(374 days)
The Osstem Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-units restorations including; cemented retained, or overdenture restorations, and final or temporary abutment support for fixed bridgework. It is intended for delayed loading. Ultra wide Implant System is intended to be used in the molar region.
Products with diameter of less than 3.25mm should be used exclusively for the lateral incisor in the maxilla and a central or lateral incisor in the mandible.
The Osstem Implant System is a dental implant made of titanium metal intended to be surgically placed in the bone of the upper or lower jaw arches. The Ultra-Wide implants are intended to be used only to replace molar teeth and angled abutments are not to be used with the Ultra-Wide implants.
Osstem Implant System is similar to other commercially available products based on the intended use, technology used, claims, material composition employed and performance characteristics.
Here's an analysis of the provided text to extract information about acceptance criteria and the supporting study:
The document is a 510(k) summary for the Osstem Implant System, seeking substantial equivalence to predicate devices. As such, it focuses on demonstrating that the new device modifications (primarily additional dimensions and a non-hex connection for some implants) are as safe and effective as the previously cleared predicate devices. Therefore, the "acceptance criteria" discussed are primarily about meeting existing performance standards (like ISO 14801 for fatigue testing) and demonstrating consistency with the predicate devices in terms of materials, manufacturing, indications for use, etc.
Since this is a substantial equivalence submission for a dental implant system involving physical product variations rather than a novel AI/software device, many of the typical AI-specific criteria (like MRMC studies, effect size of AI assistance, standalone algorithm performance, number of experts for ground truth, adjudication methods, training set size/ground truth establishment) are generally not applicable or explicitly stated in the context of this traditional medical device submission.
1. A table of acceptance criteria and the reported device performance
For the specific modifications in the proposed device, the primary acceptance criterion for mechanical performance is successful fatigue testing according to ISO 14801:2016 for the worst-case scenario. Other performance criteria are met by leveraging tests performed on predicate devices, demonstrating equivalence in materials, manufacturing, and design principles.
| Acceptance Criteria (Study Performed) | Reported Device Performance |
|---|---|
| Fatigue Testing (ISO 14801:2016) for worst-case implant-abutment combination (specifically for TSIII SA Implant (Non-Hex)) | Test results demonstrate that the proposed devices perform as intended and support substantial equivalence to the predicate devices. (No specific numerical values are given in this summary.) |
| Gamma Sterilization Validation (ISO 11137-1,2,3) (leveraged from K121585) | Met the standards. No change to manufacturing or sterilization processes. |
| Shelf-Life Testing (ASTM F1980) (leveraged from K121585) | Met the standards. |
| Biocompatibility Testing (ISO 10993-1, -6, -10, -11) (leveraged from K121995) | Met the standards. Subject device is biocompatible and substantially equivalent due to same materials and manufacturing. |
| Bacterial Endotoxin Test (ISO 10993-11, USP) (leveraged from K161604) | Met the standards. |
| MR Compatibility Review (magnetic displacement force and torque evaluation per FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment") | Non-clinical worst-case MRI review performed using scientific rationale and published literature for the entire system and material composition. Rationale addressed parameters per FDA guidance. (No specific results stated beyond review was performed.) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Fatigue Testing (ISO 14801:2016): The document mentions "worst-case implant-abutment combination" was chosen. ISO 14801 typically specifies minimum sample sizes (e.g., 5 or 10 samples per test condition for static or dynamic testing). The exact number of samples tested for the new Non-Hex implants is not explicitly stated in this summary, nor is the provenance of the test data (e.g., conducted in-house, by a certified lab). However, such tests are generally conducted prospectively on newly manufactured devices or representative samples.
- Other tests (Sterilization, Shelf-Life, Biocompatibility, Bacterial Endotoxin): These were leveraged from predicate devices (K121585, K121995, K161604). The sample sizes and provenance for those original predicate device studies are not detailed in this submission.
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 for this type of device submission. This is a mechanical and material performance evaluation, not a diagnostic or interpretative device requiring clinical expert ground truth for a test set. Design requirements and performance standards (like ISO 14801) define the "ground truth" to be met.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable for this type of device submission. Adjudication methods are typically used in clinical or image-based studies to resolve discrepancies among experts.
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 dental implant system, not a diagnostic or AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a hardware medical device; there is no algorithm or AI component for standalone performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For mechanical performance (like fatigue testing), the "ground truth" is defined by international standards (ISO 14801:2016) and applicable FDA guidance documents. These standards specify test methods, failure criteria, and acceptable performance limits for dental implants.
- For material and biological compatibility, the "ground truth" is established by adherence to ISO 10993 standards for biocompatibility, ISO 11137 for sterilization, and ASTM F1980 for shelf-life. These are laboratory-based, objective performance measures.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device that requires a training set. The device design and materials are based on established engineering principles and prior predicate devices.
9. How the ground truth for the training set was established
- Not applicable.
§ 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.