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The ISO Abutment is appropriate for use with overdentures or partial dentures retained in whole or in part by endosseous implants in the mandible or maxilla. The ISO Abutment is compatible with the following fixtures.

The ISO Abutment is to be placed into the dental implant to provide support for a prosthetic restoration. The ISO Abutment is made from Titanium grade Ti-6AI-4V ELI (meets ASTM Standard F-136) and compatible with several fixtures made by 3rd party implant manufactures.

This 510(k) clearance letter details the regulatory approval for the ISO Abutment, an endosseous dental implant abutment. It establishes its substantial equivalence to a predicate device based on similar indications for use, technological characteristics, materials, design, and sterilization methods.

However, the provided document does not contain information related to software, artificial intelligence (AI), diagnostic accuracy studies, or clinical performance data typically associated with acceptance criteria tables, sample sizes for medical imaging datasets, expert adjudication, or MRMC studies. The device itself is a physical dental implant component, not an AI-powered diagnostic tool.

Therefore, I cannot extract the requested information regarding:

• A table of acceptance criteria and reported device performance (as these would be mechanical and biocompatibility tests, not diagnostic accuracy metrics)
• Sample sizes used for the test set and data provenance (not applicable for this type of device)
• Number of experts used to establish ground truth and qualifications (not applicable)
• Adjudication method (not applicable)
• MRMC comparative effectiveness study (not applicable)
• Standalone (algorithm-only) performance (not applicable)
• Type of ground truth used (e.g., pathology, outcomes data - not applicable for this device beyond engineering/material testing)
• Sample size for the training set (not applicable)
• How the ground truth for the training set was established (not applicable)

The "Non-clinical Tests" section (Page 13) describes the types of studies performed for a physical device, which include:

• Sterilization validation testing (ISO 17665-1 & 2)
• Biocompatibility tests (ISO 10993-5, -10, -11, -3, -33) including:
  • Cytotoxicity
  • Oral mucosa irritation
  • Skin sensitization
  • Acute systemic toxicity
  • Subchronic systemic toxicity
  • Bacterial reverse mutation
• Reverse engineering analysis of OEM implant body, abutment, and fixation screw (for compatibility verification)
• TiN coating tests (F1044, F1147, F1160)
• Non-clinical worst-case MRI review (using scientific evidence and published literature) to assess magnetic induction displacement force (ASTM F2052), magnetic induction torque (ASTM F2213), RF induction heating (ASTM F2182), and image artifact (ASTM F2119).

These tests establish the physical, mechanical, and biological safety and compatibility of the dental abutment, rather than the diagnostic performance of an AI system.

Ask a specific question about this device

The Elos Accurate® Customized Abutments are intended for attaching to dental implants in order to provide basis for single or multiple tooth prosthetic restorations. The Elos Accurate® Customized Abutment will be attached to a dental implant using the included Elos Prosthetic screw. The Elos Accurate® Customized Abutments are compatible with the implant systems listed in Table 1.

The Elos Accurate® Customized Abutment is a patient specific abutment intended for attaching to dental implants in order to provide basis for single- or multiple tooth prosthetic restorations. The Elos Accurate® Customized Abutment will be attached to the implant using the included Elos Prosthetic Screw and attached to the crown/coping manually by cementation. The Elos Accurate® Customized Abutment consists of an Abuttnent Blank used in fabricating of a full patient-specific abutment in Titanium alloy per ASTM F136. The Abutment Blank used in creation of the Elos Accurate® Customized Abutment has a pre-manufactured connection interface that fits directly to a pre-specified dental implant. The customized shape of the abutument is intended to be manufactured according to a digital dentistry workflow or intended to be manufactured at an FDA registered Elos Medtech approved milling facility. The Elos Accurate® Customized Abutment is delivered non-sterile and the final restoration including corresponding Elos Prosthetic Screw is intended to be sterilized at the dental clinic before it is placed in the patient. The Elos Accurate® Customized Abutment provides clinicians and laboratories with a prosthetic device that can be used in definitive (permanent) single- or multi restorations.

The provided document, K231307 for Elos Accurate® Customized Abutment, is an FDA 510(k) premarket notification. This document focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a standalone study with defined acceptance criteria and performance metrics in the way a clinical trial or a performance study for an AI/ML powered medical device would.

The "acceptance criteria" discussed in this document pertain to the device meeting the requirements for FDA 510(k) clearance by demonstrating substantial equivalence to predicate devices, primarily through engineering, dimensional, and non-clinical testing. There is no mention of a human-in-the-loop study, a multi-reader multi-case (MRMC) study, or an AI/ML algorithm-only standalone performance study.

