(206 days)
Z5m(t) implants are designed for surgical implantation into the upper and lower jaw for the attachment of prosthodontic appliances to replace missing teeth. The Z5m(t) implant system is also suitable for patients with metal allergies and the chronic diseases resulting from them.
Z5m(t) is a one-piece, root-form, threaded implant made from yttria-stabilized zirconia (Y-TZP). It has a tapered implant body, a double thread design in the coronal third of the implant and a self-tapping apex. The Z5m(t) endosseous surface is laser modified, identical to the Z5m surface cleared under K120793. Z5m(t) and Z5m utilize the same prosthetic components. Z5m(t) is designed for single or multiple tooth restorations and provided in two diameters (4.0, and 5.0 mm), each in three lengths (8. 10, and 12 mm). The Z5m(t) implant system is suitable for patients with metal allergies and the chronic diseases resulting from them.
This document is a 510(k) Pre-market Notification for a dental implant system called Z5m(t). It does not describe an AI medical device or a study proving that an AI device meets acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, AI performance, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, and standalone AI performance cannot be extracted from this document.
However, I can extract the general "performance data" that was submitted for this non-AI device:
Performance Data for Z5m(t) Dental Implant System (Non-AI device)
This device is not an AI/ML device, so much of the requested information (AI performance, sample sizes for test/training sets, expert qualifications for ground truth, adjudication methods, MRMC studies) is not applicable. The document describes performance data for the dental implant itself, focusing on physical and biological aspects, not a diagnostic or prognostic AI algorithm.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a physical medical device (dental implant) and not an AI algorithm, the "acceptance criteria" are related to product standards and validation rather than diagnostic performance metrics. Similarly, "reported device performance" refers to the validation results against these standards.
| Acceptance Criteria (Standard / Test) | Reported Device Performance / Compliance |
|---|---|
| Sterilization Validation (according to ISO 14937: Sterilization of health care products -- General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices) | Sterilization parameters have been validated to a Sterility Assurance Level (SAL) of 10-6. |
| Biocompatibility Evaluation (according to ISO 10993-1: Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process) | No new biocompatibility testing was performed. The materials and manufacturing methods are identical to those used for the predicate device, which was previously evaluated for biocompatibility. |
| Static and Dynamic Compression-Bending Testing (according to ISO 14801: Dentistry - Implants -Dynamic fatigue test for endosseous dental implants) | The subject device does not represent a new worst-case in mechanical testing compared to the predicate. (Implies it meets or exceeds the predicate's performance). |
| Software Validation (Implicit for any embedded software, though not detailed) | Software validation was conducted (details not provided). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not applicable in the context of typical AI/ML test sets. The tests mentioned (sterilization, biocompatibility, mechanical) involve specific numbers of device units or biological assays per standard, but are not usually referred to as "test sets" in the AI sense.
- Data Provenance: Not applicable in the context of this type of device submission. The data would be generated in laboratories according to international standards (ISO).
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. This is not an AI device that requires expert-established ground truth for diagnostic accuracy.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is not an AI device that requires expert adjudication for a ground truth dataset.
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 device, and no human reader comparative effectiveness studies are mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a physical dental implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. For this device, "ground truth" would be established by physical and biological measurements against regulatory and industry standards (e.g., a device is sterile if it meets the SAL, it is biocompatible if it passes ISO 10993 tests, it is mechanically sound if it passes ISO 14801 fatigue tests).
8. The sample size for the training set
Not applicable. This is a physical device, not an AI algorithm. No training set is used.
9. How the ground truth for the training set was established
Not applicable. This is a physical device, not an AI algorithm. No training set or ground truth for a training set is relevant.
§ 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.