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510(k) Data Aggregation
(248 days)
BRANEMARK SYSTEM ZYGOMATICUS FIXTURE SYSTEM
The Nobel Biocare Branemark System - Zygomaticus Fixture System is an endosseous implant with components made of titanium intended to be placed in the upper jaw arch to provide support for prosthetic devices such as artificial teeth, and to restore the patient's chewing function. The system includes Fixtures, Drills, Hand Instruments, Cover Screws and Accessories.
The Nobel Biocare BRANEMARK SYSTEM® Zygomaticus Fixture System is an endosseous implant with components made of titanium intended to be placed in the upper jaw arch to provide support for prosthetic devices such as artificial teeth, and to restore the patient's chewing function. The system includes Fixtures, Drills, Hand Instruments, Cover screws and accessories.
This document is a 510(k) Pre-market Notification for the Nobel Biocare BRÅNEMARK SYSTEM® Zygomaticus Fixture System. It is an older document from 1997, and the information provided is typical for devices seeking substantial equivalence to predicate devices, rather than establishing performance against specific acceptance criteria through clinical studies in the way modern AI/ML medical devices would.
Therefore, many of the requested categories for AI/ML device studies (like sample sizes for test/training sets, ground truth establishment, MRMC studies, effect sizes, etc.) are not applicable or present in this document.
The core of this submission is a comparison of technological characteristics to predicate devices to establish substantial equivalence.
Here's an attempt to fill in the table and address the questions based on the provided text, highlighting where information is not available:
Acceptance Criteria and Device Performance Study Summary (K970499)
This 510(k) submission primarily relies on demonstrating substantial equivalence to existing predicate devices. Performance acceptance criteria for a "new" device, as would be expected for an AI/ML device, are not explicitly defined or tested in the way typically required today. Instead, the "acceptance criteria" here implicitly revolve around demonstrating that the new device's components are technologically identical to the predicate components and serve the same intended use.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category (Implicit from 510(k)) | Stated Acceptance Criteria (Implied) | Reported Device Performance (as per submission) |
|---|---|---|
| Material Composition | Components made of titanium (same as predicate). | The device system "consists of fixtures and numerous components to be used in conjunction with the BRÅNEMARK SYSTEM® Zygomaticus Fixture System, including Fixtures, Drills, Hand Instruments, Cover Screws and accessories specific to the Zygomaticus Fixture System" and "components made of titanium." This matches the implicit understanding of the predicate devices. |
| Intended Use | To be used as an endosseous implant in the upper jaw for prosthetic support and chewing function restoration (same as predicate). | "The Nobel Biocare BRÅNEMARK SYSTEM® Zygomaticus Fixture System is an endosseous implant with components made of titanium intended to be placed in the upper jaw arch to provide support for prosthetic devices such as artificial teeth, and to restore the patient's chewing function." This aligns with the stated intended use of similar existing devices. |
| Technological Characteristics | Identical to corresponding predicate products. | "The technological characteristics between the components of Zygomaticus Fixture System and the corresponding predicate products, comparable components in the BRÅNEMARK SYSTEM® and the drill guide manufactured by Ace Surgical Supply Co. are identical." This is the core claim of the submission regarding performance/safety equivalence. No specific quantitative performance metrics are provided because the claim is identity with already-cleared devices. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not applicable. This submission does not describe a clinical performance study with a "test set" in the context of an AI/ML device. The "test" here is the comparison of technological characteristics to predicate devices.
- Data Provenance: Not applicable. No clinical or dataset-based performance data is presented.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable. No "ground truth" was established for a test set as would be done for an AI/ML device. The "ground truth" for this submission is essentially the understanding of the design and materials of the predicate devices.
- Qualifications of Experts: N/A
4. Adjudication method for the test set
- Adjudication Method: Not applicable. No test set requiring expert adjudication was 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
- MRMC Study: No. This is not an AI-assisted device.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This is not an algorithmic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: Not applicable in the context of AI/ML. The "ground truth" for this 510(k) is the established technological characteristics and intended uses of the predicate devices.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established
- Ground Truth for Training Set Establishment: Not applicable.
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