Search Results

NobelProcera Zirconia Implant Bridge (previously cleared per K202452) The NobelProcera® Zirconia Implant Bridge are indicated for use as a bridge anatomically shaped and/or framework in the treatment of partially edentulous jaws for the purpose of restoring chewing function.

TiUltra Implants and Xeal Abutments (previously cleared per K202344) NobelActive TiUltra NobelActive TiUltra implants are endosseous implants intended to be surgically placed in the upper or lower jaw bone for anchoring or supporting tooth replacements to restore patient esthetics and chewing function. Nobel Active Tilltra implants are indicated for single or multiple unit restorations in splinted applications. This can be achieved by a 2-stage or 1-stage surgical technique in combination with immediate, early or delayed loading protocols, recognizing sufficient primary stability and appropriate occlusal loading for the selected technique. NobelActive TiUltra 3.0 implants are intended to replace a lateral incisor in the maxilla and/or a central incisor in the mandible. Nobel Active TiUltra 3.0 implants are indicated for single-unit restorations only. NobelReplace CC TiUltra NobelReplace CC TiUltra implants are endosseous dental implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. The NobelReplace CC TiUltra implants are indicated for single or multiple unit restorations. The NobelReplace CC Tilltra implants can be used in splinted or non-splications. The NobelReplace CC TiUltra implant may be placed immediately and put into immediate function provided that initial stability requirements detailed in the manual are satisfied. NobelParallel CC TiUltra NobelParallel CC TiUltra implants are endosseous implants intended to be surgically placed in the upper or lower jaw bone for anchoring or supporting replacements to restore patient esthetics and chewing function. NobelParallel CC TiUltra implants are indicated for single or multiple restorations in splinted applications. This can be achieved by a 2-stage or 1-stage surgical techniques in combination with immediate, early of delayed loading protocols, recognizing sufficient primary stability and appropriate occlusal loading for the selected technique. Implants with < 7 mm length are for delayed loading only when appropriate stability has been achieved. MUA Xeal: The MUA Xeal is a pre-manufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation. On1 Base Xeal: The On1 Base Xeal device is a premanufactured prosthetic component directly connected to an endosseous implant and it is intended for use in prosthetic rehabilitation. The On1 Universal Abutments consist of three major parts. Specifically, the On1 Base Xeal, the On1 Universal Abutment, and the mesostructure components make up a multi-piece abutment. The system integrates multiple components of the digital dentistry workflow: scan files from Intra-Oral Scanners, CAM software, ceramic material, milling machine and associated tooling and accessories.

Onl Universal Abutment (previously cleared by K181869) The Onl 11M device is a premanufactured prosthetic component directly connected to an endosseous implant and it is intended for use in prosthetic rehabilitation. The Onl Universal Abutunent consist of three major parts. Specifically, the Onl Base, the Onl Universal Abutment, and the mesostructure components make up a multi-piece abutment. The system integrates multiple components of the digital dentistry workflow: scan files from Intra-oral Scanners, CAD software, CAM software, ceramic material , milling machine and associated tooling and accessories.

TREFOIL System (previously cleared per K172352) The TREFOIL System is used to restore chewing function in fully edentulous mandibles. The three implants of the Trefoil Implants are placed between the mental foramina in fully edentulous mandibles in a 1-stage surgical technique combined with an immediate function loading protocol, provided sufficient primary stability for the selected technique is achieved. In cases where sufficient primary stability for two implants or more is not reached, the implants along with the Framework may also be used with an early or delayed loading protocol. The following prerequisites must be fulfilled: -Adequate quantity of bone (minimum height of 13 mm implant and 14.5 mm for 13.0implant and minimum width of 6-7 mm). -Adequate mouth opening (minimum 40 mm) to accommodate the guided surgery instruments. -Implant-supported prosthetics seated directly on dedicated implants

Healing Cap Multi-Unit Titanium (previously cleared per K171142) The Healing Cap Multi-unit Titanium is a premanufactured prosthetic component to be directly connected to the dental abutment during soft tissue healing to protect the internal connection of the abutments and prepare the soft tissue for the prosthetic procedure. Maximum intra-oral use is 180-days.

