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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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smARTrack™ Feeding Tube System can guide operator to correctly re-position the tube.
The smARTrack™ Feeding Tube System is designed to aid qualified operators in the smARTrack Feeding Tube into the stomach of patients requiring enteral feeding. The smARTrack™ tube is equipped with sensors designed to provide information about the location of the tube tip relative to the lower esophageal sphincter (LES) thus assisting in reducing the incidence of misplacement during first positioning. The smARTrack™ tube also monitors the position continuously during the course of the feeding and automatically and in real time alerts of tube migration. The smARTrack equipped with a motorized mechanism which automatically and in real-time stops feeding tube moves out of position during ongoing use. Furthermore, smARTrack™ Feeding Tube System can guide operator to correctly re-position the tube.
The smARTrack™ Feeding Tube is intended for gastric decompression, gastric lavage, and the administration of nutrition, fluids and medications by the naso-enteric route for patients who have an intact gastrointestinal tract but are manage nutritional intake through normal mastication and deglutition.

The smARTrack™ Feeding Tube System is based on sensor-lined tubes that transmit real-time information to an external console. The information relayed to the console is used to transmit information about the location of the tube tip relative to the lower esophageal sphincter (LES).
The smARTrack™ System contains the following:
a) Feeding tube (multi-lumen, feeding inlet compatible with standard gravity bag unit and impedance sensors)
b) Electronic console which: indicate the location of the tube in the body, stops the feeding in case of overfeeding and keep a patient event log.

The provided text describes the smARTrack™ Feeding Tube System and smARTrack™ Feeding Tube, seeking 510(k) clearance. Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" in a tabular format with specific numerical targets. However, based on the performance data section and conclusions, the implied acceptance criteria revolve around:

• Correct tube placement: The system should guide the user to ensure the feeding tube is correctly placed into the stomach relative to the Lower Esophageal Sphincter (LES).
• Identification of tube malposition/migration: The system should continuously monitor the tube's position and alert in real-time if it moves out of position.
• Automatic feeding cessation: The motorized mechanism should automatically stop feeding if the tube moves out of position.
• Safety: The device should be safe for use, as demonstrated by biocompatibility, electrical safety, and the absence of unexpected adverse events in clinical trials.
• Functionality: All components and features (sensors, console, motorized mechanism) should function correctly as intended.

Here's a table summarizing the reported device performance against these implied criteria:

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

• Clinical Test Set Sample Size: 10 healthy volunteers.
• Data Provenance: The document explicitly states "A feasibility study was conducted on 10 healthy volunteers." It does not specify the country of origin, but the applicant company is ART Healthcare Ltd. in Israel. The study appears to be prospective, as indicated by "was conducted."

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

The document states, "Correct placement of the tube was verified via X-Ray." It does not specify the number or qualifications of experts (e.g., radiologists) who interpreted the X-Rays to establish ground truth.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for the test set results (e.g., 2+1, 3+1 for resolving discrepancies). It simply states that X-Ray was used for verification.

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, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The clinical study was a feasibility study on 10 healthy volunteers to assess the system's functionality and safety, with X-Ray as independent verification for correct placement. It does not compare human reader performance with or without AI assistance, nor does it report an effect size for such a comparison. The device is a guiding system rather than an AI interpretation tool.

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

No, a standalone (algorithm only) performance study was not conducted or reported. The device is explicitly designed as a "system" to "guide the operator," implying human-in-the-loop operation. The "automatic mechanism which stops feeding" is part of the integrated system and validated in that context.

7. The Type of Ground Truth Used

The primary ground truth used for verifying correct tube placement in the clinical study was X-Ray verification.

8. The Sample Size for the Training Set

The document does not specify a training set sample size. This is a medical device clearance document, not a machine learning model submission, so the concept of a "training set" in the context of an AI/ML algorithm might not directly apply in the way it's typically understood for neural networks or similar models. The "software verification and validation testing" is mentioned, implying traditional software engineering approaches rather than specific machine learning training datasets. The system uses "impedance sensors" to provide information about tube location, suggesting a physics-based model or rule-based system validated through bench and animal studies, rather than a data-driven model requiring a large training set in the AI sense.

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

As no specific "training set" is mentioned in the context of a machine learning model, the method for establishing its ground truth is also not provided. The development and validation relied on:

• Engineering principles and testing (bench studies).
• Animal studies (Ex-Vivo and In-Vivo) where the "correct location of the LES" was identified through direct observation or established biological markers.
• Clinical feasibility study where X-Ray served as the ground truth for human-guided placement.

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Plethysmography Module:
The device provides non-invasive measurement of pulse waveform and heart rate by photoclectric plethysmography.

Electrogastrography (EGG) Module:
A device that receives, records, and produces a visual display of the myoelectrical signal produced by the stomach as an aid to diagnosis of various gastric disorders.

