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NeoConvert Solution: The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. The NeoConvert Solution may be used with single-stage or two-stage procedures, for temporary multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading.

Direct Screw to MUA: The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. The Direct Screw to MUA may be used with single-stage or two-stage procedures, for screw-retained multi-unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. All digitally designed personalized copings to be used with the Direct to Multi Unit Abutment Screw are intended to be sent to Straumann for manufacture at a validated milling center.

GM Attachment TiN 30°: The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. The GM Attachment TiN 30° may be used with single-stage or two-stage procedures, for multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading.

This premarket notification includes the following additions to the Neodent Implant System: NeoConvert Solution, Direct Screw to MUA, GM Attachment TiN 30°. The Neodent Multi-Unit Abutments proposed on this submission are similar to devices already cleared in previous submissions of Neodent Implant System, according to predicate devices described above. This submission intends to expand the portfolio of Neodent Abutments with these new solutions for multi-unit restorations, to provide more treatment options to customers. The NeoConvert Solution is a technique comprised by some abutments (not subject of this submission) used for converting removable temporary prosthesis into a screw-retained fixed temporary prosthesis. The Direct Screw to MUA is a prosthetic component designed to fix planned and digitally designed multi-unit milled restorations directly onto mini or micro abutments, eliminating the need for using the passive seating cylinder to restore chewing function. The GM Attachment TiN 30° is a prosthetic component used to stabilize implant-mucosa-supported removable full prosthesis (retained on the implant and supported on the mucosa), on implants installed in the maxilla or mandible. Although all these three new solutions are compatible with the same implants and components of Neodent Implant System and used for multiple unit rehabilitation, they are not used in conjunction with each other.

The provided text describes a 510(k) premarket notification for the "Neodent Implant System," focusing on the NeoConvert Solution, Direct Screw to MUA, and GM Attachment TiN 30°. This document details the device's technical characteristics, intended use, and its substantial equivalence to previously cleared predicate devices.

However, the provided text does not contain information about acceptance criteria and a study proving a device meets those criteria in the context of an AI/ML medical device submission. The document is a traditional 510(k) submission for dental implants and abutments, which are physical medical devices, not AI/ML software. Therefore, the specific requirements for an AI/ML device study (such as sample sizes for test and training sets, expert qualifications for ground truth, MRMC studies, or standalone performance) are not applicable or present in this document.

The "Performance Testing" section (pages 15-16) describes bench testing (dynamic fatigue, torsion, SEM images), MRI compatibility testing, biocompatibility testing, sterilization validation, and shelf-life testing for the physical dental implant components. These are standard performance tests for this type of physical device, not AI/ML algorithm validation.

Therefore, I cannot provide a table of acceptance criteria and a study proving the device meets acceptance criteria as typically outlined for an AI/ML medical device, as this information is not present in the provided document. The document focuses on demonstrating substantial equivalence of a physical dental device to predicate devices through engineering and material testing.

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Indications for Use for Zygoma-S GM Implant:

Zygomatic implants are indicated for intraoral surgical procedures in the zygoma region in cases of severe maxilla bone resorption, to restore the patient's chewing function and aesthetics. Zygomatic Implants may be used in one or two-stage procedures, multiple unit restorations, and immediate loading when there is primary stability and adequate occlusal load.

Indications for Use for GM Mini Conical Abutment 52° and 45°:

Product indicated for surgical procedures in zygomatic bones, making possible the rehabilitation with screw-retained abutments over the implant, thus restoring the chewing function. It may be used in one- or two-stage procedures, multiple unit restorations, and immediate loading when there is primary stability and adequate occlusal load. Multiple rehabilitations may be splinted rigidly.

Indications for Use for Coping for Removable Prosthesis:

The product, when used with non-zygomatic implants, is intended to be surgically placed in the bone of the upper or lower jaw, to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. It may be used with single stage or two-stage procedures, for multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with approprate occlusal loading. Multiple tooth applications may be rigidly splinted. When used with zygomatic implants, the product is indicated for surgical procedure only in upper jaw to provide support for prosthetic devices, such as artificial teeth, to restore chewing function. It may be used in two-stage procedures (delayed loading protocol) and for multiple unit restorations. Multiple rehabilitations may be splinted rigidly.

