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Smartcord is knitted retraction cord made from 100% cotton for the temporary gingival retraction.

Smartcord X is knitted retraction cord made from 100% cotton, impregnated with Aluminum Chloride for the temporary gingival retraction and hemostasis of the gingival margin.

Smartcord is non-impregnated knitted retraction cord made from 100% cotton. Smartcord X is knitted retraction cord made from 100% cotton, impregnated with Aluminum Chloride Hexahydrate.

The provided document is a 510(k) summary for the medical devices Smartcord and Smartcord X. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed acceptance criteria and a study proving the device meets those criteria.

Therefore, many of the requested sections about acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, multi-reader multi-case studies, and standalone performance results are not available in this type of document.

Here's an analysis based on the information available in the document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly define specific performance acceptance criteria (e.g., minimum tensile strength, specific retraction efficacy metrics) or report quantitative results for the device against such criteria. Instead, it relies on demonstrating equivalence in material composition, intended use, and general properties to the predicate device.

The "performance" described is in the context of biocompatibility testing, which confirmed the device is biocompatible as directed.

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

• Sample Size for Test Set: Not specified. The biocompatibility tests would have involved samples of the Smartcord X device, but the number of samples is not stated.
• Data Provenance: Not specified, but generally, non-clinical performance testing for 510(k) submissions is conducted as part of the device development and validation process by the manufacturer or accredited labs on behalf of the manufacturer. It's prospective in the sense that the tests are planned and executed to evaluate the device. The country of origin of the data is not specified beyond "EASTDENT CO., LTD." being from Korea.

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

• Number of Experts: Not applicable. For biocompatibility testing, the "ground truth" is established by the standardized methods outlined in ISO 10993, and the results are interpreted by trained laboratory personnel. There isn't a concept of "expert ground truth" in the way it would be applied to diagnostic imaging interpretation.
• Qualifications of Experts: Not specified, but implied to be qualified laboratory personnel experienced in conducting and interpreting biocompatibility tests according to ISO standards.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable. Biocompatibility testing involves objective laboratory measurements and observations against pre-defined criteria in the ISO standards, rather than subjective judgments requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices where human readers interpret results, often with and without AI assistance, to assess performance improvement. Smartcord and Smartcord X are physical dental retraction cords, not diagnostic algorithms.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

• Standalone Performance Study: No, this is not applicable. There is no algorithm involved in the Smartcord or Smartcord X product. The assessment is of the physical device's properties and biological safety.

7. The Type of Ground Truth Used:

• Ground Truth: For biocompatibility, the "ground truth" is defined by the established biological responses and thresholds outlined in the ISO 10993 series of standards. This involves measuring cytotoxicity, irritation, and sensitization responses in laboratory models (e.g., cell cultures, animal models) and comparing them to acceptable limits defined by the standards.

8. The Sample Size for the Training Set:

• Training Set Sample Size: Not applicable. There is no AI or machine learning algorithm in these devices, so there is no training set.

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

• Ground Truth for Training Set: Not applicable, as there is no training set for an AI/ML algorithm.

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