the evaluation of colonic transit in patients with chronic constipation, to aid in differentiating slow and normal transit constipation. In the case where ileocecal junction transit cannot be determined, the system will report combined Small and Large Bowel Transit Time (SLBTT).

Transit times are derived from measures of temperature, hydrogen concentration, and carbon dioxide concentration, and indicators of oxygen level, Capsule tumble, and antenna reflectance.

Not for use in pediatric patients.

The Atmo Gas Capsule System is a prescription only ingestible telemetric medical device system used to measure transit times of the gastrointestinal (GI) tract. The system consists of a single-use Capsule, reusable Receiver, Mobile Device with Clinician App, and an online Clinician Portal.

Sensors onboard the Capsule provide measurements for temperature, hydrogen concentration, and carbon dioxide concentration, along with indicators of oxygen level, capsule tumble, and antenna reflectance that are used to identify regional gastrointestinal anatomical landmarks. The Capsule data is transmitted from within the GI tract via radiofrequency communication to a Receiver worn by the patient. The Mobile Device runs the Atmo Clinic App, a software application which guides the clinician through the pairing process, Capsule administration, and subsequent transfer of stored data from the Receiver to a cloud server. The Atmo Clinician Portal, accessible through a web browser, displays the resulting data and provides guidance for the physician to review, confirm and create a downloadable Motility Study Report containing whole and regional gut transit times.

The provided FDA 510(k) clearance letter and its associated 510(k) summary pertain to the Atmo Gas Capsule System. However, this document does not contain specific acceptance criteria or the detailed results of a study designed to prove the device met those criteria in the format requested.

The information provided largely describes the device, its intended use, comparison to a predicate device, and general details about the clinical study (e.g., multi-site, prospective, sample size, Bland-Altman analysis for agreement) and non-clinical testing. It states that "all pre-determined end points successfully met" for agreement with the predicate device, but it does not specify what those pre-determined endpoints/acceptance criteria were (e.g., a specific agreement percentage, limits of agreement, maximum allowable difference, or statistical p-value for non-inferiority).

Therefore, based on the provided text, I cannot complete most of the requested table and details about the study that proves the device meets the acceptance criteria. I can only extract what is present.

Here's what can be inferred and what information is missing:

Acceptance Criteria and Device Performance

Since the document does not explicitly state the acceptance criteria for GET and CTT agreement, I cannot fill this table as requested. It only says "all pre-determined end points successfully met."

Table of Acceptance Criteria and Reported Device Performance (Information Not Provided in Source):

Study Details Proving Device Meets Acceptance Criteria

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

   • Sample Size: 213 participants.
   • Data Provenance: Multi-site, prospective study across 12 US sites and 1 OUS (Outside US) site. Participants had "confirmed or suspected dysmotility issues of the gastric and/or colonic regions."

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

   • Not provided. The study assessed agreement between the Atmo Gas Capsule System and a predicate device (SmartPill GI Monitoring System, version 2.0). It doesn't explicitly mention external expert consensus for ground truth on transit times, but rather the comparative performance against an already cleared device. For a "gastrointestinal motility monitoring system," the ground truth for transit times is typically derived from the measurements themselves, not from expert interpretation of images or other subjective data.

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

   • Not provided. This type of adjudication (e.g., for image interpretation or diagnosis) is generally not applicable to the direct measurement of physiological parameters like transit times by a capsule system. The study focused on agreement between two devices.

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, an MRMC study was not done. This device is a measurement system, not an AI-assisted diagnostic tool that humans interpret. The study compared the device's measurements to those of a predicate device.

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

   • Yes, in the context of the device itself. The Atmo Gas Capsule System and the predicate device both automatically identify transit markers, with the user then manually confirming them. The study evaluated the agreement of the Atmo system's derived transit times against the predicate, implying the performance of the system's algorithm in calculating these times. The "human-in-the-loop" aspect (manual confirmation of markers) is part of the system's operation, but the core measurement and algorithm for transit time derivation is standalone.

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

   • The "ground truth" for the Atmo Gas Capsule System's performance was the measurements obtained by the legally marketed predicate device, the SmartPill GI Monitoring System, version 2.0. The study's primary objective was assessing agreement between the investigational device and the predicate device.

