(80 days)
The Quickdent 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 applications. Korticale TPR IH, Ossi Classic IH, Acti Fix CC and Kortifix Pro CC 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. Trabeos 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.
Korticale SP one piece implant is indicated for support and retention of fixed single tooth and fixed partial denture restorations in premolar, cuspid and incisor regions of partially edentulous jaws. Korticale SP one piece implants may be loaded immediately in the anterior mandibular arch if four implants are splinted together with a bar. Korticale SP one piece implants may be immediately restored with a temporary prosthesis that is not in functional occlusion.
The Quickdent Dental Implant System contains 3 designs of internal hex implants and various types of abutments as described below as well as 2 designs of conical implant with NP and RP platforms and abutments corresponding to both platforms. Additionally, a one piece implant is available. 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.
Ossi Classic IH 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. Ossi Classic IH 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).
Trabecos IH implants are cylindrical internal hex implants with evenly spaced threads which are flat edged at the top and sharp edged in the lower section. Trabecos 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 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.
Korticale TPR IH are spiral internal hex implants with widely spaced threads. Korticale TPR IH comes in 3.5 and 4.2 mm diameter with lengths of 10, 12, 14 and 16mm.
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.
Quickloc IH attachments come in 3.85mm diameter with cuff heights 1,2,3,4,5,6 mm. The Quickloc IH 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.
Acti Fix CC 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. Acti Fix CC comes in 3.5 (NP), 4.3 (RP) and, 5.0 (RP) mm diameter with lengths of 8, 10, 11.5, 13, and 16mm.
Kortifix Pro CC are spiral conical implants with widely space threads. Kortifix Pro CC comes in 3.5 (NP) and 4.2 (RP) diameters in lengths of 10, 12, 14, 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.
Quicksnap CC attachments in 3.5mm diameter for NP and 5.0mm diameter for RP with cuff heights of 1,2,3,4 mm. The Quicksnap CC 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.
Korticale SP one piece implant comes in diameters of 3.5 and 4.2mm with lengths of 8, 10, 12, 14, and 16mm. The abutment portion has a 2mm gingival collar and a 7mm abutment post height above the gingival collar. Only straight models of Korticale SP are available angular correction.
Here's an analysis of the provided text regarding the acceptance criteria and study proving a medical device meets those criteria, formatted as requested.
The provided document is an FDA 510(k) summary for the "Quickdent Dental Implant System," which focuses on establishing substantial equivalence to previously cleared predicate devices rather than proving the device meets specific performance acceptance criteria for an AI/algorithm-driven device. Therefore, much of the requested information regarding AI device testing (e.g., sample size for test/training sets, data provenance, expert adjudication, MRMC studies, standalone performance, ground truth establishment) is not present in this type of submission.
This document describes a traditional medical device (dental implants) and its physical and mechanical properties, alongside biocompatibility and sterilization testing. It does not involve an AI/algorithm component, hence the absence of information related to AI model evaluation.
Here's a breakdown based on the provided text, highlighting what is present and what is absent relative to your request for an AI-driven device:
1. A table of acceptance criteria and the reported device performance
The document uses a "Substantial Equivalence" table (starting on page 8) comparing the subject device (Quickdent Dental Implant System) to predicate devices. This table implicitly defines "acceptance criteria" through comparison to the predicates' characteristics and documented performance.
| Criterion/Feature | Quickdent Dental Implant System (Subject Device) | TOV Dental Implant System (Primary Predicate) | Zimmer One Piece Implant (Reference Predicate for Korticale SP) |
|---|---|---|---|
| Indications for Use | Endosseous implants surgically placed in upper/lower jaw for prosthetic support to restore esthetics/chewing. Intended for single/multiple unit restorations on splinted/non-splinted applications. Korticale TPR IH, Ossi Classic IH, Acti Fix CC, and Kortifix Pro CC are for immediate loading (with good primary stability & appropriate occlusive loading), or conventional healing. Trabecos 3.3 for lateral incisor (maxilla) / central or lateral incisor (mandible), with splinting for adjacent mandibular central/lateral incisors. Korticale SP one piece for fixed single tooth/partial denture in premolar, cuspid, incisor regions of partially edentulous jaws. Korticale SP for immediate loading in anterior mandibular arch if four implants splinted with a bar; immediately restored with temporary prosthesis (not in functional occlusion). | Endosseous implants surgically placed in upper/lower jaw for prosthetic support to restore esthetics/chewing. Intended for single/multiple unit restorations on splinted/non-splinted applications. Maer, Ragil, and TCX for immediate loading (with good primary stability & appropriate occlusive loading), or conventional healing. Ragil 3.3 for lateral incisor (maxilla) / central or lateral incisor (mandible), with splinting for adjacent mandibular central/lateral incisors. | Indicated for support and retention of fixed single tooth and fixed partial denture restorations in premolar, cuspid, and incisor regions of partially edentulous jaws. May be loaded immediately in the anterior mandibular arch if four are splinted together with a bar. May be immediately restored with a temporary prosthesis that is not in functional occlusion. |
