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The Medtronic Single Use Esophageal Manometric Catheter is intended for water-perfused manometry of the GI tract.

The Medtronic Single Use Anorectal Manometric Catheter is intended for water-perfused manometry of the rectal and anal canal.

The Medtronic Single Use Esophageal Manometric Catheter is intended for water-perfused manometry of the GI tract. The Medtronic Single Use Anorectal Manometric Catheter are intended for water-perfused manometry of the rectal and anal tract.

These catheters consist of a multi-lumen PVC tube connected to multiple PVC capillary tubes. The capillary tubes connect to pressure transducers of an infusion system that perfuses each lumen of the catheter with water. Pressure measurements are made at side holes in the multi-lumen PVC tube along the gastro-intestinal tract. A silicone balloon is attached to the end of the catheter body of the anorectal model.

The provided text describes a 510(k) premarket notification for Medtronic Single Use Esophageal Manometric Catheter and Medtronic Single Use Anorectal Manometric Catheter. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting new clinical study data with specific acceptance criteria and performance metrics for a novel AI device.

Therefore, the document does not contain the detailed information requested regarding:

1. A table of acceptance criteria and reported device performance.
2. Sample size and data provenance for a test set.
3. Number and qualifications of experts for ground truth establishment.
4. Adjudication method for a test set.
5. MRMC comparative effectiveness study results.
6. Standalone algorithm performance.
7. Type of ground truth used (e.g., pathology, outcomes data).
8. Sample size for the training set.
9. How ground truth for the training set was established.

Instead, the document states:

• No applicable mandatory performance standards or special controls exist for this device. This indicates that the device is not subject to specific quantifiable performance targets set by regulatory bodies.
• In-vitro testing was performed to support substantial equivalence to the predicate devices. This implies that the testing focused on demonstrating that the device performs similarly to existing, cleared devices, rather than meeting novel performance criteria.
• The results of this testing indicate that the Medtronic Single Use Esophageal Manometric Catheter and Medtronic Single Use Anorectal Manometric Catheter meet all of the design and performance requirements. While this broadly states the device meets "requirements," it does not specify what those requirements are or provide quantitative performance metrics.

In summary, this 510(k) submission does not include the type of detailed performance study and acceptance criteria specific to an AI/ML device that would typically be described in the requested format. Its purpose is to demonstrate substantial equivalence to predicate devices through biocompatibility and in-vitro functional testing, not to quantify diagnostic or clinical accuracy against a defined ground truth using a clinical study.

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