(224 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.
Euroteknika's range of implants refer to sets of root form endosseous dental implants made of pure titanium (grade iv) and titanium alloy (TA6V) and components for surgical placement in maxillary and/or mandibular arch to support crowns, bridges, overdentures in endentulous or partially edentulous patients.
Here's an analysis of the provided text regarding the dental implants' acceptance criteria and study, structured as requested:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text for K083670 is a 510(k) summary for dental implants. 510(k) submissions primarily focus on demonstrating substantial equivalence to predicate devices, rather than establishing specific performance acceptance criteria for novel device functions like an AI algorithm. Therefore, explicit, quantitative acceptance criteria and corresponding performance metrics are not present in the provided document.
Instead, the "performance" demonstrated is that the Euroteknika dental implants (AESTHETICA, UNIVERSAL, NATURA, NATEA) were found to be substantially equivalent to their listed predicate devices. This equivalence is based on:
- Identical Intended Use: All devices share the same intended use: "surgical placement in maxillary and/or mandibular arch to support crowns, bridges, overdentures in edentulous or partially edentulous patients."
- Similar Design and Material: The devices are described as "sets of root form endosseous dental implants made of pure titanium (grade iv) and titanium alloy (TA6V) and components for surgical placement." This description aligns with the common materials and forms for dental implants, implicitly similar to the predicate devices.
- Laboratory Testing: The document states, "Laboratory testing was conducted to determine device functionality and conformance to design requirements." While the specific tests and their passing criteria are not detailed, the conclusion drawn is that the devices are "Substantially equivalent to the cited predicate devices."
Therefore, the "acceptance criteria" is implicitly that the new devices perform comparably to predicate devices in terms of safety and effectiveness for their intended use, as demonstrated through laboratory testing.
| Acceptance Criteria (Implicit from 510(k) process) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Devices | Achieved; "Substantially equivalent to the cited predicate devices" |
| Conformance to Design Requirements (via lab tests) | Achieved; "Laboratory testing was conducted to determine device functionality and conformance to design requirements." |
| Identical Intended Use | Achieved; Intended Use for all devices is identical to predicate device's presumed use. |
| Similar Materials and Design | Achieved; Made of pure titanium (grade iv) and titanium alloy (TA6V). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a "test set" in the context of an AI algorithm or a clinical study with a specific patient sample size. The testing mentioned is "Laboratory testing" for functionality and conformance. Therefore, there is no information provided regarding a sample size for a test set, data provenance (country of origin, retrospective/prospective), or any human subject data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Since this is not an AI or diagnostic device requiring human interpretation for a "ground truth" test set, there is no information provided regarding the number or qualifications of experts for establishing ground truth.
4. Adjudication Method for the Test Set
As there is no "test set" or human subject data requiring adjudication, there is no information provided regarding an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study was conducted or reported. This submission is for a medical device (dental implant), not a diagnostic or AI-driven imaging device that would typically involve an MRMC study. Therefore, no effect size for human reader improvement with AI assistance is applicable or provided.
6. Standalone (Algorithm Only) Performance Study
This device is a physical dental implant, not an algorithm. Therefore, no standalone algorithm performance study was conducted or reported.
7. Type of Ground Truth Used
The concept of "ground truth" as typically applied to AI or diagnostic studies (e.g., pathology, expert consensus) does not apply to this submission. The "truth" for this device rests on its physical and mechanical properties demonstrated through laboratory testing and engineering principles, showing it functions as intended and is comparable to existing, legally marketed devices.
8. Sample Size for the Training Set
This submission is for a physical medical device, not an AI algorithm. Therefore, there is no "training set" or sample size mentioned in the context of machine learning.
9. How the Ground Truth for the Training Set Was Established
As there is no training set mentioned (this being a physical device), this question is 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.