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• Impressions for the production of temporary restorations .
• . All types of preliminary impressions
• . Impressions of the opposing jaw
• Impressions for orthodontic models .

Flash AR and Flash AR Quick are classified as impression materials (21 C.F.R. § 872.3660) because they are devices intended to reproduce the structure of a patient's teeth. As the predicate devices Flash AR Penta™ and Flash AR Penta™ Quick (K131404), Flash AR and Flash AR Quick are medium-bodied (ISO Type 2) consistency A-silicone impression materials for all kinds of preliminary impressions. Like Flash AR Penta™ and Flash AR Penta™ Quick, Flash AR and Flash AR Quick are two component (base paste/catalyst) vinyl polysiloxane impression materials to be used for impressions, where typically alginates are used. Whereas Flash AR Penta™ and Flash AR Penta™ Quick are designed to automatically be mixed and dispensed in all versions of Pentamix™ devices of 3M Deutschland GmbH and the mixing ratio for both materials is base paste:catalyst, 5:1 (by volume), Flash AR and Flash AR Ouick will be delivered in Garant™ cartridges (50 ml plastic cartridges) and can be mixed and extruded using the Garant™ dispenser manufactured by 3M Deutschland GmbH with the mixing ratio for both materials of base paste:catalyst, 1:1 (by volume).

The provided text describes a 510(k) premarket notification for two dental impression materials, Flash AR and Flash AR Quick. The study presented focuses on demonstrating substantial equivalence to predicate devices rather than the performance of an AI/ML powered device. Therefore, many of the requested categories (such as sample size for test set, number of experts for ground truth, MRMC study, standalone study, and training set details) are not applicable to this submission.

Here's an analysis of the available information:

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

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

• Sample Size for Test Set: Not specified in the provided text. The study references "Test results according to ISO 4823" and "Biocompatibility testing," but does not detail the sample sizes for these tests.
• Data Provenance: The tests were conducted to establish substantial equivalence to predicate devices manufactured by 3M Deutschland GmbH, Germany. The actual location of the testing is not explicitly stated, but given the company's location, it is likely that the studies were performed in Germany or under the purview of a German entity. The exact nature (retrospective or prospective) of the physical/mechanical and biocompatibility testing is not specified, but typically these types of studies for product equivalency are laboratory-based and controlled.

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)

• This information is not applicable as the submission is for a dental impression material, not an AI/ML powered device requiring interpretation by experts to establish ground truth. Substantial equivalence was based on physical, mechanical, chemical, and biocompatibility testing against ISO standards and predicate devices.

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

• This information is not applicable as the submission is for a dental impression material. Ground truth in this context is established through objective physical, mechanical, chemical, and biological tests, not through expert consensus requiring 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

• This information is not applicable as the submission is for a dental impression material and does not involve AI or human readers.

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

• This information is not applicable as the submission is for a dental impression material and does not involve an algorithm or AI.

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

• The "ground truth" for the device's performance was established through:
  • Objective physical and mechanical property measurements: Conducted according to ISO 4823, comparing working time, intra-oral setting time, consistency, and other properties.
  • Chemical composition analysis: To ensure similarity with predicate devices.
  • Biocompatibility evaluations: Performed in consideration of FDA and internationally recognized guidelines.
• The primary "ground truth" for the submission's goal was the established performance and safety of the predicate devices (Flash AR Penta™ and Flash AR Penta™ Quick), against which substantial equivalence was demonstrated.

8. The sample size for the training set

• This information is not applicable as the device is not an AI/ML powered device and therefore does not have a "training set."

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

• This information is not applicable as the device is not an AI/ML powered device and therefore does not have a "training set" or ground truth for it.

Summary of the Study Proving Acceptance Criteria:

The study proving the device meets the acceptance criteria is a substantial equivalence evaluation comparing the new devices (Flash AR and Flash AR Quick) to their predicate devices (Flash AR Penta™ and Flash AR Penta™ Quick). This evaluation involved:

• Performance testing: According to ISO 4823, focusing on physical and mechanical properties such as working time and intra-oral setting time. The new devices reportedly had the "same" working and intra-oral setting times as their respective predicates.
• Chemical composition comparison: Demonstrating similarity to the predicate devices.
• Biocompatibility evaluations: Performed under FDA and international guidelines, concluding that the materials are biocompatible for their intended use.
• Indications for Use comparison: Establishing that the new devices share the same intended uses as the predicate devices.

