Search Results
Found 4 results
510(k) Data Aggregation
(106 days)
The MiVu Mucosal Integrity Testing System is indicated for use by gastroenterologists, surgeons, and medical personnel trained in endoscopic procedures during an endoscopy to obtain real-time measurement of esophageal epithelial integrity as an adjunct for the evaluation of esophageal disorders. The device is not for use as a sole diagnostic screening tool.
The Diversatek Healthcare MiVu Esophageal Endo Cap is the candidate accessory device for use with the approved predicate Diversatek Healthcare's MiVu Mucosal Integrity Testing system (MiVu System). The MiVu Esophageal Endo Cap is a new patient-contacting accessory that will be used in place of the MiVu Balloon Probe already approved as part of the MiVu System.
The MiVu Esophageal Endo Cap device consists of a patient contacting sensor tip that is installed over the working end of an endoscope. The tip is a flexible thermoplastic elastomeric tube with a single row of four (4) gold plated pads, providing three (3) impedance sensors evenly spaced along the length of the impedance sensors are mounted on a pivoting platform to promote even contact of all sensor pads with the tissue. A polyurethane conduit tube containing interconnecting wires connects the individual impedance sensor pads on the sensor tip to the circuit board inside the connector housing. The connector is then attached to the remainder of the predicate MiVu System through the MiVu Endo Cap Cable. The MiVu System digitizes the impedance signals and passes the data to the PC-based Zvu software for display and analysis.
The provided text describes a 510(k) premarket notification for the MiVu™ Esophageal Endo Cap, a device intended to replace the MiVu™ Balloon Probe as an accessory for the MiVu Mucosal Integrity Testing System. The submission aims to demonstrate substantial equivalence to the predicate device.
Here's an analysis of the acceptance criteria and study information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria in a table format for performance metrics (e.g., sensitivity, specificity, accuracy). Instead, the clinical study aims to demonstrate "clinically equivalent or better results" compared to the predicate device based on "disease probabilities."
However, we can infer some criteria based on the testing performed:
| Acceptance Criterion (Inferred) | Reported Device Performance |
|---|---|
| Functional Compatibility | The MiVu Esophageal Endo Cap and MiVu Endo Cap Cable were tested to verify compatibility with the MiVu Mucosal Integrity Testing System. Functional testing demonstrated the acquisition of impedance data and the authentication of the Endo Cap device. |
| Equivalence to Predicate Function and Performance | Bench testing compared the MiVu System with the Endo Cap to the MiVu System with the predicate Balloon Probe using a test medium for true impedance readings. The implied acceptance is that the performance is equivalent. Clinical studies found the MiVu System with the MiVu Esophageal Endo Cap device provided clinically equivalent or better results than the MiVu Balloon Probe based on the disease probabilities generated by the MiVu System. |
| Biocompatibility (ISO 10993-1) | Complies with all applicable parts of the standard. |
| Electrical Safety and EMC (IEC 60601-1, IEC 60601-1-6, IEC 60601-1-2) | System configuration complies with the applicable requirements of these standards. |
| Mechanical Safety (Tensile testing, pull test) | Tensile testing performed according to ISO 10555-1:2013+A1:2017. A pull test of retention on a 9.9mm endoscope was performed. The implied acceptance is that the device meets mechanical safety requirements. |
| Reprocessing Effectiveness (for reusable cable) | Reprocessing instructions for the MiVu Endo Cap Cable were validated by a third-party testing lab. |
| Bioburden and Packaging Integrity | Devices tested for bioburden levels pre- and post-shipping simulation to verify packaging effectiveness and mechanical integrity. The implied acceptance is that bioburden levels are acceptable and packaging is effective. |
| Software Level of Concern | Firmware and software classified as "minor level of concern" (a failure will not pose any risk of harm to the patient or user). |
| Clinical Equivalence/Usability | All clinical studies found the MiVu System with the MiVu Esophageal Endo Cap device provided clinically equivalent or better results than the MiVu Balloon Probe based on the disease probabilities generated by the MiVu System. No patient adverse effects or complications were reported. |
2. Sample size used for the test set and the data provenance
- Sample Size:
- Comparative Test Set: 17 random patients were tested using both the MiVu Esophageal Endo Cap and the predicate MiVu Balloon Probe.
