(147 days)
MIS Dental Implant Systems are 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 masticatory function. When a one-stage surgical procedure is applied, the implant may be immediately loaded when good primary stability is achieved and the occlusal load is appropriate. Narrow implants (Ø3.3mm) are indicated for use in surgical and restorative applications for placement only in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws, to provide support for prosthetic devices such as artificial teeth, in order to restore the patient chewing function. Mandibular central and lateral incisors must be splinted if using two or more narrow implants adjacent to one another.
The MIS CONNECT Conical Connection abutment is an endosseous dental implant abutment device which is intended for use by a dental clinician with a root-form endosseous dental implant to aid in prosthetic rehabilitation, by incorporation in the upper or lower jaw for supporting tooth replacements to restore chewing function. The MIS CONNECT Conical Connection abutment is intended to be used with MIS Conical Connection Implants, such as MIS V3 Conical Connection Dental Implant System and Connection Implants cleared under K112162 and K163349, respectively, and is intended to be placed above the bone level and within the gingival tissue. The MIS CONNECT Conical Connection abutment can be fitted with a variety of complementary accessories, including Healing caps, Cementing caps and Temporary abutments (which are proposed for clearance in the present submission), and also including Prosthetic screws, Impression copings, Analogs, and Scan posts (which are class I products and are therefore exempt from clearance requirements). The MIS CONNECT Conical Connection abutment is not intended to be removed.
The provided text describes the 510(k) summary for the MIS CONNECT Conical Connection Abutment. This type of FDA submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel clinical effectiveness with extensive clinical trials. Therefore, the information typically requested in your prompt (e.g., sample sizes for test sets, number of experts for ground truth, MRMC studies, training set details) is generally not present in such a document.
However, based on the provided text, I can extract and infer some information regarding acceptance criteria and performance studies, specifically non-clinical ones.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Performance Metric | Reported Device Performance (MIS CONNECT Conical Connection Abutment) |
|---|---|
| Fatigue Testing (per ISO 14801:2007) | Withstood 5,000,000 cycles without failure at a substantially equivalent load to the cited reference device. |
| Screw Loosening Testing (per Tsuge et al, 2009) | Demonstrated a higher release torque post loading than its initial tightening torque before loading, indicating no screw-loosening hazard during lateral dynamic loading. |
| Biocompatibility (comparison to predicate K163349) | Not required; device manufactured using identical methods, facility, raw material, sterilization, packaging, and has the same intended use, patient contact duration, and type as the predicate. |
| Sterilization Validation (Gamma Irradiation for abutments, healing caps) (per ANSI/AAMI/ISO 11137-1 & -2) | Achieved a Sterility Assurance Level (SAL) of 10-6. All testing requirements were met. |
| Sterilization Validation (Steam for cementing caps, temporary abutments) (per ANSI/AAMI/ISO 17665-1:2006 & -2:2009) | Validated for two methods: gravity displacement steam sterilization and pre-vacuum steam sterilization. |
| Disinfection Validation (for user-steam-sterilized abutments) (per ANSI/AAMI/ISO 11737-1:2006 (R)2011, AAMI TIR 30:2011, AAMI TIR 12:2010) | Demonstrated a reduction of at least 10^3 of the microbiological challenge. This appears to be a typo in the original document, often 10^6 reduction is required but 10^3 is stated. Assuming the intent was a significant reduction. (Clarification: The PDF excerpt says "10º", which is likely a rendering error for "10^3" or similar, representing a log reduction.) |
| Shelf Life Testing (for sterile products) (per ISO 11607-1) | Test results were successful and supported a 5-year shelf life for sterilized products. |
2. Sample Sizes Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not specify the exact number of units used for each non-clinical test (e.g., how many abutments were subjected to fatigue testing). It refers to "test articles."
- Data Provenance: The studies are non-clinical, laboratory-based mechanical and sterilization tests, performed by MIS Implants Technologies Ltd. (Israel) and an "independent testing laboratory" for shelf life. No geographical or temporal patient data (retrospective/prospective) is involved, as these are not clinical studies.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- This information is not applicable. The studies described are non-clinical (mechanical, sterilization, biocompatibility rationale), not requiring expert consensus on clinical findings or "ground truth" as might be established for diagnostic AI.
4. Adjudication Method for the Test Set
- This information is not applicable for non-clinical performance testing. Adjudication methods like 2+1 or 3+1 are used in clinical studies, particularly for radiology or pathology assessments, to establish a definitive diagnosis based on multiple reader opinions.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- No, an MRMC comparative effectiveness study was not done. These types of studies are relevant for evaluating the impact of AI on human reader performance in diagnostic tasks. The submission describes non-clinical testing for a dental implant abutment and its superstructures.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- No, a standalone study was not done. This concept applies to AI/software as a medical device (SaMD). The device in question is a physical dental implant component, not an algorithm.
7. The Type of Ground Truth Used
- This information is not applicable in the context of this 510(k) submission for a physical medical device. "Ground truth" (e.g., pathology, outcomes data) is typically established in clinical studies or for diagnostic devices. For this device, "ground truth" in the context of the studies means adherence to established engineering standards (e.g., ISO 14801:2007 for fatigue, specific ISO and AAMI standards for sterilization).
8. The Sample Size for the Training Set
- This information is not applicable. There is no "training set" as this is not an artificial intelligence/machine learning device. The device is a manufactured medical component.
9. How the Ground Truth for the Training Set Was Established
- This information is not applicable as there is no training set or AI component.
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). 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.)