7. The sample size for the training set:

   • Not provided. The document describes a clinical validation study (test set) but does not mention details about the training data used for the device's algorithms.

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

   • Not provided, as training set details are absent.

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The MotiliCap GI Monitoring System measures whole gut and regional gut (stomach, small bowel, and colon) transit times. Measurements of gastrointestinal tract transit times are used for evaluating motility disorders.

Gastric transit time (gastric emptying time, GET) is indicated for the evaluation of patients with suspected gastroparesis. Delayed gastric emptying is implicated in such disorders as idiopathic and diabetic gastroparesis and functional non-ulcer dyspepsia.

Colonic transit time (CTT) is indicated for the evaluation of colonic transit in patients with chronic constipation and used to aid in differentiating slow and normal transit constipation. Combined small and large bowel transit time (SLBTT) is used as a surrogate measure of colonic transit in patients with chronic constipation when colonic transit time alone cannot be determined.

The system measures pH, pressure, and temperature throughout the GI tract. Pressure contraction data from the antrum and duodenum can be used to calculate motility indices.

Not for use in pediatric patients.

The MotiliCap GI Monitoring System is comprised of the following components:

• MotiliCap Capsule (Catalog Number: CP-US-7010)
• Data Recorder (Catalog Number: MO-US-8001)
• Computer Software (MotiliScan: V1. MO-US-8005)
• Smartphone App (MotiliCap: V1. MO-US-8006)

The single-use capsule consists of the pressure sensor, the pH sensor, and the temperature sensor, which separately measure the pressure, pH, and temperature in the GI tract to determine transit times of the stomach, small bowel, and colon. The system provides information that aids clinicians in the evaluation of motility-related disorders. The data recorder records biomedical data transmitted by the capsule. The MotiliScan software is installed on a general-purpose computer. Before the examination, the software can create a case to start a test. After the test is complete, the software can receive, and process downloaded test data from the data recorder and graphically display the data for easy analysis and review. The MotiliScan software analyzes data and calculates motility indices such as GET, SBTT, CTT, and WGTT. The MotiliCap App is installed on a smartphone. This App is connected to the data recorder via Bluetooth, displays the connection status, and shows information about the capsule connected to the data recorder.

The provided FDA 510(k) clearance letter and summary for the MotiliCap GI Monitoring System does not contain the specific acceptance criteria or details of a study proving the device meets acceptance criteria.

The document states that substantial equivalence was based on "technological similarities of the devices and the results of the bench testing." It also briefly mentions "A small clinical evaluation of the device supported that the device could function as intended in the clinical environment and the patient is generally satisfied with the examination and software operation." However, it does not provide quantitative acceptance criteria for performance metrics (like accuracy, sensitivity, or specificity for transit times or other measurements), nor does it detail a study that demonstrates these criteria were met.

Therefore, I cannot populate the table or answer most of your detailed questions based on the provided text. The document focuses on demonstrating substantial equivalence to a predicate device (SmartPill GI Monitoring System), largely based on similar indications for use and technological characteristics, and general bench testing results.

Here's a breakdown of what can and cannot be answered from the provided text:

1. Table of acceptance criteria and the reported device performance:

• Cannot be provided. The document does not list specific acceptance criteria (e.g., "GET accuracy must be within X minutes of reference method") or quantitative reported device performance for clinical metrics. It only generally states that "The MotiliCap GI Monitoring System demonstrates the ability to measure pressure, pH, and temperature per the developed specifications."

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

• Cannot be provided for performance metrics. The document mentions "A small clinical evaluation," but does not specify the sample size for this evaluation, its design (e.g., prospective/retrospective), or the country of origin of the data. The bench testing would have a "sample size" of capsles/components, but this is not typically what is sought when asking about a "test set" for clinical performance.

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

• Cannot be provided. Ground truth establishment methods, number of experts, and their qualifications are not mentioned in relation to the "small clinical evaluation."

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

• Cannot be provided. The document does not describe any adjudication method.

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:

• No evidence of an MRMC study related to AI assistance. The document makes no mention of AI assistance or MRMC studies evaluating its impact on human readers. The device calculates motility indices, but the clearance is for its measurement capabilities, not necessarily for interpretative AI that assists human readers.