- Endo Cap Only Test Set: An additional 7 random patients were tested using only the MiVu Esophageal Endo Cap.
- Total Patients in Clinical Study: 24 patients.
- Patient Demographics: Adult age (20 to 70 years), 12 males, 8 females, 4 unknowns.
- Data Provenance: Clinical studies were performed at one United States located facility. The study was prospective as patients were enrolled and tested within the context of the study.
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 how ground truth for the test set was established or the number/qualifications of experts involved in determining the actual disease state (GERD, non-GERD, EoE) for the patients in the clinical study.
The study compared the device's generated "disease probabilities" against those generated by the predicate device, implying the predicate device's output or a physician's interpretation of it might serve as a de facto reference point for "clinically equivalent or better results."
It does mention that the clinical studies were performed by three gastroenterologists who were familiar with both MiVu System configurations. While these gastroenterologists performed the studies and interpreted the results, it's not explicitly stated if they established a definitive "ground truth" for each patient's actual disease. The system itself "generates a probability of the tissue disease type (GERD, non-GERD, EoE) which is used by the physician as an input to the treatment plan."
4. Adjudication method for the test set
The document does not specify any formal adjudication method (e.g., 2+1, 3+1) for the clinical study. The conclusion states that results were "clinically equivalent or better results than the MiVu Balloon Probe based on the disease probabilities generated by the MiVu System," suggesting a direct comparison of the outputs of both systems, possibly evaluated by the performing gastroenterologists.
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: While the study involved three gastroenterologists and multiple cases, it was not a traditional MRMC comparative effectiveness study focused on "human reader improvement with/without AI assistance." The study's primary goal was to compare the performance of the new accessory (Endo Cap) to the predicate accessory (Balloon Probe) within the existing MiVu System, which already includes an algorithm for determining disease probabilities. The comparison was device-to-device, not human-with-AI vs. human-without-AI.
- Effect Size of Human Readers: No such effect size is reported as this was not the objective of the study. The device's output ("disease probabilities") is an input for the physician's treatment plan, but the study doesn't isolate the impact of this input on a human reader's diagnostic accuracy.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the MiVu System, which includes the algorithm, generates "disease probabilities for GERD (Gastro-Esophageal Reflux Disease), non-GERD and EoE (Eosinophilic Esophagitis)." This is an algorithm-only output. The clinical study compares these probabilities generated when using the new Endo Cap versus when using the predicate Balloon Probe. The system's output is then "used by the physician as an input to the treatment plan," indicating the algorithm provides a standalone assessment.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The document primarily refers to comparing the "disease probabilities generated by the MiVu System" when using the new Endo Cap versus the predicate Balloon Probe. It does not explicitly state that a definitive, independent ground truth (e.g., biopsy/pathology results, long-term outcomes, or a gold-standard expert consensus) was established for each patient's condition to validate the accuracy of these probabilities themselves. The comparison is largely relative to the predicate device's performance within the same system.
The study selected patients "based on the known or highly suspected esophageal disease type (GERD, non-GERD, EoE)," which implies some pre-existing diagnostic information, but whether this served as the formal "ground truth" for the device's output validation is not explicitly detailed.
8. The sample size for the training set
The document for the MiVu™ Esophageal Endo Cap does not provide information on the sample size for the training set used to develop the algorithm within the MiVu System. It only describes the clinical study for the new accessory and its comparison to the predicate. The algorithm for determining disease probabilities (GERD, non-GERD, EoE) was developed for the original MiVu System. The submission refers to the De Novo submission for the MiVu System (DEN180067) for details on the operating principle and changes in mucosal conductivity, which likely includes information about the algorithm's development.