The subject devices implants are single use devices, provided sterile by Gamma Radiation, made of commercially pure Titanium grade 4 (ASTM F67). The Zygomatic Implant is a long implant with a nominal diameter of 3.50 and 3.75mm, conical apex with rounded tip, 3 helical chambers, trapezoidal thread and GM prosthetic interface. The cervical portion in both models has Ø 4.3 mm. The length varies from 30 to 55 mm. Zygomatic Implants are intended to provide support for a fixed prosthesis in patients with severe atrophy in the maxillary region. They are extra-long to allow bone anchorage in the zygomatic bone. The subject implants consider the Zygoma Anatomy-Guided approach (ZAGA) for planning the surgical steps, being indicated for extrasinus and extra maxillary installation technique (ZAGA-4).

The subject abutments are single use devices, provided sterile by Ethylene Oxide, made of Titanium alloy (Tl6Al4V-ELI). They are intermediate prosthetic components angled at 52 and 45 degrees with gingiva heights 1.5 and 2.5 mm, to be installed on the implant, offering a structure to support the screw-retained multiple prosthesis. The abutments present GM prosthetic interface and are available in the anti-rotational form in the implant to abutment interface, and rotational form in the abutment to prosthesis interface, presenting different transmucosal heights.

The subject coping is single use device, provided sterile by Ethylene Oxide, made of titanium alloy (Ti6Al4V-ELI). It presents a NEO torque interface for torque application. The subject device has diameter 4.80 mm and total height 4.60 mm. They are indicated for removable prostheses with fitting over Mini Conical Abutment installed in the maxilla or mandible and can be used in partial removable prostheses or over dentures. They are compatible with all previously cleared GM Mini Conical abutments.

The provided document is a 510(k) premarket notification for a medical device (Neodent Implant System - GM Zygomatic Implant System). It focuses on demonstrating substantial equivalence to predicate devices through comparisons of indications for use, technological characteristics, and performance data, primarily bench testing, sterilization validation, shelf life validation, and biocompatibility.

Crucially, this document does not contain information about an AI/ML algorithm or a study validating its performance, nor does it detail acceptance criteria for software or AI/ML components. The product being cleared is a set of dental implants and abutments. Therefore, I cannot extract the acceptance criteria and study details for an AI-powered device as requested.

The document discusses performance data in the context of the physical dental implants and abutments, which includes:

• Performance Testing – Bench: Dynamic fatigue testing (ISO 14801), insertion tests, torsion tests, and microscopic analysis of the implant body.
• Surface treatment: Discussion of the NeoPoros surface.
• MR Compatibility testing: Assessment of safety in MRI environments.
• Sterilization validation: Conformance to ISO standards for Gamma Irradiation (implants) and Ethylene Oxide (abutments).
• Shelf Life validation: Based on packaging integrity and physical stability.
• Biocompatibility: Testing per ISO 10993 standards.
• Clinical data: A review of published literature on zygomatic implants, including survival rates and observed complications (not a specific clinical study conducted for this device clearance).

If you are looking for information regarding acceptance criteria and study data for an AI/ML medical device, this document does not provide it, as it pertains to a different type of medical device.

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Indications for Use for NUVO IF Implants and conventional abutments:

The NUVO IF Implant System is intended to be surgically placed in the maxilla or mandible to provide support for prosthetic devices such as artificial teeth in order to restore chewing function. It may be used with single-stage or twostage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. Multiple tooth applications may be rigidly splinted.

The Titanium Temporary Abutment is indicated to provide temporary support for prosthesis structure for up to 6 months.

The Attachment Equator and Attachment Removable Prosthesis are indicated for the attachment of full or partial dentures to NUVO implants.

Indications for Use for Rotational and Anti-rotational Titanium Bases abutments:

Titanium Base Abutment is a titanium base placed onto dental implants to provide support for customized prosthetic restorations. It is used with a coping and crown, or crown alone, and is indicated for cement or screw-retained single or multi-unit restorations or screw-retained single restorations.

All digitally designed copings and/or crowns to be used with the Titanium Base Abutment System are intended to be sent to Straumann for manufacture at a validated milling center.

