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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 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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IntraMarX 3D Radiopaque Markers is a diagnostic test indicated for assisting in the evaluation of colonic motility in patients with severe constipation, as diagnosed by a healthcare professional, but otherwise negative GI evaluations. For use in adult, IntraMarX 3D Radiopaque Markers is dispensed only by physicians to patients for oral intake.

The IntraMarX 3D Radiopaque Markers can be used for the diagnosis of many Gl conditions, including chronic constipation, colonic inertia, hypomotility and outlet delay. Each of the IntraMarX 3D capsules contains 24 tiny radiopaque rings within the capsule is swallowed by the patient under the direction of physician. As this capsule moves through the digestive system, the capsule shell will dissolve and leave the rings in the GI tract of the patient; which will show up later during an x-ray scan. Five days after swallowing the capsule, a single x-ray scan of the abdomen will be taken to see the location of the rings and how many are left in the Gl tract of the patient. The physician will make evaluations based on the rings remaining and make a diagnosis of GI conditions of the patient.

Here's an analysis of the provided text regarding the acceptance criteria and study for the IntraMarX 3D Radiopaque Marker, formatted as requested:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text describes a 510(k) submission, which primarily focuses on demonstrating substantial equivalence to a predicate device rather than setting new acceptance criteria for novel performance claims. The "acceptance criteria" here are therefore inferred from the comparison of characteristics and the non-clinical performance data, which aim to show the device meets existing standards and is as safe and effective as the predicate.

• Same Mechanism of Action (oral intake).
• Same Capsule Material (HPMC).
• Similar Radiopaque Marker Material (Thermoplastic Elastomer 50% for subject vs. Polyvinyl Chloride 45-46% for predicate, both with Barium Sulfate).
• Same Sterile status (No), Single-Use (Yes), Shelf Life (2 Years).
• Differences in capsule packaging and image area diameter are acknowledged but not stated to impact safety/effectiveness as they don't raise new questions. |
  | Safety and Effectiveness: | Performance testing demonstrated the IntraMarX 3D is as safe and effective as the predicate device. |

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

The document does not specify a sample size for a test set in the context of clinical performance or diagnostic accuracy. The studies mentioned are primarily non-clinical (biocompatibility, radiopacity). The data provenance is generally not explicitly stated beyond implying these are results from tests conducted by the manufacturer, Ankon Medical Technologies (Shanghai) Co., Ltd., to support substantial equivalence. It does not refer to patient data or clinical studies.

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

This information is not provided in the document. The studies mentioned are non-clinical hardware/material tests rather than diagnostic performance studies requiring expert ground truth for interpretation.

4. Adjudication Method for the Test Set

This information is not provided as the document does not describe a clinical study or a test set requiring adjudication.

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

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or described in this submission. The document focuses on showing substantial equivalence of a physical medical device (radiopaque markers) to a predicate device, based on material properties and non-clinical performance, not on the diagnostic accuracy of an AI algorithm or its impact on human reader performance.

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

This device, the "IntraMarX 3D Radiopaque Marker," is a physical diagnostic aid. It is not an AI algorithm and therefore, no standalone algorithm performance study was mentioned or would be applicable in this context. The "diagnosis" is made by a physician based on the visualization of the markers on an X-ray.

7. The Type of Ground Truth Used

For the non-clinical tests (biocompatibility, radiopacity), the "ground truth" implicitly comes from the established pass/fail criteria of the referenced international and national standards (ISO, ASTM). For example, a material either passes or fails the cytotoxicity test based on the standard's definition. There is no mention of expert consensus, pathology, or outcomes data as "ground truth" for the device, as it's not a diagnostic algorithm being evaluated for accuracy against such benchmarks.

8. The Sample Size for the Training Set

This information is not applicable/not provided. The IntraMarX 3D Radiopaque Marker is a physical device, not an AI algorithm that requires a training set.

