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Intended for use in CAD/CAM technology to produce copings, bridges, and framework core material usage for fixed prosthodontics. Then veneered with porcelain glass to create final restoration.

DLMS-Zirblocks is a partially sintered yttria (yttrium oxide) stabilized zirconia (zirconium oxide) powder that is capable of machining by modern methods. The material is designated as TZP (slightly stronger) or TZPA (slightly more translucent). The dentist prepares the tooth surfaces, sends a properly prepared impression of those surfaces to the dental laboratory where it is scanned and an inlay or onlay prepared by modern computerized lathe methods, sintered to full density, and returned to the dentist. The dentist then finally prepares the tooth surfaces involved and cements (lutes) the inlay or only in place with standard dental adhesives (luting) materials. The material is radio-opaque, for ready visualization.

The provided documents describe a 510(k) premarket notification for a dental material, DLMS-Zirblocks. This submission focuses on establishing substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria in the typical sense of evaluating a digital health device or AI algorithm.

Therefore, many of the requested elements (acceptance criteria table, sample size, ground truth experts, MRMC studies, standalone performance, training set details) are not applicable to this type of submission. The "study" here is essentially a declaration and comparison of material properties and intended use.

Here's an breakdown based on the provided information:

1. Table of Acceptance Criteria and Reported Device Performance

This type of information is not provided in the context of this 510(k) submission. The submission is a declaration of substantial equivalence, not a performance study against specific acceptance criteria for a diagnostic or AI device. The "performance" is implicitly assumed to be equivalent to the predicate device based on identical material and intended use.

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

Not Applicable. This submission does not detail a test set of images or patient data to evaluate an algorithm's performance. It is a material science submission.

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

Not Applicable. No ground truth establishment by experts is described for a test set in this material submission.

4. Adjudication method for the test set

Not Applicable. No test set or adjudication process 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 a material submission, not an AI or diagnostic imaging device.

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

Not Applicable. This is a material submission, not an AI or algorithm.

7. The type of ground truth used

Not Applicable. No ground truth in the context of clinical or diagnostic performance is used. The "truth" being established is the equivalence of the material properties and intended use to the predicate device.

8. The sample size for the training set

Not Applicable. There is no training set mentioned as this is not an AI/algorithm submission.

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

Not Applicable. There is no training set mentioned.

Summary of the 510(k) Submission's Approach to "Acceptance Criteria" and "Study":

The "acceptance criteria" for this 510(k) submission revolve around demonstrating substantial equivalence to a legally marketed predicate device. The "study" or evidence provided to meet these criteria is primarily through direct comparison and declaration of identical material composition and intended use.

• Acceptance Criteria (Implicit for 510(k) Substantial Equivalence):

  • The device must have the same intended use as the predicate device.
  • The device must have the same technological characteristics as the predicate device.
  • If there are differences in technological characteristics, those differences must not raise new questions of safety and effectiveness.
  • The device must be as safe and effective as the predicate device.

• Reported Device "Performance" (as per the submission):

  • Intended Use: Identical to the predicate device (Metoxit CAM-Blanks) - "Intended for use in CAD/CAM technology to produce copings, bridges, and framework core material usage for fixed prosthodontics. Then veneered with porcelain glass to create final restoration."
  • Material Composition: Identical to the predicate device - "partially sintered yttria (yttrium oxide) stabilized zirconia (zirconium oxide) powder."
  • Technological Characteristics: Declared as "identical." "There is no difference in fundamental technology. They have the same intended use and are made from the same materials."
  • Safety and Effectiveness: Concluded to be "equally safe and effective" due to the identical nature to the predicate device.

In essence, the entire 510(k) document serves as the "study" by asserting that the DLMS-Zirblocks are fundamentally the same as the predicate device, Metoxit CAM-Blanks, and therefore meet the implicit safety and effectiveness criteria by virtue of that equivalence.

Ask a specific question about this device

ZirBlock® is used in the manufacture of dental prosthetics: crowns, bridges, inlays, and onlays.

ZirBlock® is a pre-formed material for use by dental laboratories in filling orders/prescriptions for dental prosthetics

I am sorry, but based on the provided text, there is no information regarding acceptance criteria or a study that proves the device meets specific acceptance criteria.

The document is a 510(k) summary for a dental material called ZirBlock®. It focuses on demonstrating substantial equivalence to predicate devices (other legally marketed dental materials) rather than presenting performance data against defined acceptance criteria.

Here's why I cannot provide the requested information:

• No Acceptance Criteria Defined: The summary states: "None required. The claim of substantial equivalence is based on comparisons of formulations, mechanical characteristics, and intended uses of the devices to legally marketed predicates and to the IDENTIFICATION of porcelain powders in 21 CFR 872.6660." This explicitly states that performance data against acceptance criteria was not required for this submission.
• No Performance Study Described: The document mentions "comparisons of formulations, mechanical characteristics, and intended uses," but it does not detail any specific study design, methodology, results, or statistical analysis that would constitute a "study that proves the device meets the acceptance criteria."
• Focus on Substantial Equivalence: The entire submission is built around the concept of substantial equivalence to existing predicate devices, meaning the device is considered as safe and effective as devices already on the market, without necessarily requiring a new, independent performance study against novel acceptance criteria.

Therefore, since the input document does not contain the information you've requested, I cannot complete the table or answer the specific questions about sample size, expert ground truth, adjudication, or MRMC studies.

Ask a specific question about this device