(166 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) 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. Mandibular central and lateral incisors must be splinted if using two or more narrow implants adjacent to one another.
The proposed MIS LYNX Conical Connection Dental Implants are intended for one- or two-stage dental implant procedures and are used in the upper or lower jaw for supporting tooth replacement to restore chewing function. The proposed dental implants have an internal conical connection with an anti-rotation index of six positions for standard and wide platforms and four positions for narrow platform. The proposed implants and cover screw are manufactured from titanium alloy (Ti-6A1-4V ELI complying with standard ASTM F136-13 - Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant). The 3.3 mm diameter size implant is available in 10, 11.5, 13, and 16 mm lengths while the 3.75, 4.2, and 5.0 mm diameter size implants are available in 8, 10, 11.5, 13, and 16 mm lengths. The proposed implants feature an outer profile which has a coronal half which is cylindrical and an apical half which is conical. The threads are designed so the implant has a self-drilling property. The geometric design also includes spiral channels (flutes) stemming from the apex. These spiral channels are designed to enable insertion torque reduction when applying reverse torque. The proposed implant design also includes circumferential grooves at the coronal area which are called "micro-rings". These horizontal micro-rings are designed to increase the BIC (Bone to Implant Contact) of the implant with the bone. The proposed implants also feature a triangular neck ("V-Cut''). The gaps around the sides of the implant neck are designed to result in an open, compression free zone. The implant-abutment connection surface of the proposed MIS LYNX Conical Connection Implant is anodized for color coding to indicate the platform: yellow for narrow platform implants, purple for standard platform implants, and green for wide platform implants. The proposed implants are packaged in either a dry or wet package. Implants packaged in the wet packaging configuration are packaged in NaCl solution and are not anodized. The liquid environment is intended to maintain the super-hydrophilic (contact angle exhibited by water in contact with the surface is equal to zero degrees) property of the proposed dental implants until the implants are installed in the patients. Cover screws are intended to be used in a two-stage surgical procedure as temporary components to the proposed endosseous implant to allow healing of the soft tissue. They are inserted into the implant and the gums are sutured over it. Their purpose is to let the osseointegration begin without any forces being applied to the implant. After a healing period, the cover screw is exposed and removed, and replaced by either a healing cap or an abutment. The cover screws are also anodized for color coding.
The provided document is a 510(k) Summary for the MIS LYNX Conical Connection Implant System. It details the device, its intended use, and a comparison to predicate devices, focusing on demonstrating substantial equivalence through non-clinical testing.
However, the document does not describe a study that proves the device meets specific acceptance criteria based on clinical performance or an AI/algorithm-driven component. Instead, it focuses on non-clinical testing (fatigue, biocompatibility, sterilization, shelf-life, and MRI compatibility) to demonstrate the safety and effectiveness of the dental implant system itself, relative to predicate devices. There is no mention of an AI component, human-in-the-loop study, or any performance metrics like accuracy, sensitivity, or specificity that would be typical for an AI-driven medical device.
The section titled "8. Clinical Tests Summary and Conclusion" explicitly states: "Not applicable. There are no clinical tests submitted, referenced, or relied on in the 510(k) for a determination of substantial equivalence."
Therefore, based solely on the provided text, I cannot generate a response that fulfills the request for acceptance criteria and study details related to an AI/algorithm's performance because such information is not present in the document. The device in question is a dental implant system, not a software device that would typically have acceptance criteria focused on AI performance metrics.
To directly answer your prompt, given the provided text:
1. A table of acceptance criteria and the reported device performance:
Not applicable. The document describes non-clinical testing for a dental implant system, not performance metrics for an AI/algorithm. The "acceptance criteria" for the non-clinical tests are implied as meeting the standards (e.g., ISO 14801:2016 for fatigue, ISO 10993 series for biocompatibility) and demonstrating equivalence or superiority to predicate devices. For example, "Fatigue testing... confirms that the proposed device is similar or exceeds performance when compared to the predicate device (K172505) and reference (K112162) devices." And "Test results met acceptance criteria" for shelf-life testing. However, specific numerical acceptance criteria and reported performance values for each of these tests are not provided in a table format within this summary.
2. Sample sized used for the test set and the data provenance:
Not applicable for an AI test set. The document refers to samples used for non-clinical tests (e.g., implants for fatigue testing, materials for biocompatibility). Specific sample sizes are not detailed, but the tests are conducted on representative devices. Data provenance is implied as being from the manufacturer's internal testing as part of the 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This is not an AI/imaging device requiring expert ground truth for interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable.
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:
Not applicable. This is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device does not have an algorithm providing standalone performance.
7. The type of ground truth used:
Not applicable.
8. The sample size for the training set:
Not applicable. There is no mention of a training set as this is not an AI/machine learning device.
9. How the ground truth for the training set was established:
Not applicable.
§ 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.