(86 days)
The Bioline Dental Implant System are endosseous implants intended to be surgically placed in the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient's esthetics and chewing function. Implants are intended for single or multiple unit restorations on splinted or non-splinted applications. Charanga, Bolero and DACA are intended for immediate loading when good primary stability is achieved, and with appropriate occlusive loading. These implants can also be used for loading after a conventional healing period. Bolero 3.3 implants are intended to replace a lateral incisor in the maxilla and/or a central or lateral incisor in the mandible. Mandibular central and lateral incisors must be splinted if using two or more 3.3 implants adjacent to one another.
The Bioline Dental Implant System contains 2 designs of internal hex implants and various types of abutments as described below as well as 1 design of conical implant with NP and RP platforms and abutments corresponding to both platforms. All devices are made from Ti-6AL-4V ELI unless otherwise noted. The implants have a grit blasted and acid etched surface. Conical abutments need to match the implant platform of narrow or regular. No abutments other than UCLA abutments are intended to be modified by the user.
Charanga implants are tapered internal hex implants with more tightly spaced flat edge threads at the top and wider spaced flat edge threads in the lower tapered section. Maer comes in 3.5, 3.75, 4.2, 5.0 and 6.0 mm diameter with lengths of 8, 10, 11.5, 13, and 16mm (no 16mm in 6.0mm diameter).
Bolero implants are cylindrical internal hex implants with evenly spaced threads which are flat edged at the top and sharp edged in the lower section. Ragil comes in 3.3, 3.75, 4.2, 5.0, and 6.0 mm diameter with lengths of 8, 10, 11.5, 13, and 16mm (no 16mm in 5.0 or 6.0mm diameter). 3.3mm diameter implants are not for use with angled abutments in the posterior region of the mouth.
Internal Hex Healing Abutments come in 4.5mm diameter with cuff heights of 2, 3, 4, 5, 6,7 mm. They come in narrow with a diameter 3.8mm with cuff heights of 3, 4, 5,6, 7 mm and wide with a diameter 5.5mm with cuff heights of 2,3,4,5,6,7 mm. Extra wide healing caps are 6.3mm diameter and come in cuff heights of 2,3,4,5 mm. An internal hex cover screw is also available. A healing cap for multi-units is available.
Internal Hex Straight Abutments have a 3.75mm interface diameter and come in 4.5mm diameter with total heights above the platform of 5,7,9,11,13,15 mm, and in 5.5mm diameter with heights above the platform of 9, 11, and 13 mm.
Internal Hex Straight Narrow Abutments have a 3.75mm interface area and come 3.75mm diameter with heights above the platform of 5,7,9, 11 mm.
Internal Hex Straight Shouldered Abutments come in 3.75mm interface diameter in 4.5 and 5.4 mm diameter with gingival heights of 1,2,3,4 mm.
Internal Hex Angled Abutments come in 15° 3.75mm diameter with height above platform of 9, and 11.4mm, and 25° 3.75mm diameter with height above platform of 8.5 mm.
Internal Hex Angled Anatomic Abutments come in 15° 3.75mm diameter with cuff heights of 1,2,3,4 mm and height above low side of shoulder of 8,9,10,11 mm and 25° 3.75mm diameter with cuff heights of 1,2,3,4 mm and height above platform of 8.3, 9.2, 10.3, 10.3 mm.
Internal Hex UCLA abutment bases come in 3.75mm diameter and use a Delrin plastic sleeve. The UCLA are for making straight restorations which are 4mm above the gingival collar and have a post height of no more than 12mm. The minimum wall thickness of the cast abutments is 0.3mm. The angulation, wall thickness and diameter of the UCLA base component are not intended to be modified.
Internal Hex Ball attachments come in 4.0mm diameter with cuff heights of 2, 3, 4, 5, 6, or 7mm.The ball attachments snap into a stainless steel housing which has a polyamide or polyether retention cap. The Retention Caps come in the colors yellow, pink and clear which represent 0.5, 0.9, and 1.3 kg retention levels. The retention caps allow implants to be within 14° of vertical and still snap into place.
