(274 days)
Intended Use for Two-Piece Implant Systems
- For implantation into any area of the fully 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 .
- 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.
- Unsplinted narrow implants and angled abutments are not to be used in the posterior areas. .
- . Taper Hex Implant System is compatible with NobelActive implants and prosthetics
- Double Hex Implant System is compatible with Astra double hex implants and prosthetics .
- Square Taper Implant System is compatible with Straumann Bone-Level implants and . prosthetics
Intended Use for One-Piece Implant System
- For implantation into any area of the fully edentulous maxilla and mandible for the support . of a removable or fixed dental prosthesis
- For single tooth or multiple unit prosthesis ●
- For single stage surgical procedure .
- 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. In edentulous cases four or more implants must be used
- Overdenture Implants are intended for support of removable prosthesis. .
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 , screw retained and overdenture-type restorative options. The implants and abutments are made out of Ti6Al4V titanium alloy and have an internal anti-rotational geometry or have a one-piece design with the abutment portion being an integral part of the implant. The device also includes exempt accessories such as laboratory analogs and drivers for insertion of the implants. and The activFluor surface treatment of the implants is the same as on Blue Sky Bio's predicate devices and is performed by blasting the surface and chemically etching to enhance the surface roughness for apposition of bone to the implant surface. The implants and components are supplied sterile or not sterile and are labeled accordingly.
The provided text describes the "Blue Sky Bio Dental Implant System" and its modifications. It focuses on demonstrating substantial equivalence to predicate devices rather than presenting a performance study with acceptance criteria and results in the way typically seen for AI/ML-driven medical devices.
Therefore, many of the requested categories for acceptance criteria and study details cannot be directly extracted from this document, as it pertains to a traditional medical device (dental implants). There is no mention of an algorithm, AI, human-in-the-loop, or a test set with ground truth established by experts.
However, I will extract the information that is available and indicate when information is not present.
Acceptance Criteria and Device Performance for Blue Sky Bio Dental Implant System
This device is not an AI/ML device, so typical performance metrics like sensitivity, specificity, or AUC are not applicable, nor are direct comparisons of human performance with and without AI. The acceptance is based on demonstrating substantial equivalence to predicate devices through material, technological, and safety comparisons, as well as performance testing for compatibility and fatigue.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance / Justification |
|---|---|
| Material | Subject device: Titanium Alloy, Ti-6Al-4V; Predicate devices use CP Titanium Grade 4, Ti-6Al-4V, CP Titanium, or Surgical Alloy. The subject device's material is considered equivalent or similar to predicate devices. |
| Stages of Use | Subject device: 1 Stage and 2 Stage; Matches predicate devices. |
| Surface Treatment | Subject device: Blasted with resorbable medium, or Aluminum Oxide and Acid Etched; Same as original Blue Sky Bio Dental Implant System predicates. Similar to other predicate devices with galvanic process or blasting and acid etching. |
| Body Diameter (mm) | Subject device: 3.25 - 5.0 (Tapered & Straight and Tapered); Within range or comparable to predicate devices of 3.3mm-6.0mm. |
| Platform Diameter (mm) | Subject device: 3.25 - 5.0; Within range or comparable to predicate devices of 3.0mm-6.5mm. |
| Lengths (mm) | Subject device: 6-16mm; Within range or comparable to predicate devices of 8-16mm (for most; Nobel Biocare 10-15mm). |
| External Screw Threads | Subject device: Yes; Matches predicate devices. |
| Anti-rotational Feature | Subject device: Internal Hex with taper, Internal Square with taper; Comparable to predicate features (internal taper with, internal octagon, or Trilobe; Internal Hex with taper; Internal Square with taper). |
| Sterilization | Subject device: Gamma Sterilized; Matches predicate devices. |
| Abutment Types | Two-Piece Screwed Abutment: Yes; Matches predicate devices. Overdenture Abutment: Yes; Matches predicate devices. Angled Abutments (15, 25, 30 deg.): Introduced/Modified; Deemed acceptable due to larger wall thickness and equal/smaller angulation than predicate devices used in fatigue testing. |
| Narrow Diameter Implants | Down to 3.0mm; Deemed acceptable based on fatigue testing being equivalent or stronger than predicate devices due to design. |
| Compatibility Tests | Performed according to "Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document; Root-form Endosseous Dental Implants and Endosseous Dental Abutments". Tests showed new devices are compatible with predicate devices and fit is adequate. |
| Fatigue Testing | Performed according to ISO 14801 for predicate devices. New devices (angled abutments and narrow diameter implants) have larger wall thickness and equal or smaller angulation than predicate devices, demonstrating they are equivalent or stronger. |
2. Sample size used for the test set and the data provenance
Not applicable. This is a traditional medical device (dental implant). The "test set" and "data provenance" as understood in AI/ML studies are not relevant here. Performance was assessed through compatibility and fatigue testing of the physical device, not on a dataset of patient information.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is a traditional medical device. Ground truth, in the context of expert review of data, is not established for this type of device submission. The assessment relies on engineering and material standards, and clinical experience with predicate devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This is a traditional medical device. No adjudication method for a test set of data is mentioned.
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 a traditional medical device. No AI assistance or human reader studies are mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a traditional medical device. There is no algorithm or standalone performance to evaluate.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. For this device, ground truth as typically understood in AI/ML studies (e.g., confirmed diagnoses) isn't directly relevant. The "truth" or acceptance is based on:
- Compliance with manufacturing specifications.
- Material properties meeting standards.
- Mechanical performance (compatibility, fatigue) meeting or exceeding predicate device performance and industry standards (e.g., ISO 14801).
- Demonstration of substantial equivalence to legally marketed predicate devices.
8. The sample size for the training set
Not applicable. This is a traditional medical device. There is no training set for an AI/ML algorithm.
9. How the ground truth for the training set was established
Not applicable. This is a traditional medical device. There is no training set for an AI/ML algorithm.
§ 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.