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NobelProcera® Titanium ASC Abutments:

NobelProcera® Abutment Titanium is a patient-matched CAD/CAM prosthetic component directly connected to endosseous dental implants and is indicated for use as an aid in prosthetic rehabilitation.

Omnigrip Clinical Screw Titanium:

Clinical and Abutment Screws are indicated for use to secure a dental abutment or framework to a dental implant in the maxilla or mandible for supporting tooth replacements and are indicated as an aid in prosthetic rehabilitation.

The Subject Device NobelProcera® Titanium ASC Abutment is composed of two device lines: NobelProcera® Titanium ASC Abutment and the Clinical Screw Omnigrip Titanium.

NobelProcera® Titanium ASC Abutment is a patient matched CAD/CAM dental prosthesis which is connected to the Nobel Biocare implants featuring an internal conical and/or internal tri-channel connection, is available in the platform sizes NP, RP WP and 6.0 (for internal tri-channel connection only) and is intended for use as an aid in prosthetic rehabilitation to restore chewing function and esthetic appearance.

NobelProcera® Titanium ASC Abutments undergo patient matched customization at a Nobel Biocare production facility for the final, finished abutment device manufacturing.

NobelProcera® Titanium ASC Abutment is connected to the implant with a clinical screw and features an angulated screw channel which can be defined by the customer in an angulation (to the implant's axis) between 0° and 25°, in addition the abutment can be angulated to a maximum of 30°. The clinical screw features the Omnigrip Interface which allows tightening up to 25°.

NobelProcera® Titanium ASC Abutment and Omnigrip Clinical Screw Titanium are composed of titanium vanadium alloy Ti6Al4V ELI (ISO 5832-3, ASTM F136) and the surface of the abutments are provided with and without anodization and the Omnigrip Clinical Screw Titanium are provided with and without DLC coating.

The finished NobelProcera® Titanium ASC Abutment supports the placement of a cement-retained dental prosthesis.

Omnigrip Clinical Screw Titanium is available for the NP, RP, WP and 6.0 (for internal tri-channel connection only) platform, the devices connect the NobelProcera Titanium ASC Abutments to the dental implants. The devices feature an Omnigrip interface.

Here's an analysis of the provided text regarding acceptance criteria and device performance.

Important Note: The provided document is an FDA 510(k) Premarket Notification letter. This type of document is a submission seeking regulatory clearance, not a standalone study report. As such, it outlines the basis for demonstrating substantial equivalence to a predicate device, which includes non-clinical testing. It does not typically contain detailed acceptance criteria and performance data for a study proving a device meets those criteria in the way a clinical trial report or a comprehensive validation study would.

The document primarily focuses on demonstrating that the new device is substantially equivalent to legally marketed predicate devices, meaning it is as safe and effective. It refers to non-clinical tests that were performed, but does not present the specific acceptance criteria or the numerical results of those tests in a "performance table" format.

Therefore, many of the requested points below cannot be fully extracted from this document, as it's not the type of report that contains that level of detail for acceptance criteria and specific study outcomes. I will highlight what can be inferred or directly stated from the provided text, and what cannot.

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present a table of "acceptance criteria" alongside "reported device performance" in a quantitative manner as one might find in a detailed engineering validation report or a clinical study. Instead, it states that "non-clinical tests demonstrate that the device is substantial equivalent."

The document mentions several tests and standards the device was subjected to:

• Packaging system performance testing: per ASTM D4169. (Specific acceptance criteria and reported performance not detailed.)
• Dynamic loading testing: conducted according to ISO 14801 and FDA Guidance Document ("Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments" (May 12, 2004)). (Specific acceptance criteria and reported performance not detailed.)
• Magnetic Resonance compatibility testing: according to ASTM F2052, ASTM F2213, ASTM F2119, and ASTM F2182. Status: "MR Conditional." (This is a performance outcome, but the specific metrics and acceptance thresholds for each ASTM standard are not detailed.)
• Verification of biocompatibility: in accordance with ISO 10993-1. (The conclusion is that "no new issues regarding biocompatibility were raised," implying acceptance, but specific criteria and test results not detailed.)
• End user cleaning and sterilization validation: in accordance with ISO 17665-1. (Implied acceptance, but specific criteria and results not detailed.)

