(372 days)
The ManoScan System provides mapping of pressures and, optionally, impedance within organs of the human gastrointestinal tract. These include the pharynx, upper esophageal sphincter (UES), 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 and then store the corresponding data for visualization and analysis. The real-time data as well as the analysis information can be viewed by trained personnel for diagnostic and analytic purposes. The ManoScan HRM modules provide high-resolution mapping of the pressure and impedance data. The ManoScan CLT module provides conventional line trace mapping of the pressure data.
The ManoScan System provides hardware and software for performing gastrointestinal (GI), sphincter of Oddi, and colorectal manometry. The ManoScan System comprises two sub-systems: the ManoScan HRM System and the ManoScan CLT System. The ManoScan HRM modular series is a high resolution manometry system used for GI manometry. The base system includes a manometric catheter probe, a ManoScan HRM module (A120 module), and software for data acquisition and analysis. Various probe configurations are available depending on the application (esophageal or anorectal manometry), size (regular or small), and catheter diameter. The ManoScan A200 module enables measuring pressure and impedance data using different dedicated catheters. The ManoScan A300 module is used for high-definition 3D catheters which pass pressure data through to the ManoScan A120 module. When enabled, the optional ManoScan A400 module will enable video acquisition through video inputs that originate in typical medical imaging equipment. The ManoScan 3.0 software supports display of video from the ManoScan A400 module (or other video input) and displays it concurrently with pressure (and impedance if enabled) to allow for improved physiological review of the esophageal or anorectal motility function. The ManoScan CLT series is a conventional line trace system used for GI manometry. The system includes a manometric catheter probe, the ManoScan CLT module (A550), and software for data acquisition and analysis. The system is supplied as an integrated cart system consisting of: a cart, manometric catheter, ManoScan CLT A550 module, Computer, monitor and computer peripherals (keyboard, mouse, etc.), power isolation station, ManoScan 3.0 and ManoView CLT software. The ManoScan CLT A550 module acquires pressure data from three catheter types: water-perfused, solid state, and air-charged, manufactured by specific vendors. Each catheter type is connected to the ManoScan CLT A550 module by means of corresponding transducer cable.
The provided document, a 510(k) summary for the ManoScan® System, focuses on demonstrating substantial equivalence to predicate devices rather than presenting a standalone study with detailed acceptance criteria and performance data for the current device. Therefore, much of the requested information regarding specific acceptance criteria, sample sizes, expert involvement, and ground truth types for a study proving device performance is not explicitly available in this document.
However, based on the information provided, here's what can be extracted and inferred:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present a formal table of acceptance criteria with corresponding performance data in the same way a clinical trial report might. Instead, it focuses on demonstrating equivalence through technical specifications and verification against standards.
| Acceptance Criterion (Inferred from testing) | Reported Device Performance (Summary) |
|---|---|
| Electrical Safety | Complies with IEC 60601-1 standard for electrical safety. |
| Electromagnetic Compatibility (EMC) | Complies with IEC 60601-1-2 standard for EMC. |
| Hardware Verification (CLT A550 module) | Performance evaluated and found acceptable. |
| Pressure Mapping Equivalence (CLT A550) | Verified that the mapping of pressure data is equivalent to the predicate device (Polygraf ID module). |
| Software Verification & Validation | Conducted according to FDA guidance; considered "moderate" level of concern, with no new safety/performance issues. |
2. Sample Size Used for the Test Set and Data Provenance
The document describes bench testing for hardware and pressure mapping.
- Sample Size for Test Set: Not explicitly stated. The nature of bench testing typically involves testing a representative number of units or datasets to cover operational ranges and functionalities, but specific numbers are not provided.
- Data Provenance: This would be retrospective in the sense that physical devices and software were tested in a controlled bench environment, rather than prospective clinical data collection. The location is not explicitly stated beyond Given Imaging's location in Israel, implying the testing was performed internally or by a contracted lab.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not provided in the document. For bench testing of hardware and software, "ground truth" would typically be established by comparing measurements to known physical standards, specifications, or the performance of a predicate device/golden standard, rather than expert consensus on medical images or diagnoses.
4. Adjudication Method for the Test Set
This information is not provided. Given the nature of bench testing against standards and predicate devices, a formal adjudication method like "2+1" (which implies multiple human reviewers) is unlikely to have been used. Verification would be against objective technical criteria.
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 or reported in this 510(k) summary. The document focuses on technical equivalence and safety rather than comparative clinical effectiveness with human readers. Therefore, an effect size of human improvement with AI assistance is not applicable here.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device is a Gastrointestinal Motility Monitoring System that acquires pressure and impedance data for visualization and analysis by trained personnel. It is not an AI algorithm intended for standalone diagnostic performance without human interpretation. Therefore, a standalone "algorithm only" performance study in the sense of an AI diagnostic tool is not applicable or reported for this device. The software performs data processing and visualization, not autonomous diagnostic decisions.
7. The Type of Ground Truth Used
For the bench testing, the ground truth would be:
- Technical Specifications/Standards: For electrical safety and EMC.
- Predicate Device Performance: For pressure mapping equivalence, the performance of the Polygraf ID module served as a reference. This is a form of measurement comparison rather than clinical ground truth like pathology or outcomes data.
8. The Sample Size for the Training Set
This information is not applicable/not provided in the context of this 510(k) submission. The ManoScan® System is described as a data acquisition, visualization, and analysis system, not a machine learning or AI system that requires a "training set" to learn patterns for diagnostic prediction. The software is developed through traditional software engineering processes, not machine learning model training.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable, as there is no "training set" for an AI/ML model for this device.
§ 876.1725 Gastrointestinal motility monitoring system.
(a)
Identification. A gastrointestinal motility monitoring system is a device used to measure peristalic activity or pressure in the stomach or esophagus by means of a probe with transducers that is introduced through the mouth into the gastrointestinal tract. The device may include signal conditioning, amplifying, and recording equipment. This generic type of device includes the esophageal motility monitor and tube, the gastrointestinal motility (electrical) system, and certain accessories, such as a pressure transducer, amplifier, and external recorder.(b)
Classification. Class II (performance standards).