VONFLEX S BITE by VERICOM CO., LTD.

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):

Acceptance Criteria (Related to Substantial Equivalence)	Reported Device Performance (Likely included in 510(k) submission)
Intended Use Equivalence: Same indications for use as predicate.	- 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 (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.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 15, 2014

VERICOM Co., Ltd. Mr. Myung-Hwan Oh R&D Director 48 Toegyegongdan 1- Gil Chuncheon- Si, Gangwon-Do Republic of Korea 430-817

Re: K140966

Trade/Device Name: Vonflex™ S Bite Regulation Number: 21 CFR 872.3660 Regulation Name: Impression Material Regulatory Class: II Product Code: ELW Dated: May 8, 2014 Received: May 23, 2014

Dear Mr. Oh:

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 marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Mr. Oh

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mary S. Runner -S

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number K

Device Name: Vonflex™ S Bite

Indication for use:

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

Prescription Use		OR
(Per 21 CFR Subpart D)

Over-The-Counter Use _ (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Regulation Number and Section

§ 872.3660 Impression material.

(a)
Identification. Impression material is a device composed of materials such as alginate or polysulfide intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.(b)
Classification. Class II (Special Controls).