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510(k) Data Aggregation
(180 days)
NobelProcera HT ML FCZ Implant Bridge and Framework
The NobelProcera® HT ML FCZ (full contour zirconia) and framework Implant Bridge are indicated for use as a bridge anatomically shaped and/or framework in the treatment of partially or totally edentulous jaws for the purpose of restoring chewing function.
The NobelProcera HT ML FCZ Implant Bridge and Framework is an individualized implant supported screw-retained dental implant bridge for the partially dentate and edentulous patients. The NobelProcera HT ML FCZ Implant Bridge and Framework is available as either a framework requiring veneering in a dental lab or as a full anatomic contour design requiring minimum laboratory processing. The NobelProcera HT ML FCZ Implant Bridge and Framework is available for bridges between 2 to 14 units. The bridge is made of a titanium base and a highly transparent multi layered zirconia material which is available in 6 shades. The NobelProcera HT ML FCZ Implant Bridge and Framework is available for the Nobel Biocare internal conical connection, external hex, and internal tri-channel implants and the Multi-unit abutments.
Here's an analysis of the provided text regarding the acceptance criteria and study for the NobelProcera HT ML FCZ Implant Bridge and Framework:
The document is a 510(k) premarket notification summary for a dental implant bridge and framework. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a novel device with performance criteria requiring a complex clinical study. Therefore, many of the requested categories (like MRMC studies, ground truth for training sets, etc.) are not applicable or not detailed in this type of submission.
Acceptance Criteria and Study for NobelProcera HT ML FCZ Implant Bridge and Framework
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Characteristic | Acceptance Criteria (Implicit) | Reported Device Performance and Methodology |
|---|---|---|
| Fatigue Limit | • Must demonstrate equivalent or superior fatigue strength compared to the predicate device. | |
| • Must withstand likely worst-case clinical use conditions. | • Tested using a modified version of ISO 14801. | |
| • Modifications were made to reflect "likely worst-case clinical use." | ||
| • Both the subject device (NobelProcera HT ML FCZ Implant Bridge and Framework) and the predicate device (NobelProcera Implant Bridge Zirconia - K091907) were tested under "identical conditions." | ||
| • The results were used to address questions of substantial equivalence based on design differences. (Specific numerical results for fatigue limits are not provided in this summary.) | ||
| Sterilization | • Must be validated according to relevant ISO standards. | • Validation of recommended sterilization parameters was conducted according to ISO 17665-1 and ISO 17665-2. |
| Biocompatibility | • Must not exhibit cytotoxicity. | |
| • Must not release harmful leachables/extractables. | • Cytotoxicity testing was performed according to ISO 10993-5. | |
| • BC-MS (Biocompatibility-Mass Spectrometry?) analysis for leachables/extractables was conducted. | ||
| • These tests were performed on the ISO 6872 ceramic and ASTM F136 titanium alloy material composition of the device. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Fatigue Testing: Not explicitly stated. The document mentions "the subject and predicate device were tested," implying a comparative, laboratory-based study. However, the number of units tested for fatigue is not given.
- Data Provenance: The studies were laboratory-based performance tests, not human data. The exact location of the testing laboratories is not specified, but the manufacturer (Nobel Biocare AB) is based in Sweden, and the submission is from their US entity.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- This question is not applicable as the studies conducted were performance testing of the device's physical properties and biocompatibility, not studies involving human interpretation or clinical outcomes requiring expert ground truth establishment.
4. Adjudication Method for the Test Set
- This question is not applicable for the same reasons as (3).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size.
- No, an MRMC comparative effectiveness study was not done. The submission explicitly states: "No clinical data was used to support the decision of substantial equivalence." This type of study would involve human readers (e.g., dentists, prosthodontists) evaluating cases with and without the device, which was not performed or submitted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- This question is not applicable. The device is a physical dental implant bridge and framework, not an algorithm or AI system.
7. The Type of Ground Truth Used
- This question is not applicable in the traditional sense for these types of engineering and biocompatibility tests. The "ground truth" for these tests would be the established scientific and engineering principles and the specified values/limits within the ISO standards themselves. For example, for fatigue, the "truth" is the device's actual fatigue life as measured objectively under controlled conditions, compared against the predicate's measured fatigue life and relevant industry standards.
8. The Sample Size for the Training Set
- This question is not applicable. There is no "training set" as this is a physical medical device undergoing performance testing, not an AI/ML algorithm development.
9. How the Ground Truth for the Training Set was Established
- This question is not applicable for the same reasons as (8).
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