9. How the ground truth for the training set was established
Similar to the training set size, the document for the MiVu™ Esophageal Endo Cap does not detail how the ground truth was established for the training set of the MiVu System's algorithm. This information would typically be found in the original De Novo submission (DEN180067) for the MiVu System, which introduced the core technology and its algorithm. The current submission focuses on the substantial equivalence of a new accessory, not the development of the underlying diagnostic algorithm itself.
Ask a specific question about this device
(60 days)
The Diversatek Healthcare PureFlo™ System (tubing and accessories to accommodate various gastrointestinal endoscopes and irrigation pumps) is intended to provide irrigation fluids, such as sterile water, during gastrointestinal endoscopic procedures when used in conjunction pump or electrosurgical unit.
The Diversatek Healthcare PureFlo™ Auxiliary Water Jet Connector is used in conjunction with the PureFlo™ Irrigation Tubing and is intended to provide irrigation fluids such as sterile water supplied during gastrointestinal endoscopic procedures when used in conjunction with an irrigation pump or electrosurgical unit.
The Diversatek Healthcare PureFlo™ Water Bottle Tubing is intended to be used with an air source from an endoscope with the purpose of supplying sterile water to the endoscopic procedures. It is compatible with U.S. commercially available sterile water bottles.
The Diversatek Healthcare PureFlo™ Water Bottle Tubing CO2 is intended to be used with an air or carbon dioxide (CO2) source with the purpose of supplying sterile water to the endoscopic procedures. It is compatible with U.S. commercially available sterile water bottles.
This submission includes the Diversatek Healthcare PureFlo™ Irrigation System and Water Bottle Tubing. All devices within this submission are provided sterile.
The Diversatek Healthcare PureFlo™ Irrigation System (tubing and accessories to accommodate various gastrointestinal endoscopes and irrigation pumps) is intended to provide irrigation via irrigation fluids, such as sterile water, during gastrointestinal endoscopic procedures when used in conjunction with an irrigation pump or electrosurgical unit.
The Diversatek Healthcare PureFlo™ Auxiliary Water Jet Connector is used in conjunction with the PureFlo™ Irrigation Tubing and is intended to provide irrigation via irrigation fluids such as sterile water supplied during gastrointestinal endoscopic procedures when used in conjunction with an irrigation pump or electrosurgical unit.
The irrigation system consists of irrigation tubing and a single-use auxiliary water jet connector. The tubing is inserted into a water bottle and the cap is screwed on the water bottle. The roller pump tubing of the irrigation tubing is then positioned within one of the specified pumps. The tubing is then connected to the auxiliary water jet connector. The auxiliary water jet connector is then connected to the auxiliary water port of the endoscope. To activate the flow of water, the foot pedal of the pump is pressed. The tubing should be primed prior to insertion of the endoscope in the patient.
The auxiliary water jet connector is replaced after each patient. The irrigation tubing can be used for up to 24 hours on multiple patients.
The Diversatek Healthcare PureFlo™ Water Bottle Tubing is intended to be used with an air source from an endoscope with the purpose of supplying sterile water to the endoscope during endoscopic procedures. It is compatible with U.S. commercially available sterile water bottles.
With the pinch clip open, the water bottle tubing is inserted into a water bottle and the cap is screwed on the water bottle. The endoscope connector is then connected to the air/water port on the Gl endoscope. The tubing is then primed prior to insertion of the endoscope in the patient.
The water bottle tubing can be used for up to 24 hours on multiple patients.
The Diversatek Healthcare PureFlo™ Water Bottle Tubing CO2 is intended to be used with an air or carbon dioxide (CO2) source with the purpose of supplying sterile water to the endoscope during endoscopic procedures. It is compatible with U.S. commercially available sterile water bottles.
The PureFlo™ Water Bottle Tubing CO2 is used with either air or CO2.
