(86 days)
Zsmlb: Z mlb implants are designed for surgical implantation into the edentulous upper and lower jaw for the attachment of dentures to replace missing teeth. Z5mlb implant system is also suitable for patients with metal allergies and the chronic diseases resulting from them.
Z
The purpose of this submission is to expand the Z-Look3 Evo SLM implant line (K 120793) to include two implant designs indicated for denture attachment. The Z5mlb and Z5mlc are onepiece, root-form, threaded implants made from yttria-stabilized zirconia (Y -TZP). Zsmlb and 25mlc implants are designed for full or partial denture restorations. Z5mlb implants are provided in two diameters (3.6 and 4.0 mm) and two endosseous lengths (8 and 10 mm). Zsmlc implants are provided in one diameter (4.0 mm) and one endosseous length (10 mm).
The provided text describes the Z5mlb and Z5mlc dental implants and their substantial equivalence to predicate devices. However, it does not contain any information about acceptance criteria or a study that proves the device meets specific performance metrics in terms of effectiveness or accuracy.
Therefore, I cannot provide the requested table or answer most of the questions because the necessary data is absent from the provided 510(k) summary. This document primarily focuses on establishing substantial equivalence based on intended use, design principles, and material similarities to already marketed devices, rather than presenting a performance study with acceptance criteria.
Here's what I can extract based on the limitations of the provided text:
1. A table of acceptance criteria and the reported device performance:
- Not available. The document does not specify any quantitative acceptance criteria for device performance (e.g., success rates, functional scores) and therefore does not report device performance against such criteria. The submission is a 510(k) for substantial equivalence, which relies on demonstrating similarity to predicate devices rather than proving performance against novel metrics.
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. No test set for performance evaluation is described in the provided document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No test set or ground truth establishment process for performance evaluation is described.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. No test set or adjudication method for performance evaluation is 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:
- 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:
- Not applicable. This device is a physical dental implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable. No test set or ground truth establishment process for performance evaluation is described. The "ground truth" for a physical implant's safety and efficacy is typically established through a combination of preclinical testing (mechanical, biocompatibility) and clinical data (which is not detailed in this 510(k) summary beyond the general claim of substantial equivalence).
8. The sample size for the training set:
- Not applicable. This device is a physical dental implant, not an AI model requiring a training set.
9. How the ground truth for the training set was established:
- Not applicable. This device is a physical dental implant, not an AI model requiring a training set.
Summary of available information:
The provided document is a 510(k) summary for dental implants (Z5mlb and Z5mlc). It asserts substantial equivalence to several predicate devices based on:
- Same intended use: Surgical implantation into the edentulous upper and lower jaw for the attachment of dentures to replace missing teeth. Also suitable for patients with metal allergies.
- Same operating principle: Implantation of a root-form, threaded implant.
- Same basic design: One-piece, root-form, threaded implants made from yttria-stabilized zirconia (Y-TZP).
- Same or very similar materials: Y-TZP.
- Similar packaging and sterilization processes.
- Similar physical dimensions: The subject device (Z5mlb: 3.6 & 4.0 mm diameter, 8 & 10 mm length; Z5mlc: 4.0 mm diameter, 10 mm length) falls within the range of predicate devices.
The 510(k) process primarily relies on demonstrating that a new device is as safe and effective as a legally marketed predicate device, rather than requiring extensive new clinical trials with defined acceptance criteria and performance studies. The "study" referenced in the prompt implicitly refers to the comparison done for substantial equivalence. The "proof" is the FDA's concurrence that the device is substantially equivalent, implying it meets safety and efficacy standards equivalent to the predicate devices.
§ 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.