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510(k) Data Aggregation
(170 days)
Straumann n!ce Glass Ceramic A14 Blocks
The Straumann n!ce Glass Ceramic A14 Blocks are intended to be ceramic mesostructures cemented to the Ti-base for a two-piece hybrid abutment for single tooth restorations or hybrid abutment crowns, used in conjunction with endosseous dental implant to restore chewing function. The following compatibilities apply:
| Ti-Base | Block | ||
|---|---|---|---|
| manufacturer | system | Reference | interface size |
| Straumann | RC Variobase® for CEREC | 022.0024 | L |
| NC Variobase® for CEREC | 022.0025 | L | |
| RN Variobase® for CEREC | 022.0019 | L | |
| WN Variobase® for CEREC | 022.0020 | L |
Straumann® n!ce® glass ceramic is a proprietary lithium disilicate (Li2O-SiO2) dental glass ceramic material. The n!ce® glass-ceramic A14 blocks feature a pre milled interface that fits the Straumann® Variobase® for CEREC®. The blocks are further processed by the trained professional to make individually designed mesostructure that are milled into the desired shape of a hybrid abutment or hybrid abutment crown using the Sirona inLab (Version3.65) and CEREC® software (Version 4.2). n!ce® mesostructures can be additional crystallization firing. Stain & glaze techniques can be applied.
n!ce® A14 blocks are available in two levels of translucency: HT (High Translucency) and LT (Low Translucency). Both translucencies are available in shades , A1, A2, A3, B2, B4 and C2 for flexibility and application variety to meet individual patient needs. n!ce®A14 blocks are available with one interface size large (L)
The provided text describes the submission for a 510(k) premarket notification for the "Straumann® n!ce Glass Ceramic A14 Blocks," a dental device. It focuses on demonstrating substantial equivalence to a predicate device, rather than outlining acceptance criteria and a study proving the device meets those criteria in the context of an AI/ML medical device.
Therefore, many of the requested items (Acceptance Criteria Table, Sample Size for Test Set, Data Provenance, Number of Experts, Adjudication method, MRMC study, Standalone performance, Training set size, Training set GT establishment) are not applicable to this type of regulatory submission, as it is for a physical dental material block, not an AI/ML algorithm.
However, I can extract the "Performance Data" section which describes the types of tests conducted to support the device's safety and effectiveness and its substantial equivalence.
Here's the information that can be extracted from the document, focusing on what is relevant to "acceptance criteria" and "study."
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of "acceptance criteria" paired with "reported device performance" in the way one might expect for an AI/ML device (e.g., sensitivity, specificity thresholds). Instead, it lists the types of performance tests that were conducted and implied their results supported substantial equivalence.
| Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|
| ISO 6872 compliance | Test data submitted or referenced to support the evaluation of the subject n!ce® Glass-Ceramic A14 Blocks, indicating compliance with ISO 6872 (Dentistry-Ceramic materials). |
| ISO 14801 compliance | Test data submitted or referenced, indicating compliance with ISO 14801 (Dentistry-Implants-Dynamic fatigue test for endosseous dental implants). |
| FDA guidance compliance | Test data submitted or referenced, indicating compliance with FDA guidance "Root-form endosseous dental implants and endosseous dental implant abutments." |
| ISO 7991 compliance | Test data submitted or referenced, indicating compliance with ISO 7991 (Glass—Determination of coefficient of mean linear thermal expansion). |
| ISTA 2A compliance | Transport and package testing per ISTA 2A and the standards referenced therein was submitted or referenced. |
| Sterilization effects | Effects of steam sterilization on product performance consistent with FDA guidance "Reprocessing Medical Devices in Health Care Setting: Validation Methods and Labeling, Guidance for Industry and Food and Drug Administration Staff, Appendix C" were evaluated. |
| Steam sterilization | Steam sterilization validation per ISO 17665 series standards was conducted. |
| Biocompatibility | Biocompatibility assessment per the ISO 10993 series of standards was conducted. |
| Chemical characterization | Chemical characterization per ISO 10993-18 (Biological evaluation of medical devices—Part 18: Chemical characterization of materials) was conducted. |
| Shelf life | Evaluation of shelf life per ASTM F1980 (Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices) was conducted. |
| Processing/Machinability | Laboratory processing including Workflow validation, and Machinability of blocks were performed. "The compatibility of the n!ce glass blocks with the existing IPS e.max CAD milling program is validated as part of this submission." (Implies successful milling and processing according to existing dental CAD/CAM systems). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document refers to various standards and guidances but does not detail the specific sample sizes or the provenance of the data for each test.
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)
This is not applicable as the document describes a physical dental material, not an AI/ML device requiring expert-established ground truth for a diagnostic task.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable as the document describes a physical dental material.
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
This is not applicable as the document describes a physical dental material.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This is not applicable as the document describes a physical dental material.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This is not applicable in the context of an AI/ML diagnostic device. For the dental material, "ground truth" would relate to its physical, chemical, and mechanical properties as defined by relevant ISO and ASTM standards and confirmed through laboratory testing.
8. The sample size for the training set
This is not applicable as the document describes a physical dental material, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
This is not applicable as the document describes a physical dental material.
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