The "acceptance criteria" here are generally referred to as meeting the requirements of the standards and demonstrating substantial equivalence to the predicate device. The "reported device performance" is summarized as favorable results sufficient for substantial equivalence determination.

2. Sample sizes used for the test set and the data provenance

• Sample sizes: Not specified in the provided text for any of the non-clinical tests mentioned (packaging, dynamic loading, MR compatibility, biocompatibility, sterilization validation).
• Data provenance: Not explicitly stated (e.g., country of origin). The testing is non-clinical/bench testing, not patient data. It is implied to be internal testing by the manufacturer, Nobel Biocare AB (Sweden).
• Retrospective or prospective: N/A, as these are non-clinical/bench tests, not clinical studies involving patient data.

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

• Applicability: This question is not directly applicable to the type of non-clinical, bench testing described for the NobelProcera® Titanium ASC Abutment and Omnigrip Clinical Screw Titanium. "Ground truth" established by experts (e.g., radiologists for image interpretation) is relevant for AI/ML device evaluations, particularly in diagnostics. This document refers to physical device testing (mechanical, biocompatibility, etc.).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Applicability: Not applicable. Adjudication methods are typically used in clinical studies or expert reviews to resolve disagreements in interpretations or diagnoses for establishing "ground truth," which is not the nature of the non-clinical tests described here.

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

• Applicability: Not applicable. This device is a dental abutment and screw, not an AI/ML-enabled diagnostic device for image interpretation. Therefore, no MRMC study or AI assistance evaluation would have been performed.

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

• Applicability: Not applicable. See point 5. This is a physical medical device, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Applicability: The concept of "ground truth" as typically applied in AI/ML validation (e.g., for diagnostic accuracy) does not directly apply to the non-clinical device testing described. For these tests, the "ground truth" is typically defined by the specified parameters and performance requirements of the relevant international standards (e.g., ISO 14801 for dynamic loading, ISO 10993-1 for biocompatibility). The devices are expected to meet the performance criteria defined by these standards.

8. The sample size for the training set

• Applicability: Not applicable. This refers to the training of an AI/ML algorithm. The document describes a physical medical device.

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

• Applicability: Not applicable. See point 8.

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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 NobelPerfect Abutments are pre-manufactured prosthetic components directly connected to the endosseous dental implant and are intended for use as an aid in prosthetic rehabilitation.

The NobelPerfect Abutments are direct replacement abutments for the Replace Scalloped Margin Implant System which was marketed under the trade name NobelPerfect. The NobelPerfect Abutments consist of both healing and definitive abutments. Both abutment types are co-packed with the necessary clinical screw. The NobelPerfect Abutments are available for the narrow platform (NP), regular platform (RP), and wide platform (WP). The definitive abutments are 12.0 mm height from the base of the abutment and have no angulation. Both the healing and definitive abutments are made of titanium vanadium alloy.

This FDA 510(k) summary describes Nobel Biocare AB's NobelPerfect Abutments and asserts their substantial equivalence to a predicate device, the Replace Scalloped Margin Implant System (K021584). The document does not contain acceptance criteria or study results that prove the device meets acceptance criteria for performance metrics often associated with AI/ML-driven medical devices (e.g., accuracy, sensitivity, specificity).

Instead, the document focuses on demonstrating substantial equivalence primarily through comparison of technological characteristics and leveraging existing data from predicate devices for aspects like sterilization, packaging, shelf life, and biocompatibility.

The only "performance data" mentioned is the fatigue limit determination for the NobelPerfect Abutment using ISO 14801. However, the document does not provide the acceptance criteria for this test nor the reported results.

Therefore, I cannot provide the requested information regarding acceptance criteria and study results for device performance in the context of typical AI/ML medical device evaluation. The information provided in the document is for a traditional medical device (dental abutments) seeking 510(k) clearance based on substantial equivalence to a predicate, not for an AI-driven device with performance metrics like accuracy or sensitivity.