The ACEM is an electronic accessory signal acquisition device. The ACEM includes five (5) signal conditioning circuits: respiration, plethysmograph, ECG and two channels of the EGG. Respiration and ECG have previous clearance under the InSight 510(k) K012232. The new plethysmograph accessory consists of a small, red LED placed against the finger and a photoelectric sensor to measure changes in the light intensity. The filter signal is amplified and digitized.

The added EGG signal conditioning unit receives signals from the body through standard pad electrodes. The signals are filtered and digitized.

Both the plethysmograph and EGG signals are forwarded to the Sandhill InSight System (K012232) for display.

The provided document is a 510(k) summary for the ACEM (Sensor Pac, signal acquisition) device. It describes the device's intended use and technological characteristics, as well as its substantial equivalence to predicate devices. However, the document does not contain specific acceptance criteria, a detailed study description with performance metrics, sample sizes, ground truth establishment methods, or information about MRMC studies.

Based on the provided text, here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly stated in the provided document. The document primarily focuses on establishing substantial equivalence to predicate devices and electrical safety. It states:

• "Bench data confirms the plethysmograph and EGG channels meet the product specifications."

This implies that there were product specifications and that bench data was used to demonstrate adherence to them, but the specifications themselves and the exact performance results are not detailed.

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

This information is not present in the document. No specific test set, sample size, or data provenance (e.g., country of origin, retrospective/prospective) is described. The relevant section states:

• "Bench data confirms the plethysmograph and EGG channels meet the product specifications."

This suggests internal testing, but no details are given.

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

This information is not present in the document. There is no mention of human experts or ground truth establishment for a test set.

4. Adjudication Method for the Test Set

This information is not present in the document.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size.

This information is not present in the document. The document does not describe any studies involving human readers or comparative effectiveness.

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

The device (ACEM) is a signal acquisition device that forwards signals to another system (Sandhill InSight System, K012232) for display. It is not an AI algorithm that produces an interpretation or diagnosis on its own. Therefore, the concept of "standalone performance" for an algorithm, as typically applied to AI, does not directly apply here. The "bench data" mentioned would likely be an assessment of the hardware's ability to accurately acquire and condition the physiological signals according to its specifications.

7. The Type of Ground Truth Used

The concept of "ground truth" as typically applied to diagnostic AI models (e.g., pathology, outcomes data, expert concensus) is not applicable to this device in the context of the provided information. The ACEM is a signal acquisition device. Its "performance" would be related to the accuracy and reliability of signal capture and conditioning, likely verified against known physical inputs or established measurement standards, rather than a diagnostic "ground truth." The document states:

• "Bench data confirms the plethysmograph and EGG channels meet the product specifications."

This implies that the "ground truth" for this device's performance would be the expected electrical or physiological signals that the device is designed to measure, and its ability to accurately and reliably capture them.

8. The Sample Size for the Training Set

This information is not present in the document. As this device is a signal acquisition hardware and not an AI algorithm, a "training set" in the machine learning sense is not relevant.

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

This information is not present in the document, as it is not an AI algorithm, and therefore, a training set with established ground truth is not applicable in the context of this 510(k) summary.

Summary of Study Information Provided:

The document describes electrical safety testing and bench data testing to confirm product specifications.

• Acceptance Criteria (Implied): The device must meet IEC 60601-1 and IEC 60601-1-2 safety standards. The plethysmograph and EGG channels must meet their respective product specifications.
• Study Proving Acceptance Criteria:
  • Electrical Safety Testing: The ACEM was demonstrated electrically safe through testing and meeting IEC 60601-1 and IEC 60601-1-2 safety standards.
  • Performance Bench Testing: Bench data was used to confirm that the plethysmograph and EGG channels meet the product specifications.
• Sample Size for Test Set: Not specified, but likely refers to a series of controlled bench tests.
• Data Provenance: Implied to be internal bench testing.
• Experts for Ground Truth: Not applicable/not specified.
• Adjudication Method: Not applicable/not specified.
• MRMC Study: No.
• Standalone Performance (Algorithm): Not applicable, as it's a hardware signal acquisition device.
• Type of Ground Truth: For safety, adherence to international electrical safety standards. For performance, meeting "product specifications" through bench data, likely implying accuracy against known inputs.
• Training Set Sample Size: Not applicable.
• Training Set Ground Truth Establishment: Not applicable.

In essence, the 510(k) summary for the ACEM device is based on demonstrating substantial equivalence to predicate devices and verifying electrical safety and basic functional performance through bench testing, rather than a clinical trial or AI model validation study.