Therefore, many of the requested fields regarding expert adjudication, MRMC studies, and ground truth establishment for AI/ML models are not applicable to the information contained within this 510(k) submission.

Here's an interpretation of the document's contents in relation to your request, with a focus on non-clinical testing and substantial equivalence:

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

The "acceptance criteria" for this device are implicitly tied to demonstrating substantial equivalence to its predicates and meeting established material and dental implant abutment standards. The document doesn't present a table with numerical acceptance criteria and performance for a diagnostic AI algorithm. Instead, it lists various non-clinical tests and their successful outcomes as evidence of substantial equivalence and safety/effectiveness.

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

• Test Set Sample Size: The document does not specify exact "sample sizes" in terms of number of abutments or implants tested for each reported non-clinical test. The tests are general performance validations (e.g., fatigue, cytotoxicity, sterilization efficacy) and dimensional analyses that demonstrate compliance with relevant standards or a worst-case scenario. For example, fatigue testing often involves a small number of samples (e.g., 6 minimum per ISO 14801, though more are often used for statistical power) under specific loading conditions. Similarly, biocompatibility is performed on representative samples.
• Data Provenance: The data comes from the manufacturer's (Elos Medtech Pinol A/S) internal testing and leverages data from previously cleared devices where material, size, and geometry are substantially equivalent. The provenance is therefore the manufacturer's testing facilities and associated regulatory submissions. There is no indication of different countries of origin for the data concerning these non-clinical tests. The tests are prospective in nature, as they are part of the premarket submission process.

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

This question is not applicable. The "ground truth" for this medical device (dental abutment) is established by engineering specifications, material properties, performance standards (e.g., ISO, ASTM), and clinical safety and effectiveness data from the predicates. There is no AI/ML component described that would require expert human review or "ground truth" establishment in the context of diagnostic interpretation.

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

This question is not applicable as there is no human interpretation or diagnostic "test set" that would require adjudication.

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 question is not applicable. The device is a physical dental abutment and its associated digital design workflow, not an AI-powered diagnostic tool requiring human reader studies.

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

This question is not applicable. The device is not a standalone AI algorithm. The digital dentistry workflow involves CAD software and CAM software, but these are tools for designing and manufacturing the physical abutment, not for automated diagnostic interpretation or decision-making in the clinical sense of an AI/ML algorithm.

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

The "ground truth" for this device's performance, as demonstrated in the submission, is based on:

• Compliance with international standards (e.g., ISO 14801 for fatigue, ISO 10993-5 for biocompatibility, ISO 17665 for sterilization).
• Engineering and dimensional analysis against established dental implant system specifications.
• Physical testing results (e.g., torque, heating, displacement) for MR compatibility.
• Validation of the digital workflow ensuring design constraints and manufacturing accuracy.
• The fundamental demonstration is substantial equivalence to existing legally marketed predicate devices, implying that their established safety and effectiveness forms the basis of the "ground truth" for this device's intended use.

8. The sample size for the training set

This question is not applicable. This is not an AI/ML device that requires a training set for model development. The design software has built-in constraints ("design limitations" and "design limits in the library file"), which are more akin to pre-programmed rules and geometric parameters rather than a learned model from data.

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

This question is not applicable. No AI/ML training set is mentioned or implied. The "ground truth" for the design limitations within the software (e.g., minimum material thickness) would be established by engineering principles, biomechanical studies (often in labs, not clinical trials), and clinical experience with dental prosthetics, which define safe and effective design parameters.

Ask a specific question about this device

The Elos Accurate® Hybrid Base™ is intended for attaching to dental implants in order to provide basis for single or multiple tooth prosthetic restorations. The Hybrid Base™ is used as an interface between a dental implant and a zirconia superstructure and will be attached to the implant using a prosthetic screw and attached to the zirconia superstructure by cementing. The Elos Accurate® Hybrid Base™ is compatible with the implant systems listed in table 1:

| Implant Platform compatibility | Platform diameter
[mm] | Implant Body diameter
[mm] |
|--------------------------------|---------------------------|--------------------------------|
| Zimmer Screw-vent 3.5 | Ø3.5 | Ø3.7/Ø4.1 |
| Zimmer Screw-vent 4.5 | Ø4.5 | Ø4.7 |
| Zimmer Screw-vent 5.7 | Ø5.7 | Ø6.0 |
| Biomet 3i Certain 3.4 | Ø3.4 | Ø3.25 |
| Biomet 3i Certain 4.1 | Ø4.1 | Ø4 |
| Biomet 3i Certain 5.0 | Ø5 | Ø5 |
| Biomet 3i Certain 6.0 | Ø6 | Ø6 |
| Straumann Standard RN | Ø4.8 | Ø3.3/Ø4.1/Ø4.8 |
| Straumann Standard WN | Ø6.5 | Ø4.8 |
| Neodent GM | Ø3.5/Ø4.5/Ø5.5/Ø 6.5 | Ø3.5/Ø3.75/Ø4/Ø4.3/Ø 5/Ø 6/Ø 7 |
| Hiossen ET Mini | Ø3.2/Ø3.5 | Ø3.2/Ø3.5 |
| Hiossen ET Regular | Ø4/Ø4.5/Ø5/ Ø5.5/Ø6/Ø7 | Ø4/Ø4.5/Ø5/ Ø5.5/Ø6/Ø7 |

