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510(k) Data Aggregation
(261 days)
The NaturaLLock implant system is an endosseous dental implant system made of titanium. NaturaLLock implants are indicated for the support and retention of fixed single tooth and fixed partial denture restorations in the molar, premolar, cuspid, and incisor regions of partially edentulous jaws. NaturaLLock implants may be loaded immediately in the anterior mandibular arch if four are splinted together with a bar. NaturaLLock implants may be immediately restored with a temporary prosthesis that is not in functional occlusion.
The NaturaLLock single-stage implant for immediate restoration combines the endosteal and prosthetic implant sections in one piece (integrated abutment). The anatomically shaped implant has a self-tapping thread.
The NaturaLLock implant system includes single-stage implants, dental tools, instruments, drills, drill guide sleeves and a surgical tray, which contains a complete set of instruments structured according to the logical sequences of surgery.
The system is colour coded as follows: red Ø 3.5 mm, yellow Ø 4.3 mm, blue Ø 5.0 mm, green Ø 6.0 mm. The instruments are laser marked with the following information: drills: Ø and length, implant driver: Ø
The provided document is a 510(k) Summary for the ZL Microdent NaturaLLock Implant System. It does not describe a study involving an AI/ML device, but rather a dental implant. Therefore, most of the requested information regarding AI/ML study details (such as sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, training set size, and ground truth for training set) is not applicable to this document.
However, I can extract the acceptance criteria and reported device performance from the "Substantial Equivalence Comparison Table" and the "Summary of the non-clinical testing data" as it relates to the dental implant itself.
Here's the information derived from the document, focusing on the device's substantial equivalence to predicate devices:
1. Table of acceptance criteria and the reported device performance
For a 510(k) submission, "acceptance criteria" for demonstrating substantial equivalence are typically aligned with showing that the new device is as safe and effective as, and performs as well as predicate devices, and does not raise new questions of safety or effectiveness. The "reported device performance" is a demonstration of how the new device meets or is comparable to these aspects of the predicate devices.
| Acceptance Criteria (Demonstrated by Equivalence to Predicate) | Reported Device Performance (ZL Microdent NaturaLLock Implant System) |
|---|---|
| Intended Use / Indications for Use: Similar functionality and indications as predicate devices. Ensure support and retention for fixed single tooth/partial denture restorations, immediate loading in specific cases, and immediate temporary restoration without functional occlusion. | The NaturaLLock implant system is an endosseous dental implant system made of titanium. NaturaLLock implants are indicated for the support and retention of fixed single tooth and fixed partial denture restorations in the molar, premolar, cuspid, and incisor regions of partially edentulous jaws. NaturaLLock implants may be loaded immediately in the anterior mandibular arch if four are splinted together with a bar. NaturaLLock implants may be immediately restored with a temporary prosthesis that is not in functional occlusion. (Result: s.e. - substantially equivalent) |
| Material: Composed of biocompatible material (e.g., titanium/titanium alloy) | ZL Microdent NaturaLLock implants are made of Titanium. (Result: s.e. - Identical to predicate device materials) |
| Target Population: Professional use by qualified dental implantologists, oral surgeons, or maxilla surgeons. | Professional use only - qualified dental implantologists, oral surgeons or maxilla surgeons only. Strictly reserved to specialised and trained users. (Result: s.e. - Identical to predicate device target population) |
| Where Used: Dental practices. | Dental practises. (Result: s.e. - Identical to predicate device usage environment) |
| Packaging: Appropriate for maintaining sterility and device integrity, with clear labeling. | The NaturaLLock implant packaging comprises a non-sterile storage packaging with instructions for use (paper), a secondary packaging as a germ barrier and implant holding unit (glass) and a sterile primary packaging (glass). The glass container is delivered with a sticker showing all relevant information. Furthermore the storage packaging includes a sandwich tag for transference to the patient file (LOT No.). (Result: s.e. - Similar to predicate device packaging) |
| Performance / Biocompatibility: Demonstrate biocompatibility according to ISO 10993 and comparable performance to predicate devices. | Testing according ISO 10993 Biological Evaluation of Medical Devices applying all relevant provisions for the devices. All relevant testing regarding biocompatibility was carried out by ZL Microdent-Attachment GmbH & Co. KG with a total compliance with the provisions of ISO 10993. The same material is used for the predicate devices manufactured and distributed by Nobel Biocare USA and Leader Italia, which received market clearance and are in commercial distribution. (Result: s.e. - Identical material and compliance with standards as predicate devices) |
| Sterilization: Sterile or sterilizable according to validated processes. | All implants are sold sterile. Drills, instruments and other invasive components are sold non sterile and need to be sterilized according to the manufacturers validated processing instructions. All components and instruments need to be sterilized prior to use. (Result: s.e. - Identical to predicate device sterilization approaches) |
| Sizes & Diameters: Available in a range of sizes and diameters comparable to predicate devices. | ZL Microdent NaturaLLock implants and its components are available in the following lengths and diameters: Ø 3.5 – lengths: 10, 13 & 16mm; Ø 4.3 – lengths: 8, 10, 13 & 16mm; Ø 5.0 – lengths: 8, 10, 13 & 16mm; Ø 6.0 – lengths: 8, 10, 13 & 16mm. (Result: s.e. - Comparable ranges to predicate devices) |
| Non-clinical Testing: Show safety and efficacy through relevant non-clinical tests (risk analysis, cleanliness, cytotoxicity, packaging, bench performance). | Results of risk analysis, case studies, cleanliness testing, biocompatibility, sterilization, cytotoxicity and packaging testing have demonstrated that ZL Microdent NaturaLLock implants are equivalent to the predicate device implants tested. When compared with predicate devices, results of bench performance testing indicated all acceptance criteria were met, and demonstrated the subject implants are equivalent. (Result: All acceptance criteria met, demonstrated equivalence and no new issues of safety/efficacy) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable: This document describes a dental implant, not an AI/ML device. The "testing" referred to is laboratory and bench testing of the physical implant, not a clinical study involving a "test set" of patient data for AI/ML performance evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable: As above, this is not an AI/ML device study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable: As above, this is not an AI/ML device study.
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 is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable: This is not an AI/ML device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not Applicable: For this physical device, "ground truth" in the AI/ML sense is not relevant. The "truth" is established by adherence to recognized standards (e.g., ISO 10993 for biocompatibility) and successful bench testing outcomes demonstrating properties like mechanical strength, sterility, and material composition, all compared to legally marketed predicate devices.
8. The sample size for the training set
- Not Applicable: This is not an AI/ML device.
9. How the ground truth for the training set was established
- Not Applicable: This is not an AI/ML device.
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