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

• Cannot be definitively answered with specific performance metrics. The device "calculates motility indices such as GET, SBTT, CTT, and WGTT." This implies a standalone algorithm for these calculations. However, the document does not present quantitative performance data for these calculations as a standalone algorithm against a reference standard in a dedicated study. It only states the system demonstrates the "ability to measure" these parameters.

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

• Cannot be provided. The document does not specify the type of ground truth used for any clinical evaluation or for validating the calculated transit times. For bench testing, the ground truth would be known physical parameters (e.g., calibrated pH solutions).

8. The sample size for the training set:

• Cannot be provided. The document does not discuss a "training set," implying the product development and validation relied on existing knowledge and bench testing, rather than a machine learning model developed with a distinct training/test split that would require a separate training set.

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

• Cannot be provided. As no training set is discussed, its ground truth establishment is also not mentioned.

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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 Compact is intended to record, store, view, and analyze pressure, impedance, and EMG data, gathered from anywhere in the gastrointestinal tract (pharynx, esophagus, stomach, and anorectal area, including rectum and pelvic floor) to assist in the diagnosis and evaluation of gastrointestinal and swallowing disorders. Designated catheters and accessories are required for measurement in each specific area of the gastrointestinal tract.

An optional perfusion pump can also be used for automated balloon filling (for anorectal manometry studies). The filling lumen of the catheter can be connected to the perfusion pump.

The Solar Compact is indicated for use in adult to infants with common gastrointestinal conditions, for the monitoring and diagnosis of motility disorders of the GI tract.

The Solar Compact is a medical device for measuring gastrointestinal motility characteristics. The system consists of an electromechanical hardware device which connects to pressure catheters (air-charged or solid-state), and a PC software. Catheters provide measurements of pressure and impedance to the device from various sites along the gastrointestinal tract, which are then displayed and analyzed by the Laborie PC software. This provides the clinician with data that may aid in the diagnosis or management of various gastrointestinal disorders. Additionally, the system connects to provide EMG measurements of the muscles along the pelvic floor. Devices such as pressure catheters and surface electrodes are required to complete a gastrointestinal motility investigation, but they are not considered part of the Solar Compact device and not included standard with the system.

The device hardware consists of an external housing, pneumatics to inflate and deflate rectal balloons, and electronics to readout data from the pressure catheters and to control all other functions of the system. The device connects to a PC via Bluetooth to display measurements within the Laborie software. The Laborie software contains a patient database module, and an analysis module. The software displays measurements from the system as time-tracing based plots, Clouse Countour Plots (High Resolution Manometry), and as 3D plots. Clinicians can analyze the data provided by placing markers and using calculations within the software. The device does not provide an independent diagnosis.

The Solar Compact device is compatible with a number of of catheters for these aforementioned parameter measurements. For a full list of these compatible catheters please consult the instructions for use.

The provided text is an FDA 510(k) clearance letter and summary for a medical device called "Solar Compact (G4-1)". It contains information about the device's indications for use, technological characteristics, and comparison to predicate devices, but it explicitly states that "Clinical testing was not conducted and is not applicable for demonstrating substantial equivalence."

Therefore, I cannot provide the requested information about acceptance criteria and a study proving the device meets those criteria, as no such clinical study was performed or needed for this specific 510(k) clearance based on the provided document.

To clarify, the document focuses on demonstrating substantial equivalence to existing legally marketed devices (predicates) through non-clinical testing and comparison of technological characteristics. This pathway to market typically does not require a full clinical study with acceptance criteria like those outlined in the request, especially for devices that are considered well-understood or incremental improvements.

The document does mention "System verifications were conducted, including functional, electrical, lifetime verification testing, calibration and volume measurement, to ensure that the Solar Compact demonstrates by meeting requirements defined for the device." These "requirements defined for the device" are internal engineering and design specifications, not clinical acceptance criteria derived from a human study.

Therefore, since the document explicitly states "Clinical testing was not conducted and is not applicable," it's impossible to extract:

1. A table of acceptance criteria and reported device performance from a clinical study.
2. Sample size used for the test set and data provenance from a clinical study.
3. Number of experts used to establish ground truth or their qualifications from a clinical study.
4. Adjudication method from a clinical study.
5. MRMC study details or effect size from a clinical study.
6. Standalone performance details from a clinical study.
7. Type of ground truth used from a clinical study.
8. Sample size for the training set from a clinical study.
9. How the ground truth for the training set was established from a clinical study.