The zirconia superstructures for use with the Elos Accurate® Hybrid Base™ are either intended to be sent and manufactured at an FDA registered Elos Medtech approved milling facility or to be designed and manufactured according to digital dentistry workflow 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.

The Elos Accurate® Hybrid Base™ is intended for attaching to dental implants in order to provide basis for single or multiple tooth prosthetic restorations. The Hybrid Base™ is used as an interface between a dental implant and a zirconia superstructure and will be attached to the implant using the included prosthetic screw and attached to the zirconia superstructure by cementing. The Elos Accurate® Hybrid Base™ is a two-piece abutment composed of the Hybrid Base as the bottomhalf and the zirconia superstructure as the top-half, which when assembled comprises the final finished medical device.

The Elos Accurate® Hybrid Base™ consists of a pre-manufactured prosthetic component in Titanium alloy per ASTM F136, as well as supporting digital library file for 510(k) cleared design software (3Shape Abutment Designer™ Software, K151455) which facilitates the design of a patient specific zirconia superstructure by the laboratory/clinician. The Elos Accurate® Hybrid Base™ fits directly to an endosseous dental implant. The laboratory designed superstructure is manufactured from 510(k) cleared Zirconia (Lava Plus, K011394) according to digital dentistry workflow. For all Elos Accurate® Hybrid Base™ models the zirconia superstructure must be designed according to following limits:

• 1. Minimum wall thickness 0.5 mm
• 2. Minimum post height 4.0 mm (for single unit restorations)
• 3. Maximum gingival height 5.0 mm (min. GH of 0.5mm)
• 4. Maximum angulation 20°

The laboratory designed superstructure is attached to the Elos Accurate® Hybrid Base by use of 510(k) cleared cement (Multilink Hybrid Abutment, K130436 or Panavia V5, K150704) and the final prosthetic restoration is attached to the implant using a Prosthetic screw.

The Elos Accurate® Hybrid Bas has a gold-colored anodized surface to increase the esthetics of the dental restoration - the same surface as in predicate device K201860.

Some of the prosthetic screws are uncoated and two screws are Medicarb coated, identical to the Medicarb coating in predicate device K201860. The subject uncoated screws are compatible with implant platforms Zimmer Screw-vent, Biomet 3i, Neodent GM and Straumann Standard RN and WN. The subject Medicarb coated screws are compatible with the implant platforms Hiossen ET Mini and ET Regular. The purpose of the coating is to lower friction in the thread connection and the screw seat connection.

The Elos Accurate® Hybrid Base™ is delivered non-sterile and the final restoration and corresponding screw is intended to be sterilized at the dental clinic before it is placed in the patient.

The Elos Accurate® Hybrid Base™ is a dental device intended for attaching to dental implants to provide a basis for single or multiple tooth prosthetic restorations. It acts as an interface between a dental implant and a zirconia superstructure.

Here's a breakdown of the acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance:

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

   • Fatigue Testing: "fatigue testing was performed on the subject devices per ISO 14801." The exact number of samples tested per device type is not specified but implied to be sufficient for ISO 14801 compliance.
   • Engineering and Dimensional Analysis: Performed on "original manufactures' components (abutments, implants & abutment screws)." The number of components is not specified.
   • Digital Dentistry Workflow Validation/Design Limitation Test: "The digital dentistry workflow validation was completed on selected models of subject product line" and "A design limitation test is performed...". Number of models/tests not specified.
   • Biocompatibility (Cytotoxicity): A cytotoxicity test was performed on "a complete restoration produced via the described validated workflow." Exact number of samples not specified.
   • Data Provenance: Not explicitly stated, but the testing appears to be conducted by or for the manufacturer (Elos Medtech Pinol A/S). No information is given about the country of origin of the data or if it was retrospective or prospective in the context of clinical studies (as this is a non-clinical submission).

