(270 days)
OsteoReady® Dental Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. RidgeReady® 3.0 implants are intended to replace a lateral incisor in the maxilla and/or a central or lateral incisor in the mandible.
OsteoReady® Dental Implant System is consist of endosseous form dental implants, internal hex implants, tapered design; cover screws, healing caps and abutment systems;
Dental Implants:
Performance implants are available as follow: Diameters 3.85, 4.2, 5.0 and 6.0mm with lengths, 7 ( 7mm only to 5&6 dmm), 8, 10, 11.5, 13, & 15 (15mm not for 6.0 dm);
Performance Hybrid Implants are available as follow: Diameter 3.85mm with lengths of 10, 11.5, 13 and 15mm;
RidgeReady Implants are available as follow: Diameter 3.0mm with lengths of 8.0, 10, 12, and 14mm;
Dental Abutments:
Healing Caps, Temporary Abutment, Anatomic Angulated Abutment 15, Anti-Rotation Abutment Slim / Standard, Anatomic Abutment, Angulated Abutment 15, Anti-Rotation Abutment with Collar, Ball Attachments, PEEK Temporary Abutment, O-Ring Abutments, Direct Clip Abutments, attachments for ball.
The provided document is a 510(k) Premarket Notification summary for the OsteoReady® Dental Implant System. It primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a study to prove the device meets specific acceptance criteria for a novel AI/ML-driven medical device.
Therefore, many of the requested details regarding acceptance criteria, performance metrics, sample sizes for test/training sets, expert adjudication, MRMC studies, and ground truth establishment for AI/ML performance are not present in this document.
The document details the device's technical specifications, materials, and intended use, and then compares them to predicate devices to argue for substantial equivalence. The "performance" mentioned in the document refers to non-clinical bench testing (e.g., sterilization, shelf life, fatigue, biocompatibility) rather than clinical performance metrics typically associated with AI/ML device validation.
Here's an attempt to answer the questions based only on the provided text, highlighting what is not available:
1. A table of acceptance criteria and the reported device performance
The document does not define explicit quantitative acceptance criteria for clinical performance that would typically be seen for an AI/ML device, nor does it report clinical performance metrics. Instead, the "performance" discussed relates to non-clinical bench testing.
| Acceptance Criteria (Not explicitly stated for clinical performance, but implied for non-clinical) | Reported Device Performance (from non-clinical tests) |
|---|---|
| Sterilization (SAL of 10^-6 achieved per ISO 11137) | Test results demonstrated SAL of 10^-6 was achieved and all testing requirements met. |
| LAL/Endotoxin (Met criteria per USP 161 and USP 85) | Test results met the criteria. |
| Shelf Life (5 years per ASTM F-1980) | Test results demonstrated 5 years shelf life. |
| Packaging Validation (Safety during transportation per ASTM D4169) | Test results met the criteria. |
| Biocompatibility (Cytotoxicity, Irritation, Sensitization per ISO 10993-5, 10993-10) | All test results met the criteria. Manufacturing process did not change biocompatibility. |
| Fatigue (Mechanical connection strength per ISO 14801) | Results demonstrated high performance of implant/abutment mechanical connection. |
| Surface Cleanliness | Surface results met OsteoReady requirements. |
| Risk Assessment (No new safety/effectiveness issues per ISO 14971) | Demonstrated no new safety and/or effectiveness issues. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not provided as the submission focuses on substantial equivalence based on material properties, design, and non-clinical bench testing, not clinical studies with test sets of patient data for an AI/ML device.
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)
This information is not provided. Ground truth for an AI/ML device performance study would typically involve expert annotations or pathology reports, which are not relevant to this type of 510(k) submission for a dental implant system.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not provided as no clinical test set for performance evaluation of an AI/ML device was conducted or reported.
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
This information is not provided. This type of study is specifically relevant to AI/ML devices that assist human readers, which is not the nature of the OsteoReady® Dental Implant System.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not provided. This refers to AI/ML algorithm performance, which is not applicable to a physical dental implant system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" in this context is the conformity to established engineering and material standards through non-clinical testing (e.g., ISO, ASTM, USP standards). There is no "ground truth" derived from clinical patient data or expert consensus in the sense of an AI/ML device.
8. The sample size for the training set
This information is not provided. There is no "training set" in the context of this 510(k) submission for a physical medical device.
9. How the ground truth for the training set was established
This information is not provided as there is no training set mentioned or relevant to this type of 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.