(101 days)
The 24° Co-Axis implant is intended to be implanted in the upper or lower jaw arches to provide support for fixed or removable dental prostheses in a single tooth, partially edentulous prostheses, or full arch prostheses. It further adds the option for immediate placement and function on single and splinted multiple unit restorations when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. This implant is not intended, nor should it be used, in conjunction with an angled abutment.
The 24° Co-Axis implant is intended to be implanted in the upper or lower jaw arches to provide support for fixed or removable dental prostheses in a single tooth, partially edentulous prostheses, or full arch prostheses. It further adds the option for immediate placement and function on single and splinted multiple unit restorations when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. This implant is not intended, nor should it be used, in conjunction with an angled abutment. The physical properties and designs of the additional implants and accessories in the NSI Hexed and Non-Hexed Implant System were compared with legally marketed predicate devices. The technological characteristics were comparable.
The provided text is a 510(k) Premarket Notification Summary for a dental implant system. This type of submission is for medical devices and focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing extensive clinical trial data with specific acceptance criteria as you might see for a novel drug or a high-risk device.
Based on the document, here's an analysis of the requested information:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Material Compliance | The materials (ASTM F67-95 Grade III or Grade IV titanium) meet applicable voluntary standards. |
| Fatigue Resistance | Achieved a stable screw joint at the highest forces tested, as per ISO 14801:2003 (E) - (Dentistry - Fatigue test for endosseous dental implants). |
| Technological Characteristics | The physical properties and designs of the additional implants and accessories were comparable to legally marketed predicate devices. Any differences did not raise new issues of safety or effectiveness. |
| Intended Use | The 24° Co-Axis implant and associated components have the same intended use as legally marketed predicate devices. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document primarily discusses engineering studies (fatigue testing). It does not specify a "test set" in the context of human subjects or clinical data.
- Sample Size: Not specified for engineering studies, but typically these involve a defined number of devices tested to destruction or specific load cycles.
- Data Provenance: Not applicable in the context of clinical data for this submission. The engineering studies were conducted under ISO standards, implying a controlled laboratory environment.
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. This 510(k) submission did not involve clinical studies or expert-driven ground truth establishment in the way you'd expect for an AI diagnostic device. The evaluation relied on engineering testing and comparison to predicate devices, which is typically overseen by engineers and regulatory specialists.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. No clinical test set or expert adjudication process was performed for this 510(k) submission.
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, an MRMC comparative effectiveness study was not done. The document explicitly states: "Brief Discussion of Clinical Studies were not conducted, or deemed necessary, for the purpose of this 510(k) submission." This device is a physical implant, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
No, a standalone performance study was not done. This device is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The concept of "ground truth" as it relates to expert consensus or pathology is not applicable here. The primary "truth" established for this device was:
- Material properties: Measured against ASTM standards.
- Mechanical performance: Measured against ISO 14801:2003 (E) for fatigue, demonstrating physical stability.
- Technological characteristics and intended use: Established by comparison to existing legally marketed predicate devices.
8. The sample size for the training set
Not applicable. This submission is for a physical medical device (dental implant) and does not involve AI or machine learning models that require a training set.
9. How the ground truth for the training set was established
Not applicable. As above, no training set was used.
§ 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.