The Rotational Titanium Base is indicated for cement or screw-retained multi-unit restorations.

Indications for Use for CARES® Abutment IF:

The CARES® Abutment is a customized prosthetic abutment, manufactured in titanium alloy, placed onto dental implants to provide support for customized prosthetic restorations (copings or crowns). It is indicated for cementretained single restorations. All digitally designed abutments for use with the CARES® Abutment are intended to be sent to Straumann for manufacturing at a validated milling center.

The NUVO IF Implant System consists of implants, cover screws, and abutments.

Implants: Intended for single use, provided sterile via gamma irradiation, manufactured of commercially pure titanium (Grade 4), bone level design, apically tapered thread-form with apical cutting flutes in various diameters and lengths, and provided with an internal hexagonal implant-to-abutment interface.

Cover Screws: Intended for single use, used to protect the internal geometry of the implants during healing, placed out of occlusion, provided sterile via gamma irradiation or ethylene oxide gas, manufactured of titanium alloy (Ti6Al4V-ELI), and provided with an implant-to-abutment interface compatible with the internal hexagonal geometry of the implants.

Abutments: Intended for single use, provided sterile via ethylene oxide gas or non-sterile, manufactured of titanium alloy (Ti6Al4V-ELI) or a combination of POM polymer and cobalt-chromium alloy, conical format available in different diameters, height of cementable area and gingival height, screw-retained to the implant, provided with an implant-to-abutment interface compatible with the internal hexagonal geometry of the implants, provided with coronal geometries in rotational (non-indexed) and anti-rotational (indexed) versions, and Titanium Base abutments are two-piece abutments composed of a titanium base and a patient-specific CAD/CAM top-half.

This looks like a 510(k) summary for a dental implant system (NUVO IF Implant System), not a study describing acceptance criteria and performance data for an AI/ML medical device. Therefore, I cannot extract the requested information regarding acceptance criteria and performance studies for an AI device.

The document discusses:

• Trade/Device Name: NUVO IF Implant System
• Regulation Number/Name: 21 CFR 872.3640, Endosseous Dental Implant
• Regulatory Class: Class II
• Product Code: DZE, NHA
• Indications for Use: Surgical placement in maxilla or mandible for prosthetic device support, including immediate loading, temporary support, and attachment of dentures.
• Device Description: Details on implants (material, design, size, sterilization), cover screws (material, use, sterilization), and various abutment types (materials, design, sterilization, use).
• Predicate Devices: Several predicate devices are listed and compared for substantial equivalence.
• Performance Data: This section details non-AI/ML performance testing, including:
  • Dynamic fatigue testing per ISO 14801.
  • Sterilization validation (gamma irradiation per ISO 11137-1/2, ethylene oxide per ISO 11135, moist heat per ISO 17665-2).
  • Ethylene oxide residuals testing per ISO 10993-7.
  • Biological Safety Assessment per ISO 10993-1 (cytotoxicity per ISO 10993-5, chemical characterization per ISO 10993-18).
  • Package transport integrity per ISTA 2A.
  • Product and package stability per ASTM F1980.
  • Product endotoxin testing (LAL) per ANSI/AAMI ST72.

There is no mention of an AI/human-in-the-loop study, ground truth establishment, sample sizes for training/test sets for AI, or expert adjudication.

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Implacil Implant System is intended for placement in the maxillary or mandibular arch to provide support for single-unit and/or multi-unit restorations. When a one-stage surgical is applied, the Implacil Implant System is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

Implacil Implant System is composed of three implant lines that are divided according to the implant-toabutment interface: External Hex (HE), Internal Hex (HI) and Morse Taper AR Due Cone (CM AR). HE and HI lines are composed of tissue-level implants while CM AR line of bone-level implants. Each implant line is composed of implants and related prosthetic components available in multiple designs (temporary, screwed, cementable, angled, straight, UCLA, ball).

