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BLT Dental Implant Systems are intended to be placed in the upper and lower jaw to support prosthetic devices and to restore a patient's chewing function. BLT Dental Implant systems are also indicated for immediate or early implantation following extraction or loss of natural teeth. Implants can be placed with immediate function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading to restore chewing function. The prosthetic restorations used are single crowns, bridges and partial or full dentures, which are connected to the implants through the corresponding components (abutments). In cases of fully edentulous patients, 4 or more implants must be used in immediately loaded cases.

The proposed devices, BLT Dental Implant Systems, are indicated for oral endosteal implantation in the upper and lower jaw and for the functional and esthetic oral rehabilitation of edentulous and partially dentate patients. The proposed devices can also be used for immediate or early implantation following extraction or loss of natural teeth. The proposed device contains dental implant, healing cap and abutment. The dental implant system is available in two types, NC type and RC type.

The request asks for acceptance criteria and details of the study proving these criteria are met. The provided text is a 510(k) Summary for a dental implant system. This type of submission focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical testing and comparison of characteristics, rather than a clinical study with detailed acceptance criteria and performance metrics typically found for AI/ML devices. Therefore, much of the requested information (like effect size, ground truth, sample size for training/test sets, expert qualifications, and adjudication methods) is not applicable or unavailable from this document.

However, I can extract information related to the device's performance based on non-clinical testing and the acceptance criteria implicitly defined by compliance with recognized standards and demonstrated equivalence to the predicate device.

Here's the summary based on the provided document:

Acceptance Criteria and Study Details for BLT Dental Implant System (K212364)

The "acceptance criteria" for this device are implicitly defined by its compliance with various ISO and ASTM standards, and its demonstrated substantial equivalence to a legally marketed predicate device (K150388) and several reference devices. The "study" proving these criteria is a series of non-clinical tests and a comparison of technological characteristics.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not explicitly stated for specific non-clinical tests. Non-clinical tests like mechanical testing (ISO 14801) typically involve a specific number of samples for destructive testing, but the exact count isn't provided in the summary.
• Data Provenance: The tests were conducted by the manufacturer, Bio Concept Co., Ltd. and leverage data from previously cleared devices where materials or processes are identical. The document does not specify the country of origin of the raw test data (e.g., where the mechanical tests were physically performed) beyond the manufacturer's location in China. The data is retrospective in the sense that prior clearance data (K192274, K150388) is referenced for aspects like biocompatibility and surface analysis.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• This is not applicable as this is a non-clinical submission for a physical medical device (dental implant system), not an AI/ML device relying on expert-annotated ground truth. The "ground truth" for non-clinical tests comes from physical measurements against established standards.

4. Adjudication Method for the Test Set

• Not applicable as this is a non-clinical submission for a physical medical device.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable. This device is a physical dental implant system, not an AI/ML device, so no MRMC study was performed.

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

• Not applicable. This is a physical device, not an algorithm.

7. The Type of Ground Truth Used

• The "ground truth" for establishing device performance in this context is derived from:
  • Scientific Standards: Compliance with recognized international and national standards (ISO 14801 for mechanical properties, ISO 10993 for biocompatibility, ISO 11137-2 for sterilization, ASTM standards for materials and packaging).
  • Predicate Device Equivalence: Direct comparison of technological characteristics, materials, and intended use to an existing legally marketed device (K150388) and numerous reference devices.
  • Laboratory Testing: Results from mechanical tests, sterilization validation, bacterial endotoxin tests, and packaging integrity tests.

8. The Sample Size for the Training Set

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

9. How the Ground Truth for the Training Set Was Established

• Not applicable.

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The BTI Dental Implant System UnicCa® for oral implant surgery is to be used for the partial or total replacement of teeth in edentulate patients. Once attached to the bone, the implants act as an anchor for various fixed or removable prosthetic solutions that can be used to improve or restore a patient's mastication function.

In the case of 5.5 - 6.5mm long UnicCa® implants should be used in a two-stage surgical procedure. These implants are indicated for delayed loading. These implants are indicated only for straight abutments and to support permanently fixed restorations.

In the case of Tiny® 3.0 UnicCa® implants: These implants shall be used only to replace maxillary lateral incisors and mandibular lateral and central incisors. Immediate loading is recommended when there is good primary stability and an appropriate occlusal load.

BTI Dental Implant System UnicCa® is a self-tapping, threaded, root form dental titanium implant provided in two types of connections: external (i.e., Externa®) and interna®), in a variety of platforms and range of diameters (3.0 – 6.0 mm) and lengths (5.5 – 18.0 mm). BTI Dental Implant System UnicCa® features an implant surface treatment that improves the hydrophilicity of the implant.