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

This information is not applicable/not provided for the same reason as above.

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IntraMarX Radiopaque Markers is a diagnostic test indicated for assisting in the evaluation of colonic motility in patients with severe constipation, as diagnosed by a healthcare professional, but otherwise negative GI evaluations. For use in adult only, IntraMarX Radiopaque Markers is dispensed by physicians to patients for oral intake.

The IntraMarX capsule can be used for the diagnosis of many GI conditions, including chronic constipation, colonic inertia, hypomotility and outlet delay. Each of the IntraMarX capsules contains 24 tiny radiopaque rings within the capsule shell. The capsule is swallowed by the direction of physician. As this capsule moves through the digestive system, the capsule shell will dissolve and leave the rings in the GI tract of the patient; which will show up later during an X-ray scan. Five days after swallowing the capsule, a single scan of the abdomen will be taken to see the location of the rings and how many are left in the GI tract of the patient. The physician will make evaluations based on the rings remaining and make a diagnosis of GI conditions of the patient.

The provided text describes the submission for FDA clearance of the "IntraMarX Radiopaque Markers" device (K191087) and compares it to a predicate device, the "SITZMARKS Capsule" (K181750).

However, the document does not contain specific acceptance criteria for "device performance" in terms of clinical outcomes, nor does it present a detailed study that proves the device meets such criteria in a comparative effectiveness manner (e.g., against human readers or other diagnostic methods). Instead, it focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance data (material safety, physical properties, etc.).

Here's an analysis based on the available information, noting what's present and what's missing:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria for clinical performance (e.g., sensitivity, specificity, accuracy in diagnosing colonic motility issues) and thus does not report device performance against such criteria. The reported "performance" falls under non-clinical testing for safety and basic functionality.

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

The document does not describe a clinical "test set" in the context of diagnostic accuracy for colonic motility. All listed tests are non-clinical, focusing on material and physical properties of the device itself. Therefore, information on sample size and data provenance (country, retrospective/prospective) related to a clinical test set is not provided.

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

Not applicable. As no clinical test set for diagnostic performance is described, there's no mention of experts establishing ground truth for such a set.

4. Adjudication method for the test set

Not applicable. No clinical test set needing 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 passive radiopaque marker, not an AI software. Therefore, an MRMC study related to AI assistance is not relevant or described.

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

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used

For the non-clinical tests, the "ground truth" is defined by the specific parameters and requirements of the cited ISO, ASTM, USP, and ICH standards/protocols. For example:

• Cytotoxicity: Ground truth is whether cell viability falls below a certain threshold when exposed to device materials.
• Radiopacity: Ground truth is whether the markers are visible on X-ray according to the specified standard.
• Heavy metal testing: Ground truth is whether heavy metal levels are within established safe limits.

8. The sample size for the training set

Not applicable. This device is not an AI algorithm that requires a training set.

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

Not applicable. This device is not an AI algorithm.

Summary of Device and Approval Context:

The "IntraMarX Radiopaque Markers" device is a diagnostic aid consisting of capsules containing radiopaque rings. Patients swallow the capsule, and after five days, an X-ray of the abdomen is taken to observe the remaining rings in the GI tract. Physicians interpret the location and number of rings to evaluate colonic motility in patients with severe constipation.

The FDA clearance (K191087) is based on demonstrating substantial equivalence to a previously cleared predicate device, the "SITZMARKS Capsule" (K181750). This means the applicant showed that their device has the same intended use and similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness. The core of this demonstration relies entirely on the non-clinical performance data listed above, proving the physical and biological safety of the marker material and its radiopacity. There is no mention of new clinical studies on diagnostic accuracy for this submission. The effectiveness is presumed to be equivalent to the predicate device, which itself would have had to demonstrate effectiveness.