The conclusion of the study was that Flash AR and Flash AR Quick are substantially equivalent in safety and effectiveness to the predicate devices, thereby meeting the necessary criteria for regulatory clearance.

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• Impressions for the production of temporary restorations
• All types of preliminary impressions .
• Impressions of the opposing jaw .
• Impressions for orthodontic models .

Flash AR Penta™ and Flash AR Penta™ Quick are classified as impression materials (21 C.F.R. § 872.3660) because they are devices intended to reproduce the structure of a patient's teeth. Flash AR Penta™ and Flash AR Penta™ Quick are medium-bodied (ISO Type 2) consistency A-silicone impression materials for all kinds of preliminary impressions. Like Position Penta™ & Position Penta™ Quick, Flash AR Penta™ and Flash AR Penta™ Quick are two component (base paste/catalyst) vinyl polysiloxane impression materials designed to automatically be mixed and dispensed in all versions of Pentamix™ devices of 3M Deutschland GmbH. The mixing ratio for both materials is base paste:catalyst, 5:1 (by volume).

The provided 510(k) summary describes a dental impression material (Flash AR Penta™ and Flash AR Penta™ Quick), not an AI-powered medical device. Therefore, much of the requested information regarding acceptance criteria for AI performance, clinical studies with human readers, and ground truth establishment is not applicable to this submission.

However, I can extract the relevant information about the device and its demonstrated equivalence.

Nature of the Device:
The device is described as "medium-bodied (ISO Type 2) consistency A-silicone impression materials for all kinds of preliminary impressions." It is a two-component vinyl polysiloxane impression material.

Equivalence Claim:
The core of this 510(k) submission is to demonstrate substantial equivalence to predicate devices (Position Penta™ & Position Penta™ Quick, and Flash materials by 3M Deutschland GmbH) based on indications for use, physical and mechanical properties, and chemical composition.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a dental impression material, the "acceptance criteria" and "reported device performance" are primarily related to physical and mechanical properties, chemical composition, and biocompatibility rather than diagnostic performance metrics like sensitivity or specificity. The submission states that these properties were compared to predicate devices.

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

• Test Set Sample Size: Not explicitly stated. The comparison against predicate devices involved evaluating physical and mechanical properties, chemical composition, and biocompatibility. The specific number of samples tested for each property is not detailed in the summary.
• Data Provenance: The device manufacturer (3M Deutschland GmbH) is located in Germany. Biocompatibility evaluations considered FDA and internationally recognized guidelines, implying data generated adheres to these standards. The comparison studies would have been conducted by the manufacturer as part of the submission package. The data is retrospective in the sense that it evaluates the device's properties against established benchmarks and predicate devices.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Not Applicable. For a dental impression material, "ground truth" in the context of diagnostic accuracy (like in AI studies) is not relevant. The evaluation relies on standardized material testing (e.g., ISO standards) and chemical analysis.

4. Adjudication Method for the Test Set

• Not Applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among human reviewers (e.g., radiologists) when establishing ground truth for diagnostic AI. This device does not involve such a process. Material testing results are typically objective measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

• No. An MRMC study is designed for evaluating the impact of AI assistance on human reader performance in diagnostic tasks. This is a material, not a diagnostic AI device.

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

• No. This is not an AI algorithm. Its performance is evaluated through material science testing.

7. The Type of Ground Truth Used

• For this device, the "ground truth" refers to accepted standards for material properties, chemical composition, and biocompatibility. This would involve:
  • Standardized Material Testing: Adherence to relevant ISO standards (e.g., for impression materials) for properties like tear strength, dimensional stability, working time, setting time, etc.
  • Chemical Analysis: Verification of the chemical composition against the formulation and comparison to predicate devices.
  • Biocompatibility Standards: Compliance with ISO 10993 series for medical device biocompatibility, which involves tests like cytotoxicity, sensitization, and irritation.

8. The Sample Size for the Training Set

• Not Applicable. This is not an AI/machine learning device, so there is no "training set." The materials are formulated and manufactured, then tested.

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

• Not Applicable. As there is no training set for an AI model, this question does not apply. The development of the material is based on chemical and polymer science principles, with iterative formulation and testing, rather than an AI training paradigm.

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