(132 days)
MIS dental implant system 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 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 & UNO) 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 C1 NP Conical Connection dental implants are manufactured from Ti-6AI-4V ELI. The conical root-shaped, screw-type implants are designed for both two-stage and single stage procedures, with one internal thread for screwed abutment. The implants are self-tapping, root-form with tapered threads. They have a 3.3 mm diameter and the following lengths: 10mm, 11.5mm, 13mm and 16mm. The internal part of the implant and the lower part of the abutment are anodized for coloring purposes for a quick identification of the diameter and to ensure the adequate abutments. The Implants are supplied sterile.
This submission also includes wide platform (WP) conical connection abutments which are compatible to the previously cleared (K112162) MIS conical connection wide platform implants.
Components:
The MIS C1 Conical Connection Dental Implant is to be used in combination with a variety of conical connection abutments (cover screws, healing caps, cement-retained abutments, gold abutments, OT-equators & ball attachments, multi unit abutments, and temporary Ti and PEEK abutments). These abutments are manufactured with a conical connection, ensuring compatibility to the conical connection implants. The abutments in this submission include NP abutments, compatible with the C1 NP implants also submitted here; and WP abutments compatible with previously cleared (K112162) MIS conical connection WP implants.
The acceptance criteria described in this document are for the MIS C1 Narrow Platform Conical Connection Implant System and MIS C1 Wide Platform Conical Connection Abutments.
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
The document describes several non-clinical performance tests conducted to demonstrate substantial equivalence. The "acceptance criteria" are implied by successful completion of these tests in accordance with relevant ISO standards.
| Acceptance Criteria (Implied by standard) | Reported Device Performance (as stated in the document) |
|---|---|
| Biocompatibility: Device materials and manufacturing processes are safe for biological use. (Implied: equivalent to predicate with established biocompatibility) | "The subject device is manufactured using identical manufacturing methods... and using the same raw material as the previously cleared predicate, K163349. The subject device is sterilized and packaged using identical materials and processing as the predicate. Finally, the subject device has the same intended use, patient contact duration and type as the predicate. For these reasons, biocompatibility testing was not required to support the substantial equivalence of the subject device." |
| Fatigue Testing (Implants): Withstand 5,000,000 cycles without failure at a load equivalent to predicate devices per ISO 14801:2007. | "The test articles were able to withstand 5,000,000 cycles without failure at a substantially equivalent load to the cited predicates." |
| Fatigue Testing (Abutments): Withstand fatigue limits (specific criteria not detailed, but 'met success criteria'). | "The subject worst case abutment was tested for fatigue limits and met the pre-determined success criteria." |
| Sterilization (Gamma Irradiation): A Sterility Assurance Level (SAL) of 10⁻⁶ achieved, all testing requirements met per ANSI/AAMI/ISO 11137-1 and 11137-2. | "Test results have demonstrated that the SAL of 10-6 was achieved and all testing requirements were met." |
| Sterilization (Steam - User): Steam sterilization parameters validated per ANSI/AAMI/ISO 17665-1:2006 and ANSI/AAMI/ISO 17665-2:2009. | "The steam sterilization parameters were validated according to ANSI/AAMI/ISO 17665-1:2006 and ANSI/AAMI/ISO 17665-2:2009 for two methods: gravity displacement steam sterilization and pre vacuum steam sterilization." |
| Endotoxin Limit: Within acceptance criteria per USP 85, USP 161, and ANSI/AAMI/ ST72 for sterile products. | "For products supplied sterile, a LAL test is conducted periodically to verify the endotoxin limit is within acceptance criteria according to USP 85, USP 161 and ANSI/AAMI/ ST72." |
| Disinfection Validation: Reduction of at least 10⁶ of microbiological challenge per ANSI/AAMI/ISO 11737-1:2006 (R)2011, AAMI TIR 30:2011, and AAMI TIR 12:2010 for non-sterile abutments. | "demonstrating a reduction of at least 106 of the microbiological challenge." |
| Shelf Life Testing: Package integrity demonstrated for the specified shelf life per ISO 11607-1. | "Test results were successful and supported a 5 year shelf life of the sterilized products." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact numerical sample size for the fatigue testing or sterilization validation. It refers to "the worst case narrow platform implant and abutment" for fatigue testing. For sterilization, it mentions "each group of products" and "abutments supplied non-sterile".
- Data Provenance: The studies are non-clinical (laboratory testing). The document heavily references ISO and AAMI standards. The manufacturer is "MIS Implants Technologies Ltd." based in "Bar Lev Industrial Park, ISRAEL". This suggests the testing was likely conducted in Israel or by contract labs following international standards. The document does not mention retrospective or prospective data as it pertains to clinical studies, which were not performed.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This section is not applicable as the ground truth for these tests is established by physical measurements and compliance with engineering and sterilization standards, not expert clinical consensus.
4. Adjudication Method
This section is not applicable as the "ground truth" (i.e., test results meeting predefined acceptance criteria) is determined by objective physical and biological testing, not by expert adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission explicitly states: "There was no human clinical testing required to support the medical device as the indications for use is equivalent to the predicate device."
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No, a standalone "algorithm only" study was not done. This device is a physical medical implant, not an AI or software-as-a-medical-device (SaMD) product. Performance is determined by non-clinical engineering and biological testing.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical tests described is based on:
- Engineering Standards: For mechanical fatigue, compliance with ISO 14801:2007.
- Sterilization and Biocompatibility Standards: For sterilization (ANSI/AAMI/ISO 11137-1, 11137-2, 17665-1, 17665-2), endotoxin testing (USP 85, USP 161, ANSI/AAMI/ ST72), disinfection (ANSI/AAMI/ISO 11737-1:2006 (R)2011, AAMI TIR 30:2011, AAMI TIR 12:2010), and biocompatibility (implied equivalence to previously cleared predicate).
- Shelf Life Standards: For package integrity, compliance with ISO 11607-1.
These are objective, measurable criteria established by recognized national and international standards.
8. The Sample Size for the Training Set
This section is not applicable. The device is a physical dental implant system and does not involve machine learning or AI, thus there is no "training set."
9. How the Ground Truth for the Training Set Was Established
This section is not applicable for the same reasons as above.
§ 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.