If using with air: With both blue and white pinch clips open, the water bottle tubing is inserted into a water bottle and the cap is screwed on the water bottle. The endoscope connector is then connected to the air/water port on the GI endoscope. The white pinch clamp is then closed. The tubing is then primed prior to insertion of the endoscope in the patient.
If using with CO2: With both blue and white pinch clips open, the water bottle tubing is inserted into a water bottle and the cap is screwed on the water bottle. The endoscope connector is then connected to the air/water port on the GI endoscope. The CO2 Connector / Luer Lock is then connected to the luer lock connection on the CO2 insufflator. The CO2 source and insufflator is then turned on. Then turn on the light source of the processor. The tubing is then primed prior to insertion of the endoscope in the patient.
The water bottle tubing CO2 can be used for up to 24 hours on multiple patients.
Here's a breakdown of the acceptance criteria and the study information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes non-clinical performance testing for the Diversatek Healthcare PureFlo™ Irrigation System / Water Bottle Tubing units. While explicit "acceptance criteria" are not listed with numerical thresholds, the document states: "All test results passed, demonstrating that the device is as safe, as effective, and performs as well as or better than the predicate device." This implies that the acceptance criteria were defined by achieving outcomes comparable to or superior to the predicate devices and demonstrating safety and effectiveness.
| Test Performed | Implied Acceptance Criteria (Based on "passed" statement) | Reported Device Performance |
|---|---|---|
| 1. Device Specification Conformation | Device specifications met | Passed |
| 2. Leakage Test | No detectable leaks | Passed |
| 3. Irrigation Tubing Simulated Use Test | Functioned as intended during simulated use | Passed |
| 4. Pinch Clip Test | Pinch clip operated correctly and maintained integrity | Passed |
| 5. Water Bottle Tubing Simulated Use Test | Functioned as intended during simulated use | Passed |
| 6. Backflow Test | No backflow observed | Passed |
| 7. 24-Hour Simulated Use Test | Maintained performance and integrity over 24 hours of simulated use | Passed |
| 8. Tensile Test | Components maintained strength and integrity under tensile forces | Passed |
| Sterilization (EO Gas) | Sterility Assurance Level (SAL) of 10⁻⁶ achieved and maintained for 3 years shelf life | Passed (validated EO cycle, aging validation passed) |
| Biocompatibility (Cytotoxicity) | No cytotoxic effects | Passed |
| Biocompatibility (Sensitization) | No sensitization reactions | Passed |
| Biocompatibility (Intracutaneous Reactivity) | No adverse intracutaneous reactions | Passed |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not specify the exact number of units used for each non-clinical test. It states "Diversatek Healthcare performed bench testing to support substantial equivalence. The following testing was performed on Diversatek Healthcare samples from final, finished devices that were subjected to all manufacturing processes for the 'to be marketed' device (including sterilization, environmental conditioning, and transportation)."
- Data Provenance: The data is from non-clinical bench testing performed by Diversatek Healthcare. It is prospective in the sense that fresh, "to be marketed" devices were used for testing. The country of origin of the data is not explicitly stated, but the submission is to the U.S. FDA, suggesting the testing was conducted to meet U.S. regulatory standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This section is not applicable as the described study is a non-clinical bench testing study, not a clinical study involving human experts or ground truth in that sense. The "ground truth" for these tests would be the established engineering and biological specifications and performance standards.
4. Adjudication Method for the Test Set:
This section is not applicable for the same reason as point 3. No human experts were involved in adjudicating outcomes for these bench tests. The results were likely assessed against predetermined engineering and biological standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document describes non-clinical bench testing, not a clinical study comparing human readers with and without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
No, this is not applicable. The device described (irrigation system/water bottle tubing) is a physical medical device, not an AI algorithm.