HE implant line implants are available in two root-forms designs: conical (tapered) and cylindrical. Conical implants are available in three diameters and platforms (3.5, 4.0 and 5.0 mm) and five lengths (7.0, 9.0, 11.0, 13.0 and 15.0 mm). Cylindrical implants are provided in four diameters (3.3, 3.75, 4.0 and 4.75 mm), three platforms (3.5, 4.0 and 5.0 mm) and five lengths (8.0, 10.0, 11.5, 13.0 and 15.0 mm). HE cylindrical implants of diameters 3.75 and 4.0 share the same platform of 4.0 mm.

HI implant line implants are available in two root-forms designs: conical (tapered) and cylindrical. Conical implants are available in three diameters and platforms (3.5, 4.0 and 5.0 mm). For diameters 3.5 and 4.0 are available in the lengths 8.0, 9.0, 11.0, 13.0 and 15.0 mm, and for diameters 5.0 are available in the lengths 7.0, 9.0, 11.0, 13.0 and 15.0 mm. Cylindrical implants are provided in four diameters (3.3, 3.75, 4.3 and 4.75 mm) and three platforms (3.5, 4.0 and 5.0 mm). For diameter 3.3 are available in the lengths 8.0, 9.0, 11.0, 13.0 and 15.0 mm, and for diameters 3.75 and 4.3 are available in the lengths 7.0, 9.0, 11.0, 13.0 and 15.0 mm. HI cylindrical implants of diameters 3.75 and 4.3 share the same platform of 4.0 mm.

CM AR implant line implants are available in conical root-form design only, in four diameters (3.5, 4.0, 4.5 and 5.0 mm) and five lengths (7.0, 9.0, 11.0, 13.0 and 15.0 mm).

lmplacil implants are made of commercially pure titanium (ASTM F67). Implacil prosthetic components are made of commercially pure titanium (ASTM F67) or titanium alloy (ASTM F136). Implant System screws (abutment screw, UCLA screws and coping screws) are made of titanium alloy (ASTM F136).

The subject device abutments components mate exclusively with the subject implants of the same line (HJ, HE, CM AR).

The provided document is a 510(k) Summary for a dental implant system. It outlines the device description, intended use, and a comparison to predicate and reference devices to demonstrate substantial equivalence. Crucially, this document does not contain information about acceptance criteria or a study proving the device meets specific acceptance criteria in the context of AI/ML-based medical devices.

The "Performance Data" section explicitly states: "No clinical data were included in this submission." Instead, it lists non-clinical data for physical and material properties of the dental implants, such as sterilization validation, shelf life testing, biocompatibility, and mechanical performance (fatigue and torsional loading).

Therefore, I cannot provide the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, ground truth establishment, or MRMC comparative effectiveness studies, as these types of studies are not described in this 510(k) submission for a traditional medical device (dental implants), which are not a software device or AI/ML-based device.

If you are looking for information on acceptance criteria and study data for AI/ML-based medical devices, you would need to consult a different type of FDA submission, specifically for software as a medical device (SaMD) or AI-enabled medical devices, where such performance data would be critical for demonstrating safety and effectiveness.

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Straumann BLX Healing Abutments for Bars and Bridges: Straumann Healing abutments are indicated to be placed in the patient's mouth at the end of the implant placement to protect the inner configuration of the implant and to form, maintain and stabilize the soft tissue during the healing process. Healing abutments should be used only with suitable implant connections. Healing components have a maximum duration of usage of 6 months.

Straumann BLX Temporary Abutments for Bars and Bridges: Prosthetic components directly or indirectly connected to the endosseous dental implant are intended for use as an aid in prosthetic rehabilitations. Temporary components can be used prior to the insertion of the final components to maintain, stabilize and shape the soft tissue during the healing phase; they may not be placed into occlusion. Final abutments may be placed into occlusion when the implant is fully osseointegrated. BLX Temporary Abutments have a maximum duration of usage of 180 days.

Straumann BLX Variobase Abutments for Bar and Bridges: Straumann® Variobase® prosthetic components directly or indirectly connected to the endosseous dental implant are intended for use as an aid in prosthetic rehabilitations. The prosthetic restoration (bridge or overdenture) can be cemented on the Straumann® Variobase® prosthetic components. A temporary restoration can be used prior to the insertion of the final components to maintain, stabilize and form the soft tissue during the healing phase. They may not be placed into occlusion. Final abutments and restorations may be placed into occlusion when the implant is fully osseointegrated.

