(319 days)
Southern Implants' External Hex Implants are intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment of crowns, bridges or overdentures utilizing delayed or immediate loading.
Southern Implants' External Hex Implants are intended for immediate function when good primary stability with appropriate occlusal loading is achieved.
The subject device consists of four product lines, External Hex Tapered Implants, External Hex Tapered Internal Drive Implants, External Hex Cylindrical Internal Drive Implants, and External Hex Co-Axis Tapered Implants. Internal drive implants are inserted with a removable tool as opposed to a fixture mount. All product line implants have an external hex implant/abutment connection and a grit-blasted surface. External Hex Tapered Implants and CoAxis Implants come in an MSC design with a machined coronal portion. One product line implant, Co-Axis Tapered, has an angled coronal portion.
Each product line includes corresponding abutments in multiple designs (Cover Screws, Healing Caps, Healing Abutments, Titanium Abutments, Anatomic Abutments, Cosmetic Abutments, Gold Abutments, Chrome Cobalt Abutments, Compact Conical Abutments, Passive Abutments) for cement-retained and screw-retained restorations. All retaining screws compatible with the subject device have been previously cleared in K053478. Retaining screws TSHZ3 and TSH1 were used for mechanical testing according to ISO 14801. Compact Conical Abutments and Chrome Cobalt Abutments are designed for multi-unit restorations. Compact Conical Abutment is available in straight, 17°, and 30° designs. Cosmetic abutments are available in 12° and 24°. All other abutments are straight (0°). Subject Device components are made of unalloyed titanium, titanium alloy, gold alloy, or cobalt-chromium alloy. Material standards for the subject device components are ASTM F67, ASTM F136, ASTM 1537, and ASTM F1562. Small diameter implants and angled abutments are not recommended for the posterior region
Here's a breakdown of the acceptance criteria and the study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Standard | Acceptance Criterion | Reported Device Performance |
|---|---|---|---|
| Sterilization | ISO 11137-1, 11137-2 (Radiation Sterilization) | Sterility Assurance Level (SAL) of 10-6 | Achieved SAL of 10-6 |
| ISO 17665-1, 17665-2 (Steam Sterilization) | Sterility Assurance Level (SAL) of 10-6 | Achieved SAL of 10-6 | |
| Shelf Life | ISO 11607-1, ISO 11607-2, ASTM F88, ASTM 1929, ASTM 1980 | Demonstrated appropriate shelf life | Met by testing |
| Bacterial Endotoxin | AAMI/ANSI ST 72 | Acceptable endotoxin limits | Demonstrated acceptable limits |
| Biocompatibility | ISO 10993-5 (Cytotoxicity) | Acceptable biocompatibility | Demonstrated acceptable biocompatibility |
| Mechanical Strength | ISO 14801 | Strong enough for intended use | Demonstrated sufficient strength |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the specific sample sizes used for each test set in the non-clinical studies. It mentions that "retaining screws TSHZ3 and TSH1 were used for mechanical testing according to ISO 14801," implying a specific set of components were tested.
The data provenance is from non-clinical bench testing. The manufacturer, Southern Implants (Pty) Ltd., is located in Irene, South Africa. The studies are non-clinical, so the terms "retrospective" or "prospective" as applied to clinical data are not directly applicable. These are laboratory-based tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The "ground truth" for non-clinical performance data like sterilization, shelf life, endotoxin, biocompatibility, and mechanical strength is established by compliance with international and national standards (e.g., ISO, ASTM, AAMI/ANSI) rather than expert consensus on a test set. Experts in specific fields (e.g., microbiology for sterilization, materials science for mechanical testing) would design and interpret these tests, but it's not a "ground truth" establishment in the way it would be for, say, an AI diagnostic device.
4. Adjudication Method for the Test Set
Not applicable. This is not a clinical study involving human assessment or interpretation for which adjudication would be relevant. The assessment is based on objective measurements against predefined criteria in engineering and laboratory tests.
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
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic or assistive devices where human readers or clinicians interact with the AI. The device in question, an endosseous dental implant, is a physical medical device, not an AI system.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This describes an AI algorithm's performance, which is not applicable to a physical dental implant.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance data in this submission is compliance with established international and national standards and objective laboratory measurements:
- Sterility: Achieved absence of viable microorganisms as defined by SAL of 10-6 according to ISO standards.
- Shelf Life: Maintenance of product integrity and function over time, validated by ASTM and ISO standards for packaging and stability.
- Bacterial Endotoxin: Levels below acceptable limits defined by AAMI/ANSI standards.
- Biocompatibility: Absence of toxic effects on cells as per ISO 10993-5.
- Mechanical Strength: Ability to withstand forces encountered in its intended use, as determined by ISO 14801.
8. The Sample Size for the Training Set
Not applicable. There is no "training set" as this is a physical medical device, not an AI algorithm that undergoes training.
9. How the Ground Truth for the Training Set was Established
Not applicable. As noted above, there is no training set for 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.