(75 days)
SmearClear is a cleaning solution designed to facilitate removal of dentinal debris from the walls of root canals prior to obturation.
SmearClear is a cleaning solution designed to facilitate removal of dentinal debris from the walls of root canals prior to obturation.
This is a 510(k) premarket notification for a medical device called SmearClear, an endodontic irrigating solution. The document states that the device is substantially equivalent to a legally marketed predicate device, "PulpDent's EDTA Solution."
Here's an analysis of the provided text regarding acceptance criteria and study information:
Based on the information provided in the 510(k) summary, there is no detailed information about specific acceptance criteria or a study proving the device meets those criteria in the way you've outlined for a typical diagnostic or AI-driven device. This document is a premarket notification for a Class II medical device, and its primary purpose is to demonstrate substantial equivalence to a predicate device rather than to provide detailed performance study results against predefined acceptance criteria.
Therefore, many of your requested fields cannot be filled directly from this document.
Here's what can be inferred or stated based on the provided text:
Acceptance Criteria and Device Performance
Since this is a substantial equivalence submission for a solution, the "acceptance criteria" revolve around demonstrating that SmearClear functions in a manner similar to and is intended for the same use as the predicate device (PulpDent's EDTA Solution). The document does not provide a table with numerical acceptance criteria and reported device performance in the context of, for example, sensitivity, specificity, or accuracy, which would be typical for a diagnostic or AI device.
Study Information (as inferable from the document's type)
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Table of Acceptance Criteria and Reported Device Performance: This information is not explicitly provided in the format of specific numerical acceptance criteria and study results. The "acceptance criteria" here are implied by the FDA's "substantial equivalence" determination, meaning the device's characteristics and performance are deemed comparable to the predicate device for its intended use.
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Sample Size used for the test set and the data provenance: Not applicable or not provided. This type of submission (510(k) for a basic solution) typically relies on chemical composition, intended use comparison, and existing knowledge of the predicate device rather than a new clinical performance study with a test set.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable or not provided. There's no mention of a test set requiring expert ground truthing.
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Adjudication method for the test set: Not applicable or not provided.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable or not provided. This type of study is relevant for diagnostic devices where human interpretation plays a significant role, often with AI assistance. SmearClear is an irrigating solution, not a diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable or not provided. SmearClear is a chemical solution, not an algorithm.
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The type of ground truth used: Not applicable. For a chemical solution, "ground truth" often relates to its chemical properties and biological effects, which would be assessed through standard laboratory tests (e.g., pH, concentration, efficacy in dissolving debris in vitro), but these specific results are not detailed in this 510(k) summary. The "ground truth" for substantial equivalence is the established safe and effective use of the predicate device.
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The sample size for the training set: Not applicable or not provided. This concept is relevant for machine learning models, not for a chemical solution.
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How the ground truth for the training set was established: Not applicable or not provided.
Summary of what is known from the document about the "study":
The "study" in this context is the 510(k) submission process itself, where Sybron Dental Specialties demonstrates that SmearClear is "substantially equivalent" to PulpDent's EDTA Solution. This involves comparing:
- Intended Use: Both devices are "designed to facilitate removal of dentinal debris from the walls of root canals prior to obturation."
- Technological Characteristics: While not detailed in this summary, the submission would have included information on the chemical composition and physical properties of SmearClear, comparing them to EDTA solutions.
- Performance: The claim is that SmearClear "functions in a manner similar to" the predicate device. This implies that any testing performed would have shown comparable efficacy for its intended use, typically through in-vitro studies for a product of this nature, but specific study details are not in this summary.
In essence, this document is a regulatory filing focused on establishing market clearance via substantial equivalence, not a detailed scientific publication of a performance study against specific, quantifiable acceptance criteria.
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