(340 days)
The SIMPLI Simpler Implant System is indicated for use in surgical and restorative applications for placement of implants in the mandible and maxilla to provide support for prosthetic devices such as artificial teeth to provide chewing function to a patient with missing teeth. It is indicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
The SIMPLI™ Simpler implant system is a threaded, endosseous dental implant designed to be one piece immediate load as well as delayed load to replace one, several or all missing teeth.
The provided text describes a 510(k) submission for the SIMPLI Simpler Dental Implant System. This submission is for a medical device that replaces missing teeth, not an AI/ML-powered device. Therefore, the questions related to AI/ML device performance, such as acceptance criteria based on accuracy, sample sizes for test and training sets, expert adjudication, MRMC studies, and standalone performance, are not applicable.
The submission focuses on demonstrating substantial equivalence to predicate devices based on design, materials, intended use, and existing safety records of the predicate.
Here's the information that can be extracted from the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Torque during insertion | Up to 100NCm of torque can be applied without damage to the implant. |
| Clinical Safety & Efficacy | Substantially equivalent to predicate devices, which have been sold globally for over 20 years without recalls, lawsuits, or non-compliance issues. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test set sample size: Not applicable for a typical AI/ML-based test set. The "testing" referred to is bench testing for torque and reliance on the safety record of predicate devices.
- Data provenance: Bench testing was performed on "prototypes" of the SIMPLI Simpler implants. The clinical safety and efficacy data rely on the predicate device, Simpler System, which has been sold worldwide.
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 as there is no mention of a "test set" in the context of expert-established ground truth for an AI/ML algorithm.
- Dr. Harold Bergman, who developed the device, states he has personally placed over 10,000 predicate device Simpler implants and found the system reliable and successful. This acts as an expert endorsement for the predicate device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. There is no mention of an adjudication method as this is not an AI/ML diagnostic or prognostic device study.
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 comparative effectiveness study was not done. This is a medical device for implantation, not an AI/ML diagnostic aid for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the bench testing, the "ground truth" was the physical integrity of the implant under torque.
- For clinical efficacy and safety, the "ground truth" relied on the established long-term market performance (20+ years, no recalls, lawsuits, or non-compliance issues) of the predicate devices.
8. The sample size for the training set
- Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/ML 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.