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510(k) Data Aggregation
(432 days)
Zuga Dental Implant System
The Zuga™ Dental Implant System is indicated for immediate or delayed implant placement for surgical and restorative applications in maxillary and/or mandibular arches to support prosthetic devices, such as artificial teeth, crowns, bridges, and overdentures. The Zuga™ Dental Implant System is indicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
The Zuga™ Dental Implant System includes endosseous dental implants, sealing caps, healing caps, dental implant abutments, and fixation screws in a variety of sizes to accommodate differing patient anatomy. Implantation is suitable for one-or two-stage procedures. Endosseous implants are bone level, self-tapping, root-form, threaded. The threaded surface is blasted, then passivated. Sizematched anterior and posterior abutments are offered. Thes are fastened to the implant using a fixation screw. Sealing caps and healing caps provide protection to the abutment connection threads during endosseous and gingival healing. The implants are provided sterile, the remaining components must be sterilized prior to use.
The provided text describes a 510(k) premarket notification for the Zuga™ Dental Implant System. This type of submission focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than proving that the device meets a set of specific acceptance criteria through clinical performance metrics like sensitivity, specificity, or accuracy, as would be common for AI-driven diagnostic devices.
Therefore, the document does not contain the information requested regarding acceptance criteria in terms of performance metrics for an AI/ML device, nor does it detail a study proving the device meets such criteria with respect to AI performance.
Instead, the "Performance Data" section ([15]) focuses on biological and mechanical compatibility/safety testing, which is standard for medical devices like dental implants. These tests are designed to show that the physical device itself is safe and performs as intended, not to evaluate an AI algorithm's diagnostic or predictive capabilities.
Here's an breakdown of the information present and what's missing, based on the prompt's requirements:
1. A table of acceptance criteria and the reported device performance:
- Present: The document lists various tests performed and their outcomes which act as "acceptance criteria" for a physical medical device. These are:
- Static fatigue tests and dynamic fatigue tests (per ISO 14801 and FDA Guidance): "The results show that the Zuga™ Dental Implant System has sufficient mechanical strength for the intended clinical application."
- Cytotoxicity testing (per ISO 10993-5 and USP ): "The results showed that the Zuga™ Dental Implant System received a passing score and is thus acceptable for clinical application."
- Sterility tests (per ISO 10993, ISO 11137-1, 11137-2, ISO 17665-1, 17665-2): "yielded no difference in performance between the Zuga™ Dental Implant System and the predicate device."
- LAL (Limulus Amebocyte Lysate) bacterial endotoxin tests (per ISO 10993 and USP , ): "yielded a EU/Device value that was less than the established acceptance criteria of 20 EU/Device".
- Shelf life tests (per ISO 11607): "established the shelf life to be five years provided the sterile seal is not breached."
- Missing (for an AI/ML device context): Specific performance metrics like sensitivity, specificity, accuracy, AUC, FROC, etc., and their corresponding acceptance thresholds.
2. Sample sized used for the test set and the data provenance:
- Present: For LAL tests, it states: "The sampling plan consists of selecting 3% of the batch up to a maximum of 10 samples to be pooled for testing."
- Missing (for an AI/ML device context): Sample size for a "test set" of patient data (e.g., medical images, clinical records) for an AI algorithm. Data provenance (country of origin, retrospective/prospective) is not applicable or mentioned for these physical/biological tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Missing: This information is not relevant to the mechanical/biological testing of a physical implant. It would be crucial for an AI/ML device based on clinical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Missing: Not applicable to the presented data.
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:
- Missing: Not applicable. This device is a physical dental implant, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Missing: Not applicable.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- Present (for physical device tests): The "ground truth" here is adherence to international standards (ISO, ASTM) and USP guidelines for mechanical strength, biocompatibility, sterilization, and endotoxin levels.
- Missing (for an AI/ML device context): Clinical ground truth established by experts or pathology for diagnostic purposes.
8. The sample size for the training set:
- Missing: Not applicable, as this is not an AI/ML device.
9. How the ground truth for the training set was established:
- Missing: Not applicable.
