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Rodo Abutment System is intended to be used in conjunction with compatible implant systems in the maxillary or mandibular arch to provide support for crowns, bridges or overdentures.

The Rodo Abutment System includes the Rodo Abutment, Smileloc Sleeve, Titanium Coping, Temporary Cap, abutment screws, the Smileloc Activator (or Smileloc Remover) (all cleared under K160786) and Smilekey (cleared under K180609). The Smileloc Sleeve is used to lock and unlock the Titanium Coping for final restoration to or from the abutment. This makes the prosthesis removable. The Rodo Abutment System eliminates the need for an access hole on the occlusal surface of a screw-retained restoration and also eliminates the possibility of prosthetic screw loosening. The Smilekey is an induction heating device for dental prosthesis removal of the Smileloc Sleeve in the Rodo Abutment System. The Smilekey was cleared as an accessory to the Abutment System in K180609, and there have been no changes to the Smilekey since this clearance.

The Rodo Abutment is provided in five series designs (100 F, 200 P, 300 S, 400 M, 500 D) with the 200 P and 500 D series having angled abutments (17°, 30°), for a total of nine designs. The 300 S series is designed for limited occlusal space and the 400 M series is designed for large interproximal spaces. Abutments are available in sizes ranging from 3.0 mm to 6.0 mm depending on the compatible implant system in use. Designs are available with engaging and non-engaging implant-abutment interfaces.

The provided text describes a 510(k) premarket notification for the Rodo Abutment System, focusing on adding compatibility with new implant lines. However, it does not contain the detailed information typically found in a study proving a device meets specific performance acceptance criteria for an AI/ML medical device.

The Rodo Abutment System is a hardware dental device, not an AI/ML software device. The "performance data" section discusses non-clinical testing such as dimensional analysis, reverse engineering, and fatigue testing according to ISO 14801. It does not refer to AI/ML model performance metrics, ground truth establishment, or human reader studies.

Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, or multi-reader multi-case studies, as the provided document pertains to the clearance of a mechanical dental device and not an AI/ML-driven diagnostic tool.

Specifically, the document does NOT contain information on:

• A table of acceptance criteria and reported device performance for an AI/ML model (e.g., sensitivity, specificity, AUC).
• Any sample sizes used for a test set in the context of AI/ML performance.
• Data provenance for AI/ML data (country of origin, retrospective/prospective).
• Number of experts used to establish ground truth for an AI/ML model.
• Adjudication method for an AI/ML test set.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone (algorithm-only) performance of an AI/ML model.
• Type of ground truth used (pathology, outcomes data, etc.) for an AI/ML model.
• Sample size for a training set in the context of AI/ML.
• How ground truth for a training set was established for an AI/ML model.

The document's "Performance Data" section solely refers to non-clinical bench testing for a mechanical device.

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BioHorizons CAD/CAM Abutments are dental abutments placed onto a dental implant to provide support for dental prosthetic restorations. The abutments include: 1) Titanium abutment blanks with a pre-machined implant connection where the upper portion may be custom-milled in accordance with a patient-specific design using CAD/CAM techniques; and 2) Titanium bases with a pre-machined implant connection upon which a CAD/CAM designed superstructure may be fitted to complete a two-piece dental abutments include an abutment screw for fixation to the underlying implant. The abutments may be used for single-unit (single-tooth) or multiple-unit (bridges and bars) restorations and are compatible for use with BioHorizons Internal and Tapered Internal implant systems and Zimmer® Dental Screw-Vent® and Tapered Screw-Vent® implants with 3.5mm, 4.5mm and 5.7mm internal hex-connection mating platform diameters.

All digitally designed abutments and/or copings for use with BioHorizons CAD/CAM Abutments are intended to be sent to a BioHorizons-validated milling center for manufacture. BioHorizons abutments designed using CAD/CAM techniques must fulfill the BioHorizons allowable range of design parameters.

BioHorizons CAD/CAM Abutments are dental implant final restorative abutments supplied in platform diameters of 3.0mm, 3.5mm, 4.5mm and 5.7mm. The abutments are intended to provide support for dental prosthetic restorations. Each abutment includes an abutment screw for fixation to the underlying implant. Abutment material is titanium alloy as specified in ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy (UNS R56401) for Surgical Implant Applications.

Select abutments are further processed by applying patterns of micro-machined grooves or channels, known as Laser-Lok, to a specified region of the abutment margin. The abutments are provided non-sterile, and they are packaged using materials known in the industry to be appropriate for medical device packaging.