TREFOIL System (previously cleared per K170135) The Trefoil system is used to restore chewing function in fully edentulous mandibles. The three implants of the Trefoil system are placed between the mental foramina in fully edentitious mandibles in a 1-stage surgical technique combined with an immediate function loading protocol, provided sufficient primary stability for the selected technique is achieved. In cases where sufficient primary stability of one or more implants is not reached, the implants along with the bar may also be used with an early or delayed loading protocol. The following prerequisities must be fulfilled: - Adequate quantity of bone (minimum width of 7 mm; and minimum heights of 13 mm implant and 14.5 mm for 13.0 mm implant) -Adequate mouth opening (minimum 40 mm) to accomodate the guided surgery intruments. -Implant-supported prosthetics seated directly on dedicated implants

Onl Concept (previously cleared per K161655) The On 17M device is a premanufactured prosthetic component directly connected to an endosseous implant and it is intended for use in prosthetic rehabilitation.

NobelZygoma 0° (previously cleared per K 161598) Nobel Zygoma implants are endosseous dental implants intended to be surgically placed in the bone of the upper jaw arch to provide support for prosthetic devices, such as artificial teeth, in order to restore patient esthetics and chewing function. The NobelZygoma Implants are appropriate for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

Temporary Snap Abutment (previously cleared per K161435) The Temporary Snap Abutment is intended to be used to fabricate and support provisional restorations that and in creating an esthetic emergence through the gingiva during period and prior to final restoration. The Temporary SnapAbutment can be used for cement retained or screw-retained provisional restorations. The abutments can be used for single-unit and multi-unit restorations. Use of the Temporary Snap Abutiment is not to exceed one hundred and eighty(180) days.

Multi-Unit Abutment Plus (previously cleared per K161416) The Multi-unit Abutment Plus is a pre-manufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.

NobelProcera HT ML FCZ Implant Bridge and Framework (previously cleared per K160158) The NobelProcera HT ML FCZ (full contour zirconia) and framework Implant Bridge are indicated for use as a bridge anatomically shaped and/or framework in the treatment of partially or totally edentulous jaws for the purpose of restoring chewing function.

NobelSpeedy Groovy (previously cleared per K160119) NobelSpeedy® Groovy implants are endosseous implants intended to be surgically placed in the upper or lower jaw bone for anchoring or supporting tooth replacements to restore patient esthetics and chewing function. NobelSpeedy® Groovy implants are indicated for single or multiple unit restorations in splinted applications. This can be achieved by a 2-stage or 1-stage surgical technique in combination with immediate, early or delayed loading protocols, recognizing sufficient primary stability and appropriate occlusal loading for the selected technique. Implants allow also for bicortical anchorage in cases of reduced bone density. NobelSpeedy® Groovy implants 20, 22, 25 mm when placed in the maxilla are only indicated for multiple unit restoration in splinted applications that utilize at least two implants.

TREFOIL System (previously cleared per K152836) The TREFOIL System is used to restore chewing function in fully edentulous mandibles. The three implants of the TREFOIL System are placed between the mental foramina in fully edentulous mandibles in a 1-stage surgical technique combined with an immediate function loading protocol, provided sufficient primary stability for the selected technique is acheved. In cases where sufficient primary stability for two implants or more is not reached, the implants along with the Framework may also be used with an early or delayed loading protocol. The following prerequisites must be fulfilled: -Adequate quantity of bone (minimum height of 13 mm and minimum width of 6-7 mm). -Adequate mouth opening (minimum 40 mm) to accommodate the guided surgery instruments. -Implant-supported prosthetics seated directly on dedicated implants

NobelZygoma 45° (previously cleared per K152093) Nobel Biocare's Zygoma implants are endosseous dental implants intended to be surgically placed in the upper jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore patient esthelies and chewing finction. The Zygoma Implants may be put into immediate function provided that stability requirements detailed in the directions for use are satisfied.