7. The Type of Ground Truth Used:
The "ground truth" for the non-clinical tests was based on established engineering specifications, performance standards, and biological safety criteria (e.g., ISO 10993-1 for biocompatibility). The claim is for "substantial equivalence" to predicate devices, inferring that the performance benchmarks of the predicate devices also serve as a form of reference.
8. The Sample Size for the Training Set:
This section is not applicable. The device is not an AI/machine learning algorithm, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established:
This section is not applicable for the same reason as point 8.
Ask a specific question about this device
(371 days)
The Mucosal Integrity Conductivity Test System is indicated for use by gastroenterologists, surgeons, and medically trained personnel during an endoscopy to obtain a real time measurement of esophageal epithelial impedance. The device is not for use as a sole diagnostic screening tool.
The Mucosal Integrity Conductivity (MI) Test System provides real-time measurements of alterations in esophageal evithelial integrity. The device is intended to aid in the evaluation of esophageal epithelial integrity by means of a balloon probe with direct electrical contact with the mucosal epithelium of the esophagus along with associated signal conditioning, hardware, and software for measuring and displaying information.
The provided text describes the "Mucosal Integrity Conductivity (MI) Test System," an esophageal tissue characterization system. However, the document does not contain information about a study that assesses the device's performance against specific acceptance criteria using a test set of patient data or
human readers in a comparative effectiveness study. The "Performance Testing - Bench" section details benchtop tests of the device's physical properties and electrical measurement capabilities, but this is distinct from a clinical performance study using patient data.
The "Summary of Clinical Information" section briefly mentions two prospective clinical studies where the device was used in patients, noting its ability to measure esophageal mucosal impedance and the occurrence of few adverse events. However, these descriptions do not provide specific acceptance criteria, performance metrics (like sensitivity, specificity, accuracy), or details on how ground truth was established for diagnosis or classification of esophageal conditions based on the impedance measurements, which would typically be part of a study proving the device meets clinical acceptance criteria for its intended use as an aid in evaluation.
Therefore,Based on the provided text, I cannot answer all parts of your request as it does not detail a study that proves the clinical performance of the device against specific acceptance criteria for diagnostic accuracy or human-in-the-loop improvement for clinical decision making. The information focuses on bench testing, safety, and general functionality.
However, I can extract the acceptance criteria and performance for the benchtop performance tests.
Acceptance Criteria and Reported Device Performance (Benchtop Testing)
Here's a table summarizing the acceptance criteria and reported "Pass" results for the benchtop performance testing:
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Balloon Functionality Testing | ||
| Double Wall Thickness | .00045" +/- .00025" | Pass |
| Compliance Diameter @ 0.5atm | 20 mm +/- .65 mm | Pass |
| Burst Pressure | 2.04 atm minimum | Pass |
| Dimensional Design Verification Testing | ||
| Probe Overall Length | 55.25" +/- 2.0" | Pass |
| Probe, Balloon Diameter when Inflated | 2.0 cm +/- 0.1 cm | Pass |
| Probe Weight | 2.8 oz. +/- 0.5 oz. | Pass |
| Bond between Sensors and Balloon Testing | ||
| Adhesive Strength after Exposure to Saline | ≥ adhesive strength without saline exposure2.267 lbf | Pass |
| Tensile Strength, Distal Tip to Catheter of MI Probe | ||
| Tensile Strength Distal Tip Joint MI Probe (Initial) | ≥ 3.0 lbf based on independent study | Pass |
| Tensile Strength Distal Tip Joint MI Probe (Added to Submission) | ≥ 4.5 lbf from EN 1617 (20 Newtons) | Pass |
| Impedance Measurements of MI Probe Sensors | ||
| Impedance Measurement Accuracy | 174+/- 100 Ohms | Pass |
| Impedance Signal Noise | < 20 Ohms | Pass |
| Impedance Thermal Stability | +/- 100 Ohms | Pass |
| Impedance Temporal Stability | +/- 100 Ohms | Pass |
Since the document primarily describes benchtop performance and safety testing, and general clinical use observations rather than a clinical performance study with diagnostic accuracy outcomes, the following information is not available or not applicable based on the provided text:
- Sample size used for the test set: Not specified for a clinical performance test set. The bench tests specify n=10 for balloon functionality, n=33 for some dimensional tests, n=1 for impedance accuracy tests, and n=4 or n(g) for tensile strength.
