(22 days)
The Cresco Ti® Implant Concept is intended a) for implantation into the fully edentulous ridge for the support of a dental prosthesis; b) for implantation into the partially edentulous ridge for support of a dental prosthesis; c) for single toolh implantation use.
The proposed system which is the subject of this Special 510(k) Notification, is a modification to the existing Cresco Ti implant concept, which has been previously cleared by the FDA under 510(k) Number K981052 on December 18, 2001. This exaced includes a single non-sterile package containing all components necessary for the laboratory work and the prosthetic work to produce bridge supports and related accessories which are compatible with non-Cresco Ti endosseous implants. Modifications have been made to apply the same concept as that used for the Cresco . Hourient system to other inplant interfaces other than those included on page 134 of the original 510(k) Notification K980152. Additional bridge supports are included in this 510(k) Notification which are designed to fit a broader range of implant interfaces. In addition, the Cresco concept can also be used for other metals or metal alloys in addition to Titanium (e.g. procious metal, Co-Cr),
The Cresco Ti® Implant Concept K042354 submission describes a modification to an existing dental implant system. The document focuses on demonstrating substantial equivalence to a predicate device (K981052) and does not contain detailed information on acceptance criteria for device performance as would be found in a clinical study report for an AI/ML medical device.
Therefore, many of your specific questions regarding acceptance criteria, sample sizes for test and training sets, ground truth establishment, expert qualifications, and MRMC studies, cannot be directly answered from the provided text. The document describes a traditional medical device modification, not an AI/ML system.
However, I can extract information related to the non-clinical and clinical tests mentioned, which serve as evidence for device performance.
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) for a device modification, the "acceptance criteria" are not reported as numerical performance metrics, but rather as showing that the modified device performs similarly to or better than the predicate, especially regarding mechanical integrity and compatibility.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Non-Clinical Testing (Mechanical/Fatigue) | In vitro testing performed to assess validity of the design and the interface with various implant types (external hex, internal hex, internal/external tapered cone). Detailed torque angle signature analysis confirmed validity and design. |
| Clinical Testing (Long-term Validity) | Clinical testing demonstrates long-term validity of the concept on Cresco platform and other platforms (Branemark, ITI systems). |
| Material Compatibility | The Cresco concept can also be used for other metals or metal alloys in addition to Titanium (e.g., precious metal, Co-Cr). |
| Compatibility with Other Implant Interfaces | Modifications allow compatibility of Cresco TI screws and bridge supports to additional designs of dental implants from manufacturers other than Cresco Ti Systems AB. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size: Not explicitly stated. The document refers to "in vitro testing" and "clinical testing" generally, without providing specific numbers of tests or subjects.
- Data Provenance: Not explicitly stated. The "Clinical Test Results" section vaguely mentions "long-term validity of the concept," but gives no details on the study's origin or type (retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Not applicable as this is not an AI/ML device or a study involving expert readers for ground truth establishment.
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 device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical dental implant system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For non-clinical tests, the "ground truth" would be established by engineering standards and measurement accuracy (e.g., successful retention during fatigue testing, specific torque values achieved).
- For clinical tests, the ground truth for "long-term validity" would likely be patient outcomes, such as implant survival rates, lack of complications, and successful integration, assessed over time, but no specifics are provided.
8. The sample size for the training set
- Not applicable. This is not an AI/ML 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.