3I STANDARD THREADED IMPLANT by IMPLANT INNOVATIONS, INC.

The 3i Implant System is designed for use in dental implant surgery. The 3i Implant System includes a variety of types and sizes of specially designed bone-implantable titanium and titanium alloy implants. These implants are surgically inserted into the upper and/or lower jawbones.

A successfully osseointegrated implant will achieve a firm and direct connection between the living bone and the surface of the titanium or titanium alloy implant when surgically implanted under controlled conditions, per well known clinical studies.

Device Description

3i's Endosseous screw type dental implants have historically been constructed of Commercially Pure (CP) Titanium, and are available in diameters between 3.25 and 6.00mm and lengths between 7.00 and 20.0mm.

This change covers all styles, sizes, and lengths of 3i's screw type implants and pertains to a new alloy, that will be used in the production of the implants; from previously recognized Commercially Pure (CP) Titanium, to a Titanium Alloy identified as Ti-13Nb-13Zr.

There is no change in the manufacturing or processing operations from those employed using the original material. The implants are machined, finished, cleaned packaged and sterilized. A placement instrument and cover screw (where specified), will be included with the implant.

AI/ML Overview

This document is a 510(k) submission from Implant Innovations (3i) for a material change to their threaded dental implants, specifically changing from Commercially Pure (CP) Titanium to a Titanium Alloy identified as Ti-13Nb-13Zr.

The document does not describe acceptance criteria or a study proving that a device meets those acceptance criteria in the context of performance metrics like sensitivity, specificity, or AI model effectiveness.

Instead, it is focused on demonstrating substantial equivalence of a material change for an existing medical device. The "performance" discussed relates to the material and manufacturing process, not to diagnostic accuracy or clinical outcomes in the way one might expect for a new diagnostic device or AI system.

Here's a breakdown of why the requested information cannot be provided from this document based on the prompt's context (AI/diagnostic device performance):

No Acceptance Criteria Table & Reported Device Performance (Metrics like sensitivity, specificity, etc.): The document does not define numerical performance targets for the device's clinical efficacy (e.g., how well it predicts an outcome or identifies a condition). The "performance standards" section explicitly states "Not applicable at this time." The document emphasizes material properties and safety.
No Sample Size for Test Set or Data Provenance: This document is not about testing an AI model or a diagnostic device on a clinical dataset.
No Number of Experts for Ground Truth or Qualifications: Ground truth, in the context of AI/diagnostic devices, refers to the definitive label for training or testing data. This concept isn't applicable here. The "ground truth" for the material change is its physical and biological properties.
No Adjudication Method: Not applicable for a material change submission.
No Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: This is for evaluating changes in human reader performance with AI assistance, which is not relevant to a material change for a dental implant.
No Standalone Performance Study: This document is about a material change, not a standalone diagnostic algorithm.
No Type of Ground Truth (Expert Consensus, Pathology, Outcomes Data, etc.): The "ground truth" for the material is its inherent physical and chemical properties and biocompatibility.
No Sample Size for Training Set & How Ground Truth for Training Set Was Established: This document concerns regulatory approval for a material change, not the development or training of a machine learning model.

What the document does provide regarding "performance" and "studies":

The document mentions:

"Extensive physical and biological testing of the Alloy Ti-13Nb-13Zr has been performed by the developer and is currently used in orthopedic implant applications." (Page 0, point 6)
The change in material "will not alter the previously obtained substantial equivalence determination" because there is "no change in the implant design..., and there are no other changes in manufacturing or processing." (Page 1, point 8)
"Validation of sterilization shall be accomplished as specified by AAMI (Association for the Advancement of Medical Instrumentation) Guidelines." (Page 1)

Summary of "Acceptance Criteria" implicitly present (related to material/manufacturing, not AI/diagnostic performance):