NobelActive Wide Platform (WP) ( previously cleared per K133731) Nobel Biocare's NobelActive implants are endosseous implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient estherics and chewing function. Nobel Biocare's NobelActive implants are indicated for single or multiple unit restorations in splinted or non-splinted applications. Nobel Biocare's NobelActive implants are intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

NobelProcera Overdenture Bar (previously cleared per K132749) The NobelProcera Overdenture Bar is indicated for use as an overdenture bar that attaches to implants in the treatment of partially or totally edentulous jaws for the purpose of restoring function.

NobelProcera Angulated Screw Channel Abuttment Conical Connection (previously cleared per K 132746) The NobelProcera Angulated Screw Channel Conical Connection are premanufactured prostheire components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation.

Nobel Biocare PEEK Abutments (previously cleared per K120954) The Nobel Biocare PEEK Abuments are premanufactured prosthetic components directly connected to the endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation.

NobelActive 3.0 (previously cleared per K111581) The Nobel Active 3.0 implant is indicated for use in the treatment of missing maxillary lateral incisors or the mandibular central and lateral incisors to support prosthetic devices, such as artificial teeth, in order to restore chewing function in partially edentulous patients. The NobelActive 3.0 implants may be put into immediate finction provided that stability requirements detailed in the manual are satisfied.

NobelActive 3.0mm (previously cleared per K102436) The NobelActive 3.0mm implant is indicated for use in the treatment of missing maxillary lateral incisors or the mandibular central and lateral incisors to support prosthetic devices, such as artificial teeth, in order to restore chewing function in partially edentulous patients. The NobelActive 3.0 implants may be put into immediate function provided that stability requirements detailed in the manual are satisfied.

NobelProcera Implant Bridge Zirconia (previously cleared per K091907) The NobelProcera Implant Bridge Zirconia is indicated for use as a bridge framework in the treatment of partially or totally edentulous jaws for the purpose of restoring chewing function.

NobelProcera Zi Abutments (previously cleared per K091904) The NobelProcera Zi Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation.

NobelProcera Ti Abutment (previously cleared per K091756) The NobelProcera Ti Abutments are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation.

NobelActive 8.5 mm & 18.0 mm (previously cleared per K083205) Nobel Biocare's Nobel Active implants are endosseous implant intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. Nobel Biocare's NobelActive implants are indicated for single or multiple unit restorations in splinted or non-splinted applications. Nobel Biocare's Nobel ective implants may be placed immediately and put into immediate function provided that initial stability requirements detailed in the manual are satisfied.

NobelReplace Hexagonal Implants (previously cleared per K073142) Nobel Biocare's NobelReplace Hexagonal Implants are endosseous implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. The NobelReplace Hexagonal Implants are indicated for single or multiple unit restorations. The NobelReplace Hexagonal Implants can be used in splinted or non-splinted applications. The NobelReplace Hexagonal Implants may be placed immediate function provided that initial stability requirements detailed in the manual are satisfied.

NobelActive Multi Unit Abutment (previously cleared per K072570) NobelActive Multi Unit Abutment is a pre-manufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.

NobelActive Internal Connection Implant (previously cleared per K071370) Nobel Biocare's Nobel Active implant are endosseous implant intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. Nobel Biocare's NobelActive mplants are indicated for single or multiple unit restorations in splinted or non-splinted applications. Nobel Biocare's NobelActive implants may be placed immediately and put into immediate function provided that initial stability requirements detailed in the manual are satisfied.

Adapter PS (previously cleared per K063592) Nobel Biocare's Adapter PS is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.

Zygoma Angled Abutments (previously cleared per K052885) The Nobel Biocare Zygoma Angled Abutment is intended to be used as a prosthetic component directly connected to the implant and is intended for use as an aid in prosthetic rehabilitation.

Zygoma TiUnite (previously cleared per K050641) Nobel Biocare's zygoma TiUnite is a tianium, endosseous implant with components intended to be placed in the upper jaw arch to provide support for prosthetic devices such as artificial teeth in order to restore patient esthetics and chewing function, Nobel Biocare's Zygoma TiUnite inclueds endosseous implants, a cover screw, healing abutments, and multi unit abutments.