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The ManoScan Motility with Impedance Visualization System obtains a high resolution mapping of pressures and impedance levels within organs of the human gastrointestinal tract. These include the pharynx, upper esophageal sphincter (UES), esophagus, lower esophageal sphincter (LES), stomach, sphincter of oddi, small bowel, colon, duodenum and anorectal organs. It is used in a medical clinical setting to acquire pressures, impedance levels and video and store the corresponding data. The system also provides visualization and analysis tools and information. The real time data as well as the analysis information can be viewed for diagnostic and analysis purposes with an intention of assisting in the diagnosis and evaluation of gastrointestinal and swallowing disorders. The device is intended for use by gastroenterologists, surgeons and medically trained personnel.

The ManoScan Motility with Impedance Visualization System is used to acquire gastrointestinal tract data in order to present a high-resolution mapping of pressures with Impedance levels within tubular organs. It includes the ability to acquire, display and replay video data captured from within the gastrointestinal tract organs. The ManoScan Motility with Impedance Visualization can be used with either or both of the video with Impedance data capture features disabled.

The System is used in a medical clinical setting to sense pressure and Impedance levels, acquire and store the corresponding data and enable viewing or analyzing in real time or anytime after the data is acquired and stored. Accordingly, the System provides visualization and analysis tools that can be used for evaluation of the data and analytic diagnosis.

The system includes a catheter probe that can be configured with a variety of pressure sensing element with Impedance sensor channels. During the clinical procedure, the catheter is inserted transorally or via rectal intubation and pressure with Impedance levels from inside the gastrointestinal tract are monitored. Data collection can include acquisition of data from different segments of the GI tract, including the pharynx, upper esophageal sphincter (UES), esophagus, lower esophageal sphincter (LES), stomach, sphincter of oddi, small bowel, colon, duodenum and anorectal area. Real-time data is sampled from each sensing channel via the interface electronics and made available to the software during each sample period. The software displays the data in real-time to support the clinical procedure.

The Sierra Scientific Instruments ManoScan Motility with Impedance Visualization System is a device used to acquire gastrointestinal tract data, presenting a high-resolution mapping of pressures and impedance levels within tubular organs. The system is intended to aid in the documentation, diagnosis, and evaluation of motility, digestive tract, and swallowing disorders.

Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance:

The 510(k) summary indicates that the device's acceptance criteria are based on meeting or exceeding the performance characteristics of its predicate devices. The study performed involved bench-top verification tests.

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

• Test Set Sample Size: Not explicitly stated as a numerical sample size. The "test set" for performance evaluation consisted of bench-top verification tests to assess pressure with impedance accuracy, noise, and repeatability.
• Data Provenance: The data is from non-clinical bench-top testing conducted by Sierra Scientific Instruments, Inc. No specific country of origin for the data is mentioned beyond the company's location in Los Angeles, CA, USA. The study was non-clinical and therefore neither retrospective nor prospective in the human subject sense.

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

• Number of Experts: Not applicable. The "ground truth" for the bench-top tests was established by objective measurements and comparisons against the performance of predicate devices, not by human expert assessment.
• Qualifications of Experts: Not applicable, as expert consensus was not used for the bench-top testing.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable. The "test set" involved objective measurements against established engineering and performance benchmarks, and comparison to predicate device specifications, rather than a clinical interpretation requiring adjudication.

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

• MRMC Study: No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The submission explicitly states: "No formal clinical testing has been performed, nor is any believed to be necessary."
• Effect Size: Not applicable, as no MRMC study was conducted.

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

• Standalone Study: Yes, in essence, the "bench-top verification tests" can be considered a form of standalone performance evaluation for the device's technical specifications (accuracy, noise, repeatability) in a controlled environment. However, this is not an algorithm-only standalone study for diagnostic performance in the same way an AI device might be evaluated. This device is a measurement system, and its standalone performance relates to its ability to acquire and display accurate data. The system is designed to provide "visualization and analysis tools and reports that can be viewed for diagnostic purposes by appropriately trained medical personnel," implying a human-in-the-loop for diagnosis, even though the system's core measurement capabilities were tested in standalone bench-top settings.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.):

• Ground Truth Type: For the bench-top verification tests, the ground truth was based on objective physical measurements using calibrated instruments and comparison to the established performance characteristics/specifications of the predicate devices. For example, pressure accuracy would be verified against known pressure inputs from a calibrated pump, and noise/repeatability would be measured against engineering specifications.

8. The Sample Size for the Training Set:

• Training Set Sample Size: Not applicable. This device is a hardware and software system for acquiring and presenting physiological data. It does not appear to involve machine learning or AI models that require a "training set" for diagnostic classification in the conventional sense. The software's "analysis and diagnostic tools" are based on algorithms designed to process the acquired pressure and impedance data, not on learned patterns from a training set.

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

• Ground Truth for Training Set: Not applicable, as no training set was used for machine learning or AI algorithm development. The software's functionality is based on established biophysical principles and data processing algorithms.

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