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MR Core is an option within Vitrea® that allows the examination of a series of medical images obtained from MRI scanners.

The option also enables clinicians to compare multiple series for the same patient, side-by-side, and switch to other integrated applications to further examine the data.

MR Core allows intuitive navigation, quantification, and manipulation of medical images obtained from MRI scanners. This application enables clinicians to compare multiple series of the same patient, side-by-side, and switch to other integrated applications to further examine the data. It provides rich clinical tools to review images for efficient and effective patient care.

The provided document is a 510(k) summary for a medical device called "MR Core software." This document outlines the device's indications for use, its comparison to predicate and reference devices, and a summary of non-clinical tests conducted. However, it explicitly states that "The subject of traditional 510(k) notification, MR Core software, did not require clinical studies to support safety and effectiveness of the software."

Therefore, I cannot provide details on acceptance criteria and a study proving the device meets those criteria from this document. The document primarily focuses on demonstrating substantial equivalence to a predicate device (Softread Software K040305) and a reference device (Myrian K091001) through technological and functional comparisons, not through a standalone clinical performance study with specific acceptance criteria.

Despite the lack of explicit clinical performance study data, here's what can be inferred or stated based on the provided text regarding verification and validation:

1. Table of Acceptance Criteria and Reported Device Performance:

Since no clinical study with explicit performance metrics is mentioned, a table of acceptance criteria and reported device performance directly from a clinical study cannot be created. The document focuses on showing that the functional equivalency and design controls were met. Implicit "acceptance criteria" can be derived from the non-clinical tests described, which confirm that the software operates according to its requirements and fulfills its intended uses.

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

• Sample Size for Test Set: Not explicitly stated. The document mentions "previously acquired medical images" were used for verification, validation, and evaluation. It does not provide the number of images or cases.
• Data Provenance: Not explicitly stated. The medical images were "previously acquired," but their country of origin or whether they were retrospective or prospective is not mentioned.

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

• Number of Experts: "Experienced medical professionals" evaluated the application during external validation. The exact number is not specified.
• Qualifications of Experts: They are referred to as "experienced medical professionals." No specific qualifications (e.g., radiologist with X years of experience) are provided.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not explicitly mentioned. The document states, "All validators confirmed that the MR Core software fulfills its intended uses." This suggests a consensus or individual validation approach, but no formal adjudication process (like 2+1 or 3+1) is described.

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

• No, an MRMC comparative effectiveness study was not done. The document explicitly states that "MR Core software, did not require clinical studies to support safety and effectiveness of the software." The validation involved experienced medical professionals reviewing the application, which is more akin to usability testing than a comparative effectiveness study measuring improved reader performance with or without AI assistance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

• The device is "Radiological Image Processing Software" and its intended use involves "examination and manipulation of a series of medical images obtained from MRI scanners" by clinicians. The features described (viewing, manipulation, analysis tools) are meant to be used by clinicians. The "external validation" involved "experienced medical professionals [evaluating] the application." Therefore, the focus is on a human-in-the-loop performance, not a standalone algorithm's diagnostic performance. There is no mention of an algorithm-only standalone performance evaluation.

7. The Type of Ground Truth Used:

• Given the nature of the device (image viewing and manipulation tools) and the non-clinical validation, the "ground truth" was centered on expert confirmation of functional correctness and fulfillment of intended use. This means the "ground truth" was established by expert consensus/opinion regarding whether the software tools worked as expected and met user needs, rather than a definitive medical diagnosis (e.g., pathology, outcomes data).

8. The Sample Size for the Training Set:

• Not applicable / not provided. The document describes a traditional 510(k) for a software device that primarily offers image viewing and manipulation functionalities, not an AI/ML algorithm that requires a training set. The descriptions relate to software engineering practices (requirements, code reviews, verification, validation) rather than machine learning model development.

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

• Not applicable / not provided. As there is no mention of a training set for an AI/ML model, there is no discussion of how any "ground truth" for such a set was established.

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Ascent Universal Adhesive is intended for all direct and indirect restorations where light cure is possible. It is indicated as an adhesive for: light cured restorative composites, Methacrylate resin cements, dentin, enamel, metal alloys and porcelain.

Ascent Universal Adhesive is indicated for direct bonding to:

• Dentin
• Enamel
• Composite
• Porcelain
• Metal

The Ascent Universal Adhesive is an ethanol-based composition containing a special formulation of resins to achieve an excellent bond to materials such as restorative composites, dentin, enamel, metals and porcelain. The composition is polymerized by means of a dental polymerization light source.

The provided document is a 510(k) summary for a dental adhesive, Ascent Universal Adhesive. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting an extensive study with detailed acceptance criteria and performance metrics typically found for AI/software-as-a-medical-device.

Based on the content of the provided text, the following information can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance:

   The document explicitly states "Performance Standards: None" and "Performance Data: See Part 7: Performance Data". Since "Part 7: Performance Data" is not included in the provided text, a table of specific acceptance criteria and reported device performance cannot be created from the given information. The submission relies on demonstrating substantial equivalence to a predicate device rather than meeting specific performance metrics against defined acceptance criteria.

2. Sample size used for the test set and the data provenance:

   No information is provided regarding a "test set" or its sample size or data provenance. The submission focuses on comparing the proposed device's characteristics to a predicate device rather than conducting a performance study on a test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   Not applicable. There is no mention of a test set, ground truth establishment, or experts involved in such a process.

4. Adjudication method for the test set:

   Not applicable. No test set is described.

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 is not an AI/software-as-a-medical-device submission. No MRMC study or AI assistance is mentioned.

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

   Not applicable. This is not an AI/software-as-a-medical-device submission.

7. The type of ground truth used:

   Not applicable. There is no concept of "ground truth" as relevant to performance evaluation of an AI-driven device in this document. The assessment is based on material composition, intended use, and application methods compared to a predicate device.

8. The sample size for the training set:

   Not applicable. This is not an AI/software-as-a-medical-device submission; therefore, there is no training set.

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

   Not applicable. There is no training set mentioned in the document.

Summary of what is present in the document regarding acceptance criteria and studies:

The document primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device (Prime & Bond NT Dual Cure, K982394). The "acceptance criteria" in this context are implicit in the FDA's regulatory framework for 510(k)s, meaning the device must be as safe and effective as the predicate device.

The study or data proving this substantial equivalence is described as:

• Rationale for Substantial Equivalence:
  • Shared similarities in use in the oral environment.
  • Similar indications for use.
  • Similar application methods.
  • "Similar active constituents in similar concentrations."
  • "Exact information regarding the material's constituents is found in Part 6: Specifications." (This indicates that the "study" is likely a comparison of material specifications and performance data, which is mentioned as being in "Part 7: Performance Data" but not provided in the extract).

The "study" here is not a clinical trial or an AI performance study, but a technical comparison of the material properties, composition, and intended use against a previously cleared device. The "acceptance criteria" are met if the FDA agrees that the similarities are sufficient to declare the new device substantially equivalent to the predicate, "without raising any new issues regarding safety and/or effectiveness."

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