(120 days)
The device is intended for surgical placement in maxillary and/ or mandibular arch to support crowns, bridges, overdentures in edentulous or partially edentulous patients. As with the predicate devices, the subject device is indicated for use in areas with available bone, including posterior regions with sufficient transverse bone and limited vertical bone height.
The ITI Wide Diameter Implant is a one-stage root-form design made of commercially pure titanium Grade 4 conforming to ASTM Standard Specification F67. It differs from the previously cleared 11 4.1 mm Solid Screw Implant (K894595, K920769) only in the diameter. The portion of the implant intended to be implanted into bone has an anchorage surface of a titanium plasma-sprayed coating 20 - 30 um thick. The neck of the implant, intended to remain above the crest of the bone upon implantation, is a smooth machined surface to allow for the attachment of epithelial tissue. It is 2.8 mm in height and tapers to 4.8 mm in diameter at the coronal end to permit all standard 171 The abutment mates with a tapered internal cone of the abutments to be used. implant; at its apex is a threaded region into which the matching thread of the The implant shoulder, which forms a mating surface for abutment is screwed. prosthetic components, is machined with a 45° chamter to maximize prosthesis The diameter at the coronal end, the internal taper, and thread for stability. attachment of the abutment and the 45° chamfer are identical to those of the 177 4.1 mm Solid Screw Implant.
For the junction between the primary part (the implant) and the secondary part (the abutment), a cone-screw construction is used, which helps ensure an accurate marginal tit within the implant, reducing risk of loosening or rotation of the abutment. All ITI abutments have a tapered cone-to-screw base which screws into the coronal portion of the implant and creates a mechanically locking triction fit (similar to Morse taper, a principle that has been used in machine shops for many years).
The external shape of the ITI Wide Diameter Implant consists of a solid body of 4.95 mm diameter with an external spiral screw having a major diameter of 5.6 mm. The principal teature of the thread form is the fact that the compressive (flank) songce of the thread is oriented at 75° to the implant axis, directing compressive forces into gre bone, rather than parallel to the implant axis. The thread pitch and thread form are identical to those of the ITI 4.1 mm Solid Screw Implant. The most apical 2 mm of the implant and the first 1.5 mm below the crest of the bone have no threads. The apex has a near-hemispherical shape. The implant is manufactured in sink depths (the depth intended to be implanted into bone, excluding the 2.8 mm neck) of 8 and 10 mm.
Accessories: The surgical technique intended for the implant includes initial use of the same IT 2.2 mm and 2.8 mm pilot drills as are used for other ITI solid screw implants, followed by The use of the standard ITI 3.5 mm twist drills of 4.2 mm and 5.0 mm and 5.0 mm diameter, included in this submission, are then used, followed by a thread tap. All IT twist drills and thread taps are made from martensitic stainless steel (DIN 1.4] 12, equivalent to AISI 440B) and include grooves to show the correct placement depth for each implant length. The depth gauge provided for use with the ITI Wide Diameter is made from austenitic stainless steel (DIN 1.4305, equivalent to AISI 303).
The provided document is a 510(k) Summary for the ITI Wide Diameter Implant. While it details the device's characteristics and compares it to predicate devices, it does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML device.
The study described is a nonclinical test comparing the strength of the ITI Wide Diameter Implant to a predicate device. This is a performance test for a medical device (an implant), not a study for an AI/ML device.
Therefore, I cannot provide the requested information for an AI/ML device based on this document.
However, I can extract information about the nonclinical test described:
1. Table of Acceptance Criteria and Reported Device Performance (Nonclinical Study)
| Performance Metric | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Failure Loads (45° loading) | Exceed those of 111 4.1 mm Solid Screw Implants | Consistently exceeded those of 171 4.1 mm Solid Screw Implants |
| Failure Loads (90° loading) | Exceed those of 111 4.1 mm Solid Screw Implants | Consistently exceeded those of 171 4.1 mm Solid Screw Implants |
| Bending Strength | Substantially stronger than 171 4.1 mm diameter implant | Substantially stronger in bending than the previously cleared 171 4.1 mm diameter solid screw implant |
Explanation of Implied Acceptance Criteria: The stated objective of the nonclinical test was to demonstrate the substantial equivalence of the new device by showing it performs at least as well as, and in this case, better than, a predicate device specifically in terms of strength and bending. The acceptance criteria are implicitly defined as "exceeding" or being "substantially stronger than" the predicate device's performance.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated. The text says "Implants were imbedded..." and "Force vs. deflection curves were recorded for each test." It does not specify the number of implants or tests performed.
- Data Provenance: Not specified, but given it's a nonclinical test performed by the applicant (Straumann USA), it's likely internal lab testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This was a physical strength test, not an AI/ML study requiring expert ground truth for image interpretation or diagnosis.
4. Adjudication method for the test set:
- Not applicable. This was a physical strength test.
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 was a physical strength test, not an AI/ML study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This was a physical strength test, not an AI/ML study.
7. The type of ground truth used:
- Ground Truth: Physical measurement of failure loads and observation of failure modes during mechanical testing.
8. The sample size for the training set:
- Not applicable. This was a nonclinical performance test, not an AI/ML study involving training data.
9. How the ground truth for the training set was established:
- Not applicable. This was a nonclinical performance test, not an AI/ML study involving training data.
§ 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.