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

   • This submission focuses on non-clinical testing and substantial equivalence to predicate devices based on engineering and performance standards. There is no mention of "experts" establishing ground truth in the context of diagnostic performance or clinical outcomes. The "ground truth" for the engineering and material properties would be established by validated test methods and established standards (e.g., ISO 14801, ISO 10993).

4. Adjudication Method for the Test Set:

   • Not applicable. This is a non-clinical submission based on engineering tests and standards, not a clinical study requiring adjudication of diagnostic results.

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:

   • No MRMC study was mentioned or performed. This device is a dental implant component, not an AI-assisted diagnostic tool.

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

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

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

   • The "ground truth" in this context refers to established engineering standards, material properties, and performance requirements for dental implant abutments. This includes:
     • ISO 14801: "Dentistry – Implants – Dynamic fatigue test for endosseous dental implants" for fatigue testing.
     • ISO 17665-1 & ISO 17665-2: For sterilization validation.
     • ISO 10993-1 & ISO 10993-5: For biocompatibility (cytotoxicity).
     • Engineering and dimensional analysis: Based on specifications of original manufacturers' components.

8. The sample size for the training set:

   • Not applicable. This device is not an AI/machine learning product and does not have a "training set." The closest analogy could be the design and manufacturing parameters used to create the device, which are based on established engineering principles and prior device knowledge.

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

   • Not applicable, as there is no "training set" for this type of medical device. The design and manufacturing are based on established engineering principles and validation against performance standards.

Ask a specific question about this device

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.

Ask a specific question about this device

Straumann TLX Implants are suitable for endosteal implantation in the upper and for the functional and esthetic oral rehabilitation of edentulous patients. TLX Implants can be 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 are connected to the implants through the corresponding abutment components.

TLX Closure Caps and Healing Caps:
Straumann Closure Caps and Healing Caps 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 stabilize the soft tissue during the healing process. Closure caps and healing caps should be used only with suitable implant connections. They have a maximum duration of usage of 6 months.

TLX Temporary Abutment:
TLX Temporary Abutments 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. TLX Temporary Abutments have a maximum duration of usage of 180 days.

TLX Variobase for Crown:
Straumann Variobase prosthetic components directly 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 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 osseontegrated. 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.

TLX CARES Abutment TAN:
The Straumann CARES Abutments TAN are indicated for single tooth replacement and multiple tooth restorations. The prosthetic restoration can be cemented.

TLX Screw-retained Bridges and Bars:
CARES Screw-retained Bridges and Bars (SRBB) are indicated for use as bars and bridges that attach to implants to provide support for prosthetic reconstructions such as bridges and overdentures. The final processed products have the purpose of restoring chewing function. Straumann CARES Screw-retained Bridges and Bars are indicated for Screw-retained restorations. Straumann CARES Screw-retained Bridges and Bars are designed to interface with the Bone Level (BL), Tissue Level (TL), BLX implants of the Straumann Dental Implant System (SDIS).

TLX Dental Implant:
The TLX Dental Implant 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. TLX implants are presented with 3 prosthetic platforms as listed below:

• NT (Narrow TorcFit)
• RT (Regular TorcFit)
• WT (Wide TorcFit)
  The internal connection is identical for all prosthetic platforms, implant diameters, and implant lengths.

TLX Closure Caps and Healing Caps:
The closure caps are screwed into the implant to protect the inner configuration and shoulder of the implant during the healing phase in cases of submucosal) healing protocols. The healing caps are screwed into the implant to protect the inner configuration of the implant in cases of transmucosal healing protocols. They are placed out of occlusion and do not support a prosthetic restoration. Closure caps and healing caps are used during the healing phase only.
The TLX Closure Caps and Healing Caps are manufactured from Titanium Grade 4 and are laser marked with NT, RT or WT for identification purposes. They are provided sterile and are available in different heights and diameters.

TLX Temporary Abutment
TLX Temporary Abutments 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.
TLX Temporary Abutments have a maximum duration of usage of 180 days.
The TLX Temporary Abutments are manufactured from TAN and consist of a coronal section, a platform and a connection part. The abutments are provided non-sterile with instructions for end user sterilization. The Temporary Abutments are seated in the implant with a basal screw which is also manufactured from TAN and are laser marked with NT, RT or WT for identification purposes. The Basal screw is delivered with the abutment. The TLX Temporary Abutments are available for Crown and Bridge/Bar restorations.