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The High Resolution Impedance Manometry (HRiM) Probe is intended for use by gastroenterologists, surgeons, and medically trained personnel for gastrointestinal tract studies to obtain a high resolution mapping of peristaltic activity or pressure within the organs of the gastrointestinal tract, and to allow storage of the corresponding data.

The device is used in conjunction with a manometry system. Studies performed with this system require a skilled interpretation by a physician to aid in making a diagnosis of gastrointestinal motility disorders.

The device is indicated for use on adult populations only.

The Diversatek Healthcare High Resolution Impedance Manometry (HRiM) Probe is a flexible polyurethane tube with a series of pressure and impedance sensors evenly spaced along the distal section of the device, an atraumatic tip, and a proximal end electrical connector/handle with an internal signal processor.

This probe is used in conjunction with the Sandhill Scientific Gastrointestinal Motility System (K012232). This motility system consists of a Central Unit, an Interface Cable. Software, and a system cart to organize and hold the system components and computer. The Central Unit receives and conditions electrical signals from the probe to display manometric information through the software. The predicate probe from Unisensor currently uses this same Sandhill Scientific Gastrointestinal Motility (Manometry) system. The overall system provides information to trained clinicians as an aid in documenting and diagnosing digestive motility disorders. The probe is the primary patient measurement device during a gastrointestinal tract motility study.

The HRiM Probe pressure transducers produce electrical signals that vary in direct proportion to the maqnitude of the applied pressure from muscular contractions (peristalsis) within the qastrointestinal tract. The pressure sensor elements are semiconductor strain gauge devices that convert the applied external forces to proportional electrical signals. These pressure sensors each have a unique digital address controlled by the internal signal processor in the proximal end connector/handle of the probe. The probe uses a time multiplexor that generates the address of the pressure sensor to activate, sends that request to the sensor, and then reads the results. Pressure during a motility study is used to assess GI tract clearance via peristalsis.

In addition to pressure sensors for monitoring peristalsis, the probe also contains impedance sensors to provide data to assess bolus transit dynamics. The impedance sensor data is used to detect the direction and transition time of the fluid or food bolus in the GI tract by making use of their natural conductivity. These sensors are made from stainless steel and are designed to show relative impedance changes between GI tract baseline impedance and the impedance seen when a fluid/bolus passes the sensors.

Using pressure (manometry) and impedance together clarifies which patients with manometric abnormalities may have GI tract function disorders.

The provided text describes the non-clinical performance data for the Diversatek Healthcare High Resolution Impedance Manometry (HRiM) Probe to support its substantial equivalence to a predicate device. It does not contain information about a study proving the device meets specific acceptance criteria in the format requested. However, I can extract the reported performance and the type of studies conducted.

Here is a summary of the information available:

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

The document does not explicitly present acceptance criteria in a tabular format with corresponding reported performance for specific metrics. Instead, it describes various bench tests performed to demonstrate equivalence to the predicate device and compliance with relevant standards.

Here's an interpretation of the performance demonstrated through the testing:

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 mentions "samples from initial production lots" were used for testing (Page 7). However, it does not specify the exact sample size (number of probes) for each test. All testing appears to be prospective bench testing conducted by Diversatek Healthcare. There is no information provided about the country of origin of the data beyond "Diversatek Healthcare performed bench testing."

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 information is not applicable as the studies described are non-clinical bench tests comparing the device against a predicate and established engineering standards, rather than clinical studies requiring expert interpretation of results for ground truth.

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

This information is not applicable as the studies described are non-clinical bench tests.

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

No MRMC comparative effectiveness study was done. The document explicitly states: "Clinical testing was deemed unnecessary to support substantial equivalence. The nonclinical testing performed supports safety and efficacy of the device and provides data to show substantial equivalence to the predicate device." (Page 8). This device is a measurement probe, not an AI-assisted diagnostic tool.

