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• Standard bite registrations in the end bite position -
• Portrayal of antagonists -
• Coating of bite forks -
• Key material for needle point registration -
• -Production of small model segments

Not Found

1. Acceptance Criteria and Reported Device Performance:

The provided document (K140966) is a 510(k) clearance letter for a dental impression material, "Vonflex™ S Bite." It appears to be a traditional 510(k) submission seeking substantial equivalence to a predicate device. This type of regulatory submission typically focuses on demonstrating that the new device has the same intended use and technological characteristics as a legally marketed predicate device, or that any differences do not raise new questions of safety or effectiveness.

Therefore, the "acceptance criteria" for this device are not framed as specific performance metrics against a pre-defined threshold for an AI algorithm. Instead, the acceptance criteria revolve around demonstating substantial equivalence to an existing predicate device. The "reported device performance" would be the summary of the tests and data provided by the manufacturer in their 510(k) submission to support this substantial equivalence.

Without additional documents (like the full 510(k) submission), it's impossible to provide a table of specific quantitative acceptance criteria directly from the FDA letter. However, based on the nature of a 510(k) for an impression material, the acceptance criteria and likely performance evaluation would revolve around characteristics relevant to dental impressions.

Likely Acceptance Criteria and Reported Performance (General based on impression materials):

• Portrayal of antagonists
• Coating of bite forks
• Key material for needle point registration
• Production of small model segments (as stated in the "Indication for use" section) |
  | Technological Characteristics Equivalence:
• Material composition and properties
• Physical/mechanical properties relevant to impressions
• Biocompatibility | - Composition: Likely similar elastomer (e.g., vinyl polysiloxane, polyether) to predicate.
• Setting Time: Within clinically acceptable range, comparable to predicate.
• Dimensional Stability/Accuracy: Demonstrated to be stable and accurate post-setting, comparable to predicate via in-vitro testing.
• Tear Strength: Sufficient to prevent tearing during removal, comparable to predicate.
• Hydrophilicity/Wettability: Adequate for good adaptation to oral tissues, comparable to predicate.
• Flowability/Viscosity: Appropriate for specific impression techniques, comparable to predicate.
• Biocompatibility: Demonstrated via ISO 10993 testing or reference to predicate's biocompatibility. |
  | Performance Data Equivalence:
• Functional performance
• Safety | - Clinical Performance (if studies were performed): E.g., successful impression taking and model fabrication. If clinical studies were performed, they would compare Vonflex™ S Bite to the predicate device.
• Safety: Evaluation for adverse reactions, allergic responses, or cytotoxic effects (often covered under biocompatibility). |

Note: The FDA letter explicitly states, "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." This confirms the focus on substantial equivalence.

The document provided does not contain information on points 2 through 9, as it is a 510(k) clearance letter and not a detailed study report. The information requested in points 2-9 is typical for the evaluation of a novel AI/ML-driven medical device, especially regarding diagnostic accuracy or performance improvement studies. Since this device is a dental impression material, these specific types of studies (MRMC, expert adjudication for AI ground truth, training and test sets for AI) are not applicable.

However, to address the prompt for completeness based on typical medical device evaluations for non-AI devices, I can infer the general approaches for similar materials:

Hypothetical General Information for a Non-AI Device (like an Impression Material), if Study Details were Available:

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

• Test Set: For an impression material, "test set" typically refers to the number of impressions taken, or the number of samples subjected to physical/mechanical testing.
  • In-vitro testing: Might involve dozens to hundreds of samples for various physical and mechanical properties (tensile strength, tear strength, dimensional accuracy, etc.).
  • Clinical testing (if performed): Could range from 20-50 patients for a pilot study, to several hundred for a larger comparative study, depending on the endpoints.
• Data Provenance:
  • In-vitro: Lab-controlled environment, likely conducted by the manufacturer or a contract research organization.
  • Clinical: Could be retrospective (review of existing patient records where the material was used) or prospective (new clinical study specifically designed for the 510(k)). Country of origin would be where the manufacturing and/or clinical sites are located (e.g., Republic of Korea, based on the applicant's address).

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

• For an impression material, "ground truth" isn't typically established by expert consensus in the same way it is for diagnostic AI. Instead, "ground truth" often refers to:
  • Reference standards in physical/mechanical tests: E.g., measurements against a known calibration standard, or a predicate device's established performance.
  • Clinical outcomes: E.g., success of prosthetic fit, patient satisfaction, absence of complications.
• "Experts" involved:
  • Lab technicians/Engineers: With expertise in material science and dental materials testing.
  • Dentists/Prosthodontists: With clinical experience in taking impressions and evaluating restoration fit. Qualifications would be standard dental degrees and potentially specialty certifications.

4. Adjudication Method for the Test Set:

• Not applicable in the AI sense. For clinical outcomes, if multiple clinicians evaluate the impressions or restorations, agreement might be assessed via inter-rater reliability statistics (e.g., Kappa statistic). For lab tests, standard quality control and reproducibility measures are used.

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

• No. MRMC studies are specific to evaluating human reader performance with and without AI assistance, particularly in diagnostic contexts. This is not relevant for an impression material.

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

• No. This concept is specific to AI algorithms.

7. The Type of Ground Truth Used:

• Defined Standards/Reference Materials: For physical and mechanical properties, ground truth comes from established metrics (e.g., ISO standards for dental materials), standardized measurement techniques, and comparison to the predicate device.
• Clinical Success/Outcomes: In clinical studies, the "ground truth" would be the successful clinical application as judged by objective criteria (e.g., excellent marginal fit of restoration, stable bite registration, no patient discomfort) and potentially subjective patient feedback.

8. The Sample Size for the Training Set:

• Not applicable in the AI sense. For an impression material, "training set" doesn't exist for an algorithm. Instead, it would refer to the data used in the material's development and optimization phase. This might involve numerous iterations of formulation changes and subsequent small-batch testing.

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

• Not applicable in the AI sense. For material development, "ground truth" during "training" would be established by desired performance targets (e.g., "we need a setting time of 3-5 minutes," "tear strength must exceed X MPa") derived from clinical needs, market analysis, and predicate device performance. These targets guide the iterative development process.

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