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The Optical Dilator is indicated for dilation of strictures of the esophagus under endoscopic visualization.

The Ethicon Endo-Surgery Optical Dilator is a sterile, single-use disposable esophageal dilator for use with an endoscope to dilate esophageal strictures under endoscopic visualization. The Optical Dilator is made from a clear flexible polymer. An endoscope having an outer diameter of 10mm or less, such as a standard gastroscope, is positioned within the Optical Dilator to allow for visualization at the stricture site.

The provided 510(k) summary (K093236) concerns the Ethicon Endo Surgery® Optical Dilator, a device indicated for the dilation of esophageal strictures under endoscopic visualization. This submission is a Special 510(k) as it details modifications to an existing predicate device (Ethicon Endo-Surgery Optical DVS Esophageal Dilator K031147). The changes are limited to the addition of a handle retainer component to secure the handle to the shaft and a change in the handle material from gray to black.

Given these minor modifications and the nature of the device, the studies conducted focus on verifying the safety and functionality of these specific changes rather than a comprehensive clinical study assessing the device's diagnostic or interventional efficacy in a clinical setting.

Here's the breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified for either the attachment strength or biocompatibility testing. These are typically bench tests performed on a representative number of units or material samples.
• Data Provenance: Not explicitly stated but implied to be from bench testing at the manufacturer's facilities. This is not clinical data, so country of origin and retrospective/prospective distinctions are not applicable in this context.

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

• Not Applicable. The ground truth for bench tests (attachment strength and biocompatibility) is established by predefined engineering specifications and international standards (ISO 10993-1). There is no need for expert clinical consensus for these types of tests.

4. Adjudication Method for the Test Set

• Not Applicable. Adjudication methods like 2+1 or 3+1 are used for clinical studies involving human interpretation or assessments. Bench testing results are typically evaluated against objective, predefined pass/fail criteria.

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

• No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic or image-guided devices where human readers interpret results, and the AI's impact on their performance is being evaluated. The modifications to this esophageal dilator do not involve AI or human interpretation in its use.

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

• No, a standalone study was not done. This type of study is relevant for AI-powered devices to assess the algorithm's performance independent of human interaction. The Ethicon Endo Surgery® Optical Dilator is a mechanical medical device, not an AI or algorithm-driven system.

7. Type of Ground Truth Used

• For Attachment Strength: Engineering specifications and design requirements (e.g., a minimum force required to detach the handle).
• For Biocompatibility: International standard ISO 10993-1, which outlines biological evaluation of medical devices.

8. Sample Size for the Training Set

• Not Applicable. This device is hardware; there is no AI algorithm to be trained, therefore no training set.

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

• Not Applicable. As there is no training set for an AI algorithm, no ground truth needed to be established for it.

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