(277 days)
The Optical DVS (Dual Vector Shearing) Esophageal Dilator is indicated for dilation of strictures of the esophagus under endoscopic visualization.
The Optical DVS is a sterile, single use, disposable esophageal dilator for use with an endoscope to dilate esophageal strictures under endoscopic visualization. The Optical DVS 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 DVS to allow for visualization at the stricture site.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Optical DVS Esophageal Dilator:
Summary of Device and Context:
The Optical DVS (Dual Vector Shearing) Esophageal Dilator is a sterile, single-use, disposable device designed for dilating esophageal strictures. Its key differentiating feature from its predicate device (Savary-Gilliard Dilators) is that it allows for visualization of strictures with an endoscope, whereas the predicate device does not. This 510(k) submission (K031147) was cleared by the FDA on January 12, 2004.
Acceptance Criteria and Device Performance:
Based on the provided document, the device's acceptance criteria primarily revolve around its equivalency to a predicate device in terms of "dilation performance" and its general safety and effectiveness for its intended use. However, the document does not explicitly state quantitative or qualitative acceptance criteria in a structured table format with corresponding performance data for the Optical DVS Esophageal Dilator itself.
The document states:
"Bench testing was performed to verify dilation performance. These data, combined with descriptive intended use and design information, indicate the Optical DVS is substantially equivalent to the Savary-Gilliard Dilator."
This implies that the acceptance criteria were inherently linked to demonstrating substantial equivalence to the predicate device, particularly in its ability to dilate esophageal strictures. The "dilation performance" was verified through bench testing.
Therefore, we can infer the following:
| Acceptance Criteria Category | Specific Criteria (Inferred) | Reported Device Performance |
|---|---|---|
| Dilation Performance | Ability to effectively dilate esophageal strictures. | Verified through "Bench testing." The data "indicate the Optical DVS is substantially equivalent to the Savary-Gilliard Dilator." |
| Safety | Safe for its intended use (implied by 510(k) clearance based on substantial equivalence). | Not explicitly detailed, but implied by regulatory clearance. |
| Effectiveness | Effective for its intended use (dilation of esophageal strictures under endoscopic visualization). | Not explicitly detailed, but implied by regulatory clearance. |
| Technological Equivalence | Similar design and function to the predicate device, with the added benefit of endoscopic visualization. | "The Optical DVS is similar to the predicate device with respect to design. The Optical DVS allows for visualization of strictures with the use of an endoscope where as the predicate device does not." |
Details of the Supporting Study:
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Sample size used for the test set and the data provenance:
- The document mentions "Bench testing was performed to verify dilation performance." It does not specify the sample size for this bench testing.
- The data provenance is not specified (e.g., country of origin, retrospective/prospective). Bench testing typically takes place in a laboratory setting.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document does not mention the involvement of experts for establishing ground truth as this was a bench test verifying "dilation performance." For such physical performance tests, ground truth is typically based on objective measurements against engineering specifications or physical properties.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Adjudication methods are typically relevant for studies involving human interpretation (e.g., image reading). Since this was "bench testing" of dilation performance, an adjudication method is not applicable and therefore not mentioned.
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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:
- No, an MRMC comparative effectiveness study was not done. This device is a physical medical instrument (an esophageal dilator), not an AI-powered diagnostic or assistive tool for human readers. Therefore, questions about human reader improvement with/without AI assistance are not relevant to this device.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No, a standalone algorithm-only performance study was not done. This device is a physical instrument, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the "bench testing" verifying "dilation performance," the ground truth would most likely be based on objective physical measurements and engineering specifications related to the device's ability to mechanically dilate a given material or simulate a stricture. It would not typically involve expert consensus, pathology, or outcomes data, which are more common for diagnostic or therapeutic efficacy studies involving patients.
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The sample size for the training set:
- This question is not applicable as there is no mention of machine learning or an "algorithm" that would require a training set for this device.
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How the ground truth for the training set was established:
- This question is not applicable as there is no mention of machine learning or an "algorithm" and thus no training set for this device.
§ 876.5365 Esophageal dilator.
(a)
Identification. An esophageal dilator is a device that consists of a cylindrical instrument that may be hollow and weighted with mercury or a metal olive-shaped weight that slides on a guide, such as a string or wire and is used to dilate a stricture of the esophagus. This generic type of device includes esophageal or gastrointestinal bougies and the esophageal dilator (metal olive).(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.