Internal Hex IH Retentor Attachments come in 3.85mm diameter with cuff heights 1,2,3,4,5,6 mm. The IH Retentor attachments snap into a Ti6AL4V ELI housing which has a polyamide, polyether or polyoxymethylene retention cap. The Retention Caps come in the colors yellow, pink, clear, purple which represent 0.6, 0.8, 1.0, 1.5 kg retention levels. The retention caps allow implants to be within 20° of vertical and still snap into place.
Internal Hex Straight Multi-Unit come in 4.8mm diameter with cuff heights of 1, 2, 3, 4, 5 mm.
Internal Hex Angled Multi-Units come in 17° and 30° with cuff heights of 1, or 2 mm.
DACA implants are very slightly tapered conical implants with more tightly spaced flat edge threads at the top and wider spaced sharp edge threads in the lower tapered section. DACA comes in 3.5 (NP), 4.3 (RP) and, 5.0 (RP) mm diameter with lengths of 8, 10, 11.5, 13, and 16mm.
Conical healing caps come in NP and RP with cuff heights of 2,3,4,5 mm. NP and RP conical cover screws are also available. A healing cap for multi-units is available.
Conical straight abutments come in NP and RP with heights above platform of 9 or 13 mm.
Conical shoulder abutments come in NP and RP with gingival heights of 1,2,3 mm.
Conical angled shoulder abutments 15° come in NP and RP with cuff heights of 1,2,3 mm and total heights of 10.7, 12.2, 13.7 mm for NP and 11, 12, 13 mm for RP.
Conical angled shoulder abutments 25° come in NP and RP with cuff heights of 1,2,3 mm and total heights of 10.7, 12.2, 13.7 mm for NP and 11, 12, 13 mm for RP.
Conical ball attachments come in 3.5mm diameter for NP and 5.0mm diameter for RP with cuff heights of 1,2,3,4,5,6 mm. The ball attachments snap into a stainless steel housing which has a polyamide or polyether retention cap. The Retention Caps come in the colors yellow, pink and clear which represent 0.5, 0.9, and 1.3 kg retention levels. The retention caps allow implants to be within 14° of vertical and still snap into place.
Conical Retentor attachments in 3.5mm diameter for NP and 5.0mm diameter for RP with cuff heights of 1,2,3,4 mm. The Retentor attachments snap into a Ti6AL4V ELI housing which has a polyamide, polyether or polyoxymethylene retention cap. The Retention Caps come in the colors yellow, pink, clear, purple which represent 0.6, 0.8, 1.0, 1.5 kg retention levels. The retention caps allow implants to be within 20° of vertical and still snap into place.
Conical straight multi-units in NP and RP are 4.8mm in diameter with cuff heights of 1,2,3,4,5 mm.
Conical NP and RP Angled Multi-Units come in 17° and 30° with cuff heights of 1, or 2 mm.
The provided FDA 510(k) clearance letter and 510(k) Summary for the Bioline Dental Implant System describe the device and its equivalence to a predicate device. However, this documentation does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria for software-based performance, human-in-the-loop studies, ground truth establishment, or training set details.
The document primarily focuses on:
- Mechanical and Biocompatibility Testing: Dynamic fatigue testing (ISO 14801), cytotoxicity (ISO 10993), skin sensitization (ISO 10993-10:2021), irritation (ISO 10993-23:2021), sterilization validation (ISO 17665-1, ANSI/AAMI ST72:2019, USP , ISO 11137-2), package testing (ASTM D999-08, ASTM F3039-13, ASTM D5276-98(2009), ASTM F1929-12, ASTM F1980-07), and surface cleanliness.
- Substantial Equivalence: Comparing the Bioline system to the TOV Dental Implant System (K240837) based on indications for use, materials, design, and fatigue performance.
