(90 days)
The Esophageal Manometry System is intended to record, store, view and analyze data on line in the gastrointestinal tract to assist in the diagnoses of gastrointestinal disorders.
The system is a stationary manometry system for use in evaluating the function of the gastrointestinal tract. The system measures pressure and other parameters online using sensors on and in the patient. The parameters are presented during the capture and are also recorded for later display, analysis and reporting.
The provided 510(k) summary for the Medtronic Esophageal Manometry System (K992713) does not describe specific acceptance criteria or a detailed study proving the device meets said criteria in the way typically expected for an AI/ML or new complex device submission. Instead, it relies on a comparison to a predicate device and verification results.
Here's a breakdown of the information based on the provided text, addressing your specific points:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly define acceptance criteria as a set of quantified performance metrics like sensitivity, specificity, or accuracy. Instead, the "acceptance criteria" appear to be implicit in the claim of "equivalence" to the predicate device and the successful verification of enhanced technical features.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-
| Functional Equivalence to Predicate Device | "Verifications results shows that the enhanced system performs as its predicate system." The device is intended to record, store, view, and analyze data online in the GI tract to assist in the diagnoses of GI disorders, which is the "Same" as the predicate. |
| Increased Performance (Technical Features) | The new device offers enhanced performance in: |
| * Number of Channels | Up to 16 (Predicate: Up to 16) - Self-contradictory in table, previous predicate showed "up to 16", modified device showed "4-16 channels" and explanation states "Enhanced performance". This implies the modified device consistently handles 4-16 channels well. |
| * Sampling rate | 105-1674 Hz (Predicate: 1/128 to 128 Hz) |
| * Power supply | 24 V DC (Predicate: 9-12 V DC) - accommodates 110-230 V Power Supply in one. |
| * Measuring range | -2.5 Vpm, 5 % to 2.5 Vpm 5% (Predicate: 0-9 pH) |
| * Insulation | HCPL-0710. NMV 2405S, and safety power supply: class I (Predicate: Burr Brown722 dual isolated DC/DC converter); with isolation within each module of 4 channels. |
| * Current consumption | Max 0.8 A (Predicate: 260 mA nom standard (8bit)) |
| * Communication | USB (Universal Serial Bus) (Predicate: Optical serial RS 232); "Enhanced performance (band width)" |
| * Resolution | 22 bit (Predicate: 8 bit) |
| * Operating system | Windows 98 (Predicate: Windows 3.11, 95) |
| Safety | "doesn't raise any new safety or performance issues." The device complies with EN 60601-1, UL 2601-1, and CAN/CSA C22.2 No.610.1-M90. |
Study Proving Acceptance Criteria:
The document explicitly states: "Clinical trials are not performed."
The justification for equivalence and performance relies on non-clinical performance data verification. The "Verifications results shows that the enhanced system performs as its predicate system." This implies internal testing and validation of the hardware and software components to ensure they meet their design specifications and function comparably or with enhancements to the predicate. No further details on the specifics of this verification study (e.g., test protocols, results metrics, sample sizes for verification) are provided in this summary.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test set sample size: Not specified. The document states "Clinical trials are not performed" and relies on "Verifications results" (non-clinical data). This means there wasn't a "test set" in the context of patient data in a clinical study.
- Data provenance: Not applicable, as clinical trials were not performed. The data underpinning the "verifications results" would be engineering and performance test data generated internally by the manufacturer, Medtronic Functional Diagnostics A/S in Denmark.
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)
Not applicable. Since clinical trials were not performed and there was no patient-specific "test set" to establish a ground truth for diagnostic accuracy, no experts were used for this purpose in the context of this submission. The "ground truth" for the non-clinical verification would be the expected performance based on engineering specifications and comparison to the predicate device's known characteristics.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no clinical test set requiring expert adjudication was used.
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 device described appears to be a data acquisition and analysis system, not an AI-assisted diagnostic tool that directly impacts human reader interpretation in a measurable way (like an AI algorithm for image analysis). The "analysis" provided by the system is based on calculated parameters from physiological signals, not interpretation of complex images or data that typically requires an MRMC study for AI evaluations.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to a standalone performance evaluation of a diagnostic algorithm. The Esophageal Manometry System is a measurement and analysis system for physiological signals, not a standalone diagnostic algorithm in the sense of AI/ML. The "analysis" it performs (e.g., LES location, resting pressure, amplitude, duration, velocity) are calculations based on the acquired signals. The performance of these calculations would have been "verified" as part of the non-clinical performance data, ensuring their accuracy and consistency. However, no specific standalone algorithm performance study, as understood for AI, is described.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the "Verifications results" (non-clinical performance data), the "ground truth" would be engineering specifications, expected physical measurements, and the known performance/output of the predicate device. For example, testing the sampling rate would involve inputting known frequency signals and verifying the system's output. For calculated parameters, the ground truth would be established by mathematical correctness and consistency with the predicate device's calculations.
8. The sample size for the training set
Not applicable. This device is not an AI/ML system that utilizes a training set in the conventional sense.
9. How the ground truth for the training set was established
Not applicable, as there was no training set for an AI/ML algorithm.
§ 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).