(239 days)
Z5-BL implants are designed for surgical implantation into the upper and lower jaw for the attachment of prosthodontic appliances to replace missing teeth. Z5-BL implants are suitable for patients with metal allergies and the chronic diseases resulting from them. Z5-BL implants are intended for delayed loading.
Z5-BL is a dental implant system that includes root-form, endosseous threaded dental implants indicated for bone level placement. The subject device includes dental implants provided in one body diameter of 3.6 mm in lengths of 8 mm, 10 mm. The subject device also includes a gingiva former, straight abutments for single-unit cemented restorations, and a 15° angled abutment also for single-unit cemented restorations.
The subject device is compatible with components cleared previously in K190243, including a healing cap, straight abutments for multi-unit cemented restorations, Locator-type abutments for retention of overdentures, and occlusal (abutment) screws.
The subject device dental implants are manufactured from Y-TZP zirconia conforming to ISO 13356. The subject device abutments are manufactured from Y-TZP zirconia conforming to ISO 13356, or from polyetheretherketone (PEEK).
The subject device implants are provided sterilized by plasma gas. All other components are to be sterilized by the end-user by moist heat (steam).
The provided text describes a 510(k) premarket notification for a dental implant system (Z5-BL). The submission aims to demonstrate substantial equivalence to previously cleared predicate devices. The information primarily focuses on non-clinical performance data and a comparison of technological characteristics, rather than reporting on a study demonstrating the device meets specific acceptance criteria in terms of clinical performance or human-AI effectiveness.
Therefore, many of the requested details, such as acceptance criteria for clinical performance, sample sizes for test and training sets, expert qualifications for ground truth, adjudication methods, multi-reader multi-case studies, and standalone algorithm performance, are not applicable or not present in the provided document.
Here's a breakdown of the available information based on your request:
1. A table of acceptance criteria and the reported device performance:
The document does not specify quantitative clinical acceptance criteria for the Z5-BL device. Instead, it relies on demonstrating substantial equivalence to predicate devices through non-clinical performance data and technological characteristics.
The "performance data" section lists the types of non-clinical tests performed and their respective standards. The implied acceptance criterion for these tests is conformance to the referenced international or national standards, which is then used to support the claim of substantial equivalence.
| Acceptance Criteria (Implied Non-Clinical) | Reported Device Performance (Summary) |
|---|---|
| Conformance to ISO 14937, ISO 17665-1 | Sterilization validated |
| Conformance to ISO 11607-1, ISO 11607-2, ASTM F1886/F1886M, ASTM D3078 | Sterile product shelf life tested |
| Conformance to USP 40-NF 35 (LAL test) | Bacterial endotoxin testing performed |
| Conformance to ISO 13356 | Biocompatibility of Y-TZP zirconia confirmed (referenced) |
| Conformance to ISO 10993-5, ISO 10993-12, ISO 10993-10, ISO 10993-11, ISO 10993-18, USP Class VI | Biocompatibility of PEEK material confirmed (referenced) |
| Conformance to ISO 14801 | Static compression and compression fatigue testing performed; fatigue limit data demonstrated sufficient strength |
| Conformance to ISO 18130 | Assessment of abutment screw loosening and removal torque testing performed |
| Examination by light microscopy and SEM/EDX | Assessment of wear particles from Ti-6A1-4V alloy abutment screw performed |
2. Sample size used for the test set and the data provenance:
- Not applicable. This submission did not include clinical data or a "test set" in the context of clinical performance evaluation or AI model validation. The performance data listed are non-clinical, mechanical, and material tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No clinical test set or ground truth established by experts is mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No clinical 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 describes a dental implant and does not involve AI or human reader improvement studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This document describes a dental implant and does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the non-clinical performance data, the "ground truth" is established by adherence to the respective international and national standards (e.g., ISO, ASTM, USP) for material properties, sterility, biocompatibility, and mechanical performance. These standards define the accepted methods and criteria for evaluating device properties.
8. The sample size for the training set:
- Not applicable. No training set for an AI model is mentioned.
9. How the ground truth for the training set was established:
- Not applicable. No training set for an AI model is mentioned.
In summary, this 510(k) submission for the Z5-BL dental implant relies on demonstrating substantial equivalence through comprehensive non-clinical testing according to established standards. It explicitly states, "No clinical data were included in this submission" (page 5). Therefore, the requested information pertaining to clinical studies, AI performance, ground truth, and expert evaluation for a test or training set is not present.
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.