- MR Environment Conditions: A non-clinical review addressing magnetically induced displacement force and torque based on scientific rationale and published literature.
The questions you've asked are typical for the clinical validation of AI/ML-based medical devices, particularly those involving image analysis, diagnostics, or predictive capabilities where "performance" is measured by metrics like sensitivity, specificity, AUC, or reader agreement. The Bioline Dental Implant System, as described, is a physical medical device (dental implants and associated components), not a software or AI-driven diagnostic tool. Therefore, the concepts of a "test set," "ground truth," "expert readers," "MRMC study," and "training set" as they relate to AI/ML device validation are not applicable here.
Based on the provided document, I cannot fulfill your request for the tables and study details related to AI/ML device validation because the Bioline Dental Implant System is a physical medical device, and the clearance documentation focuses on its mechanical, material, and biological performance, not software performance.
If the intent was to ask about the physical performance of the device (e.g., fatigue strength), then the "acceptance criteria" would be compliance with standards like ISO 14801, and the "study that proves the device meets the acceptance criteria" would be the engineering tests described.
Here's how I would interpret the "acceptance criteria" and "study" if applied to the mechanical properties mentioned in the document:
Reinterpretation for Physical Device Performance (as per document)
Since the device is a physical dental implant system, the "performance" here refers to its mechanical integrity, biocompatibility, and sterilization effectiveness, not diagnostic or AI-driven capabilities.
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Aspect | Acceptance Criteria (Std. Compliance) | Reported Device Performance |
|---|---|---|
| Dynamic Fatigue | According to ISO 14801 | Determined "sufficient run out load for their intended use." |
| Cytotoxicity | According to ISO 10993 | "Testing was done on both implants and abutments." (Implies compliance) |
| Skin Sensitization | According to ISO 10993-10:2021 | "Conducted on implants." (Implies compliance) |
| Irritation | According to ISO 10993-23:2021 | "Conducted on implants." (Implies compliance) |
| Steam Sterilization | According to ISO 17665-1 | "Validation was conducted." (Implies compliance) |
| Bacterial Endotoxin | According to ANSI/AAMI ST72:2019 & USP | "Testing was conducted." (Implies compliance) |
| Gamma Irradiation | According to ISO 11137-2 | "Validation was conducted." (Implies compliance) |
| Package Testing | According to ASTM D999-08, ASTM F3039-13, ASTM D5276-98(2009) | "Testing was conducted." (Implies compliance) |
| Shelf Life Testing | According to ASTM F1929-12, ASTM F1980-07 | "Testing was conducted." (Implies compliance) |
| Post-Surface Treatment Cleanliness | Within limits based on relevant standards in cleaning validation protocol | "All were within the limits." (Organic carbon, hydrocarbons, SEM/EDX) |
| MR Environment Safety | FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment" | Non-clinical worst-case MRI review performed; rationale addressed parameters (magnetically induced displacement force and torque). (Implies safety) |
Regarding the other questions (2-9), these are entirely relevant for software/AI device validation and are not applicable to the physical dental implant system described in this 510(k) summary.
Summary of non-applicability for the requested AI/ML specific information:
- Sample sizes for test set and data provenance: Not applicable to a physical device. Testing is mechanical/biological, not data-driven.
- Number/qualifications of experts for ground truth: Not applicable. Ground truth for mechanical/biological testing is compliance with engineering standards and laboratory results.
- Adjudication method: Not applicable.
- MRMC comparative effectiveness study: Not applicable, as no human-AI interaction is involved.
- Standalone (algorithm only) performance: Not applicable, as there is no algorithm.
- Type of ground truth used: For physical/biological testing, ground truth is defined by established engineering and biological standards (e.g., ISO, ASTM, USP).
- Sample size for training set: Not applicable, as there is no training set for a physical device.
- How ground truth for 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.