(383 days)
Zygomatic Implants are indicated for surgical installation in the zygoma region, in cases of severe jaw resorption, in order to restore patient esthetics and chewing function. Zygomatic Implants are recommended for the posterior (pre-molar/ molar) region, one implant on each side, with at least two standard dental implants in the anterior region to support a fixed restoration. Zygomatic Implants may be loaded immediately when stability is achieved and with appropriate occlusal loading.
This submission includes threaded root-form dental implants designed for placement into the zygomatic bone with either an external hexagon abutment interface, or a Morse taper abutment interface. Both implant designs are provided with a thread major diameter of 4.4 mm at the coronal end of the implant (over a length of 10 mm), which tapers to a thread major diameter of 3.9 mm for the remaining implant length. Both implant designs are provided in multiple threaded lengths ranging from 30 mm to 52.5 mm. All implants are made of commercially pure titanium, Grade 4, conforming to ASTM F67, Standard Specification for Unalloyed Titanium for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700).
This submission includes transepithelial abutments with external hexagon or Morse taper interfaces for connection to the zygomatic implants. The external hexagon abutments have a platform diameter of 4.1 mm and are provided in gingival heights of 3, 4, or 5 mm. The Morse taper transepithelial abutments also have a platform diameter of 4.1 mm and are provided in gingival heights of 1.5, 2, 3, 4, or 5 mm.
This submission also includes a Protection Cylinder that is used to protect the abutment during healing of the gingival tissue. The Protection Cylinder may be installed on either abutment design (external hexagon or Morse taper) with the corresponding Protection Cylinder Screw.
All transepithelial abutments, external hexagon transepithelial abutment screws, protection cylinders, and protection cylinder screws are made of titanium alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401).
All zygomatic implants are packaged assembled with the corresponding implant mount and provided sterilized by gamma irradiation. All transepithelial abutments, external hexagon transepithelial abutment screws, protection cylinders, and protection cylinder screws are provided sterilized by exposure to ethylene oxide.
The provided text describes a submission for a Neodent Implant System to the FDA for 510(k) clearance, asserting its substantial equivalence to previously marketed predicate devices. This type of submission focuses on comparing a new device to existing ones rather than proving the device meets specific acceptance criteria through a clinical trial with a defined ground truth and expert adjudication.
Therefore, the document does not contain the information requested regarding acceptance criteria met by a study, sample sizes for test and training sets, data provenance, number or qualifications of experts, adjudication methods, MRMC studies, standalone performance, or how ground truth was established for the training set.
Instead, the document details:
- Non-clinical data: Biocompatibility, engineering analysis, dimensional analysis, and dynamic compression-bending testing according to ISO 14801. These are physical and material property tests to ensure the device meets certain strength and safety standards, but are not "acceptance criteria" in the sense of accuracy, sensitivity, or specificity for an AI/algorithm-based device.
- Clinical literature data: This is a review of existing data rather than a prospective study designed to meet specific performance criteria for the subject device.
Here's what can be extracted, acknowledging the limitations regarding "acceptance criteria" in the AI/algorithm sense:
1. A table of acceptance criteria and the reported device performance
The document does not specify "acceptance criteria" for performance in the typical sense of metrics like sensitivity, specificity, accuracy, etc., for a diagnostic or AI device. Instead, the "performance" demonstrated is a comparison to predicate devices, where the primary outcome considered is implant survival rates.
| Performance Metric | Reported Device Performance (Subject Device) | Reported Predicate Device Performance (K070182) |
|---|---|---|
| Zygomatic Implant Survival | 100% (after immediate loading at 12 months) | 100% (with delayed loading, 6-36 months follow-up) |
| Conventional Implant Survival | 100% (after immediate loading at 12 months) | 85.7% to 100% (6-36 months follow-up) |
2. Sample sizes used for the test set and the data provenance
- Subject device (test set, as per clinical literature):
- Sample Size: 16 subjects with a total of 37 zygomatic implants.
- Data Provenance: Clinical literature data (retrospective review of published studies). Country of origin is not specified.
- Predicate device (comparison in clinical literature):
- Sample Size: 45 subjects with a total of 90 zygomatic implants and 165 conventional dental implants.
- Data Provenance: Clinical literature data (retrospective review of published studies). Country of origin is not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This was a review of clinical literature data focusing on implant survival, not an expert-adjudicated test of an AI/algorithm's performance. The "ground truth" would implicitly be the observed clinical outcome (implant survival/failure) as reported in the literature, which is based on clinical assessment by treating physicians.
4. Adjudication method for the test set
Not applicable, as it's a review of clinical literature data, not an expert adjudication process for algorithmic output.
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 submission is for a physical medical device (dental implants), not an AI/algorithm where human reader performance would be a relevant metric.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/algorithm device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" implicitly used for the clinical literature data was outcomes data (implant survival/failure) as observed and reported in the clinical studies.
8. The sample size for the training set
Not applicable. This is not an AI/algorithm and therefore does not have a "training set."
9. How the ground truth for the training set was established
Not applicable. There is no training set for this device.
§ 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.