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StatStix is applied to control temporary bleeding caused by minor cuts and abrasions that may occur on gingival tissue during dental procedures.

StatStix is designed incorporating a hand-held polypropylene handle with a nylon polyamide applicator tip coated with a dried solution of 25% Aluminum Sulfate Hydrate Solution with Mint Flavor. The device is configured in two sizes to help control minor gingival bleeding intended for transient use by a dentist during dental restorative procedures.

The provided FDA document describes the premarket notification (510(k)) for the StatStix device (K200764). It details the device's intended use and compares its characteristics to a predicate device for substantial equivalence. However, it explicitly states that clinical testing has not been performed on this product. Therefore, a study proving the device meets acceptance criteria based on clinical performance in humans is not present in this document.

The document does, however, discuss non-clinical performance data and establishes acceptance criteria for those tests.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical):

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

• Clinical Test Set: Not applicable, as no clinical testing was performed for StatStix.
• Non-Clinical Test Set: Not specified for biocompatibility, physical properties, or shelf-life testing. The document states "standard laboratory benchtop practices" for physical properties and "consistent with ASTM F1980" for shelf-life, implying standard sample sizes for these types of tests would have been used, but specific numbers are not detailed.
• Data Provenance: Not explicitly stated, but assumed to be from Centrix Incorporated or their contracted laboratories given they are the submitter.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:

• Clinical Test Set: Not applicable.
• Non-Clinical Test Set: Not specified. For non-clinical lab tests, "ground truth" is established by the methodologies and reference standards themselves, as opposed to expert human interpretation.

4. Adjudication Method for the Test Set:

• Clinical Test Set: Not applicable.
• Non-Clinical Test Set: Not applicable. Adjudication methods are typically relevant for subjective assessments or when multiple human readers/experts are involved in ground truth establishment.

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

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states, "Clinical testing has not been performed on this product." Therefore, there is no information on how much human readers improve with AI vs. without AI assistance. The StatStix device is a physical product (applicator with astringent), not an AI-powered diagnostic or assistive tool.

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

• No, a standalone performance study in the context of an algorithm or AI was not done. StatStix is a physical device, not an algorithm.

7. Type of Ground Truth Used:

• Clinical Ground Truth: Not applicable, as no clinical testing was performed.
• Non-Clinical Ground Truth: Established through standardized laboratory testing methodologies (e.g., ISO, ASTM, FTIR/pH/dosage weight analysis) where the outcomes are measurable and objective.

8. Sample Size for the Training Set:

• Not applicable. This device is a physical product, not an AI/machine learning algorithm requiring a "training set" of data.

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

• Not applicable, as there is no training set for this type of device.

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