Straumann BLX Variobase Abutments AS: The Straumann Variobase for Crown AS is a titanium base placed onto Straumann dental implants to provide support for customized prosthetic restorations. Straumann Variobase for Crown AS are indicated for screw retained single tooth or cement-retained single tooth and bridge restorations. A temporary restoration can be used prior to the insertion of the final components to maintain, stabilize and form the soft tissue during the healing phase. Temporary restorations are indicated to be placed out of occlusion. All digitally designed copings and/or crowns for use with the Straumann Variobase for Crown AS are intended to be sent to Straumann for manufacture at a validated milling center.

Straumann BLX Novaloc Abutments: The Straumann® Retentive System is indicated for the attachment of full or partial dentures on Straumann dental implants.

Straumann BLX CARES Abutments: The Straumann CARES Abutments are indicated for single tooth replacement and multiple tooth restorations. The prosthetic restoration can be cemented or directly veneered/screw-retained.

BLX Healing Abutments for Bars and Bridges: Healing abutments are screwed into the implant in cases of transmucosal healing to protect the inner configuration of the implant and maintain, stabilize and form the soft tissue during the healing process. They are placed out of occlusion and have a maximum duration of usage of 180 days. Unlike the predicate RB/WB healing abutments (K173961), the subject healing abutments are intended to shape the soft tissue for posterior placement of bridge restorations instead of single crowns. The subject healing abutments are manufactured from Titanium Grade 4 and are anodized in violet.

BLX Temporary Abutments for Bars and Bridges: Temporary Abutments are intended to be placed into Straumann dental implants to provide support for temporary restorations. Temporary components can be used prior to the insertion of the final components to maintain, stabilize and shape the soft tissue during the healing phase, as well as provide a temporary esthetic solution. They support a temporary restoration and may not be placed into of occlusion. Straumann BLX Temporary Abutments have a maximum duration of usage of 180 days. Unlike the predicate RB/WB temporary abutments (K173961), the subject temporary abutments are intended to shape the soft tissue for posterior placement of bridge restorations instead of sinqle crowns. The subject temporary abutment cannot be shortened. The Temporary abutment for bar/bridge is a non-engaging device intended to support multiple-unit restoration. The subject temporary abutment is manufactured from TAN and is anodized in violet. The temporary abutments are fixed in the implant by means of a basal screw which is also manufactured from TAN.

BLX Variobase Abutments for Bars and Bridges: Variobase Abutments for Bars and Bridges are intended to be placed into Straumann implants to provide support for multi-unit restorations. The prosthetic restoration (bar/bridge) must be cemented onto the Variobase abutments, which is then screwed onto the implants. A temporary restoration can be used prior to the insertion of the final components to maintain, stabilize and shape the soft tissue during the healing phase; they must be placed out of occlusion. Final abutments and restorations may be placed into occlusion when the implant is fully osseointegrated. Unlike the predicate Variobase abutments (K173968), the subject Variobase abutments present 3 retention features in the chimney instead of 4. The Variobase abutments for bar/bridges are non-engaging devices intended to support multiple-unit restorations. The subject Variobase abutments are manufactured from TAN and are anodized in violet. The Variobase abutments are fixed in the implant by means of a basal screw which is also manufactured from TAN.

BLX Variobase Abutments AS for Crowns: Variobase abutments AS for crowns are intended to be placed into Straumann implants to provide support for single-unit restorations. The prosthetic restoration (crown) must be cemented onto the Variobase abutment, which is then screwed onto the implant. A temporary restoration can be used prior to the insertion of the final components to maintain, stabilize and shape the soft tissue during the healing phase; they must be placed out of occlusion. Final abutments and restorations may be placed into occlusion when the implant is fully osseointegrated. The Variobase abutments are manufactured from TAN and are anodized in violet or in brown according to the compatible BLX implant platform (RB/WB or RB). Unlike the predicate Variobase abutments (K173961/K173379), the subject Variobase abutments present 3 retention features in the chimney instead of 4. The chimney presents a cutout window to facilitate the handling of the screw driver in an angulated position. The Variobase abutments AS for crown are engaging devices intended to support single-unit restorations. The Variobase abutments are fixed in the implant by means of a basal screw which is also manufactured from TAN. The Variobase abutments for crown AS are titanium bases to be used as the lower part of two-piece abutments. The upper part of the two-piece abutment is a CAD/CAM designed and manufactured restoration. The planning and milling of the customized restoration must be made using the validated Straumann CARES Visual, Dental Wings software using the Straumann CARES Visual Plug-In. All digitally designed copings and/or crowns for use on the Variobase abutments are intended to be manufactured at a validated milling center.