The purpose of this 510(k) is to expand the product offering and include a new dental implant platform (Interna Narrow), and compatible abutments, together with additional implants for the already existing Universal Plus platform. Interna Narrow implants will be offered with implant diameters ranging from 3.3 to 4.75 mm and lengths of 5.5 to 15 mm. Additionally, new implants for the existing Universal Plus platform of diameter 6.0 mm, and lengths of 7.5 to 11.5 mm are included.

This document describes the BTI Interna Narrow/Plus Dental Implant System UnicCa®, which is a dental implant system. The information provided is for a 510(k) premarket notification to the FDA, asserting substantial equivalence to previously cleared predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state "acceptance criteria" in the typical sense of numerical thresholds for outcomes. Instead, it demonstrates substantial equivalence to predicate devices through various non-clinical tests and comparisons. The "performance" is largely reported as demonstrating "substantial equivalence" or being "identical" or "similar" to the predicate devices.

2. Sample size used for the test set and the data provenance:

• Sample Size for Test Set: The document mentions "Comparative area analyses for full external area and for bone resorption of up to 3 mm have been performed for subject implants and reference device." However, specific numerical sample sizes for this or other non-clinical tests (e.g., fatigue testing, biocompatibility) are not provided.
• Data Provenance: The document does not specify the country of origin for the data or whether it is retrospective or prospective. It refers to manufacturing in Spain (B.T.I. Biotechnology Institute, SL Jose Rivero Qualified Person Leonardo Da Vinci 14, Parque Tecnologico de Alava Minano, Alava 01510 SPAIN). The tests are non-clinical, implying laboratory or bench testing, not human patient data.

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

This information is not applicable and not provided as the submission relies on non-clinical, bench testing for substantial equivalence, not clinical study data requiring expert-established ground truth.

4. Adjudication method for the test set:

This information is not applicable and not provided as the submission relies on non-clinical, bench testing.

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 a physical dental implant system, not an AI-assisted diagnostic or therapeutic tool for which an MRMC study would be relevant.

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

This is not applicable as the device is a physical dental implant system, not a software algorithm.

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

The "ground truth" for this submission is based on established engineering and biological performance standards (e.g., ISO, ASTM standards, FDA guidance documents) and comparative data to already cleared predicate physical devices. For example:

• Biocompatibility: Conformance with ISO 10993-1.
• Fatigue Testing: Conformance with ISO 14801 and FDA guidance.
• Sterilization Validation: Conformance with ISO 11137 series.
• Physical measurements and material specifications are compared to those of the predicate devices.

8. The sample size for the training set:

This information is not applicable as there is no mention of a "training set" in the context of this physical device submission, which does not involve machine learning or AI models.

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

This information is not applicable for the reasons stated in point 8.

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The Osteon Precision Milled Suprastructure is indicated for attachment to dental abutments in the treatment of partially or fully edentulous jaws for the purpose of restoring function. The Osteon Precision Milled Suprastructures are intended for attachment to a minimum of two (2) abutments.

The Osteon Milled Suprastructure is indicated for compatibility with the following abutment systems:

• Astra Tech Implant System® Multi Base Abutment EV, 4.8 mm, max 30°
• DESS Dental Multi Unit Abutments, 3.4-5.7 mm, 0°
• 3i OSSEOTITE®
• Astra Tech OsseoSpeed™
• Neodent Grand Morse
• NobelReplace® Conical
• NobelReplace® Trilobe
• Nobel Brånemark System®
• Straumann BLX Implants
• DESS Dental Multi Unit Abutments, Angled, 3.4-6.5 mm, max 30°
• NobelActive® NobelParallel Conical
• Straumann® Bone Level
• Zimmer Screw Vent® and Tapered Screw-Vent®
• Dentium SuperLine® Abutments, 4.5-5.5 mm, max 30°
• Keystone Multi Unit Abutment, 4.8 mm, 0°
• Implant Direct GPS® Angled Abutment, 5.0 mm, max 30°
• MIS Multi-unit Abutments, 4.8 mm
• C1 Conical Connection Implant System, max 30°
• V3 Conical Connection Implant System, max 30°
• Internal Hex Implant System, max 30°
• Conical Connection, max 30°
• Neodent GM Mini Conical Abutment, 4.8 mm, max 30°
• Nobel Biocare Brånemark Multi-Unit Abutment, 4.8 mm, max 17°
• Nobel Biocare Multi-Unit Abutment Plus, 4.8 mm, max 30°
• Nobel Biocare Multi-Unit Abutment, 4.8 mm, max 30°
• Nobel Biocare Multi-Unit Abutments for Straumann and Astra Tech System, 4.8mm, max 30°
• Nobel Biocare Multi-Unit Abutments for Astra Tech, Camlog and Ankylos Implant Systems, 4.8 mm, max 30°
• Nobel Biocare Xeal Abutments, 4.8 mm, max 30°
• Paltop Multi Unit Abutment, 5.0 mm, max 17°
• Southern Compact Conical Abutments, 4.8 mm
• MAX Implant System, 0°
• Provata Implant System, max 30°
• Deep Conical (DC) Implants, 0°
• Piccolo Implants, 0°
• External Hex Implants, max 30°
• Straumann® BLX Screw Retained Abutment, 4.6 mm, max 30°
• Straumann® Screw Retained Abutment, 4.6 mm, max 30°
• Zimmer Angled Tapered Abutments, 4.5 mm, max 30°