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

This information is not applicable in the context of standalone algorithm performance. The device is a "High Resolution Impedance Manometry (HRiM) Probe" designed to obtain physiological data, not an algorithm in the traditional sense of AI. Its "standalone" performance is assessed through its ability to accurately measure pressure and impedance, which was demonstrated through the bench testing described. The probe does contain embedded firmware (software) which was verified and validated (Section 9).

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

The "ground truth" for the non-clinical performance evaluation was based on:

• Predicate device's performance: The Diversatek Healthcare HRiM Probe's function and performance were compared directly against the Unisensor predicate device for parameters like sensor spacing, span, sensitivity, etc.
• Established engineering standards: Compliance with standards like ISO 10993-1 (biocompatibility), IEC 60601-1-2 and IEC 60601-1 (electrical safety and EMC), ASTM F1980-16 (accelerated aging), and BS EN 1618 (joint strength) served as the "ground truth" for those specific tests.
• Internal specifications and design objectives: The device was designed to withstand certain cycles of use and aging, and verification confirmed it met these objectives.

8. The sample size for the training set

This information is not applicable. The device is not an AI/machine learning model that requires a training set in the conventional sense.

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

This information is not applicable. The device does not utilize a "training set" for an AI model.

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For evaluation of colonic transit in adult patients with chronic constipation and used to aid in differentiating slow and normal constipation.

Transit-Pellets 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. 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 colon a 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.

Transit-Pellets is a convenience package of radiopaque markers (22% Barium Sulphate, 78% Elastosil® R 401/60 Silicone rubber) placed in veqetarian capsules from cellulose (HPMC, Hydroxypropyl-methylcellulose), 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 and the blister pack is placed inside a folding box.

The provided text describes a 510(k) premarket notification for the "Transit-Pellets" device, which is a gastrointestinal motility monitoring system. This document is a clearance letter from the FDA, asserting substantial equivalence to a predicate device, rather than a detailed study report for a novel AI device requiring extensive performance metrics against acceptance criteria.

Therefore, much of the requested information (acceptance criteria for AI, sample size for test sets/training sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone AI performance, etc.) is not applicable to this specific device and submission type, as it is a physical medical device (radiopaque markers) and not an AI/ML software. The crucial point is that no AI component is described or evaluated in this document.

However, I can extract and present the information relevant to a traditional medical device's performance and equivalence.

Device Name: Transit-Pellets
Regulation Name: Gastrointestinal Motility Monitoring System
Regulatory Class: Class II
Product Code: FFX
Indications for Use: For evaluation of colonic transit in adult patients with chronic constipation and used to aid in differentiating slow and normal constipation.

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

The document does not explicitly state "acceptance criteria" in a quantitative, measurable table as one would for an AI model's performance (e.g., AUC > X, sensitivity > Y%). Instead, the device's performance is demonstrated through comparisons to a predicate device and safety/material testing, confirming it performs "as intended" and is "safe and effective."

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The Endoflip System is indicated for use in a clinical setting to measure and dimensions in the esophagus, pylorus, and anal sphincters in adults and to measure pressure and dimensions 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 System comprises a measuring system and a single use catheter to provide programmed balloon distensions.

The provided text describes a 510(k) premarket notification for the Endoflip System, focusing on adding a specific age range (pediatrics) to its indications for use. The document does not contain information about the acceptance criteria or a study designed to prove the device meets specific performance criteria linked to those acceptance criteria.

The submission asserts that "There is no change between the Predicate device (K160725) and Endoflip System" and "There is no change in the technological characteristics of Endoflip System from the cleared predicate device (K160725)." Therefore, the performance data presented primarily focuses on the safety and clinical utility in the pediatric population, rather than proving specific performance metrics of the device itself.

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

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

• Cannot be provided. The document does not specify quantitative acceptance criteria for device performance (e.g., accuracy, precision, sensitivity, specificity) for the Endoflip System itself. The "Clinical Evaluation" section mentions using the Endoflip in pediatric patients to assess myotomy adequacy and esophageal distensibility, but it does not present specific performance metrics from a study against predefined acceptance criteria.

