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510(k) Data Aggregation
(160 days)
OsteoReady ® ZircoSeal® Dental Abutments are intended to be used with an endosseous implant to aid prosthetic rehabilitation in order to restore the patient's chewing function. OsteoReady® ZircoSeal® Abutments are compatible with DENTIN® Dental Implant System - Prestige Implant System diameters 3.75, 4.2, 5 & 6;
OsteoReady® ZircoSeal® Abutments are Straight Anti-Rotation Abutments made of titanium alloy. OsteoReady® ZircoSeal® Abutments are available in the following measurements:
Slim Anti-Rotation Titanium Abutment with ZircoSeal®: Length 5,7,9,11,13 mm with Diameter 3.75 mm.
Anti-Rotation Titanium Abutment with ZircoSeal®: Length 5,7,9,11,13 mm Diameter 4.5 mm.
Anti-Rotation Straight Titanium Abutment with ZircoSeal®: Shoulder Length 1,2,3,4 mm Diameter 4.5 mm.
OsteoReady® ZiroSeal® Abutments are straight only and are not intended to be modified chairside or by CAD/CAM to provide an angle correction.
The ZircoSeal surface treatment is the trade name of zirconium nitride.
The ZircoSeal® simply indicates the signature zirconium nitride surface treatment of the abutment. The trade name is unrelated to claims of "sealing" of implant/abutment connection platform.
This document is a 510(k) premarket notification for the OsteoReady® ZircoSeal® Abutments, asserting substantial equivalence to previously marketed devices. It does not describe a study to prove a device meets specific acceptance criteria in the way one might expect for a diagnostic or AI-powered device.
Instead, the "acceptance criteria" here refer to meeting the requirements for demonstrating substantial equivalence to predicate devices, primarily through performance testing, biocompatibility testing, and comparison of device characteristics.
Here's an analysis based on the provided text, addressing your questions where applicable:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not present a formal table of "acceptance criteria" paired with "reported device performance" in the context of clinical accuracy or performance metrics for an AI/diagnostic device. Instead, it lists the types of tests conducted and their successful outcomes as proof of equivalence and safety.
| Test Type | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Sterilization Validation | Achieve a Safety Assurance Level (SAL) of 10⁻⁶ | Met all applicable criteria; SAL of 10⁻⁶ was achieved. |
| Biocompatibility Testing | Meet all applicable criteria as per ISO 10993-5 (cytotoxicity) | Met all applicable criteria. |
| Surface Treatment Eval. | (Implied) Consistency with predicate device characteristics | Chemical analysis and abrasion characteristics evaluated (details not provided beyond being "similar"). |
| Material Composition | (Implied) Same or equivalent to predicate devices (GR-5 Titanium) | GR-5 Titanium Ti-6Al-4V ELI (consistent with most predicates). |
| Design Characteristics | (Implied) Similar to predicate devices | Straight Anti-Rotation Abutments, various lengths/diameters, Internal Hex connection (similar to predicates). |
| Indications for Use | (Implied) Substantially equivalent to predicate devices | Minor verbiage differences, but determined not to change intended use. |
| Risk Assessment | Conducted in accordance with ISO 14971:2012 | Determined that differences raise no new safety or effectiveness issues. |
2. Sample Size Used for the Test Set and Data Provenance
This document does not describe a test set or data provenance in the context of a clinical performance study (e.g., for AI/diagnostic algorithms). The "tests" mentioned are non-clinical, such as sterilization, biocompatibility, and material characterization. Therefore, information about "sample size for a test set" or "data provenance" (country of origin, retrospective/prospective) is not applicable or provided.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. This device is a dental abutment, not an AI or diagnostic device requiring expert interpretation for ground truth.
4. Adjudication Method
Not applicable. There is no clinical study involving human interpretation or ground truth adjudication in this submission.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This document does not mention an MRMC study. The device is a physical dental abutment, not a diagnostic tool requiring human-AI comparative effectiveness evaluation.
6. Standalone Performance Study
Yes, in a non-clinical sense. The testing performed (sterilization, biocompatibility, surface treatment evaluation) assessed the standalone performance of the OsteoReady® ZircoSeal® Abutments against established standards (ISO, AAMI) and similarity to predicate devices. However, this is not a "standalone algorithm performance" study as would be relevant for an AI device.
7. Type of Ground Truth Used
The concept of "ground truth" as typically applied to diagnostic or AI studies is not directly relevant here. The "truth" in this context is established by:
- Standards compliance: E.g., ISO 10993-5 for biocompatibility, ISO 17665-1/2 and ANSI/AAMI ST79:2010 for sterilization.
- Material specifications: GR-5 Titanium Ti-6Al-4V ELI.
- Manufacturing specifications: Device design features (diameters, lengths, connection type).
- Chemical analysis: For surface treatment evaluation.
8. Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device; therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
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