TLX Variobase for Crown
The TLX Variobase for Crown incorporates the implant to abutment connection (TorcFit) and is available for each of the three implant diameter platforms (NT, RT & WT) with a different abutment chimney height and prosthetic platform diameter. The TLX Variobase Abutments for Crown 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. These components, which once assembled together and placed with the corresponding basal screw, constitute the final medical device.
TLX Variobase for Crown will be marketed as stand-alone component or through the CARES® X-Stream workflow. In the latter the prosthetic restoration is designed though CARES® Visual software (Digital CARES workflow) and manufactured in a validated Straumann milling center. The prosthetic restoration is then shipped together with the TLX Variobase for Crown and the Basal screw.
All digitally designed copings and/or crowns for use with the TLX Variobase for Crown are intended to be sent to Straumann for manufacture at a validated milling center.
The TLX Variobase for Crown is provided non-sterile with instructions for end user steam sterilization.

Prosthetic Restoration Design and Materials
The following materials are available within the digital workflow for the manufacturing of prosthetic restorations:
Final restorations:

• zerion® LT
• zerion® ML
• zerion® UTML
• IPS e.max CAD
• coron®
  Temporary restoration:
• polycon® ae

TLX CARES Abutment TAN
The TLX CARES Abutments TAN are packed and delivered with the Basel screw. Both are manufactured from TAN (titanium-aluminum-niobium alloy/ Ti-6AI-7Nb).
TLX CARES Abutments TAN 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 pre-milled blank incorporates the pre-milled implant to abutment connection (TorcFit) and has a cylindrical body with enough material volume to create a wide range of geometries for the final abutment.
The TLX CARES Abutments TAN is available for each of the three implant platforms.

TLX Screw-retained Bridges and Bars:
The Straumann CARES Screw-retained Bridges and Bars, also referred to as SRBB are packed and delivered with the corresponding basal screws.
SRBB devices are manufacture from either

• Titanium Grade 4 or
• Cobalt chromium (also referred to as CoCr (or coron).
• the Basal Screw is manufactured from TAN (titanium-aluminum-niobium alloy/ Ti-6Al-7Nb).
  SRBB are used for the restoration of Straumann dental implants with different endosteal diameters, lengths and platforms.
• CARES bars are to be combined with an overdenture to treat edentulous cases.
• CARES fixed bars are superstructures for the direct application with dental resin and prefabricated teeth to treat edentulous cases.
• CARES Screw-retained Bridges are intended to be directly veneered with dental veneering ceramics.
  The purpose of this premarket notification is to expand the currently cleared abutment-toimplant interfaces to include the TLX implant system.
  The SRBB devices are available for each of the three prosthetic platforms (NT, RT, WT).
  The design of the SRBB devices must be made using the validated Straumann CARES Visual software (Digital CARES workflow).
  Finally, the design file is transferred digitally to a Straumann validated milling center.

TLX Basal screw
The Basal screw is used to seat the temporary abutments, the TLX Variobase Abutments or the TLX Screw-retained Bridges and Bars to the dental implant and can be also be used during lab procedures to fix lab prosthetic parts on implant analogs. They are provided along the prosthetic components, but they are also provided as standalone screws. The TLX basal screws is manufactured from TAN.

The provided document is an FDA 510(k) premarket notification for the Straumann TLX Implant System. It primarily focuses on demonstrating substantial equivalence to predicate devices through comparisons of indications for use, technological characteristics, and performance testing (bench testing, biocompatibility, sterilization, and software validation).

Crucially, this document does not contain information about a study proving that the device meets specific acceptance criteria in terms of human-in-the-loop performance with AI assistance, or standalone algorithm performance, as would be expected for an AI/ML medical device submission.

The document describes a dental implant system (a physical device), not an Artificial Intelligence/Machine Learning (AI/ML) powered medical device. Therefore, the questions related to AI/ML device performance (such as MRMC studies, standalone algorithm performance, number of experts for ground truth, training/test set sample sizes for AI, etc.) are not applicable to the content of this 510(k) submission.

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the device's ability to meet the substantial equivalence criteria established by the FDA for its intended use, when compared to legally marketed predicate devices. This is demonstrated through various tests and comparisons, as outlined in section 5.7 "Performance Testing".

However, to answer your request as literally as possible, based on the information provided for this non-AI/ML device, I will extract the relevant "acceptance criteria" and descriptions of "studies" as they pertain to a traditional medical device submission for a physical product.

Based on the provided document (K200586 for the Straumann TLX Implant System), which describes a physical dental implant system and not an AI/ML medical device, the following information can be extracted:

The "acceptance criteria" for this device are implicitly tied to demonstrating substantial equivalence to existing predicate devices, as required for a 510(k) submission. The "studies" are the performance tests conducted to support this claim of substantial equivalence.

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

Since this is not an AI/ML device, the acceptance criteria are not in terms of traditional metrics like accuracy, sensitivity, or specificity for an algorithm. Instead, they relate to mechanical, biological, and processing characteristics that are equivalent or superior to predicate devices.

