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510(k) Data Aggregation
(262 days)
DIGITRAPPER DELTA, MODEL 9043G0201 AND POLYGRAM '98 PH EXTENSION MODEL 9043S0111
The pH System is intended to record, store, view and analyze esophageal and gastric pH data to diagnose reflux disorders. The pH System can also be used to locate the position of the proximal Lower Esophageal Sphincter (LES) manometrically, to assist in the accurate placement of the pH catheter.
The pH Testing System consists of a general purpose PC running the pH Application software namned EsopHogram '98, a recording device namned Digitrapper Delta and catheters appropriate for the study to be performed. The illustration below shows the various components.
The provided text describes a 510(k) Notification for a pH Testing System, focusing on its equivalence to a predicate device. However, it does not include detailed acceptance criteria or a specific study proving the device meets acceptance criteria in the manner typically found for AI/ML medical devices. The document is primarily a comparison to a predicate device to demonstrate substantial equivalence, rather than a performance study with defined criteria.
Based on the provided text, here's an analysis of the requested information:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly define acceptance criteria as pass/fail thresholds for specific performance metrics (e.g., accuracy, sensitivity, specificity) for the new device. Instead, it relies on demonstrating that the enhanced system performs "as its predicate system."
| Performance Metric/Feature | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| General Functionality | Perform "as its predicate system" (functional equivalence) | "Verifications results shows that the enhanced system performs as its predicate system." |
| Sampling Rate | Capable of recording current and future demands | Programmable through 1/16Hz up to 8 Hz (new range captures old range + flexibility for future higher sampling rates) |
| Memory Size | Sufficient for current and future enhancements | 4Mb Flash Data RAM (larger memory size to incorporate possible future enhancements) |
| Resolution | Equal to or better than predicate device (0.04 pH) | Better than 0.01 pH (new one has 12bit resolution and adjustable gain, vs. 8 bit converter and fixed gain for predicate) |
| Calculated Parameters | Must include all parameters of predicate (except specific exclusions) | Same as predicate, with specific exclusions (Symptom Association Probability, Boix-Ochoa (pediatric), Infant normals percentile graph) in the first version. |
| LES Identification | Equivalent or enhanced to predicate (Bar Graph) | Displays an actual manometric tracing on screen (enhanced user interface) |
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 states, "Field tests are on going." This indicates that any clinical performance data was not yet complete or available at the time of submission for this 510(k). Therefore, there is no disclosed sample size or data provenance for a test set. The submission focuses on non-clinical (engineering and functional) equivalence.
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. No test set involving human expert adjudication for ground truth establishing is described. The assessment is based on technical verification against the predicate device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set involving human expert adjudication for ground truth establishing is described.
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
Not applicable. This device is a pH testing system primarily for data acquisition and analysis, not an AI/ML diagnostic tool that would typically involve human readers using AI assistance. The study described is a non-clinical verification of equivalence.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document reports on "Verifications results shows that the enhanced system performs as its predicate system." This implies that standalone functional tests and comparisons were performed to ensure the new Digitrapper Delta and Polygram '98 software performed equivalently to the older system. The resolution improvement from 0.04 pH to "better than 0.01 pH" is a standalone performance metric. However, explicit details of these tests (e.g., number of test cases, methodology) are not provided beyond the general statement.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical performance assessment, the "ground truth" was the performance of the predicate system. The new device's performance was measured against the established performance and technical specifications of the Medtronic Synectics Digitrapper MK III and its associated software.
8. The sample size for the training set
Not applicable. This document describes a traditional medical device (pH testing system) and does not refer to AI/ML components that would require a training set in the conventional sense.
9. How the ground truth for the training set was established
Not applicable, as no training set for an AI/ML component is mentioned.
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