In summary: The provided document is an FDA 510(k) clearance letter for a physical dental implant system. Its "acceptance criteria" and "performance data" relate to the mechanical, chemical, and biological safety and efficacy of the implant itself, demonstrated through adherence to various international and US standards. It contains no information relevant to the development, testing, or performance of an AI/ML device.
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(242 days)
ZUGA DENTAL IMPLANT SYSTEM
The Zuga-Dental-Implant-System-is-indicated-for-immediate-or-delayed-implant-placement-forsurgical and restorative applications in maxillary and/or mandibular arches to support prosthetic devices, such as artificial teeth, crowns, bridges and overdentures. The Zuga Dental Implant System is indicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading
The Zuga™ Dental Implant System includes endosseous dental implants, sealing caps, gum shapers, dental implant abutments and fixation screws in a variety of sizes to accommodate differing patient anatomy. Implantation is suitable for one- or two-stage procedures.
Endosseous implants are bone level, self-tapping, root-form, threaded. The threaded surface is aluminum oxide (Al2O3) blasted then passivated. These are offered in diameters from 3.5 to 5.5mm in diameter with lengths ranging from 8mm to 17mm. Sizematched anterior and posterior abutments are offered having post heights from 4.0 to 7.0mm. These are fastened to the implant using a fixation screw. Sealing caps and gum shapers provide protection to the abutment connection threads during endosseous and gingival healing.
The implants are provided sterile, the remaining components must be sterilized prior to use.
The Zuga™ Dental Implant System is a dental implant device, therefore no AI or algorithm performance data is available.
Here's the information about the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Study Type) | Standard/Criterion | Reported Device Performance |
|---|---|---|
| Mechanical Testing | ISO 14801 (Fatigue testing of dental implants) | Not explicitly stated in quantitative terms but implied to meet the standard. The submission states, "Pre-clinical testing of the Zuga™ Dental Implant System included: . Mechanical testing per ISO 14801." This typically means the device demonstrated acceptable fatigue strength and other mechanical properties as defined by the standard. |
| Cytotoxicity Testing | ISO 10993-5 (Biological evaluation of medical devices – Tests for in vitro cytotoxicity) | Not explicitly stated in quantitative terms but implied to meet the standard. The submission states, "Pre-clinical testing of the Zuga™ Dental Implant System included: Cytotoxicity testing per ISO 10993-5." This indicates the device materials were found to be non-cytotoxic under the tested conditions. |
| Surface Analysis | Not a specific standard, but techniques like FTIR & SEM-EDS were used. | Not explicitly stated in quantitative terms. The submission states, "Pre-clinical testing of the Zuga™ Dental Implant System included: Surface analysis by FTIR & SEM-EDS." This typically means the surface characteristics (e.g., elemental composition, surface topography, cleanliness) were analyzed and found to be consistent with the intended design and predicate devices. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated for each test. For mechanical testing (ISO 14801), multiple samples of each implant size/design would typically be tested. For cytotoxicity, a specified number of samples or extracts would be tested.
- Data Provenance: The data is "pre-clinical testing" and was conducted by Zuga Medical Inc. There is no information regarding the country of origin of the specific lab that performed the tests. This is not human data, so terms like "retrospective" or "prospective" are not applicable.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
- This information is not applicable as the studies are pre-clinical (laboratory and bench testing) and do not involve human expert assessment of outcomes or images. The "ground truth" for these tests are the established parameters and passing criteria defined by the ISO standards and accepted engineering principles.
4. Adjudication Method for the Test Set
- Not applicable. Adjudication methods (like 2+1, 3+1) are used for discrepant interpretations in human reader studies, which were not conducted here.
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
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is a dental implant system (hardware), not an AI-powered diagnostic or assistive tool. The submission explicitly states: "No clinical data was used in support of this submission."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No, a standalone algorithm performance study was not done. This device is a physical medical device, not an algorithm or AI system.
7. The type of ground truth used
- The ground truth for the pre-clinical tests (mechanical, cytotoxicity, surface analysis) is defined by the established international standards (ISO 14801, ISO 10993-5) and generally accepted engineering and material science principles. These standards set the benchmarks and criteria for acceptable performance and material safety.
8. The sample size for the training set
- Not applicable. There is no "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established
- Not applicable. There is no "training set" as this is not an AI/ML device.
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