• Tests performed in saline (2 Hz, 37°C) for 2 million cycles (permanent) and 200,000 cycles (temporary).
• Tests performed in air (15 Hz) for 5 million cycles (permanent) and 500,000 cycles (temporary). |
  | Endosseous Surface Area & Pull-Out Force (for specific implants) | TLX Dental Implant: "Surface area comparison and pull-out testing were performed on the Ø3.75 x 6 mm NT implants and were determined to have a larger endosseous surface area and higher pull-out force compared to the reference Ø4.1 x 6 mm device." |
  | Biocompatibility | All TLX Components: "Biological assessment has been performed according to ISO 10993-1:2009... and to the FDA Guidance document... The subject device materials are identical to the predicate and reference device materials, therefore, no new issues regarding biocompatibility were raised." |
  | Sterilization Assurance Level (SAL) for Sterile Components | TLX Implants & Healing/Closure Caps (Sterile): "A sterility assurance level (SAL) of 10-6 had been validated in accordance with ISO 11137-1:2006... The validation method used was the over kill bioburden method in accordance with ISO 11137-2:2013." |
  | Pyrogenicity Limit | TLX Implants & Healing/Closure Caps (Sterile): "The method used to determine the device meets pyrogen limit specifications is LAL Endotoxin Analysis with testing limit of 20 EU/device, based on a blood contacting and implanted device." (Note: The device is not marketed as non-pyrogenic but pyrogenicity info is provided.) |
  | End-User Sterilization Validation (for Non-Sterile Components) | TLX Temporary Abutments, Variobase for Crown, CARES Abutment TAN, SRBB (Non-Sterile): "The recommended sterilization has been validated according to ISO 17665-1 and ISO 17665-2 and to applicable recommendations in the FDA guidance document 'Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling'." "There are no changes to the sterilization procedures or processes from those of the Straumann predicate devices." |
  | Software Validation (for CAD/CAM components) | Software for CAD/CAM: "Software validation testing were conducted and documentation was provided according to the FDA guidance documents 'Class II Special Controls Guidance Document: Optical Impression Systems for Computer Assisted Design and Manufacturing (CAD/CAM) of Dental Restorations' and 'General Principles of Software Validation; Final Guidance for Industry and FDA Staff'. The software for this device was considered as a 'moderate' level of concern." |
  | Material Equivalence | TLX Dental Implant: Roxolid® (Titanium-13 Zirconium alloy), same as primary predicate.
  TLX Closure Caps/Healing Caps: Titanium Grade 4, same as primary predicate.
  TLX Temporary Abutment, Variobase, CARES Abutment TAN, Basal Screw: TAN (Ti-6Al-7Nb), same as predicate/reference.
  TLX Screw-retained Bridges and Bars: Titanium Grade 4 or Cobalt Chromium, with TAN screw. Materials consistent with predicate devices. |
  | Surface Treatment Equivalence | TLX Dental Implant: Hydrophilic SLActive®, same as primary predicate. |
  | Implant-to-Abutment Connection Equivalence | TLX Dental Implant: TorcFit (with conical fitting), same as primary predicate. |
  | Manufacturing Workflow Equivalence (for CAD/CAM components) | Variobase for Crown, CARES Abutment TAN, SRBB: "Straumann Milling" / "Digital CARES workflow via Straumann milling center", consistent with predicate/reference. |
  | Design Workflow Equivalence (for CAD/CAM components) | Variobase for Crown, CARES Abutment TAN, SRBB: "Digital CARES workflow (CAD)" / "Straumann CARES Visual", consistent with predicate/reference. |
  | Indications for Use Equivalence (with minor expansions/clarifications demonstrated via testing) | TLX Dental Implant: Broadly equivalent to predicates, with expansion to "multi-unit restorations" which is supported by testing.
  TLX Closure Caps/Healing Caps: Equivalent.
  TLX Temporary Abutment: Equivalent.
  TLX Variobase for Crown: Equivalent.
  TLX CARES Abutment TAN: Equivalent.
  TLX Screw-retained Bridges and Bars: Expanded to include "TLX implants", supported by device design and testing for new interface. |

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

• Sample Sizes: The document does not specify exact sample sizes for all performance tests (e.g., how many implants were used for dynamic fatigue testing, or how many software test cases were run). For dynamic fatigue, it mentions cycles (2 million, 200,000, 5 million, 500,000 cycles). For surface area and pull-out, it refers to "the Ø3.75 x 6 mm NT implants," but not a specific count.
• Data Provenance: The document does not specify the country of origin for the test data, nor does it explicitly state if the testing was retrospective or prospective. Given it's premarket notification for a physical device, the "data" would primarily come from laboratory bench testing rather than patient data.