Nobelspeedy Implants (previously cleared per K050406) NOBELSPEEDY TM Implants are root-form endosseous implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. Nobel Biocare's NOBELS PEEDY TM Implants are indicated for single or multiple unt restorations in splinted or non-splications. Nobel Biocare NOBELSPEEDY TM Implants may be placed immediately to put into immediate function providing that the initial stability requirements detailed in the surgical manuals are satisfied. NOBELSPEEDY TM Implants are indicated for use in soft bone or whenever immediate or early loading is applied. The NOBELSPEEDY TM Implants incorporate a groove on the implant thread and are preferred over models without the groove in these soft bone indications because bone forms more rapidly in the groove than on other parts of the implant resulting in increased stability when compared to non-grooved implants. In addition, the NOBELSPEEDY TM Implants are preferred in these soft bone indications because bone formation on the Til nore rapid and greater than on machined surface implants resulting in better maintenance of initial implant stability, faster and stronger osseointegration, and higher success rates. NOBELSPEEDY TM Implants may be tilted up to 450. When used with angulations between 300 and 450 a minimum of four implants must be used and splinted.

Groovy Implants (previously cleared per K050258) Nobel Biocare's Groovy Implants are root-form endosseous implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. Nobel Biocare's Groovy Implants are indicated for single or multiple unit restorations in splinted or non-splinted applications. Nobel Biocare Groovy Implants may be placed immediately to put into immediate function providing that the initial stability requirements detailed in the surgical manuals are satisfied. Groovy implants are indicated for use in soft bone in posterior regions or whenever immediate or early loading is applied. The Groovy implants incorporate a groove on the implant thread and are preferred over models without the grove in these soft bone indications because bone forms more rapidly in the groove than on other parts of the implant resulting in increased stability when compared to non-grooved implants.

Procera Implant Bridge, models 15-1001, 15-1002, 15-1052 (previouly cleared per K041236) The Procera Implant Bridge is indicated for use as a bridge framework in the treatment of partially or totally edentulous jaws for the purpose of restoring chewing function. The Procera Implant Bridge can be used at the implant or abutment level of the following implant systems: Nobel Biocare Branemark System Nobel Biocare Replace SelectThe Procera Implant Bridge can be used at the implant level of the following implant systems: Nobel Biocare Replace Nobel Biocare Steri-Oss HL Nobel Biocare Novum Straumann Dental Implant System Regular neck 4.8 Straumann Dental Implant System Wide neck 6.5 The Procera Implant Bridge can be used at abutment level of the following implant systems: Nobel Biocare ARK abutment for Teeth-in-Hour concept.

Various Branemark System Implants-Immediate Function Indication previously cleared per K022562 The Branemark System implants are for single-stage or two-stage surgical procedures and cement or screw retained restorations. The Branemark System implants are intended for immediate placement and function on -single tooth and/or multiple tooth applications recognizing stability (type I or n bone) and appropriate occlusal loading, to restore chewing function. Multiple tooth applications may be splinted with a bar.

BRANEMARK NOVUM previously cleared per K000018 The "Immediate Loading Treatment Protocol" is intended for use with selected Brânemark System Implants, I hese implants, when placed using the Immediate Loading Treatment Protocol, are indicated for use only in the anterior mandible between the mental foramina.

Amorphous Diamond Coated Screw (previously cleared per K992538) The Amorphous Diamond Coated Screw is used to retain prosthetic components to dental implants or to other proshetic components. The amorphous diamond coating will add a greater pre-load to the screw, which in turn help prevent the screw and prosthetic components from loosening.

Procera® Preparable Abutment System (previously cleared per K974150) Nobel Biocare's Procera® Preparable Abutment System is a set of screw retained preparable abutments that are secured to an endosseous implant and are intended to function as an anchor to which prosthetic devices, such as artificial teeth, may be attached using dental cement to restore a patient's chewing function.

