(330 days)
The Zygomatic implant is intended to be implanted in the upper jaw arch to provide support for fixed or removable dental prostheses in patients with fully or partially edentulous maxillae.
The Zygomatic implant is intended to be implanted in the upper jay arch to provide support for fixed or removable dental prostheses in patients with fully or partially edentulous maxillae.
The provided document details a 510(k) premarket notification for a Zygomatic Implant System, focusing on demonstrating substantial equivalence to predicate devices rather than proving new efficacy. Therefore, much of the information typically found in acceptance criteria for AI/ML devices or clinical trials (e.g., performance metrics like sensitivity/specificity, sample sizes for test/training sets, expert qualifications, MRMC studies) is not present in this medical device submission.
This document describes a traditional medical device (dental implant), not an AI/ML device. The "acceptance criteria" here relate to engineering performance and biocompatibility standards rather than diagnostic accuracy.
Here's a breakdown of the available information, noting the absence of AI/ML-specific criteria:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are primarily based on meeting established international standards for material, manufacturing, sterilization, packaging, and mechanical performance (fatigue). The 'reported device performance' is that the device meets these standards and is technologically comparable to predicate devices.
| Acceptance Criteria Category | Specific Standards / Criteria Met | Reported Device Performance |
|---|---|---|
| Material | ASTM F67-95 Grade IV Titanium (for screw-type implants and abutments) | Manufactured from ASTM F67-95 Grade IV Titanium. |
| Sterilization | Co60 irradiation, minimum dose of 25.0 kGy (2.5 m rads), creating a Sterility Assurance Level of 10^-6. Validation per AAMI, ISO 11137, ISO 11137-2, ISO 13409. | Sterilization is achieved using Co60 irradiation at a minimum dose of 25.0 kGy, meeting the specified SAL. Validation follows AAMI and ISO standards. |
| Packaging | Adherence to numerous standards including ASTM D 4169-08, ASTM F 88-00, ASTM F 1929-98, ASTM F 1980-07, EN 552, EN226, EN 868-1:1997, EN 868-5:1999, EN 868-9:2000, EN 868-10:2000, ISO 11607. These cover performance testing of shipping containers, seal strength, leak detection, accelerated aging, and general requirements for sterile medical device packaging. | Packagingvalidated following all specified standards. Implants are placed in plastic tubing, capped, and then heat-sealed in a blister pack (transparent film and Tyvek backing) which serves as the primary microbial barrier. A sterilization indicator sticker is applied, and the blister is enclosed in a plastic box for sterilization. The packaging method is consistent with their existing cleared dental implant lines. |
| Mechanical Performance | Adherence to FDA Class II Special Controls Guidance Document and ISO standard 14801: 2007(E) for fatigue testing. | Fatigue studies conducted as per specified guidance and standard, revealing a stable screw joint at the highest forces tested. (Detailed results are not provided in this summary but were enclosed in the full submission). |
| Technological Equivalence | Comparable physical properties and designs to legally marketed predicate devices (K970499 Branemark System Zygomatic Implant; K070182 Nobel Biocare Zygoma Implant). No new issues of safety or effectiveness from any differences. | The new implants and accessories have physical properties and designs comparable to predicate devices. A specific comparison table for the Southern 55° angle-corrected tapered implant vs. Nobel Biocare Zygomatic 45° Implant shows similar material (Titanium), exterior geometry (threaded), restorative platform width (4.05 vs 4.0 mm), and internal screw access width (2.0 mm). Differences in specific lengths, maximum diameter, apical end diameter, and screw access angle (55° vs 45°) are acknowledged but deemed not to raise new safety/effectiveness issues. |
| Surface Modification | Consistent with existing cleared implant lines. Blasting with 100 micron alumina particles, low pressure, visual inspection post-enhancement, and quarterly SEM testing. | Same surface modification method as existing cleared devices: 100-micron alumina blasting with low pressure. Visual inspection of every implant and quarterly SEM testing are performed. The S value (roughness) of 1.43 microns is a fraction of the particle size (110 microns), suggesting minimal embedment. |
2. Sample Sizes and Data Provenance
- Test Set Sample Size:
- For Fatigue Studies: "Fatigue studies were conducted... Testing revealed a stable screw joint at the highest forces tested." The exact number of devices tested is not specified in this summary.
- For SEM Testing: "a sample implant is sent for SEM testing four times a year." This implies a very small, ongoing sample, not a large test set for a single study.
- For Visual Inspection: "Each and every implant is visually inspected under a microscope after surface enhancement." This is 100% inspection during manufacturing, not a formal test set for a study.
- For Packaging Validation: The standards referenced (e.g., ASTM D 4169-08) outline specific testing protocols which would involve a sample of packaged products, but the sample size itself is not stated in this document.
- Data Provenance: All studies described (fatigue, surface modification checks, packaging validation) appear to be prospective tests conducted by Southern Implants, Inc. as part of their device development and manufacturing quality control. There is no indication of country of origin for the data beyond being generated by the submitter (Southern Implants, Inc., Irvine, CA, USA).
3. Number of Experts and Qualifications for Ground Truth
- This submission does not involve establishing ground truth from expert interpretation in the way an AI/ML diagnostic device would. There are no radiologists or other clinicians involved in creating a "ground truth" for diagnostic performance.
- The 'ground truth' here is essentially objective compliance with engineering standards and material specifications, verified through laboratory testing and manufacturing protocols by technical personnel.
4. Adjudication Method for the Test Set
- Not applicable. There is no expert adjudication process described, as this is a physical medical device proven through engineering tests and comparison to existing devices, not by diagnostic interpretation.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices (especially those involving human interpretation, often with AI assistance), which this implant is not.
- The study performed was a comparison of technological characteristics and engineering performance (e.g., fatigue) against established standards and predicate devices.
6. Standalone (Algorithm Only) Performance Study
- No, this is not applicable. This device is a physical dental implant, not an algorithm. Therefore, there is no "standalone algorithm" performance to report.
7. Type of Ground Truth Used
- The "ground truth" for this device's acceptance is based on:
- Objective Engineering Standards & Specifications: Compliance of materials (ASTM Grade IV Titanium), sterilization parameters (Co60 dose, SAL), packaging integrity (numerous ASTM, EN, ISO standards), and mechanical performance (ISO 14801: 2007(E) for fatigue).
- Manufacturing Quality Control: Visual inspection, SEM testing for surface modification.
- Benchmarking/Comparison: Demonstration of comparable technological characteristics to legally marketed predicate devices.
8. Sample Size for the Training Set
- Not applicable. This is not an AI/ML device that requires a training set. The "training" in a manufacturing context would relate to process validation and operator training, not data used to develop an algorithm.
9. How Ground Truth for the Training Set was Established
- Not applicable, as there is no training set for an 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.