(84 days)
The Simpler Mini Implants (ID SM3002-4) and the Simpler HA Mini Implants (ID SM5002-4) are intended to provide long term intra-bony applications. They are designed for immediate loading when there is good primary stability and an appropriate occlusal load. They may also be used for temporary support for partial and fully edentulous restoration in the mandible and maxilla. They may be used for full or partial edentulism and are used as an option to provide a minimally invasive surgical intervention.
The HA coated Simpler Mini Implants (K 083886) are identical to the Simpler Mini Implants (K073645) except for the addition of the HA coating to the threaded area of the implants. Natural dentition is composed of a subgingival root and a supragingival crown. For both coated and uncoated mini implant designs tend to minic this structure and transitional implants are no exception. The implant base and the abutment are all in one piece. They are 2.5mm in diameter with a choice of 10, 13 or 15 mm in length for both the Simpler HA mini implants.
For partial and complete edentulism, a retaining a rubber ring acts like a socket to receive the ball on the top of the implant. A soft liner is placed into the patient's denture to adapt around the ball portion of the implant to provide retention to the denture. When seated, the denture rests on the gum tissue.
Based on the provided text, the document is a 510(k) summary for the Simpler Mini Implant and Simpler HA Mini Implant, indicating no specific acceptance criteria or a study proving that the device meets such criteria.
The primary purpose of this 510(k) submission is to demonstrate substantial equivalence to already legally marketed devices, not to prove specific performance metrics against pre-defined acceptance criteria through a dedicated study.
However, I can extract information related to the device and its intended use, as well as the regulatory decision based on substantial equivalence.
Here's an analysis of the provided text in relation to your request, with "N/A" where the information is not present:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (e.g., Performance Threshold) | Reported Device Performance |
|---|---|
| N/A (No explicit acceptance criteria stated) | N/A |
Explanation: The document does not define specific performance metrics or acceptance criteria that the device had to meet (e.g., success rates, torque values, bone-to-implant contact percentages, etc.) nor does it present data from a study directly measuring these against such criteria. The 510(k) process for this device focused on demonstrating substantial equivalence to predicate devices, implying similar performance and safety through comparison rather than independent proof against novel performance standards.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: N/A (No specific test set or clinical study data presented)
- Data Provenance: N/A (No specific clinical study data presented. The submission relies on comparison to predicate devices and general knowledge of dental implants, not on a new study's data.)
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- N/A (No specific test set or ground truth establishment process is described.)
4. Adjudication Method for the Test Set
- N/A (No specific test set or adjudication method described.)
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done
- Was it done? No. The document does not mention any MRMC comparative effectiveness study, or any clinical study of human readers with or without AI assistance. This device is a physical dental implant, not an AI-assisted diagnostic tool.
- Effect size of human readers with AI vs. without AI assistance: N/A (Not applicable to a physical dental implant.)
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was Done
- N/A (Not applicable. This device is a physical dental implant, not an algorithm.)
7. The Type of Ground Truth Used
- N/A (No specific ground truth (expert consensus, pathology, outcomes data) is mentioned as being established for the purpose of validating this device in a study.)
8. The Sample Size for the Training Set
- N/A (No "training set" is mentioned as this is not an AI/algorithm device.)
9. How the Ground Truth for the Training Set was Established
- N/A (Not applicable, as there is no training set for this type of device.)
Summary of what the document does provide:
- Device Description: The Simpler HA Mini Implants (K 083886) are identical to the Simpler Mini Implants (K073645) except for the addition of an HA coating. They are 2.5mm in diameter with lengths of 10, 13, or 15 mm. They are designed for retention of dentures in partial and complete edentulism.
- Indications for Use: Long-term intra-bony applications, immediate loading (with good primary stability and appropriate occlusal load), and temporary support for partial and fully edentulous restorations in the mandible and maxilla. They are presented as a minimally invasive surgical intervention option.
- Predicate Devices: K073645 (Simpler Mini Implants), K974856 (Simpler Threaded Implants), K031106 (Imtec Sendax MDI and MDI Plus), Mini Drive-Lock TM Dental Implants ITI Dental Implants K894593 K894595, IMTEC Sendax MDIs K031106, Nobel Biocare Branemark Implants.
- Regulatory Decision: The FDA determined the device to be substantially equivalent to legally marketed predicate devices, allowing its market entry under general controls (Class II, product code DZE). The basis for this decision is primarily the similarity in design, materials, and intended use to existing devices, and the addition of HA coating is considered equivalent to the non-HA coated version already cleared. The letter corrects an earlier substantial equivalence letter, indicating a review process.
§ 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.