The Osteon Precision Milled Suprastructures (also referred to as superstructures) are metallic dental restorative devices that are intended to be attached by screw retention to dental implant abutments to aid in the treatment of partial and totally edentulous patients for the purpose of restoring function. These suprastructures attach to dental implant abutments using the prosthetic screws from the original equipment manufacturers (OEM) and are used to support the final multi-unit restoration.

The Osteon Precision Milled Suprastructure is designed for an individual patient from scans of the patient's dental impression. The suprastructure is manufactured with the aid of Computer Aided Design (CAD) and Computer Aided Manufacturing (CAM) technology. All CAD/CAM fabrication is performed by Osteon Medical.

Osteon Precision Milled Suprastructures facilitate the attachment of both removable and fixed dental prosthesis and hence are categorized as Type A and Type B.

• Type A: Intended to act as a supporting structure to facilitate the attachment of removable dental prosthesis and include Primary Bar and Nexus Removable Bar.
• Type B: Intended to act as a supporting structure to facilitate the attachment of fixed dental prosthesis and include Melbourne Bar and Nexus Fixed Bar

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Prosthetic components directly connected to the endosseous dental implant are intended for use as an aid in prosthetic rehabilitations. Temporary components can be used prior to the final components to maintain, stabilize and shape the soft tissue during the healing phase; they are to be placed out of occlusion. Final abutments may be placed into occlusion for implants with sufficient primary stability or for implants that are fully osseointegrated.

Temporary Abutments have a maximum duration of usage of 180 days.

The subject devices described in the submission are prosthetic components that are intended for use in prosthetic rehabilitations, directly or indirectly connected to the endosseous dental implant. These devices are intended for use as an aid in prosthetic rehabilitations. The subject devices described in this submission are to be added Straumann's existing prosthetic portfolio.

The provided text is a 510(k) summary for Straumann® Screw-Retained Abutments. This document primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices through comparisons of technological characteristics and performance data, mainly bench testing and biocompatibility assessments. It explicitly states that no device-specific clinical data has been submitted.

Therefore, the information required to describe acceptance criteria and a study proving the device meets those criteria, especially in the context of an AI/human reader study or performance metrics typical for AI devices (like sensitivity, specificity, AUC), is not present in this document.

This document describes a traditional medical device (dental implants and abutments) cleared via the 510(k) pathway, which fundamentally relies on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through novel clinical studies or AI algorithm validation.

To address the user's request, I must state that the information is not available in the provided document, as it pertains to a different type of device and regulatory submission pathway.

Specifically, the document states:

• "No device specific clinical data has been submitted to demonstrate substantial equivalence." (Page 12, Section 5.7.4)

Here's an explanation with respect to the user's request:

1. A table of acceptance criteria and the reported device performance: Not applicable. The submission focuses on substantial equivalence through comparison with predicates, not on meeting predefined performance metrics from a study in the way an AI/software device would. The "performance data" refers to bench testing (dynamic fatigue, static strength, torque) and biocompatibility, which are compared to predicate devices rather than against specific numerical acceptance criteria.

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, as no clinical study (with test sets of patient data) was conducted or submitted. The 'samples' referred to in bench testing are physical abutment components.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for clinical data involving human perception (like AI for image analysis) is not relevant here as no such clinical study was performed.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is not an AI-powered device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI-powered device.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable.

8. The sample size for the training set: Not applicable. This is not an AI-powered device with a training set.

9. How the ground truth for the training set was established: Not applicable.

In summary: The provided 510(k) summary for Straumann® Screw-Retained Abutments does not contain the type of AI/clinical performance study information requested. The device is a traditional medical device (dental implant components) and its clearance is based on substantial equivalence to predicate devices, verified through bench testing and biocompatibility assessments, not through human reader studies or AI algorithm performance evaluations on clinical datasets.

