(190 days)
The ITI Dental System implants are for single-stage or two-stage surgical procedures. The ITI Dental System implants are intended for immediate placement and function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients, 4 or more implants must be used in immediately loaded cases.
The Straumann solid screw dental implants are of various diameters and lengths with an anchorage surface that is grit blasted and acid etched. This surface has been modified for faster osseointegration and secondary stability. The dental implants are composed of Grade 4 titanium, cold worked. The neck of the implant is a smooth machined surface to allow for the attachment of epithelial tissue. Straumann implants are available in a range of endosseous diameters (3.3 to 4.8 mm) and lengths. No changes to overall implant design or dimensions were made.
The provided text is a 510(k) summary for the ITI Dental Implant System, specifically focusing on a modified surface (SLActive). The core of the submission is to demonstrate substantial equivalence to previously marketed ITI dental implants, primarily based on animal studies showing faster osseointegration and earlier secondary stability with the new surface.
However, the provided text does not contain any information about acceptance criteria, device performance metrics (like accuracy, sensitivity, specificity), sample sizes for test sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth details for either test or training sets.
The document details the device description, intended use, and the basis for substantial equivalence, which revolves around animal studies comparing the SLActive surface to the SLA surface in terms of osseointegration and secondary stability. It states:
- "Increased bone to implant contact and earlier secondary stability with the modified surface compared to the SLA surface was demonstrated at early healing periods of 2-4 weeks in animal studies."
This means the study that 'proves' the device meets criteria (faster osseointegration and earlier stability) is an animal study. The acceptance criteria are implicitly those metrics related to bone-to-implant contact and stability measured in the animal study.
Therefore, for your specific request, I can only provide what is explicitly mentioned in the text.
Here's a summary of the information you requested, based only on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit from claim) | Reported Device Performance (from animal studies) |
|---|---|
| Increased bone to implant contact | Increased bone to implant contact with SLActive surface compared to SLA surface at 2-4 weeks. |
| Earlier secondary stability | Earlier secondary stability with SLActive surface compared to SLA surface at 2-4 weeks. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified in the provided text.
- Data Provenance: Animal studies. The type of animal is not specified, nor is the country of origin. The studies are prospective in nature, comparing different implant surfaces.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Not specified. The ground truth would likely be established through histological analysis and biomechanical testing from the animal studies, performed by veterinary pathologists or researchers. The text does not elaborate on this.
4. Adjudication Method for the Test Set
- Not specified.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. An MRMC study is typically for evaluating diagnostic imaging devices where human readers interpret medical images. This submission is for a dental implant, and the evidence presented is from animal studies on osseointegration, not human interpretation.
6. Standalone (Algorithm Only) Performance Study
- No. This is not a software algorithm; it is a physical medical device (dental implant).
7. Type of Ground Truth Used
- Based on the description of "increased bone to implant contact and earlier secondary stability in animal studies," the ground truth likely involved:
- Histology: Directly measuring bone-to-implant contact (BIC) from tissue sections.
- Biomechanical testing: Measuring implant stability (e.g., resonance frequency analysis or push-out/torque removal tests).
- Outcomes Data: In an animal model context, the "outcome" is the measured biological response of bone healing and implant integration.
8. Sample Size for the Training Set
- Not applicable as this is an animal study for a physical device, not an AI algorithm requiring a training set in the conventional sense.
9. How the Ground Truth for the Training Set Was Established
- Not applicable.
In summary, the provided document focuses on demonstrating substantial equivalence based on pre-clinical (animal) studies of a physical device, not on clinical performance metrics or AI algorithm validation.
§ 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.