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

• Partially available, but not for a formal test set with defined performance metrics. The "Clinical Evaluation" mentions a "literature review" of existing studies using Endoflip in pediatric populations. It states, "Specifically, Endoflip was used in pediatric achalasia patients during myotomy surgeries..." and "Other application described in the literature review involves the use of Endoflip in children with Eosinophilic esophagitis (EoE)..."
• Sample size: Not explicitly stated as a single number. It is implied that multiple studies were reviewed, involving an unspecified number of pediatric patients for achalasia and EoE.
• Data provenance: Not specified (e.g., country of origin, retrospective/prospective for the individual studies reviewed). The studies were part of a "literature review."

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)

• Cannot be provided. The document does not describe a formal process of establishing ground truth by a panel of experts for a specific performance study. The "Clinical Evaluation" refers to the device being used in clinical settings where surgeons and clinicians would interpret the device output in the context of patient care and surgical outcomes (e.g., "real time assessment of the adequacy of the myotomy"), but this is not a structured ground truth establishment for a performance study.

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

• Cannot be provided. No formal adjudication method is mentioned as there isn't a described performance study with a test set requiring such a process.

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. The Endoflip System is a gastrointestinal motility monitoring system, not an AI or imaging interpretation device that would typically involve "human readers" or "AI assistance" in the sense of a diagnostic interpretation product. The document makes no mention of AI.

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

• Not applicable / Cannot be provided. The Endoflip System measures physiological parameters (pressure and dimensions) which are then interpreted by clinicians. It is not an "algorithm only" device in a standalone performance context like an AI-based diagnostic tool.

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

• Implied clinical outcomes, but not formally defined for a performance study. For the pediatric use described, ground truth might relate to surgical success (adequacy of myotomy), patient symptoms, or other clinical assessments (e.g., diagnosis of EoE or achalasia, and response to treatment). However, this is inferred from the clinical applications mentioned, not from a specific "ground truth" definition within a performance study section.

8. The sample size for the training set

• Not applicable / Cannot be provided. The Endoflip System is a measurement device and not an AI/machine learning algorithm that would have a "training set" in the conventional sense.

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

• Not applicable / Cannot be provided. As it's not an AI/ML device with a training set, this question is not relevant.

In summary, the provided document is a 510(k) summary for a change to the indications for use of an existing device (Endoflip System) to include a pediatric age range. It relies on the substantial equivalence to a predicate device (K160725) and a "clinical evaluation" via literature review to support the safety and potential benefit of the device in the pediatric population, rather than presenting a de novo performance study against new acceptance criteria.

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SITZMARKS capsule is a diagnostic test inding in the evaluation of colonic motility in patients with severe constipation, as diagnosed by your healthcare professional, but otherwise negative GI evaluations. SITZMARKS capsule, for use in adult and pediatric patients (at least 2 years old), is to be dispensed only by physicians to patients for oral intake.

Not Found

The provided text is a 510(k) premarket notification letter from the FDA regarding the SITZMARKS device (K181750), a Gastrointestinal Motility Monitoring System. It clears the device for marketing based on substantial equivalence to a predicate device.

Crucially, this document does NOT contain information about the acceptance criteria or a study proving the device meets those criteria.

510(k) clearances, especially for Class II devices like SITZMARKS, often rely on demonstrating substantial equivalence to a legally marketed predicate device rather than extensive de novo clinical trials with predefined acceptance criteria and performance studies like those required for PMA approvals or more novel devices.

Therefore, based on the provided text alone, I cannot answer the questions regarding acceptance criteria and performance studies. The document primarily focuses on regulatory aspects, substantial equivalence, and general controls.

To answer your questions, one would typically need access to the actual 510(k) submission packet, which would include descriptions of any performance testing or clinical data submitted to support the substantial equivalence claim. This public document only states the outcome of the FDA's review.

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