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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 singletooth, bar and bridges 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® BLX SRAs and Antomic Abutments: 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 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.

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. There are two available prosthetic platforms identified as RB (Regular Base) and WB (Wide Base). The subject devices have a RB platform (a "small top/head") with a Torx-style internal connection, which is identical for all the implant lengths. They are provided sterile by gamma radiation and are available in various sizes.

Straumann® BLX SRAs are manufactured from TAN and are intended to be placed on BLX Straumann dental implants to provide support for permanent screw-retained single or multi-unit restorations. They are provided sterile by gamma radiation and are available in various sizes and angulations.

Straumann® BLX Anatomic Abutments are manufactured from TAN and are intended to be placed on BLX Straumann dental implants to provide support for permanent cement-retained single or multi-unit restorations. They are provided non-sterile and are available in various sizes and angulations. They are delivered with the corresponding basal screw. Anatomic Abutments are provided with pre-defined mucosa margins and with a size that allows for further modification by the customer via hand grinding tools.

The provided text describes a 510(k) premarket notification for the Straumann® BLX Line Extension - Implants, SRAs and Anatomic Abutments. This submission focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than performing a de novo study to establish new acceptance criteria. Therefore, the information requested in your prompt (Acceptance Criteria and study design for proving it) is not explicitly present in the provided document in the way one might find it for a novel device undergoing clinical trials.

However, based on the performance testing section, we can infer some aspects that act as "acceptance criteria" for demonstrating substantial equivalence to the predicate devices. The study conducted is primarily a series of bench tests and validation studies rather than a clinical trial or a study designed to prove new acceptance criteria.

Here's an attempt to structure the answer based on the provided text, highlighting what is implicitly or explicitly stated about "acceptance" in the context of a 510(k) submission:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission demonstrating substantial equivalence to predicate devices, explicit "acceptance criteria" as pass/fail thresholds for a novel claim are not presented. Instead, the performance tests aimed to show that the subject device performs equivalently to the predicate devices and meets relevant industry standards. The "performance" column here reflects the outcome of those equivalence demonstrations.

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

• Sterilization Validation: The document states that the validation was in accordance with ISO 11137-1:2006 and ISO 11137-2:2013, specifically mentioning the "over kill bioburden method." These standards outline protocols for sample size determination, but the exact sample sizes used for the sterilization validation are not specified in this document.
• Bench Testing (Dynamic Fatigue, Static Strength, Insertion Torque): The document mentions that "worst-case considerations" were used for testing various platforms (RB and WB) and implant sizes (e.g., Ø3.75 mm for insertion torque). Specific sample sizes for these bench tests are not provided.
• Data Provenance: All data appears to be prospective bench testing and validation studies conducted by or for the manufacturer (Institut Straumann AG / Straumann USA, LLC). No country of origin for the data is specified beyond it being conducted by the applicant's entity.

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

This information is not applicable and not provided in the document. The studies described are engineering and materials science tests (sterilization, biocompatibility, mechanical strength), not studies involving human interpretation or clinical outcomes that would require "experts to establish ground truth." The ground truth for these tests is based on established scientific and engineering principles, international standards (ISO), and FDA guidance documents.

4. Adjudication method for the test set

This information is not applicable and not provided. Adjudication methods (like 2+1, 3+1) are relevant for studies that involve human interpretation and potential disagreements, such as image reading studies. The described studies are objective engineering tests.

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 information is not applicable and not provided. The device is an endosseous dental implant system, not an AI-powered diagnostic tool or image analysis software. Therefore, an MRMC study or evaluation of AI assistance is irrelevant to this submission.

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

This information is not applicable and not provided. As stated above, this is a physical medical device, not an algorithm or AI system.

7. The type of ground truth used

The "ground truth" for the various tests described is derived from:

• International Standards: e.g., ISO 11137-1, ISO 11137-2, ISO 17665-1, ISO 17665-2, ISO 10993-1.
• FDA Guidance Documents: Such as "Guidance for Industry and FDA Staff – Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments" and "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submission for Devices Labeled as Sterile."
• Engineering Principles: For mechanical testing like fatigue, strength, and torque.
• Predicate Device Performance: The underlying "ground truth" for a 510(k) submission is that the new device is "substantially equivalent" to predicate devices, meaning it performs as safely and effectively without raising new questions of safety or effectiveness.

8. The sample size for the training set

This information is not applicable and not provided. There is no "training set" as this is not a machine learning or AI-driven device.

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

This information is not applicable and not provided. There is no "training set" for this device.

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