Here's an analysis of the provided text regarding acceptance criteria and supporting studies for the BioHorizons CAD/CAM Abutments:

The document primarily focuses on demonstrating substantial equivalence to predicate devices for regulatory approval (510(k)). This means the "acceptance criteria" are largely based on showing the device performs comparably to existing, legally marketed devices, rather than establishing de novo performance targets. The "studies" are tests conducted to support this claim of equivalence.

Acceptance Criteria and Reported Device Performance

The document doesn't explicitly list numerical acceptance criteria in a typical pass/fail format with specific thresholds. Instead, the acceptance criteria are implicitly defined by the performance of the predicate devices and relevant industry standards. The reported device performance is demonstrated through various tests designed to show that the BioHorizons CAD/CAM Abutments perform in accordance with their intended use and are substantially equivalent to predicate devices.

Further Details on the Study:

Given the nature of this 510(k) submission for a dental abutment, it's highly unlikely that components like "test sets," "ground truth experts," "adjudication methods," or "MRMC comparative effectiveness studies" were part of the presented data. These concepts are more typically associated with diagnostic imaging AI/ML devices or clinical trials involving complex human interpretation.

Therefore, many of the requested items below will be marked as "Not Applicable" or "Not Provided" based on the document's content and the typical scope of device approval for implant components.

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

   • Sample Size (Test Set): Not explicitly stated for each test, but implied to be sufficient for compliance with the respective standards (e.g., ISO 14801 typically requires 12 samples per group for fatigue testing). The document mentions "worst-case 30° angled configurations" and "representative subset" for compatibility testing.
   • Data Provenance: Not specified, but generally assumed to be internal laboratory testing by the manufacturer or contracted labs. The document does not indicate data from human subjects or clinical sites.
   • Retrospective or Prospective: Not applicable as these are laboratory and validation tests, not clinical studies involving patient data.

2. 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)

   • Not Applicable. The "ground truth" for mechanical and sterilization testing is defined by the physical properties measured against engineering standards (e.g., fracture strength, SAL level). For software validation, it's the correct implementation of defined design parameters. No human expert "ground truthing" in the sense of clinical interpretation is relevant here.

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

   • None. Adjudication methods are relevant for ambiguous human interpretations, which is not the case for material property or mechanical performance testing.

4. 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. This is not a diagnostic device involving human readers or AI assistance.

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

   • Not Directly Applicable. While software validation for the CAD/CAM milling process was performed (an "algorithm only" component), this isn't a standalone diagnostic AI. Its "performance" is about correctly enforcing design parameters, not making a diagnosis or prediction. The core device is a physical product, not a software algorithm presented for standalone performance evaluation in a clinical context.

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

   • Engineering Standards / Defined Specifications:
     • For Dynamic Mechanical Fatigue: ISO 14801 standards and BioHorizons' internal performance specifications for expected strength and durability.
     • For Compatibility: Physical fit and function with the specified implant systems.
     • For Sterilization: AAMI/ANSVISO 17665-1:2006, specifically achieving a Sterility Assurance Level (SAL) of 10⁻⁶.
     • For Software: BioHorizons' allowable range of design parameters and criteria.

7. The sample size for the training set

   • Not Applicable. As a physical medical device submission, there is no "training set" in the context of machine learning algorithms. The design process for the abutments is based on engineering principles and existing product lines, not data training.

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

   • Not Applicable. (See above, no training set for this type of device submission).

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The Implanova® Bone Level implants are intended for endosseous implantation in the mandible and maxilla for use as an artificial root structure. These root form implants can be used to replace single or multiple missing teeth and/or to support a fixed or removable prosthesis in partially or completely edentulous upper and lower dental arches. All devices in the Implanova® Bone Level system, including implant fixtures, abutments, healing caps, cover screws, and retention screws are intended for use by prescription only. Implanova® Bone Level implants are intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

Implanova® All-in-One3.0mm implants are indicated for the support and retention of fixed single tooth and fixed partial denture restorations in the mandibular central incisor and maxillary lateral incisor regions of partially edentulous jaws. The Implanova® All-in-One 3.0mm implant must be splinted if two or more are used adjacent to each other. Implanova® All-in-One 3.0mm implant are intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

All Implanova® Bone Level implant fixtures are compatible with the straight type restorative components listed in the table below, including straight type abutments, straight type abutment screws and straight type temporary abutments that are intended to be on Astra Tech's OsseoSpeed 11 TX 3.5S and OsseoSpeed "M TX 4.0S implant fixtures.

All bone fixtures within Inplanova® system are endosseous dental implants and are available in Bone Level and All-In-One implants types. Fixtures are available in the following sizes.