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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 Endoflip™ 300 System is indicated for use in a clinical setting to measure pressure and dimensions in the esophagus, pylorus, and anal sphincters in adults and to measure pressure and dimensions in the esoplagus, in patients from five years of age. It is intended to be used as an adjunct to other diagnostic methods as part of a comprehensive evaluation of patients with symptoms consistent with gastrointestinal motility disorders.

The subject Endoflip™ 300 System is equivalent to the predicate Endoflip™ 300 System (K223705) except for an update to the Endoflip™ 300 System software to remove the analysis episode feature of the predicate device. Other software updates include minor feature enhancements and bug fixes. Changes to device labeling rrom the software updates and other minor changes for clarification purposes were also addressed.

The Endoflip™ 300 System software is supplied pre-installed in the Endoflip™ 300 Display System. It is also the software used for the Endoflip™ 300 Reader in reader mode only. There is no change to the display system hardware or to how the reader is supplied (USB stick).

No changes were made to any of the other components that comprise the Endoflip™ 300 System when compared to the predicate.

The provided text describes a 510(k) premarket notification for the Endoflip™ 300 System, which involves software updates to an existing device. This entire document is a 510(k) submission meant to demonstrate substantial equivalence to a predicate device, not a study specifically designed to establish acceptance criteria for a new device.

Therefore, many of the requested details regarding a standalone study, multi-reader multi-case study, and detailed ground truth methodologies for a specific study proving acceptance criteria are not present in this type of regulatory document.

However, based on the information provided, here's what can be extracted:

Acceptance Criteria and Device Performance:

The document's primary objective is to demonstrate substantial equivalence to the predicate device (Endoflip™ 300 System K223705) after software updates. Therefore, the "acceptance criteria" are implicitly that the updated device performs equivalently to the predicate device and does not introduce new safety or effectiveness concerns.

Specific numerical acceptance criteria and reported device performance from a clinical trial or performance study are not explicitly provided in terms of metrics like sensitivity, specificity, or error rates. Instead, the performance is evaluated through software verification.

Table of Acceptance Criteria and Reported Device Performance:

Since explicit quantitative acceptance criteria for a new device's performance are not given (as this is a 510(k) for an updated software version of an existing device), we can infer the acceptance criteria for the software updates.

Study Details:

The document describes software verification testing as the primary study type to establish substantial equivalence for the software updates.

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

   • Test Set Sample Size: Not specified. Software verification typically involves testing against a range of inputs and scenarios, but a "sample size" in the context of clinical data for performance metrics is not applicable here as no clinical performance data is presented.
   • Data Provenance: Not specified, as it's software verification, not a clinical data study.

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

   • Not applicable. This was software verification, not a study requiring expert-established ground truth on clinical data. The "ground truth" for software testing would be the expected behavior of the software according to its design specifications.

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

   • Not applicable. This was software verification.

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, a multi-reader multi-case comparative effectiveness study was not done. The device (Endoflip™ 300 System) is a "Gastrointestinal Motility Monitoring System" that measures pressure and dimensions; it's not described as an AI-powered diagnostic tool for interpretation, but rather a direct measurement device with software for processing and displaying those measurements. The updates were minor software enhancements and bug fixes.

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

   • Yes, in a sense. The "study" was software verification, which inherently evaluates the algorithm's performance on its own against specifications, without human interpretation in the loop for diagnostic accuracy. The device itself is standalone in its measurement function, providing data to clinicians for their interpretation.

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

   • For software verification, the "ground truth" would be the software's design specifications and requirements. Each test case has an expected output or behavior based on these specifications, and the software's actual output is compared against this expected behavior. This is not clinical ground truth like pathology or expert consensus.

7. The sample size for the training set:

   • Not applicable. This was software verification testing for an updated version of an existing medical device, not a machine learning model involving a training set.

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

   • Not applicable for the same reason as above.

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The Endoflip™ 300 System is indicated for use in a clinical setting to measure pressure and dimensions in the esophagus, pylorus, and anal sphincters in adults and to measure pressure and dimensions in the esophagus, in patients from 5 years of age. It is intended to be used as an adjunct to other diagnostic methods as part of a comprehensive evaluation of patients with symptoms consistent with gastrointestinal motility disorders.