| Implant Diameters | Ossi Classic IH: 3.5, 3.75, 4.2, 5.0, 6.0 mm; Trabecos IH: 3.3, 3.75, 4.2, 5.0, 6.0 mm; Korticale TPR IH: 3.5, 4.2 mm; Acti Fix CC: 3.5 (NP), 4.3 (RP), 5.0 (RP) mm; Kortifix Pro CC: 3.5 (NP), 4.2 (RP); Korticale SP: 3.5, 4.2 mm | Maer: 3.5, 3.75, 4.2, 5.0, 6.0 mm; Ragil: 3.3, 3.75, 4.2, 5.0, 6.0 mm; TCX: 3.5 (NP), 4.3 (RP), 5.0 (RP) mm | One Piece: 3.7, 4.7 mm |
| Implant Lengths | Ossi Classic IH: 8, 10, 11.5, 13, 16mm (no 16mm in 6.0mm dia); Trabecos IH: 8, 10, 11.5, 13, 16mm (no 16mm in 5.0 or 6.0mm dia); Korticale TPR IH: 10, 12, 14, 16mm; Acti Fix CC: 8, 10, 11.5, 13, 16mm; Kortifix Pro CC: 10, 12, 14, 16mm; Korticale SP: 8, 10, 12, 14, 16mm. | Maer: 8, 10, 11.5, 13, 16mm (no 16mm in 6.0mm dia); Ragil: 8, 10, 11.5, 13, 16mm (no 16mm in 5.0 or 6.0mm dia); TCX: 8, 10, 11.5, 13, 16mm | One Piece: 10, 11.5, 13, 16mm |
| Material | Ti-6AL-4V ELI (unless otherwise noted) | Ti-6AL-4V ELI | Ti-6AL-4V ELI |
| Type of abutment & Max. Angulation | Pre-manufactured, no more than 30° | Pre-manufactured, no more than 30° | N/A (One-piece implant) |
| Interface type/shape | Internal hex, conical | Internal hex, conical | N/A (One-piece implant) |
| ISO 14801 Fatigue Testing | Sufficient run out load for their intended use | Sufficient run out load for their intended use | (Implies sufficient, as it's a predicate) |
| Surface Treatment | SLA (grit blasted and acid etched) | SLA | RBM and acid wash |
| Post-Surface Treatment Cleanliness | Yes | Yes | Yes |
| Other Abutment Details | Wide range of healing caps, straight, angled, multi-unit, locator, and ball attachments with varying cuff heights/diameters. UCLA bases. | Comparable range of abutments, healing caps, and attachments. | (Not applicable for one-piece implant) |
2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified in the document for the performance tests (e.g., ISO 14801 fatigue, biocompatibility). For these types of physical/mechanical tests, sample sizes are typically determined by relevant ISO standards or engineering practices, often much smaller than clinical trials, and not typically reported in such summaries.
- Data Provenance: Not applicable for a traditional hardware device's pre-market testing. The testing is performed on the device itself, not on patient data. Quickdent Devices Private Ltd. is based in India, as indicated by their address.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This device does not use an AI component that would require human expert review/ground truth for algorithm performance evaluation. Its "truth" is established by direct measurement of its physical properties against engineering standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no expert review or adjudication of data for this type of device submission.
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 not an AI-driven device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI-driven device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is derived from engineering specifications and international standards. For example:
- ISO 14801: Determines the fatigue strength of dental implants and abutments. The "acceptance criterion" is "Sufficient run out load for their intended use," meaning the device must withstand the specified load conditions without failure.
- ISO 10993 (Biocompatibility): Tests for cytotoxicity, skin sensitization, and irritation. The "acceptance criterion" is that the device must demonstrate biological compatibility as defined by these standards (e.g., no significant cytotoxic effects).
- Sterilization standards (ISO 17665-1, ANSI/AAMI ST72:2019, USP , ISO 11137-2): "Ground truth" is that the device is sterile post-processing, confirmed by bacterial endotoxin testing and validation of the sterilization process.
8. The sample size for the training set
Not applicable. This is not an AI-driven device and therefore has no training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI-driven device and therefore has no training set or associated ground truth establishment process.
In summary: The provided FDA 510(k) summary is for a mechanical medical device (dental implants). The "acceptance criteria" are defined by engineering performance standards, material science, and biocompatibility standards, with the study proving compliance being bench testing and laboratory analysis against these standards, as well as demonstrating substantial equivalence to existing predicate devices. It does not involve AI or algorithms, and thus the questions related to AI model evaluation are not relevant to this document.
§ 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.