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 question is not applicable to this type of device submission. Ground truth established by experts (like radiologists) is relevant for AI/ML devices that interpret medical images or data. For this dental implant system, "ground truth" refers to the physical and mechanical properties of the device, which are established through standardized engineering and biocompatibility tests, not human expert consensus on clinical data.

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

• This question is not applicable to this type of device submission. Adjudication methods are used in studies involving human interpretation (e.g., reading medical images) to resolve discrepancies and establish a consensus ground truth, typically for AI/ML performance evaluation. This document describes physical device 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 question is not applicable to this type of device submission. MRMC studies are specifically designed to evaluate the impact of AI on human reader performance in diagnostic tasks. This is a physical dental implant.

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

• This question is not applicable to this type of device submission. Standalone performance refers to the accuracy of an AI algorithm on its own. This is a physical dental implant, not an algorithm. (Note: Some CAD/CAM software is mentioned, but "standalone performance" in the AI context isn't relevant here; rather, the software's functionality and output are validated against engineering standards.)

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

• For this physical device, the "ground truth" for the performance claims comes from standardized laboratory testing and engineering measurements in controlled environments (e.g., dynamic fatigue machines, material analysis instruments, biological assays). There is no "expert consensus," "pathology," or "outcomes data" used as ground truth for the technical equivalence claims presented in the 510(k). The clinical indications are based on established dental practice and the equivalence to predicate devices which have a history of clinical use.

8. The sample size for the training set

• This question is not applicable to this type of device submission. "Training set" refers to data used to train an AI/ML algorithm. This document does not describe an AI/ML component.

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

• This question is not applicable to this type of device submission as there is no AI/ML training set.

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Implantswiss Dental Implant System is indicated to use for surgical placement in the upper and lower jaw arches, to provide a root form means for single and multiple units' prosthetic appliance attachment to restore a patient's chewing function. Implantswiss Dental Implant can be placed with a conventional two stage surgical process with an option for transmucosal healing or they can be placed in a single stage surgical process for immediate loading is restricted to the anterior mandible based on four splinted-interforminal placed implantswiss Dental Abutment System is used with a dental implant to provide support to prosthetic restorations such as crown, bridge and overdentures in partially or fully edentulous patients. Octa and Multi-Unit Abutment models that contain an abutment post height less than 4 mm are indicated only for multi-unit loading, such as a bridge or overdenture.

The Implantswiss Dental Implant and Implantswiss Dental Abutment Systems are compatible titanium/titanium alloy dental implants and abutments. The Implantswiss Dental Implants are provided as bone level or tissue level type implants and their surface is modified by a Sandblasted Rough Acid-etched (SRA) process. The Implantswiss Bone Level Implants have diameters of 3.3mm, 3.7mm, 4.3mm and 4.8mm with lengths of 8mm, 12mm and 14mm; and diameter of 5.5mm with lengths of 8mm, 10mm and 12mm. The 3.3mm and 3.7mm diameter Bone Level Implants are composed of Titanium Ti6Al4V ELI – ASTM F136-13. The 4.3mm, 4.8mm and 5.5mm diameter Bone Level Implants are composed of Titanium Grade 4 – ASTM F67-13. The Implantswiss Tissue Level Implants have diameters of 3.7mm, 4.3mm and 4.8mm with lengths of 8mm, 10mm, 12mm and 14mm; and diameter of 5.5mm with lengths of 8mm, 10mm and 12mm. The Tissue Level Implants are composed of Titanium Grade 4 – ASTM F67-13. The Implantswiss Dental Abutment System consists of Couple, Angled, Solid, O-ring, Multi, Octa, Synocta, Healing, Locator and Multi-Unit Abutments.

The provided text is a 510(k) summary for the Implantswiss Dental Implant System and Implantswiss Dental Abutment System. It outlines the regulatory clearance process, device description, indications for use, and a comparison to predicate devices, including performance testing.

However, it does not contain information about acceptance criteria or a study that uses a machine learning or AI model. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to non-clinical performance testing (biocompatibility, sterilization, mechanical testing) for dental implants and abutments, which are physical medical devices, not AI-driven software.

Therefore, many of the requested items (e.g., sample size for test set, data provenance, number of experts for ground truth, MRMC study, standalone performance, training set details) are not applicable to this type of medical device submission.

I will provide the information that is applicable based on the text provided, highlighting where the requested AI/ML specific details are not relevant.