- Data provenance (e.g. country of origin of the data, retrospective or prospective): The clinical studies mentioned are stated to be "prospective," but no country of origin is specified for the data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified for any clinically relevant ground truth.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not specified.
- 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 such study is mentioned or implied, as the device gives a direct measurement and is not described as an AI assistance tool for human readers.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device directly measures impedance, it's not described as an algorithm making a diagnostic decision in a standalone fashion. Its purpose is to obtain a real time measurement to aid in the evaluation.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): While one clinical study mentions patients with "active eosinophilic esophagitis (EoE, confirmed with pathology)," the document doesn't explicitly state that pathology was used as the ground truth for evaluating the device's performance against specific clinical endpoints derived from impedance measurements. The device simply measured impedance in these patients.
- The sample size for the training set: Not applicable as there's no mention of a machine learning model requiring a training set for diagnostic classification in the provided text.
- How the ground truth for the training set was established: Not applicable.
Ask a specific question about this device
(241 days)
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:
| Acceptance Criteria (Inferred) | Reported Device Performance (Demonstrated) |
|---|---|
| Mechanical Compatibility: Connects properly to the designated motility system. | HRiM Probe (HRMR201-000) mechanically compatible with accessory cable (H12R-7610) and motility system central unit (inSIGHT Ultima® H12R-2000). |
| Probe Communication: Successful transmission and display of pressure and impedance data. | Demonstrated probe communication of pressure and impedance data through serial communication interface to the system central unit. Firmware and software functionality verified. |
| Performance Equivalence to Predicate: Comparable pressure sensor spacing, span, location, module diameter, sensitivity, impedance channel measurements, and depth marking. Performance maintained after reprocessing, simulated use, and aging. | Demonstrated equivalence in these parameters to the Unisensor predicate device. Pressure and impedance sensor functions verified after reprocessing, 200 cycles of simulated use, and 2 years of accelerated aging. |
| Joint Strength and Integrity: Maintained after reprocessing, simulated use, and aging. | Reprocessed, simulated use, and aged probe joints tested for strength and integrity per BS EN 1618. (Results implied to be satisfactory as no adverse findings are mentioned). |
| Biocompatibility: Meets applicable standards. | Complies with all applicable parts of ISO 10993-1. |
| Electrical Safety and EMC: Meets applicable standards. | Complies with IEC 60601-1-2:2014 (Ed 4) and IEC 60601-1:2005 (Ed 3) + Corr. 1:2006 + Corr. 2:2007 + A1:2012. |
| Reusability/Shelf Life: Withstands 200 cleaning/disinfection cycles and 200 simulated intubation/extubation cycles, and 2 years of aging, while maintaining sensor function. | Designed to withstand 200 cleaning/disinfection and 200 simulated intubation/extubation cycles. Test articles subjected to 200 life cycles and 2 years aging per ASTM F1980-16; probe sensor function verified. |
| Reprocessing Effectiveness: Reprocessing instructions (manual cleaning + high-level disinfection) are validated. | Validation covered reprocessing instructions outlined in the HRiM Probe IFU, which included manual cleaning followed by high-level disinfection. |
| Software Verification and Validation: Meets FDA guidance for software in medical devices, considered "minor" level of concern. | Verification and validation testing conducted per FDA guidance; software considered "minor" level of concern. |
| Cybersecurity: Addresses recommended cybersecurity issues. | Information gathered to address cybersecurity issues as recommended in FDA guidance, including protection from malware, continued support, traceability, and risk analysis. Cybersecurity section included in IFU. |
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.
Ask a specific question about this device
Page 1 of 1