AurAdapt Abutment System (previously cleared per K972475) Nobel Biocare's AurAdapt Abutment System is a set of screw retained modifiable gold alloy abutnents which are secured to an endosseous implant and is intended to function as an anchor to which prosthetic devices, such as artificial teeth, may be attached using dental cement to restore a patient's chewing function.

Branemark System - Zygomaticus Fixture System (previously cleared per K970499) The Nobel Biocare Brallemark System - Zygomaticus Fixture System is an endosseous implant with components made of titanium intended to be placed in the upper jaw arch to prosthetic devices such as artificial teeth, and to restore the patient's chewing function. The system includes Fixtures, Drills, Hand Instruments, Cover Screws and Accessories.

Bio-Esthetic Indirect Abutment (previously cleared per K970073) The intended use of Steri-Oss' Bio-Esthetic Indirect Abutment retained with a lingual retaining screw, is to provide a stable, secure foundation upon which a prosthetic appliance (the purpose of which is restoration of masticatory function in the edentulous and partially edentulous patient) can be attached, yet remain retrievable.

Steri-Oss' Tiodized' screws (previously cleared per K964739) The intended use for Steri-Oss' Tiodized screws is the screw retained attachment of prosthetic components to one another and to dental implants.

Replace Titanium Implant System (previously per K964220) The implant is indicated for use in restoring masticatory function in the edentulous and/or partially edentulous patient.

STERI-OSS GOLD ATTACHMENT SYSTEM (previously cleared per K963945) Steri-Oss Gold Attachment System, the intended use of this device is for the screw retained attachment of prosthesis to abutments is for the screw and/or abutments to retained implants.

17° Angulated Abutment (previously cleared per K961736) The Nobelpharma 17° Angulated Abutment is intended to be used in edentulous patients as an anchor to support a prosthesis

MirusCone Abutment System (previously cleared per K961728) The Nobelpharma MirusCone Abutment System is intended to be used in edentulous patients as an anchor to support a prosthesis.

Branemark System- Healing Abutment (previously cleared per K925779) The Nobelpharma Branemark System- Healing Abutment is intended to be used as a temporary component to an endosseous implant to allow healing of the soft tissue.

Branemark System Estheticone Abutment complete (previously cleared per K925777) The Nobelpharma Branemark System - EsthetiCone Abutment Complete is intended to be used as a component to an endosseous implant.

Branemark Systems - Titanium CoverScrew (previously cleared per K925771) The Nobelpharma Branemark Systems - Titanium CoverScrew is intended to an endosseous implantprior to the first healing period to protect the innerthread of the fixture and prevent bone overgrowth.

Branemark System Abutment Complete (previously cleared per K925769) The Nobelpharma Branemark System Abutment Complete is intended to be used as a component to an endosseous implant to support a prosthetic device.

Branemark System Temporary Solutions (previously cleared per K925766) The Nobelpharma Branemark System Temporary Solutions are intended to be used in the same manner asthe permanent counterpart except that the former are usedto support transitional reconstructions.

Branemark System Standard 3.75 mm Fixture (previously cleared per K925765) All Nobelpharma fixtures for implant are indicated for use in the anterior and posterior regions of the maxilla and mandible. The fixtures are designed to support full arch reconstructions (fixed bridges and overdentures), partial arch reconstructions (fixed bridges) and single tooth replacement.

Brânemark System Self-Tapping Fixture (previously cleared per K925762) The "Immediate Loading Treatment Protocol" is intended for use with selected Branemark System Implants. These implants, when placed using the Immediate Loading Treatment Protocol, are indicated for use only in the anterior mandible between the mental foramina.

Titanium Plasma Spray Cylindrical Implant (previously cleared per K911592) The Steri-Oss Titanium plasma sprayed cylindrical dental implant device are indicated for use in the mandible and maxilla for denture retention in the edentulous and partially edentulous patient.

Angulated Abutment, Complete, Titanium SCDA102 (previously cleared per K905434) Devices are used as connection with osseointegration fixtures.