· IMPLANOVA® BONE LEVEL IMPLANTS Narrow Medium: 3.5mm Diameter x 10mm Length Narrow Long: 3.5mm Diameter x 12mm Length Narrow XLong (Extra Long): 3.5mm Diameter x 14mm Length

Standard Short: 4.5mm Diameter x 8mm Length Standard Medium: 4.5mm Diameter x 10mm Length Standard Long: 4.5mm Diameter x 12mm Length Standard XLong: 4.5mm Diameter x 14mm Length

Wide Short: 5.5mm Diameter x 8mm Length Wide Medium: 5.5mm Diameter x 10mm Length Wide Long: 5.5mm Diameter x 12mm Length

· IMPLANOVA® ALL-IN-ONE IMPLANTS Slender Medium: 3.0mm Diameter x 10mm Length Slender Long: 3.0mm Diameter x 12mm Length Slender XLong (Extra Long): 3.0mm Diameter x 14mm Length

The material constituents of the all implant fixtures within the Implanova® system is Grade 23 Titanium Alloy per ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vnadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401). In order to promote osseointegration, a variable portion of the implant surface, depending on the implant's overall length, is surface treated and passivated per ASTM F86 standard.

Abutments for bone level implants are utilized for cement retained restoration. Bone level abutments are available in straight and angled types as well as platform sizes ranging from 4.2mm to 6.5mm. All bone level angled abutments will utilize their respective abutment screw for installation. The material constituents of all Implanova® abutments is grade 23titanium alloy per ASTM F136 Standard Specification for Wrought Titanium 6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401).

Implanova® Bone Level Abutments offer the following models.

· IMPLANOVA® BONE LEVEL ABUTMENTS

Narrow Platform - Straight: 4.2 mm Platform Diameter x 5.7 mm Post Height Narrow Platform – 15 Degrees: 4.2 mm Platform Diameter x 7.3 mm Post Height Narrow Platform – 20 Degrees: 4.2 mm Platform Diameter x 7.3 mm Post Height

Standard Platform - Straight: 4.8 mm Platform Diameter x 5.7 mm Post Height StandardPlatform – 15 Degrees: 4.8 mm Platform Diameter x 7.3 mm Post Height StandardPlatform – 20 Degrees: 4.8 mm Platform Diameter x 7.3 mm Post Height

Wide Platform - Straight: 6.5 mm Platform Diameter x 5.7 mm Post Height WidePlatform - 15 Degrees: 6.5 mm Platform Diameter x 7.3 mm Post Height WidePlatform - 20 Degrees: 6.5 mm Platform Diameter x 7.3 mm Post Height

The system also offers Healing Caps and Cover Screws.

This document is a 510(k) Pre-market Notification for the Implanova® Dental Implant System. It aims to demonstrate substantial equivalence to legally marketed predicate devices. The document does not describe acceptance criteria or a study proving the device meets specific performance criteria with numerical results for the device itself (Implanova®). Instead, it relies on demonstrating substantial equivalence to predicate devices through comparisons of design, materials, intended use, and non-clinical testing for safety and appropriate material and manufacturing characteristics.

Here’s a breakdown of the information that is available within the provided text, and what is not present based on your request:

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

This information is not explicitly provided in the format requested. The document asserts that "the fatiguetest result of the subject device supports that the subject device is substantially equivalent to the predicate devices" (Pages 11 and 12), and that non-clinical testing "supported that the subject device is substantially equivalent to the predicate devices and it is in conformance with the FDA guidance document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments" (Page 17). However, the specific acceptance criteria for these tests (e.g., minimum fatigue strength in MPa or N) and the numerical results achieved by the Implanova® device are not listed. The document focuses on similarity to predicate devices rather than meeting discrete performance metrics presented in a table.

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

This information is not provided. The document lists types of non-clinical tests but does not specify the sample sizes used for these tests, nor the data provenance. These are typically details found in the full test reports, which are not included here.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

This information is not applicable/provided. The document describes non-clinical, laboratory-based testing (e.g., fatigue, sterilization, cytotoxicity, SEM/EDS) rather than clinical studies requiring expert review of data for ground truth establishment.

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

This information is not applicable/provided. As above, this pertains to clinical study design and human interpretation of results, which is not described here.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This information is not applicable/provided. This document describes an endosseous dental implant system, which is a physical medical device, not an AI-assisted diagnostic or decision support system that would involve human readers or AI improvement metrics.

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

This information is not applicable/provided. This is a physical medical device, not an algorithm.

