(306 days)
NexxZr T and NexxZr S are intended for the fabrication and preparation of copings and full anatomical/full contour crowns, bridges, inlays, and onlays for anterior and posterior segment restorations.
Sagemax NexxZr™ T and NexxZr™ S are zirconium dioxide-yttrium oxide ceramic material - pressed into pre-sintered discs intended for further processing using computer aided manufacturing by a dental laboratory or other similar establishment, under the order of a physician/dentist. The dentist prepares the surface(s) of the natural teeth, then cements (lutes) the restoration in place with standard dental adhesives materials. Sagemax NexxZr™ prostheses are alternatives to gold, amalgam, ceramic, porcelain, or composite filling materials, more closely resembling gold inlays or porcelain inlays, onlays or veneers. The material is radioopaque, for ready visualization.
NexxZr™ products are a modification of the previous version, Sagemax Z-Blank™
The provided text describes a 510(k) summary for the dental prosthetic materials NexxZr™ S and NexxZr™ T, which are zirconium dioxide-yttrium oxide ceramic materials. The submission seeks substantial equivalence to a predicate device, Sagemax Z-Blank™ (K062695).
However, the document does not contain information about:
- Specific quantitative acceptance criteria for the device's performance.
- A detailed study proving the device meets acceptance criteria, including sample sizes, data provenance, ground truth establishment, or expert involvement.
- Multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
The document primarily focuses on establishing substantial equivalence based on material composition and physical characteristics, asserting that the new devices have the same technological characteristics and similar mechanical and chemical stability as the predicate device.
Based on the provided text, I cannot complete a table of acceptance criteria and reported device performance or provide the detailed study information requested. The document states:
- "NexxZr™ is an oxide-based ceramic composed of isostatically pressed, partially sintered, yttria-stabilized zirconia powder. NexxZr 10 is tested according to ISO 6872: 2008 Type II/Class 6 to ensure intended strength."
- "Measurements of the physical characteristics showed that the material has the same mechanical (flexural strength) and chemical stability (solubility) as our predicate device."
- "The substantial equivalence of the intended use has also been proven by material testing (flexural strength - ISO 6872: 2008) and clinical performance."
This indicates that the material was tested, but the results of these tests, specific acceptance criteria values, sample sizes, and detailed methodology are not included in this 510(k) summary.
Therefore, I can only provide what is explicitly stated or can be inferred:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Not Explicitly Stated as Quantitative Criteria) | Reported Device Performance (Summary Statements) |
|---|---|
| Material Composition | Oxide-based ceramic composed of isostatically pressed, partially sintered, yttria-stabilized zirconia powder. (Same as predicate) |
| Technological Characteristics | Same as predicate device Sagemax Z-blank™. |
| Mechanical Strength (e.g., Flexural Strength) | Tested according to ISO 6872:2008 Type II/Class 6 to ensure intended strength. Material has the "same mechanical (flexural strength)" as the predicate device. (Specific values not provided in this summary). |
| Chemical Stability (e.g., Solubility) | Material has the "same... chemical stability (solubility)" as the predicate device. (Specific values not provided in this summary). |
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: Not specified in the provided text. The text only mentions "Measurements of the physical characteristics showed..." and "material testing (flexural strength - ISO 6872: 2008)".
- Data Provenance: Not specified.
- Retrospective/Prospective: Not specified, but generally, material characterization tests as described are prospective laboratory tests rather than clinical studies.
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)
- Not applicable. The "ground truth" here refers to the material's physical and chemical properties, measured objectively through standardized tests (e.g., ISO 6872:2008). No human expert consensus was needed to establish these empirical ground truths.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This concept typically applies to clinical studies where human interpretation or classification is involved. Material testing involves objective measurements, not 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
- Not applicable. This device is a dental material, not an AI or imaging diagnostic or assistive device for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a material, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for proving substantial equivalence was based on objective material property measurements (e.g., flexural strength, solubility) performed according to international standards (ISO 6872:2008) and comparison to the predicate device's properties.
8. The sample size for the training set
- Not applicable. This device is a material, not a machine learning model. There is no concept of a "training set" in this context.
9. How the ground truth for the training set was established
- Not applicable. As above, there is no training set for this type of device.
§ 872.6660 Porcelain powder for clinical use.
(a)
Identification. Porcelain powder for clinical use is a device consisting of a mixture of kaolin, felspar, quartz, or other substances intended for use in the production of artificial teeth in fixed or removable dentures, of jacket crowns, facings, and veneers. The device is used in prosthetic dentistry by heating the powder mixture to a high temperature in an oven to produce a hard prosthesis with a glass-like finish.(b)
Classification. Class II.