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The SMART Dilator is indicated for dilation of strictures of the esophagus under endoscopic visualization in adults 18 years or older.

The SMART Dilator is a sterile, single use disposable esophageal dilator. The SafeStitch endoscope guide dilator consists of a graduated tube with a center endoscope channel, a tapered tip and a safety handle. The flexible endoscope has a relative rigidity and in combination with the dilator will provide sufficient axial integrity for dilation. The handle provides feedback to indicate how much axial force is being placed on the device and subsequently, the esophagus.

Here’s an analysis of the provided text regarding the SafeStitch SMART Dilator (K082995):

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary only mentions that "Bench testing was performed to verify the SMART Dilator's performance to internal specifications." It also states that "bench testing was also performed to demonstrate that the SMART Dilator is substantially equivalent to both the Savory-Gilliard Dilator and the Optical DVS Esophageal Dilator."

However, the document does not explicitly list specific acceptance criteria (e.g., tensile strength, flexibility, force feedback accuracy with threshold, etc.) nor the detailed results of these tests. Therefore, I cannot populate a table with specific acceptance criteria and their corresponding reported performance values. The information available is very high-level.

2. Sample Size Used for the Test Set and Data Provenance

The document only refers to "bench testing." It does not specify:

• The sample size for any test set.
• The data provenance (e.g., country of origin, retrospective or prospective). Given it's bench testing, it would be laboratory data rather than clinical patient data.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not applicable as the provided text describes bench testing comparing device performance to internal specifications and predicate devices, not studies requiring expert-established ground truth on clinical data (e.g., image interpretation).

4. Adjudication Method for the Test Set

This information is not applicable for bench testing. Adjudication methods (like 2+1, 3+1) are used in clinical studies, particularly in image interpretation or diagnostic accuracy studies, to establish a reference standard when multiple experts disagree.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed as described in the provided document. The submission focuses on bench testing for substantial equivalence, not a clinical study involving human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This concept is not applicable to this medical device. The SMART Dilator is a physical medical device (esophageal dilator), not an algorithm or AI system. Its performance inherently involves a human user (a clinician). Therefore, there is no "standalone" algorithm-only performance to assess.

7. Type of Ground Truth Used

For the bench testing, the "ground truth" would be established by:

• Internal specifications: The device's performance was compared against predetermined engineering or design specifications.
• Predicate device characteristics: The SMART Dilator's performance was compared against the known characteristics and performance of the Savory-Gilliard Dilators and the Optical DVS Esophageal Dilator to demonstrate substantial equivalence.

8. Sample Size for the Training Set

This information is not applicable. The SMART Dilator is a physical medical device. It does not involve a "training set" in the context of machine learning or AI models. Its design and manufacturing are based on established engineering principles and materials science.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reasons as point 8. There is no concept of a "training set" or "ground truth" for a training set for this type of device.

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