BLX Novaloc Abutments: Novaloc Abutments are intended to be placed into Straumann dental implants to provide support for full arch detachable restorations (over-denture). The Novaloc abutments are manufactured from TAV (Ti-6Al-4V, Titanium-Aluminum-Vanadium) and are anodized in violet. The restoration is connected to the Novaloc abutment through a snap-on fixture provided by a negative shape of Novaloc snap-on fixture embedded into the final restoration. The snap-on feature is TiN coated. Unlike the reference Novaloc abutments (K173902), the subject Novaloc abutments are not only provided in a straight version but also angulated. The Novaloc abutments are provided non-sterile with instructions for end user sterilization. Angled models: are composed of an abutment body with a coupled basal screw. They are engaging devices. Straight models: both body and thread parts are machined in one piece. They are nonengaging devices.

BLX CARES Abutments: CARES Abutments are intended to be placed into Straumann implants to provide support for prosthetic reconstructions such as crowns and bridges. The final abutment, fabricated from a pre-milled blank, is designed to allow for individual customization regarding function and esthetics. The blank, manufactured from TAN and CoCr, is composed of a pre-milled implant-toabutment connection (TorcFit) and a cylindrical body with enough material volume to create a wide range of geometries for the final abutment. Inside the abutment, a screw channel provides access to the internal thread feature of the implant, such that the component can be firmly attached while providing fit between screw, abutment and implant. The planning and milling of the customized restoration must be made using the validated Straumann CARES Visual, Dental Wings software using the Straumann CARES Visual Plug-In. The maximum angulation allowed is 30° and the minimum wall thickness allowed is 0.4 mm. All digitally designed abutments are intended to be manufactured at a validated milling center.

BLX Basal Screws: Basal screws are used to fix abutments to dental implant, and can also be used during lab procedures to fix lab prosthetic parts on implant analogs. They are provided along the abutments and also provided as standalone screws. The subject Basal Screws are manufactured from TAN. The Basal Screw for Variobase AS is anodized in green since this color identifies Straumann devices pertaining to AS system.

The provided 510(k) summary for the Straumann® BLX Line Extension - New Abutments is a pre-market notification to the FDA. This type of submission focuses on demonstrating substantial equivalence to existing legally marketed devices, rather than proving the device meets acceptance criteria through a traditional clinical study with defined performance targets.

Instead of "acceptance criteria," the focus here is on bench testing performance demonstrating fundamental material and structural integrity compared to predicate devices, and lack of significant differences in technological characteristics and indications for use.

Therefore, the requested information elements related to clinical studies, test sets, ground truth, and expert adjudication are not applicable in the context of this 510(k) summary, as no device-specific clinical data has been submitted to demonstrate substantial equivalence. The submission relies on performance data from bench testing and biocompatibility assessments to support the claim of substantial equivalence.

Here's the information that can be extracted from the provided text, re-interpreting "acceptance criteria" as the comparable characteristics to predicate devices and "reported device performance" as the results of the bench and biocompatibility tests.

Acceptance Criteria and Study Details for Straumann® BLX Line Extension - New Abutments

As this is a 510(k) submission primarily relying on substantial equivalence to predicate devices, the concept of "acceptance criteria" is less about meeting specific numerical performance targets in a clinical setting and more about demonstrating that the new devices do not raise new questions of safety or effectiveness. The study supporting this is primarily bench testing and biocompatibility assessments, rather than a clinical trial.

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

The "acceptance criteria" for a 510(k) are implicitly that the new device's technological characteristics and performance are substantially equivalent to a predicate device, without raising new questions of safety or effectiveness. The "reported device performance" refers to the results of the bench tests and sterility/biocompatibility validations.

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