Acceptance Criteria and Study for Implantswiss Dental Implant System & Abutment System

This device clearance (K181266) is for physical dental implants and abutments, not a software or AI/ML device. Therefore, the "acceptance criteria" and "study" refer to non-clinical performance evaluations relevant to the material properties, design, and intended use of these dental devices.

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

The document does not present specific quantitative "acceptance criteria" in a table format for each test. Instead, it refers to compliance with established international standards and FDA guidance documents. The "reported device performance" is a statement of consistency with these standards.

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

• Sample Size for Test Set: This information is not explicitly provided in the summary. For mechanical and biocompatibility testing, it is generally conducted on a sample of devices (e.g., a specific number of implants/abutments) to demonstrate compliance with standards. The summary states "worst-case" testing was performed.
• Data Provenance: Not applicable in the context of device performance testing for physical implants. These are lab-based tests of the physical product.

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

Not applicable. Ground truth in this context refers to standard-compliant test methods and material properties, not expert-curated clinical data for an AI/ML model.

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

Not applicable. This is relevant to expert panel consensus for clinical data, not materials and mechanical 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

Not applicable. This device is a physical dental implant and abutment system, not an AI-assisted diagnostic or therapeutic tool.

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

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

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

The "ground truth" for this type of device clearance is established by internationally recognized standards (ISO standards), FDA guidance documents, and validated test methods (e.g., for biocompatibility, mechanical fatigue, sterilization parameters). Material specifications (e.g., ASTM F-67, ASTM F-136) also serve as a form of "ground truth" for material composition.

8. The sample size for the training set

Not applicable. There is no AI/ML training set for this physical device.

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

Not applicable. There is no AI/ML training set for this physical device.

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Straumann® Bone Level Tapered Implants 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. Straumann Bone Level Tapered Implants can also be used 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 by the corresponding elements (abutments).

The subject devices represent a line extension of the previously cleared Bone Level Tapered Implants of the Straumann Dental Implant System (K140878 and K150938). The subject devices have the same diameters (3.3, 4.1 and 4.8 mm), the same implant-to-abutment interfaces (NC, RC), the same material (Ti-13Zr) and the same surface finishes (SLA, SLActive) as the identified primary predicate devices. The subject devices differ in that the lengths are 18 mm versus a maximum length for the primary predicate devices of 16 mm.

This document describes the Straumann® Bone Level Tapered Implants, a line extension of existing dental implants. The new implants are identical to previously cleared devices except for an increased length (18mm vs. previous maximum of 16mm).

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" for the new 18mm implant length in a quantitative format as would typically be seen for AI/ML device performance. Instead, it relies on comparison to predicate devices and performance of specific bench tests. The primary acceptance criteria for the new device appear to be:

• Substantial Equivalence: The subject device is substantially equivalent to the identified predicate devices in terms of indications for use, technological characteristics (except length), and performance.
• Safety and Effectiveness through Bench Studies: The device must satisfactorily address safety and effectiveness through relevant bench studies, particularly dynamic fatigue, biological compatibility, sterilization validation, and shelf life, consistent with FDA guidance and ISO standards.
• No New Failure Modes: The new, longer implants, especially the smallest diameter (3.3mm), must not introduce new failure modes compared to predicate or reference devices when tested under simulated clinical conditions.

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

• Test Set Sample Size: Not explicitly stated as a number of devices or clinical cases. The "test set" here refers to the samples used in the bench studies.
  • For the peak insertion torque study: "all three diameters of the subject device" were tested. It is not specified how many samples per diameter were tested.
  • For the studies incorporated by reference (dynamic fatigue, biological compatibility, sterilization, shelf life), the sample sizes are not provided in this document but would have been part of the K140878 submission.
• Data Provenance: Bench studies. There is no indication of human clinical data or geographical origin for this specific submission, as it focuses on extended length and comparison to predicates through bench testing.

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

Not applicable in the context of this submission. The "ground truth" for these types of mechanical and biological tests is derived from standardized testing methods and material properties, not expert clinical interpretation of data.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods are relevant for studies involving human reviewers or subjective interpretations. The studies described are objective bench tests.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance

Not applicable. This device is a physical dental implant, not an AI/ML-driven diagnostic or assistive software. Therefore, no MRMC or AI-related studies were performed.

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.)

The ground truth for the performance claims in this submission is established through:

• Standardized Bench Testing: Adherence to international standards (e.g., ISO 14801, ISO 10993, ISO 11137, ASTM F1980) for mechanical strength, biocompatibility, sterilization, and stability.
• Material Specifications: Properties of the Roxolid® (Ti-13Zr) alloy and other materials.
• Clinical Experience/Predicate Devices: The established safety and effectiveness of the existing Straumann® Bone Level Tapered Implants and reference devices.

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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