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Stay-put impregnated are polyester cords impregnated with aluminium chloride hexahydrate for the temporary retraction and haemostasis of the gingival margin.

Stay-put impregnated is a retraction cord with a metal core and impregnated with Aluminium chloride Hexahydrate.

This is a 510(k) summary for a dental retraction cord (Stay-put impregnated), and as such, it focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study of device performance against pre-defined acceptance criteria in the way a novel diagnostic or therapeutic device might.

Therefore, many of the requested details about acceptance criteria, study design, ground truth, and expert involvement are not present in this type of submission. The primary "acceptance criterion" for a 510(k) is demonstrating that the new device is as safe and effective as a legally marketed predicate device.

Here's an attempt to answer your questions based on the provided text, and where information is not available, I will state that:

1. A table of acceptance criteria and the reported device performance

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. This 510(k) submission does not describe a clinical study with a "test set" in the context of device performance evaluation as it would for a new diagnostic or therapeutic device. The submission focuses on demonstrating substantial equivalence based on material composition, intended use, and technical characteristics.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. There is no mention of a test set requiring expert-established ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. There is no mention of a test set or adjudication.

5. 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

Not applicable. This device is a dental retraction cord, not an AI-powered diagnostic tool, so an MRMC study is not relevant or described.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device does not involve an algorithm or AI.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. The "ground truth" for this 510(k) is primarily the established safety and effectiveness profile of the predicate device, Ultrapak E, as the new device is claiming substantial equivalence to it. No independent ground truth establishment for a novel performance claim is detailed.

8. The sample size for the training set

Not applicable. There is no mention of a training set as this is not an AI/ML device or a clinical trial with a training phase.

9. How the ground truth for the training set was established

Not applicable. As there is no training set, there is no ground truth establishment for it.

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GuttaFlow is a material for permanent obturation of root canals after vital extirpation and after treatment of pulpal gangrene and temporary filling of the canal.

GuttaFlow is a Class II, permanent root canal filling material. GuttaFlow is silicone based (Polydimethysiloxane) and consists additionally of Gutta Percha, Zinc oxide, Zircondioxide, paraffin-based oil, silicone oil, hexachloroplatinic acid, and silicic acid.

Here's a breakdown of the acceptance criteria and study information for GuttaFlow based on the provided FDA 510(k) summary:

This device is cleared through the 510(k) pathway, which relies on demonstrating substantial equivalence to a predicate device rather than conducting a de novo clinical study with specific acceptance criteria and performance measures in the same way a PMA device would. Therefore, much of the requested information regarding detailed study design, sample sizes for test sets, expert adjudication, MRMC studies, standalone performance, and ground truth establishment as it relates to a "device performance study" might not be applicable in the traditional sense for this type of submission.

Instead, the "study" demonstrating adherence to acceptance criteria is primarily a comparison against a legally marketed predicate device, focusing on technical characteristics and intended use.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not explicitly stated in the provided summary. For a 510(k), the "test set" primarily refers to samples used for in vitro bench testing to demonstrate technical equivalence, rather than a clinical trial with a patient test set. No clinical studies are referenced.
• Data Provenance: Not explicitly stated. Given it's a 510(k) submission primarily comparing technical characteristics to a predicate, the data would likely be from internal laboratory testing conducted by the manufacturer (Coltène/Whaledent GmbH & Co. KG). It would be retrospective in the sense that it's comparing against existing data for the predicate and generating new data for GuttaFlow, but not a prospective clinical trial. The country of origin for the data would likely be related to the manufacturer's location, which is Germany.

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

• This information is not applicable/not provided in this 510(k) summary. For a 510(k) based on substantial equivalence to a predicate, the "ground truth" for device performance is generally established through recognized standards, predicate device performance data, and scientific principles, not through expert consensus on a clinical test set.

4. Adjudication Method for the Test Set

• This information is not applicable/not provided. There is no mention of a clinical test set requiring adjudication in this 510(k) summary.

5. 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

• This information is not applicable/not provided. This device (GuttaFlow) is a dental material, not an AI-powered diagnostic or assistive technology. Therefore, MRMC studies involving human readers and AI assistance are irrelevant to this submission.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

• This information is not applicable/not provided. As mentioned above, this is a dental material, not an algorithm or AI system.

7. The Type of Ground Truth Used

• The "ground truth" in this context is based on technical specifications, established material properties, and the performance profile of the legally marketed predicate device (RoekoSeal). Equivalence is demonstrated by showing that GuttaFlow's technical characteristics, biological properties, and intended use are "substantially equivalent" to those of the predicate device, which itself has an established safe and effective use history. This also includes adherence to relevant dental material standards (though not explicitly listed, they would be implicit in the assessment of such properties).

8. The Sample Size for the Training Set

• This information is not applicable/not provided. There is no mention of a "training set" in the context of machine learning or AI for this dental material device.

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

• This information is not applicable/not provided. As there is no training set mentioned, there's no ground truth establishment for it.

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