The Endoflip™ 300 System is the next generation of the predicate Endoflip™ System consisting of design changes to the device hardware and software components. The design changes improve device usability when compared to the predicate. Changes were made to the platform components only; no design changes were made to the system catheters (Endoflip™ or Esoflip™) except for labeling changes (not related to indications for use). The system is comprised of a pump, display, cart and accessories, including pre-use tube and balloon catheters.

The provided text is an FDA 510(k) clearance letter and summary for the Endoflip™ 300 System. It describes the device, its intended use, and the types of testing performed to demonstrate substantial equivalence to a predicate device.

However, the document does not contain information on acceptance criteria for a performance study evaluating the device's diagnostic accuracy or effectiveness against a ground truth, nor does it describe a study specifically designed to prove the device meets such criteria in terms of clinical performance.

The performance data summarized in section VII focuses on engineering, safety, and usability aspects of the device's hardware and software components, rather than its clinical diagnostic or treatment efficacy. Specifically, the document states:

• "Clinical studies were not required to demonstrate the safety and performance of the Endoflip TM 300 System."

Therefore, I cannot provide the requested information about acceptance criteria for clinical performance and a study proving those criteria are met. The document indicates that for this particular 510(k) submission, clinical studies to demonstrate safety and performance (in the sense of diagnostic or treatment efficacy) were not deemed necessary, likely due to the device being a "next generation" of an already cleared predicate with no change to the indications for use and improvements primarily in usability and platform components.

To answer your specific points based on the provided text:

1. A table of acceptance criteria and the reported device performance: Not applicable. The document describes engineering, safety, and usability testing, not clinical performance against specific diagnostic or treatment acceptance criteria.
2. Sample sized used for the test set and the data provenance: Not applicable for clinical performance. For engineering, safety, and usability tests, the sample sizes and data provenance are not specified in this summary, but would be part of the underlying test reports.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical ground truth was established for the performance studies presented.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 gastrointestinal motility monitoring system, not an AI-assisted diagnostic tool for image interpretation by human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable in the context of diagnostic performance. The device itself is a measurement system; its "standalone" performance relates to its ability to accurately measure pressure and dimensions, which would be verified through mechanical and software testing.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable for clinical performance evaluation. The "ground truth" for the tested engineering aspects would be established against calibrated standards or specifications.
8. The sample size for the training set: Not applicable. The document does not describe a machine learning or AI algorithm that would require a training set for diagnostic purposes.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided document focuses on the engineering and design controls demonstrating the safety and effectiveness for a device that is essentially an updated version of a previously cleared system, rather than a novel diagnostic or therapeutic device requiring extensive clinical performance studies to establish efficacy against a clinical ground truth.

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For evaluation of colonic transit in adult and pediatic patients (at least 2 years old) with chronic constipation and used to aid in differentiating slow and normal transit constipation.

The device is intended to be used for evaluation of colonic transit time in patients with chronic constipation and used to aid in differentiating slow and normal transit constipation in adults and pediatric patients (at least 2 years old). Ten (10) radiopaque markers per day are swallowed for six consecutive days. On day seven an abdominal radiograph is taken. Based on the number of retained markers and the position in colonic transit time is calculated and compared to reference values. Both total transit and segmental transit dysfunction in the colon can be evaluated with the device. By dividing the particle dose on day six by taking five (5) markers in the morning and five (5) markers in the evening, the whole range of transit times (slow, normal, rapid) transit can be measured from the radiograph.

The device is a convenience package of radiopaque markers (22% Barium Sulphate, 78% Elastosil® R 401/60 Silicone rubber) placed in vegetarian capsules from cellulose (HPMC, Hydroxypropylmethylcellulose), intended for single patient use. The dimension of the markers is 2x4.5mm (ring-formed markers) and 6x2mm (tube-formed markers). The capsules are packed in a blister pack is placed inside a folding box.

Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided FDA 510(k) summary for Transit-Pellets:

It's important to note that this document is a 510(k) clearance, which determines substantial equivalence to a predicate device, rather than a full pre-market approval (PMA) that requires extensive clinical trials to establish de novo safety and effectiveness. Therefore, the "studies" mentioned often refer to comparisons with predicate devices, existing literature, or post-market follow-up, rather than new, large-scale randomized controlled trials.

Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" in a quantitative, measurable format with target performance values (e.g., "sensitivity must be >X%", "specificity must be >Y%"). Instead, the performance is demonstrated by showing substantial equivalence to a legally marketed predicate device (Sitzmarks) and by leveraging existing clinical literature and post-market data.

The key performance aspect for Transit-Pellets is its ability to accurately measure colonic transit time (CTT) and thereby aid in differentiating slow and normal transit constipation. The acceptance is implicitly based on the predicate device's established performance and the demonstration that the subject device performs equivalently and safely, especially for the expanded pediatric population.

Table of Performance Comparison (based on equivalence to predicate):

Study Details:

The document primarily refers to a Post-Market Clinical Follow-Up (PMCF) study as the clinical evidence for the expanded pediatric population. This PMCF study appears to be a literature review combined with a user survey.

1. Sample Size Used for the Test Set and Data Provenance:

   • Literature Review: The PMCF study identified 18 clinical investigations involving similar devices. These studies collectively involved 1054 children and young adults.
   • Data Provenance: The document does not specify the country of origin for these 18 studies. The nature of these studies (retrospective/prospective) is also not explicitly stated, but common for such literature reviews, they could include both types.
   • User Survey (part of PMCF): No specific sample size for the user survey is provided, only that it involved "professional users." Data provenance is implied to be from current users of Transit-Pellets or similar devices, likely international given the company's location (Sweden).

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

   • Ground Truth for Literature Review: The "ground truth" in the 18 studies would have been established by the methods and clinicians within those individual studies, which are not detailed here. For colonic transit time, the ground truth is typically the radiological assessment of marker distribution and retention by medical professionals (e.g., radiologists, gastroenterologists).
   • Experts for PMCF Literature Review: The document does not explicitly state how many experts reviewed the identified 18 clinical investigations or their specific qualifications for the PMCF literature review itself. It implies a "literature review carried out during the PMCF study," suggesting a regulatory or scientific team conducted the review.
   • Experts for User Survey: "Professional users" were surveyed, but their number and specific qualifications (e.g., pediatric gastroenterologists, radiologists) are not provided.

3. Adjudication Method:

   • Not explicitly described. For the PMCF literature review, it's unlikely a formal adjudication method (like 2+1 or 3+1 for individual case review) was applied since it was a review of aggregate published data, not individual case interpretations.
   • For the original 18 studies, the adjudication methods would vary per study; this document does not provide such detail.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No, an MRMC study was not done in the context of this 510(k) submission. This is not typically required for a Class II diagnostic device seeking substantial equivalence, especially when expanding an indication based on existing technology and literature. The focus is on the device's inherent ability to measure CTT, not on reader performance improvement with AI assistance.

5. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance):

   • Yes, in essence, the "device" is standalone. Transit-Pellets are passive markers. The "performance" being evaluated is their physical and chemical properties (biocompatibility, radiopacity, mechanical strength) and their ability to be visualized and used by a clinician to manually calculate colonic transit time from an X-ray image. There is no AI component or algorithm-only performance to assess in the typical sense of software as a medical device. The physician interprets the X-ray/fluoroscopy image and calculates CTT based on the marker count and position.

6. Type of Ground Truth Used:

   • The ground truth for measuring colonic transit time is based on radiological imaging (abdominal radiograph or fluoroscopy) and the subsequent manual counting and positional analysis of the radiopaque markers by a clinician. This is a well-established method in gastroenterology.
   • For the safety and effectiveness in the pediatric population, the PMCF study relied on published clinical investigation results (which would have used radiological ground truth) and user feedback.

7. Sample Size for the Training Set:

   • Not applicable in the typical sense of AI/ML training. There is no "training set" for an algorithm, as this device consists of physical markers interpreted by human readers.
   • If viewed in a broad sense, the "training" for the device's design (marker size, material, dosing regimen) comes from decades of clinical practice and research using radiopaque markers for colonic transit studies, which predates this specific device.

8. How the Ground Truth for the Training Set Was Established:

   • Not applicable as there is no specific training set for an algorithm. The principle of "ground truth" in this context refers to the accuracy of colonic transit time measurements derived from the markers. This has been established through clinical consensus and research over time, validating the correlation between marker distribution on X-rays and actual colonic transit physiology.

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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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