Not Found

This document is a 510(k) premarket notification decision letter from the FDA to Nobel Biocare AG regarding their Dental Implant Systems Portfolio - MR Conditional. It explicitly states that the letter covers indications for use and general controls, but does not contain information about acceptance criteria or performance studies for the device itself.

Therefore, I cannot provide the requested information for the following reasons:

1. Acceptance Criteria and Performance Data: The document is a regulatory clearance letter, not a clinical study report. It does not contain acceptance criteria for device performance, nor does it present any data from studies proving the device meets particular criteria. The letter confirms substantial equivalence to legally marketed predicate devices, which means the FDA has determined the device is as safe and effective as a previously cleared device, not that specific performance metrics were tested and met in a new study.
2. Study Details (Sample size, data provenance, experts, adjudication, MRMC, Standalone, Ground Truth, Training Set): Since no performance study data is included in this FDA 510(k) clearance letter, none of these details can be extracted. The document refers to various previously cleared predicate devices (e.g., K202452, K202344, K181869), but it doesn't describe the studies that led to their clearance.

In summary, the provided text does not contain the information necessary to describe acceptance criteria or a study proving the device meets those criteria.

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The Panthera Dental Milled Bar is indicated for use as an accessory to an endosseous dental implant to support a prosthetic device in a partially or edentulous patient for purpose of restoring chewing function. It is intended for use to support multiple tooth prostheses in the mandible or maxilla. The prostheses can be screw retained.

The Panthera Dental Milled Bars are indicated for compatibility with the Zimmer Tapered Screw-Vent System for sizes 3.5 and 4.5.

The Panthera Dental Milled Bar is a metallic dental restorative device which is intended for attaching by screw retention to dental implants to aid in the treatment of partial and totally edentulous patients for the purpose of restoring chewing function.

The Panthera Dental milled bars for which clearance is requested, are included in one of the following bar types, which have distinct design specifications.

The Type I bars are specific for removable overdenture and include:

• Panthera Dental Dolder Bar, Hader Bar, Milled Bar, REBourke Bar and Paris Bar.

The Type II bars are specific for fixed prostheses and include:

• Panthera Dental Wrap-around Bar, Montreal Bar, Montreal Bar with metallic lingual, Pin Lingual Bar and Pin Wrap-Around Bar.

The Panthera Dental Milled Bar is designed to match an individual patient. Panthera Dental designs the bar from a three-dimensional optical and/or digital scanner system that scans the casting of a patient's impression: the model cast is prepared beforehand by the dental professional using standard dental techniques. The designed bar is then machined using a computer-aided design/ computer-aided manufacturing software system (CAD/CAM). The bar is milled from titanium (Ti-6AI-4V grade 5). CAD/CAM fabrication is only performed by Panthera Dental, within our manufacturing control and not by the dental laboratory.

The Panthera Dental Milled Bar is packaged as non-sterile, and delivered to a dental laboratory for completion. Once received at the laboratory, the Panthera Dental Milled Bar is matched to a denture for final placement.

The Panthera Dental Milled Bar provides retention and support for a removable or fixed denture made of standard laboratory dental materials such as resin composite.

The provided text is a 510(k) summary for a medical device (Panthera Dental Milled Bars), which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving acceptance criteria for an AI/CADe device.

Therefore, this document does not contain the information required to answer your request about acceptance criteria and a study proving device performance for an AI/CADe device.

Here's why and what kind of information would be needed:

• Acceptance Criteria & Reported Device Performance: This document only provides a comparison of design specifications between the applicant's device and a predicate device (Tables 5.1, 5.2, 5.3) for physical dimensions and material. It does not list "acceptance criteria" in the way one would for an AI/CADe system (e.g., sensitivity, specificity, AUC thresholds).
• Study That Proves the Device Meets Acceptance Criteria: The document explicitly states: "Human clinical study was not deemed necessary to support substantial equivalence." and "Panthera Dental Inc. performed no clinical testing." It discusses non-clinical testing like fatigue testing, biocompatibility, and process capability for the physical dental bar, not an AI algorithm.
• Missing Information for AI/CADe devices: The document lacks all the specific details you requested for an AI/CADe study, such as:
  • Sample sizes for test sets (it mentions "thirty (30) cylinders" for process capability testing, not an AI test set).
  • Data provenance (country of origin, retrospective/prospective).
  • Number and qualifications of experts for ground truth.
  • Adjudication method.
  • Multi-reader multi-case (MRMC) comparative effectiveness study.
  • Standalone algorithm performance.
  • Type of ground truth (pathology, outcomes data, etc.).
  • Training set sample size and ground truth establishment for the training set.

