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Straumann BLX Implants are suitable for endosteal implantation in the upper and lower jaw and for the functional and esthetic oral rehabilitation of edentulous and partially edentulous patients. BLX implants can placed with immediate function on single-tooth and multi-unit restorations when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. The prosthetic restorations used are connected to the implants through the corresponding abutment components.

The BLX Implants are fully tapered implants manufactured utilizing the Roxolid material and finished with the SLA or SLActive surface. The connection is identified as conical fitting with the Torx style engaging feature. The subject BLX implants have endosteal implant diameters of Ø3.75 and Ø4.0 mm with a length of 6 mm and are presented with one prosthetic platform: RB (Regular Base). The internal connection and the prosthetic platform are identical for all subject devices.

This is a 510(k) summary for a dental implant system, which primarily relies on demonstrating substantial equivalence to a predicate device rather than presenting comprehensive clinical study performance against specific acceptance criteria. Therefore, the requested information (acceptance criteria, specific study details like sample size, ground truth methodology, expert qualifications, effect size with AI assistance, MRMC study, and training set information) is not typically found in this type of submission.

The document describes bench testing to demonstrate equivalence, not clinical performance with acceptance criteria in the way one might see for an AI/ML medical device.

However, I can extract information related to the performance testing described:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size and Data Provenance:

• Bench Testing (Dynamic Fatigue, Insertion Tests): The document does not specify exact sample sizes for these tests. The nature of these tests (comparing against established predicates) generally involves a representative number of units to ensure consistency and meet engineering standards, but it's not a clinical trial with human subjects.
• Data Provenance: Not applicable in the context of clinical study data with geographic origin. The data is generated from laboratory bench tests.

3. Number of Experts and Qualifications for Ground Truth:

• Not applicable. These are bench tests for mechanical and material properties, not clinical studies requiring expert consensus for ground truth establishment.

4. Adjudication Method for the Test Set:

• Not applicable. This relates to clinical data review, not bench testing.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No. This is not a study involving human readers or AI assistance. It's a submission for an endosseous dental implant based on substantial equivalence to existing devices, primarily supported by bench testing.

6. Standalone (Algorithm Only) Performance:

• No. This device is a physical medical implant, not an algorithm or AI system.

7. Type of Ground Truth Used:

• For mechanical/material properties: The "ground truth" is defined by established engineering and biological standards (e.g., ISO for fatigue, ISO for biocompatibility, FDA guidance for pyrogenicity and sterility).
• For substantial equivalence claim: Comparison against the characteristics and performance of legally marketed predicate devices.

8. Sample Size for the Training Set:

• Not applicable. This is not an AI/ML device that requires a training set.

9. How the Ground Truth for the Training Set was Established:

• Not applicable.

In summary: This 510(k) submission demonstrates substantial equivalence for a dental implant system primarily through non-clinical bench testing rather than large-scale clinical studies with human subjects or AI performance evaluations. The "acceptance criteria" listed are engineering and biological performance targets derived from recognized standards and comparison to predicate devices, not diagnostic accuracy metrics.

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Straumann® BLX Implants are suitable for endosteal implantation in the upper and lower jaw and for the functional and esthetic oral rehabilitation of edentulous and partially edentulous patients. BLX Implants can be placed with immediate function on single-tooth applications when good primary stability is achieved and with appropriate occlusal loading to restore chewing function. The prosthetic restorations are connected to the implants through the corresponding abutment components.

Straumann® Closure Caps and 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 shape, maintain and stabilize the soft tissue during the healing process. Closure caps and healing abutments should be used only with suitable implant connections. Straumann Closure Caps and Healing Abutments have a maximum duration of usage of 6 months.

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® 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 (crowns) can be cemented onto the Straumann® Variobase® prosthetic components. 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. All digitally designed copings and/or crowns for use with the Straumann® Variobase® Abutment system are intended to be sent to Straumann for manufacture at a validated milling center.

The Straumann BLX Implants are fully tapered implants manufactured utilizing the Roxolid material and are finished with SLActive® surface. The connection is identified as conical fitting with Torx style engaging feature. The prosthetic platforms are identified as RB (Regular Base) and WB (Wide Base). The implants with a RB platform have a "small top/head", and implants with WB platform have a "large top/head", whereas the internal connection is identical for both platform and all the implant diameters and lengths.

The closure cap and healing abutments are manufactured from Titanium Grade 4, per ISO 5832-2 and ISO 5832-11, and are anodized signal violet for the parts compatible with the RB platform and brown for the parts compatible with the WB platform for identification purposes. Closure caps are screwed into the implant to protect the inner configuration and shoulder of the implant during the healing phase in cases of submerged (submucosal) healing. Healing abutments are screwed into the implant to protect the inner configuration in cases of transmucosal healing and are placed out of occlusion.

The temporary abutments are manufactured from TAN and are anodized signal violet (RB platform) and brown (WB platform) for identification purposes. The temporary abutments are fixed in the implant with a basal screw which is also manufactured from TAN. The basal screw will be delivered with the temporary abutment.

BLX Variobase abutments is a two-piece abutment ultimately composed by three components: Variobase™ Abutment (Ti-base), Prosthetic restoration (coping and/or crown), and Basal Screw. The BLX Variobase Abutments are manufactured and are delivered with the corresponding basal screw. The prosthetic restoration (crowns) can be cemented onto the Variobase prosthetic components.

Basal screws are used to seat the temporary abutments and the BLX Variobase Abutments to the dental implant, and can be also be used during lab procedures to fix lab prosthetic parts on implant analogs. There is one basal screw for the RB platform and one for the WB platform. They have identical designs and differ only in color-coding (signal violet and brown) to ease the handling. They are provided along the abutments but they are also provided as standalone screws. The BLX basal screws are manufactured from TAN.

This document describes the Straumann® BLX Implant System, a dental implant system, and its various components. The information provided is for a 510(k) premarket notification to the FDA. The goal is to demonstrate substantial equivalence to legally marketed predicate devices.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than setting and meeting specific, quantitative acceptance criteria for novel performance. Instead, the "acceptance criteria" are implied by successful comparative testing and adherence to existing standards and guidance documents. The "reported device performance" is the outcome of these tests.

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