(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.
§ 876.1450 Esophageal tissue characterization system.
(a)
Identification. An esophageal tissue characterization system is a device intended for obtaining measurements of electrical properties within esophageal tissue.(b)
Classification. Class II (special controls). The special controls for this device are:(1) All patient contacting components of the device must be demonstrated to be biocompatible.
(2) Performance testing must demonstrate the device can accurately measure the designated electrical characteristics.
(3) Mechanical safety testing must demonstrate that the device will withstand forces encountered during use.
(4) Software verification, validation, and hazard analysis must be performed.
(5) Electromagnetic compatibility and electrical safety, mechanical safety, and thermal safety of the device must be performed.
(6) Performance data must validate the reprocessing instructions for any reusable components of the device.
(7) Labeling must include:
(i) Specific instructions regarding the proper placement and use of the device;
(ii) Instructions for reprocessing of any reusable components; and
(iii) An expiration date for single use components.