(7 days)
The Thommen SPI® ELEMENT Dental Implant is intended to be surgically placed, either immediately after extraction or following healing, in the bone of the maxillary and/or mandibular arch to provide support for crowns, bridges or overdentures. SPI® Dental Implants can be loaded immediately if they are splinted with a bar on four implants in the mandibular arch or six implants in the maxillary arch.
The Thommen SPI® ELEMENT Platform Ø 4.0 mm is a root form endosseous dental implant made of commercially pure grade 4 titanium. The implant surface is smooth machined on the transgingival portion and sandblasted and acid-etched in the area designed to contact bone.
This K070007 510(k) submission for the Thommen SPI® ELEMENT Platform Ø 4.0 mm dental implant does not contain specific acceptance criteria, a detailed study report proving the device meets those criteria, or information on AI/ML-based performance.
The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device for device modification (addition of a new platform diameter). It primarily addresses administrative information, device description, intended use, conformance to standards (material properties only), packaging, and equivalence to a marketed product.
Therefore, I cannot populate the table or answer the specific questions related to acceptance criteria, AI/ML performance, study design, and ground truth establishment as they are not present in the provided text.
Here's an explanation of why the requested information is not available in the given document:
- Acceptance Criteria & Device Performance: This document does not present quantitative performance metrics or acceptance criteria for the device itself (e.g., success rates, torque values, osseointegration rates). The "conformance with performance standards" section only mentions compliance with material standards (ASTM F 67 and ISO 5832-2) for the pure titanium, not a clinical or mechanical performance study.
- Study Details (Sample Size, Data Provenance, Experts, Adjudication): No study is described that would provide this information. The submission relies on demonstrating similarity to a predicate device rather than presenting new clinical or in-vitro study data with defined endpoints.
- MRMC, Standalone Performance, AI/ML: The device is a physical dental implant. There is no mention or implication of any AI/ML components, software, or human interpretation studies in this 510(k) summary.
- Ground Truth Type: Since no performance study is detailed, there's no mention of how ground truth would be established.
- Training Set Sample Size & Ground Truth: These concepts are relevant to AI/ML models, which are not part of this device submission.
In summary, the provided document is a regulatory submission focused on substantial equivalence for a physical dental implant modification, not a performance study report for an AI/ML-enabled device.
§ 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.