In summary, the provided document describes a physical dental device, not an AI/CADe system, and thus does not contain the information requested about AI performance metrics or related studies.

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Implant Direct Custom Bars are patient specific devices indicated for attachment to dental implants in the treatment of partially or fully edentulous jaws for the purpose of restoring chewing function.

Custom bars are compatible at the implant level with InterActive (3.4mm Platform) & SwishActive (3.4 Platform) System implants.

Custom bars are compatible at the abutment level with InterActive (3.4mm Platform) & SwishActive (3.4 Platform) system straight multi-unit abutments.

Implant Direct Custom Bars are computer-aided design/computer-aided manufacturing, individually designed prosthetic devices for partially or fully edentulous restorations. The bars and fixation screws are made from Wrought Titanium Alloy conforming to an FDA recognized consensus standard ASTM F136. The Custom Bars consist of two device types: fixed-detachable frameworks and overdenture bars. The bar systems consists of the bars as well as fixation screws to facilitate the attachment to the dental implants.

Implant Direct Custom Bars are attached directly to an implant to provide support for the fabricated denture. The implant specific interfaces on the Custom Bars are designed and manufactured with precise mating features in order to the mating surfaces of the implants or abutments.

The Implant Direct Custom Bars are designed and produced at Implant Direct under the direction of clinical professionals. The patient requirements and implant locations are obtained conventionally or digitally and a bar is designed, using CAD software, according to established customization parameters. Once the design is finished, the bar design is sent to the clinician for approval before manufacture. After bar design approval is received, the bar design is milled using a precise CAM system, inspected, cleaned, packaged non-sterile, and shipped to the customer where it is finished into the final restoration.

This document describes the premarket notification for "Custom Bars" (K162633), which are patient-specific dental devices. The device is a physical product, not an AI/ML powered medical device. Therefore, the questions related to AI/ML device performance, such as sample sizes for test and training sets, expert ground truth establishment, MRMC studies, standalone performance, and data provenance, are not applicable.

However, I can extract information related to the performance data and the study conducted for this non-AI/ML device:

1. Table of Acceptance Criteria and Reported Device Performance:

Regarding the other requested information, since this is not an AI/ML medical device, the following points are not applicable or not provided in the document:

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for this type of mechanical and biocompatibility testing. The testing was performed on "worst-case configurations" and "worst-case sample" as described.
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. "Ground truth" in the context of expert consensus, pathology, or outcomes data is typically for diagnostic/screening devices, not for physical dental prosthetics.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for physical device performance testing against laboratory standards.
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, as this is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For this physical device, the "ground truth" or standard for acceptance is adherence to recognized international standards (ISO 14801, ASTM F382, ISO 10993-1, ISO 10993-5, ISO 17665-1, ISO 17665-2) and equivalence to predicate devices, as demonstrated through non-clinical laboratory testing.
8. The sample size for the training set: Not applicable, as this is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable, as this is not an AI/ML device.

Additional Information from the document:

• Study Type: Non-clinical testing (mechanical, biocompatibility, and cleaning/sterilization validation). Clinical performance testing was not performed and was deemed not required to support substantial equivalence.
• Predicate Device for Comparison: Dentsply International ISUS Implant Suprastructures (K122424) was the primary predicate. Nobel Biocare NobelProcera Overdenture Bar (K132749) and Biomet 3i CAM StructSURE Overdenture Bars (K101582) were used as references.
• Conclusion: The studies concluded that the Custom Bars are substantially equivalent to the legally marketed predicate devices based on the non-clinical testing performed.

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The TREFOIL System is used to restore chewing function in fully edentulous mandibles.

