(201 days)
These catheters are for use on patients requiring gastrointestinal manometry testing. The Esophageal Pressure Catheter Model number GIM-6000E is for use with esophageal motility studies. The Ano-Rectal Pressure Catheter Model number GIM-6000A is for use in ano-rectal pressure studies.
Gastrointestinal pressure catheters with pressure-sensing membrane cavities along the length of the catheter and a port for balloon inflation for the Anorectal model. This product is non-sterile, single patient use catheter. The system includes reusable cables with reusable pressure transducers.
This appears to be a 510(k) premarket notification summary for the Latitude GI Pressure Catheters, not a comprehensive clinical study report. Therefore, much of the requested information regarding detailed acceptance criteria, specific study designs, sample sizes, and expert adjudication will likely not be present. However, I will extract what can be found and explicitly state what is not provided.
Here's an analysis of the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria in a table format. However, it implicitly states that "Effectiveness is the same as the predicate devices." and that "The laboratory testing verified the performance in terms of sensor accuracy, mechanical integrity, and overall performance."
| Performance Metric | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Effectiveness | Equivalent to predicate devices | "Effectiveness is the same as the predicate devices." |
| Sensor Accuracy | Verified through lab testing | "verified the performance in terms of sensor accuracy" |
| Mechanical Integrity | Verified through lab testing | "verified the performance in terms of... mechanical integrity" |
| Overall Performance | Verified through lab testing | "verified the performance in terms of... overall performance" |
| Biocompatibility | Safe for intended application | "Biocompatibility testing shows that the materials used in the Latitude Pressure Catheters are safe for this application." |
Observation: The document focuses on demonstrating substantial equivalence to predicate devices rather than providing specific numerical performance targets.
2. Sample Size Used for the Test Set and Data Provenance
The document states "laboratory testing" was conducted, but it does not provide any details on:
- The sample size used for any test set (e.g., number of catheters, number of measurements).
- Data provenance (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not provided. The "laboratory testing" would typically involve technical experts, but their number and qualifications are not mentioned. Since this is a physical device, ground truth wouldn't typically be established by human experts in the same way as with an imaging AI model.
4. Adjudication Method for the Test Set
This information is not provided. Given the nature of "laboratory testing" for a physical medical device, human adjudication a medical sense (like 2+1 reading) is not applicable. The testing would be against established calibration standards or engineering specifications.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or at least not reported in this summary. This type of study is typically used for diagnostic imaging AI systems where human readers interpret cases with and without AI assistance. This document describes a physical pressure catheter, not an AI system that assists human interpretation.
6. Standalone Performance (Algorithm Only Without Human-in-the-Loop)
Yes, the "laboratory testing" implicitly represents a standalone performance evaluation of the device. The device itself (the catheter and its associated pressure transducers) is the "algorithm" in this context, and its performance was "verified" in a lab setting, meaning without real-time human clinical intervention beyond operating the test equipment. However, it's crucial to understand this isn't an AI "algorithm" in the modern sense.
7. Type of Ground Truth Used
For the laboratory testing, the ground truth would have been established by:
- Engineering Standards / Calibration Reference: For sensor accuracy, the device's readings would be compared against a known, highly accurate pressure reference source.
- Mechanical Specifications: For mechanical integrity, the device would be subjected to tests (e.g., tensile strength, fatigue, material composition) to ensure it meets predetermined engineering specifications for physical properties and durability.
- Biocompatibility Standards: For biocompatibility, tests would be conducted according to ISO or other relevant standards, comparing cellular responses or material characteristics against established safety profiles.
8. Sample Size for the Training Set
This concept is not applicable as this is a physical medical device, not a machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This concept is not applicable for the same reason as above.
Summary of what's provided for acceptance criteria and study:
The document serves as a 510(k) summary demonstrating substantial equivalence. It states that laboratory testing was performed to verify sensor accuracy, mechanical integrity, and overall performance, and that biocompatibility testing was done. The overarching acceptance criterion is that the device's performance (effectiveness and safety) is "the same as the predicate devices." No quantitative performance metrics, specific study designs, sample sizes, or details about the ground truth establishment for these specific tests are provided beyond a general statement of verification.
§ 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).