(87 days)
- For implantation into any area of the fully edentulous maxilla and mandible for the support of a . removable or fixed dental prosthesis
- For implantation into any area of the partially edentulous maxilla and mandible for the support of . a removable or fixed dental prosthesis
- For single tooth or multiple unit prosthesis .
- For single stage or two stage surgical procedure .
- One piece implants for single stage procedure only ●
- For immediate placement and immediate function when multiple units are splinted and for single . units when adequate initial stability is achieved in type I or type II bone and under appropriate occlusal loading. Multiple units may be splinted with a bar. In edentulous cases restored with a fixed prosthesis, four or more implants must be used.
The modification of the Blue Sky Bio Dental Implant System consists of root form dental implants of various lengths and diameters and associated abutment systems, which provide the clinician with cement retained and overdenture-type restorative options. Modifications to the existing system do not introduce new issues of safety or efficacy. The implants are supplied sterile or not sterile and are labeled accordingly. The system is suitable for a one-stage and two-stage protocol.
This submission is for a Traditional 510(k) for a Class II medical device, specifically a "Blue Sky Bio Dental Implant System." This type of submission relies on demonstrating substantial equivalence to a predicate device already on the market, rather than conducting new clinical trials to establish de novo safety and efficacy criteria. Therefore, the information typically requested in your prompt (such as acceptance criteria with reported device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment) is generally not part of a Traditional 510(k) submission.
Explanation Based on Document Content:
The provided document (K051507) is a 510(k) summary and the FDA's clearance letter for the "Blue Sky Bio Dental Implant System." Here’s why it doesn't contain the requested information in the typical format for device performance studies:
- Substantial Equivalence: The core of a 510(k) submission is to demonstrate that the new device is "substantially equivalent" to a legally marketed predicate device in terms of intended use, technological characteristics, and safety and effectiveness. It does not usually require de novo clinical studies with specific acceptance criteria and performance metrics against a defined standard.
- "Modification of the Blue Sky Bio Dental Implant System": The device description explicitly states, "The modification of the Blue Sky Bio Dental Implant System consists of root form dental implants of various lengths and diameters and associated abutment systems... Modifications to the existing system do not introduce new issues of safety or efficacy." This further reinforces that the submission is for a modification of an already cleared device, making extensive new performance studies unlikely to be required.
- FDA Letter Confirmation: The FDA's letter states, "We have reviewed your Section 510(k) premarket notification of intent to market the device... We have determined the device is substantially equivalent... to legally marketed predicate devices." This is the basis of the clearance, not evidence of meeting specific numerical performance criteria from a clinical study.
- Lack of Performance Data Section: Traditional performance data sections, including benchmarks, study designs, sample sizes, and ground truth methods, are absent from the provided document, as they are not standard requirements for this type of submission unless specific new safety/efficacy questions are raised by the modification, which the submitter explicitly denies.
Therefore, based on the provided document, I cannot fulfill your request for the following reasons:
- No explicit acceptance criteria or reported device performance table: The submission relies on substantial equivalence to a predicate device, not on meeting new quantitative acceptance criteria from a performance study.
- No sample sizes, data provenance, or details on ground truth for test/training sets: These are components of clinical or performance studies, which are not detailed in this 510(k) submission.
- No information on experts for ground truth or adjudication methods: Again, related to detailed studies which are not present.
- No MRMC comparative effectiveness study or related effect size: This type of study is not mentioned or required for a 510(k) submission focused on substantial equivalence for this device.
- No standalone (algorithm-only) performance data: The device is a physical dental implant system, not a software algorithm, so this concept is not applicable.
- No specific type of ground truth mentioned: Directly related to the absence of detailed performance studies.
- No sample size for the training set or how ground truth for the training set was established: These details pertains to the development and validation of machine learning algorithms or specific clinical trials, neither of which are described here.
This document describes a regulatory filing for a medical device that relies on demonstrating equivalence to an existing device rather than presenting new clinical study data with specific performance metrics and acceptance criteria.
§ 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.