The three implants of the TREFOIL System are placed between the mental foramina in fully edentulous mandibles in a 1-stage surgical technique combined with an immediate function loading protocol, provided sufficient primary stability for the selected technique is achieved. In cases where sufficient primary stability for two implants or more is not reached, the implants along with the Framework may also be used with an early or delayed loading protocol.

The following prerequisites must be fulfilled:

• Adequate quantity of bone (minimum height of 13 mm and minimum width of 6-7 mm).
• Adequate mouth opening (minimum 40 mm) to accommodate the guided surgery instruments.
• Implant-supported prosthetics seated directly on dedicated implants

The TREFOIL System is a method of placing three dental implants in predetermined positions (between the mental foramina) and using a pre-designed prosthetic bar to act as a screw-retained framework seated on the implants. The TREFOIL System restores chewing function and esthetics in the mandible in completely edentulous patients.

The TREFOIL System consists of dental implants, surgical components necessary to place the implants in predetermined positions, and prosthetic components that are included in the prosthetic bar or are used in the dental lab during the creation of the prosthetic bar.

The dental implants are threaded endosseous implants made of CP4 titanium. The implant is parallel walled and has an internal conical abutment connection. The implant is available in 11.5 mm length with two available collar lengths (4.5, 6.0 mm). The apex of the implants have cutting chamber allowing for self-tapping. The implant bone interface has the TiUnite implant surface treatment. The TREFOIL System bar is made of titanium vanadium alloy. The TREFOIL System surgical tooling is made of stainless steel.

The provided text describes a 510(k) premarket notification for the TREFOIL System, an endosseous dental implant system. The document focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific acceptance criteria through a clinical study.

Therefore, much of the requested information about acceptance criteria, detailed study design, sample sizes, ground truth establishment, expert qualifications, and MRMC studies is not explicitly available in the provided text.

However, I can extract the information related to the performance data presented and what it aimed to establish.

Here's a summary based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state quantitative acceptance criteria in a table format, nor does it provide numerical performance results against such criteria. Instead, it describes types of testing performed and their general conclusions.

2. Sample Size for the test set and data provenance:

• Surgical Accuracy Test: Implants were placed "into bone models." The specific number of models or implants is not stated.
• Data Provenance: The nature of the studies suggests these were retrospective (laboratory-based) tests conducted by the manufacturer, rather than prospective clinical trials with patient data. The country of origin for the data is not specified but is presumably where Nobel Biocare AB conducts its research.

3. Number of experts used to establish the ground truth for the test set and qualifications of those experts:

This information is not provided in the document. The tests described (surgical accuracy in bone models, 3D modeling for passive fit, fatigue testing) are physical or computational tests, not human-interpretation-based tests that would require expert ground truth.

4. Adjudication method for the test set:

This information is not applicable/not provided. The assessment of these non-clinical tests would have been based on measurement and engineering analysis, not expert adjudication of subjective findings.

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:

This is not applicable. The device is an endosseous dental implant system, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted or mentioned.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

This is not applicable. The device is a physical medical device (dental implant system), not an algorithm or software.

7. The type of ground truth used:

• Surgical Accuracy Test: Ground truth would have been based on physical measurements and engineering specifications of the implant placement within the bone models (e.g., deviation from planned position and angle).
• Framework Compensation Mechanism: Ground truth was established through three-dimensional modeling and simulation, confirming the design's ability to achieve a "passive fit" based on engineering principles.
• Fatigue Testing: Ground truth was based on material science and engineering standards (ISO 14801) and the device's ability to withstand a specified number of cycles at a given load.
• Other tests (Sterilization, Packaging, Shelf Life, Biocompatibility, Surface Treatment): Ground truth was established through adherence to recognized industry standards (e.g., ISO, ANSI/AAMI), analytical chemistry (Auger analysis, IR spectrum), and established biological testing methodologies (cytotoxicity).

8. The sample size for the training set:

This information is not applicable/not provided. The device is not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established:

This information is not applicable/not provided, as there is no training set for this type of device.

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