Acceptance Criteria (Implied for Material/Manufacturing)	Reported Device Performance (as stated in document)
Material Performance: Maintain equivalent physical and biological characteristics to CP Titanium.	"Extensive physical and biological testing of the Alloy Ti-13Nb-13Zr has been performed by the developer and is currently used in orthopedic implant applications."
Manufacturing Process: No change in manufacturing or processing operations.	"There is no change in the manufacturing or processing operations from those employed using the original material." (Page 0)
Sterilization: Achieve a Sterility Assurance Level (SAL) of 10^-6 via Co60 Irradiation.	"Sterilization shall be accomplished using Co60 Irradiation, at a dose providing for a Sterility Assurance Level (SAL) of ten to the minus six." (Page 1)
Sterilization Validation: Meet AAMI Guidelines.	"Validation of sterilization shall be accomplished as specified by AAMI (Association for the Advancement of Medical Instrumentation) Guidelines." (Page 1)
Labeling: Reflect new material, no other changes needed.	"The proposed process changes will not necessitate a revision to the device labeling or instruction sheets, other than catalog number and description, stating Ti-13Nb-13Zr instead of Commercially Pure Titanium." (Page 1)

Conclusion:

This document is a regulatory submission for a material change in a dental implant, focusing on demonstrating substantial equivalence. The prompt's questions are designed for evaluating AI-powered or diagnostic devices, which have very different "acceptance criteria" and "studies" compared to a material change in a pre-existing mechanical device. Therefore, most of the requested information cannot be extracted from this specific text.

Summary

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Image /page/0/Picture/0 description: The image shows a logo with a stylized letter 'i' as its main element. A triangular shape is positioned to the left of the 'i', partially obscuring it. The word 'INNOVATIONS' is written in bold, sans-serif font below a horizontal line at the bottom of the image.

West Palm Beach, FL 33407 1-800-443-8166 (407) 840-2600 FAX (407) 840-2660

APR - 1 1996

Exhibit 8

SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION TO SUPPORT A DETERMINATION OF SUBSTANTIAL EQUIVALENCE OF IMPLANT INNOVATIONS' Ti1313 THREADED IMPLANTS

510(k) SUBMISSION: MATERIAL CHANGE - TITANIUM ALLOY (Ti1313), FOR SCREW FORM ENDOSSEOUS DENTAL IMPLANTS.

1. CLASSIFICATION NAME: Endosseous Dental Implants
1. COMMON/USUAL NAMES: Standard Threaded Implants, Self-Tapping Threaded Implants, Miniplants (TM).
1. PROPRIETARY NAME: 3i Standard Threaded Implant. 3i Self-Tapping Threaded Implants and 3i Miniplant (TM) Implants. All included in the original Pre-Market Notification, titled "Innovative Implants and Cover Screws".
1. CLASSIFICATION: Endosseous dental implants, per 872.3640 have been classified as class III devices. PMA's may be required for some or all designs of endosseous dental implants in the future, but no effective date has been established for PMA submission.
1. PERFORMANCE STANDARDS: Not applicable at this time.
1. FORM: 3i's Endosseous screw type dental implants have historically been constructed of Commercially Pure (CP) Titanium, and are available in diameters between 3.25 and 6.00mm and lengths between 7.00 and 20.0mm.

Extensive physical and biological testing of the Alloy Ti-13Nb-13Zr has been performed by the developer and is currently used in orthopedic implant applications.

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screw (where specified), will be included with the implant.

Sterilization shall be accomplished using Co60 Irradiation, at a dose providing for a Sterility Assurance Level (SAL) of ten to the minus six.

Validation of sterilization shall be accomplished as specified by AAMI (Association for the Advancement of Medical Instrumentation) Guidelines.

Irradiation sterilization shall be accomplished by an FDA registered Irradiation sterilization facility.

1. LABEL/LABELING MATERIALS: The proposed process changes will not necessitate a revision to the device labeling or instruction sheets, other than catalog number and description, stating Ti-13Nb-13Zr instead of Commercially Pure Titanium. There are no promotional materials in development at this time.
1. SUBSTANTIAL EQUIVALENCE:

This material change will not alter the previously obtained substantial equivalence determination for the 3i threaded implants. This is based upon the fact that there has been no change in the implant design, other than the proposed change to Ti-13Nb-13Zr, and there are no other changes in manufacturing or processing. 3i İs making no claims relative to these changes at this time, and indications for use of the 3i threaded implant system have not changed and do not substantially differ from those offered by other dental device manufacturers.

