Search Results
Found 2 results
510(k) Data Aggregation
(278 days)
NobelZygoma implants are endosseous dental implants intended to be surgically placed in the bone of the upper jaw arch to provide support for prosthetic devices, such as artificial teeth, in order to restore patient esthetics and chewing function. The NobelZygoma Implants are appropriate for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
Nobel Biocare's NobelZygoma 0° implants are threaded, root-form titanium dental implants intended to be integrated in the Zygomaticus bone to support prosthetic devices, such as artificial teeth, in order to restore chewing function. The NobelZygoma 0° implants typically pierces the oral mucosa in the premolar region and passes through the sinus along the lateral wall of the maxilla. Depending on the contour of the lateral maxillary wall, the mid-portion of the implant may also pass lateral to the lateral wall. The NobelZygoma 0° implants are available in lengths between 30 and 50 mm and have a 4.5 mm external hex connection. They are made of commercially pure titanium and have the Nobel Biocare TiUnite surface treatment.
Nobel Biocare's NobelZygoma 0° abutments are implant abutments intended to be used with the NobelZygoma 0° implant only. The NobelZygoma 0° abutments are used to accommodate the total angle of the implant – abutment joint. This is necessary since the subject implant has a flat platform rather than the 45° platform of the predicate device implants. The NobelZygoma 0° abutments are available in lengths between 6 and 10 mm and with angle of 45° or 60°. They contain the external hex connection and are made of a titanium alloy without any additional coating.
The Temporary Coping Multi-Unit and Temporary Coping Plastic Multi-unit are premanufactured dental abutment directly connected to the Multi-unit abutment. It is used as a temporary aid in prosthetic rehabilitation until the final restoration is attached. Maximum intraoral use is 180-days.
This document does not describe an AI/ML device and therefore does not contain the information requested regarding acceptance criteria and a study proving a device meets them for such a device.
The provided text is a 510(k) premarket notification for a medical device called "NobelZygoma 0°", which is an endosseous dental implant. The notification focuses on establishing substantial equivalence to a predicate device ("NobelZygoma 45°") through non-clinical performance data (bench testing) and material/design comparisons, not on evaluating the performance of an AI/ML algorithm.
Therefore, I cannot provide the requested information, such as:
- A table of acceptance criteria and reported device performance (for an AI/ML device).
- Sample size used for the test set and data provenance.
- Number of experts used to establish ground truth and their qualifications.
- Adjudication method.
- Multi-reader multi-case (MRMC) comparative effectiveness study results.
- Standalone (algorithm only) performance.
- Type of ground truth used (for an AI/ML device).
- Sample size for the training set.
- How ground truth for the training set was established.
Ask a specific question about this device
(232 days)
Nobel Biocare's Zygoma implants are endosseous dental implants intended to be surgically placed in the bone of the upper jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore patient esthetics and chewing function. The Zygoma Implants may be put into immediate function provided that stability requirements detailed in the directions for use are satisfied.
Nobel Biocare's NobelZygoma 45° implants are threaded, root-form titanium dental implants intended to extend through the maxillary sinus into the Zygomaticus bone to support prosthetic devices, such as artificial teeth, in order to restore chewing function.
The NobelZygoma 45° implants are available in lengths between 30 and 52.5 mm and have a 4.5 mm external hex connection. They are made of commercially pure titanium and have the Nobel Biocare TiUnite surface treatment.
This document is a 510(k) premarket notification for a dental implant, the NobelZygoma 45°. It does not describe an AI/ML powered device, nor does it present clinical performance data in the typical sense of acceptance criteria for diagnostic accuracy or efficacy. Instead, it focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing and shared characteristics.
Therefore, the requested information elements related to AI/ML device performance, human readers, ground truth establishment, and training/test set details cannot be extracted from this document in their typical form.
However, I can extract and present the available information regarding the device's technical specifications and how its performance was evaluated to demonstrate substantial equivalence, which is the primary "acceptance criterion" for a 510(k) submission.
1. Table of Acceptance Criteria and Reported Device Performance (Focus on Substantial Equivalence and Non-Clinical Testing for Dental Implants)
For this type of device, "acceptance criteria" are generally tied to demonstrating that the new device is as safe and effective as a legally marketed predicate device. The primary "study" is a comparative performance test.
| Acceptance Criteria (Demonstration of Substantial Equivalence) | Reported Device Performance (NobelZygoma 45°) |
|---|---|
| Material Composition Equivalence | Device Material: CP Titanium grade 4 (Same as predicate) |
| Surface Treatment Equivalence | Surface: TiUnite (Same as predicate) |
| Sterilization Method Equivalence | Sterilization Method: Gamma radiation (Same as predicate, validated to ANSI/AAMI/ISO 11137). No additional testing required. |
| Packaging Equivalence | Packaging: Same as predicate (titanium cylinder in plastic vial with PVC shrinkwrap and tamper resistant strip). No additional testing required. |
| Shelf Life Equivalence | Shelf Life: Same as predicate (5 years expiration, determined by real-time aging). No additional testing required. |
| Biocompatibility Equivalence | Biocompatibility: Manufactured from same material with same method as predicate, same intended use and patient contact type/duration. No additional testing required. |
| Mechanical Performance (Fatigue Limit) | Fatigue Limit: Determined using a modified version of ISO 14801. Both NobelZygoma 45° (candidate) and Zygoma Implant (predicate) were tested under identical conditions. Specific numerical results for fatigue limit are not provided in this excerpt, only that the testing was performed and used to address substantial equivalence. The conclusion is that the device has been shown to be substantially equivalent to the predicate. |
| Intended Use/Indications for Use Equivalence | Indications for Use: "Nobel Biocare's Zygoma implants are endosseous dental implants intended to be surgically placed in the bone of the upper jaw arches to provide support for prosthetic devices such as artificial teeth in order to restore patient esthetics and chewing function. The Zygoma Implants may be put into immediate function provided that stability requirements detailed in the directions for use are satisfied." (Identical to predicate's indications, with minor wording change from "manual" to "directions for use"). |
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not explicitly stated as a numerical value for a typical clinical test set. The "test set" in this context refers to the samples of the NobelZygoma 45° device and the predicate device used for mechanical fatigue testing. The document states "Both the subject and predicate device were tested under identical conditions," implying multiple units were tested to determine the fatigue limit, but the exact number is not provided.
- Data Provenance: The document is a regulatory submission for a dental implant manufactured by Nobel Biocare AB (Sweden) and submitted by Nobel Biocare USA LLC (USA). The testing described is non-clinical (mechanical), performed to demonstrate the device's physical properties.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- This concept is not applicable as this is a non-clinical, mechanical device. "Ground truth" for a dental implant's mechanical properties is derived from standardized testing methods (e.g., ISO 14801), not expert consensus in the diagnostic sense.
4. Adjudication Method (for the test set):
- Not applicable as this is a mechanical device with non-clinical performance data, not subject to human adjudication for a test set.
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 document is for a physical medical device (dental implant), not an AI/ML-powered diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This document is for a physical medical device (dental implant).
7. The type of ground truth used:
- For the mechanical performance testing (fatigue limit), the "ground truth" is defined by the objective measurements obtained through the standardized mechanical test method (modified ISO 14801).
8. The sample size for the training set:
- Not applicable. This document is for a physical medical device (dental implant), not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable. No training set is involved.
Ask a specific question about this device
Page 1 of 1