If the request assumes this is an AI/ML device, that assumption is incorrect based on the provided document.

However, assuming the intent of the request is to extract any available "performance data" or evidence of meeting standards, even if not explicitly stated as "acceptance criteria" for an AI model, I can highlight what is present:

Missing Information/Not Applicable in this Document:

• Acceptance Criteria for AI Performance Metrics: Not applicable as this is not an AI/ML device description.
• Reported Device Performance (for AI metrics): Not applicable.
• Sample size for test set, data provenance: Not applicable.
• Number of experts, qualifications: Not applicable.
• Adjudication method: Not applicable.
• MRMC comparative effectiveness study: Not applicable.
• Standalone algorithm performance: Not applicable.
• Type of ground truth: Not applicable.
• Sample size for training set, ground truth for training set: Not applicable.

Information that could be broadly interpreted as "performance" or "meeting criteria" in this specific document:

The document focuses on demonstrating that the NobelPerfect Abutments are substantially equivalent to the predicate device, K021584, based on technological characteristics and non-clinical testing.

1. A table of (implied) acceptance criteria and the reported device performance:

The document doesn't present acceptance criteria in a table format with specific quantitative thresholds. Instead, it relies on demonstrating consistency with or improvement upon the predicate device's characteristics and meeting established standards for certain tests.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Fatigue Limit (ISO 14801): The sample size for this test is not specified in the summary document. Data provenance is not specified.
• Other tests (Sterilization, Packaging, Shelf Life, Biocompatibility): No new testing was performed for the subject device. Existing data from the predicate device (K170135, K021584), validated to relevant international standards (e.g., ANSI/AAMI/ISO 11137), was leveraged. The provenance of this leveraged data is not detailed in this summary.

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)

• This information is not applicable to
  • the type of medical device (physical implant components)
  • the type of evaluation performed (substantial equivalence to a predicate based on material, design, and non-clinical engineering tests like fatigue).
    There is no concept of "ground truth" established by human experts in the context of this 510(k) submission for dental abutments.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable for the reasons stated in point 3.

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)

• Not applicable. The "truth" in this context is the adherence to material specifications, validated manufacturing processes, and performance against engineering standards (like ISO 14801), rather than a diagnostic or interpretive ground truth.

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.

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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 for 11.5 mm implant and 14.5 mm for 13.0 implant 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 Trefoil Implants are made of CP4 titanium. The implants are parallel walled and have an internal conical abutment connection. The implants have a 13.0 mm threaded portion and are available with both a 4.5 and 6.0 mm collar height. The apex of the implants have cutting chambers allowing for self-tapping. The implant bone interface has the TiUnite implant surface treatment.

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves a device meets those criteria, specifically concerning an AI/algorithm-based diagnostic device. The document is a 510(k) premarket notification for a dental implant system (TREFOIL System) and discusses its substantial equivalence to previously marketed predicate devices.

The text does not include details about:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets, data provenance, or training sets for an AI/algorithm.
• Number or qualifications of experts, or ground truth adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance.
• Type of ground truth used (e.g., pathology, outcomes data).
• How ground truth for any training set was established.

The document primarily focuses on:

• Device Description: The TREFOIL System is a dental implant system consisting of implants, surgical components, and prosthetic components for restoring chewing function in fully edentulous mandibles.
• Predicate Devices: It compares the subject device to two predicate TREFOIL Systems (K152836 and K170135).
• Technological Characteristics Comparison: The key difference noted is a change in implant length from 11.5 mm to 13.0 mm, which is already present in a reference predicate. All other technological characteristics (design, material, surface modification) are stated to be the same as the predicate devices.
• Non-Clinical Testing Summary: The document explicitly states that "No clinical data was used to support the decision of safety and effectiveness." Instead, the manufacturer leveraged data from the predicate devices because the subject device "does not represent a new worst case" for aspects like sterilization, packaging, shelf life, biocompatibility, and fatigue testing.

Therefore, I cannot fulfill your request for information about acceptance criteria and an AI/algorithm study based on the provided text.

Ask a specific question about this device