1. INDICATION FOR USE:
  "The 3i Implant System is designed for use in dental implant surgery. The 3i Implant System includes a variety of types and sizes of specially designed bone-implantable titanium and titanium alloy implants. These implants are surgically inserted into the upper and/or lower jawbones.

10. CONTRAINDICATIONS:

3i implants should not be used in cases where the remaining jaw bone is too diminished to provide adequate width or height to surround the implant. Lack of osseointegration or subsequent implant failure may occur

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in cases where there is insufficient available bone , poor bone quality, poor oral hygiene, heavy smoking or tobacco abuse, or medical conditions such as blood disorders or uncontrolled diabetes.

1. WARNINGS:
  For safe and effective use of 3i implants, it is strongly suggested that specialized training be undertaken since the surgical techniques required to place dental implants are highly specialized and complex procedures. Improper patient selection and technique can cause implant failure and/or loss of supporting bone.
1. PRECAUTIONS:
  Thorough screening of prospective implant candidates must be performed. Visual inspection as well as panoramic and pariapical radiographs are essential to determine anatomical landmarks, occlusal conditions, pariodontal status, and adequacy of bone. Lateral cephalometric radiographs, CT Scans, and tomograms may also be beneficial.
1. ADVERSE EFFECTS:
  Loss of implant anchorage (failure to osseointegrate) and loss of the prosthesis are possible occurrences after surgery. Lack of quantity or quality of remaining bone, infections, poor patient oral hygiene or cooperation, and generalized diseases (diabetes, etc.) are some potential causes for loss of anchorage.
1. SURGICAL COMPLICATIONS:
  The implant procedure has risks, including localized swelling, dehiscence, tenderness of short duration, edema, hematoma, or bleeding.

Numbness of the lower lip and chin region following lower jaw surgery, and of the tissue beside the nose following upper jaw surgery, is a possible side effect of the surgery. Though it would most probably be of a temporary nature, in very rare cases, the numbness has been permanent.

Gingival/Mucosal (gum tissue) ulceration, tissue reaction, or infection may occur, but generally responds to local care.

1. PRE-MARKET NOTIFICATION CERTIFICATION AND SUMMARY FOR SUBMISSION:
  I certify that I have conducted a reasonable search of

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all information known or otherwise available to me about the types and causes of safety and/or effectiveness problems that have been reported for Endosseous Dental Implant systems.

Failure to osseointegrate or loss of osseointegration can be caused by improper patient selection (patients with systemic diseases which affect bone physiology, patients with habits such as bruxing or clenching, patients who are physically or psychologically unable to carry out proper implant hygiene, heavy smoking or alcohol use), by improper surgical technique (overheating of bone) or improper case planning or restorative technique (overloading of implants through improper placement, use of an insufficient number of implants or excessive cantilever). Improper implant processing by the manufacturer or improper handling by the customer, resulting in contamination, can also effect osseointegration.

Fracture of implants can occur, particularly in implants with apical cross-holes. Fracture occurs either on insertion of screw-type implants due to excessive torque (improper surgical technique such as an error in drill selection) or in service due to loss of bone.

Fracture of abutments and abutment screws occurs in implant systems and is usually attributed to factors within the control of the implant team, such as lack of passive fit of the restoration or excessive cantilever, or within the control of the patient, such as bruxing.

Other types of safety and efficacy problems which have been observed for endosseous dental implant systems are local soft tissue degeneration and bone resorption, paresthesia, perforation of the maxillary sinus, perforation of labial and lingual plates, local and systemic infection, prosthetic framework fracture, nerve injury, bone fracture, injury to adjacent teeth and their supporting bone, oroantral or oronasal fistula, gingival hyperplasia, soft tissue overgrowth, perforation of the gingiva by the healing screw, mucosal abscess, displacement of the implant into the mandibular canal, hemorrhage of the floor of the mouth due to transection of the sublingual artery and breakage of drill tip, requiring surgical removal.

Will

William G/ Conety Director, Requlatory Affairs/Quality Assurance

Regulation Number and Section

§ 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.