(83 days)
The ZENEX Implant System_Short is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including: cemented retained, screw retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading. ZENEX Implant System Short are intended to be used in the molar region.
ZENEX Implant System_Short is a thread type implant made of pure titanium according to ASTM F 67 and supplied sterile, which will be placed in the alveolar bone in order to support or maintain the prosthetic tooth or denture when a patient's teeth are partially or totally lost. The fixture's surface is treated with SLA (Sandblasted with Large-grit and Acid-etching). The entire length of 6.25mm of implant bodies are implanted into the bone to connect prosthetic devices of a dental implant set with the human body (mandibular or maxillary bone).
This is a premarket notification (510(k)) for the ZENEX Implant System Short, a dental implant device. The provided text describes the device, its intended use, and comparative information against predicate devices to demonstrate substantial equivalence. However, it does not contain acceptance criteria for device performance nor a study that directly proves it meets those criteria in the way you've outlined for an AI/software device.
Instead, the document focuses on demonstrating substantial equivalence to a legally marketed predicate device (TS Implant System, K121585) and leveraging testing from a reference predicate (Zenex Implant System, K211090) through a series of non-clinical bench tests and analyses. These tests are designed to show that the new device is as safe and effective as the predicate, not to report on clinical performance or AI algorithm metrics.
Therefore, many of the requested points in your template are not applicable or cannot be extracted from this document, as it's not a study evaluating an AI algorithm's performance against specific acceptance criteria with ground truth.
Here's an attempt to answer your questions based on the provided text, while also noting what information is not present given the nature of this 510(k) submission:
1. A table of acceptance criteria and the reported device performance
The document does not present a table of specific acceptance criteria for clinical performance metrics (like sensitivity, specificity, or F1 score) that would be relevant for an AI device, nor does it report device performance in that manner. Instead, the "performance" discussed relates to meeting engineering and biocompatibility standards to demonstrate substantial equivalence to a predicate device.
The "acceptance criteria" are implicitly meeting the standards of the referenced ISO and ASTM guidelines for non-clinical testing. The "reported device performance" is that the device met these standards and demonstrated substantial equivalence.
| Acceptance Criteria (Implicit from referenced standards) | Reported Device Performance |
|---|---|
| Fatigue Testing (ISO 14801:2016) | Results showed that subject devices are substantially equivalent under worst-case scenario. |
| Biocompatibility (ISO 10993-1:2009) | Subject device is biocompatible and substantially equivalent with the predicate. |
| Sterilization (ISO 11137-1, 11137-2, 11137-3) | Sterility Assurance Level (SAL) of 10-6 validated. |
| Shelf Life (ASTM F1980) | Results demonstrated equivalence to the predicate devices. Shelf life: 5 years. |
| Bacterial Endotoxin (ANSI/AAMI ST72:2011, USP , ) | (Not explicitly stated "met," but implied by leveraging predicate data for equivalence.) |
| Surface Area Analysis (Comparative) | Results showed that subject devices are substantially equivalent. |
| MR Environment Condition (Scientific rationale & literature review) | Rationale addressed parameters; implied safety in MR environment. |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: Not applicable in the context of an AI study. The "test set" here refers to the physical samples of the device used in bench testing. The specific number of physical implants or components tested for each non-clinical test (e.g., fatigue, shelf-life) is not detailed, beyond stating "worst-case scenario" constructs were tested.
- Data Provenance: Not applicable for an AI study. The testing is non-clinical/bench testing performed on physical devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a physical dental implant, not an AI algorithm requiring expert ground truth for image interpretation or diagnosis.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is a physical dental implant, not an AI algorithm study requiring adjudication of expert opinions.
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 a physical dental implant, not an AI algorithm. The text mentions "MR Environment Condition" but this refers to Magnetic Resonance (MR) safety, not Multi-Reader Multi-Case (MRMC) studies.
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 AI 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 measurements, material properties, and biological responses according to established standards (e.g., ISO, ASTM, biocompatibility guidelines), rather than expert consensus on diagnostic images or pathology.
8. The sample size for the training set
Not applicable. This is a physical dental implant, not an AI algorithm that undergoes training.
9. How the ground truth for the training set was established
Not applicable. This is a physical dental implant, not an AI algorithm.
§ 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.