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

This information is not applicable/provided in the context of clinical "ground truth." The ground truth for the non-clinical tests would be the established scientific methods and standards (e.g., ISO 14801 for fatigue testing, ISO 11137-1 for sterilization).

8. The sample size for the training set:

This information is not applicable/provided. As this is a physical medical device, there is no "training set" in the context of machine learning or AI models.

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

This information is not applicable/provided. As above, there is no "training set."

Summary of available information related to performance and predicate devices:

The document primarily demonstrates substantial equivalence by comparing the Implanova® device to several predicate devices.

Key similarities highlighted for Implanova® Bone Level Implants (compared to BioHorizons Tapered Internal Plus, BioHorizons Internal Implants, U fit Dental Implant System):

• Intended Use: Same intended use (endosseous implantation in mandible and maxilla for artificial root structure, single/multiple missing teeth, support prosthesis, immediate loading when primary stability achieved).
• Operating Principle: Same.
• Basic Design: Incorporates same basic design (self-tapping, bone-level type implant, micro-threaded implant collar, tapered implant body).
• Material: Titanium Alloy grade 23 (Ti6Al4V ELI).
• Surface Treatment: Resorbable Blast Texture Media (calcium phosphate), partial surface treatment.
• Sterile: Yes.
• Sterilization Method: Gamma Radiation.
• Size Range: Similar (e.g., Diameter: 3.5mm, 4.5mm, 5.5mm; Length: 8mm, 10mm, 12mm, 14mm).

Key differences and justification for substantial equivalence despite differences:

• Micro-machined grooves vs. Micro threads: Laser-Lok® micro-machined grooves on predicates vs. micro threads on Implanova®. Justification: "functionally identical" as osteocytes cannot differentiate microscopic differences for osseointegration.
• Flute Lengths: Implanova® has longer flute lengths. Justification: "more tapping edges simply ease the tapping processes but functions the same."
• Twist Direction of Vertical Flutes: Implanova® has a minor left-hand twist (18mm pitch) vs. straight or slight right-hand twist on predicates. Justification: "only slightly increases the sharpness of the edges... and passively guides the swarf materials to consolidate... should not render the device NSE."
• Partial Surface Treatment: Implanova® has partial surface treatment (apical 5mm untreated) vs. modified throughout the implant body on predicates. Justification: Untreated apical area maintains sharpness for cutting bone; surface treatment is not a requirement for osseointegration.
• Fatigue Test Result: The document states that "the fatiguetest result of the subject device supports that the subject device is substantially equivalent to the predicate devices." (No numerical results are provided in the excerpt).

Key similarities highlighted for Implanova® All-in-One 3.0mm Implants (compared to Zimmer One-Piece Implant System, NobelDirect 3.0):

• Intended Use: Similar indications for support and retention of fixed single tooth and fixed partial dentures in specific mandibular/maxillary incisor regions, with immediate loading when good primary stability is achieved and appropriate occlusal loading.
• Design & Size: 3.0mm diameter.
• Connection Type: N/A (one-piece design).
• Basic Design: Self-tapping, tissue-level type implant, micro-threaded implant collar, tapered implant body.
• Material: Titanium Alloy grade 23 (Ti6Al4V ELI) (NobelDirect uses CP Titanium grade 4).
• Surface Treatment: Resorbable Blast Texture Media (calcium phosphate), partial surface treatment (Zimmer uses Hydroxyapatite blast media, NobelDirect uses TiUnite).
• Sterile: Yes.
• Sterilization Method: Gamma Radiation.

Key differences and justification for substantial equivalence despite differences:

• Microthreads: Implanova® has microthreads vs. lack of microthreads on predicates. Justification: "only slightly increase the surface area... insignificant deviation... does not render the subject device NSE."
• Flute Lengths, Twist Direction, Partial Surface Treatment: Similar justifications to the bone-level implants regarding these differences.
• Surface Treatment Material: Implanova® uses calcium phosphate blast media; predicates use Hydroxyapatite or TiUnite. Justification: "chemical analysis data... supports that the blast media used for the subject device does not alter surface chemical compositions."

Non-Clinical Testing Performed (Page 17):

• Fatigue Testing (ISO 14801)
• 3rd Party Compatibility
• Sterilization Validation (ISO 11137-1, ISO 11137-2, ISO11737-1, ISO11737-2, ISO 17665-1 and ISO 17665-2)
• Shelf-life Validation (ASTM F1980, ISO 11607-1, ISO 11607-2, ASTM F88, and ASTM F 1929)
• Cytotoxicity Testing (ISO 10993-5)
• SEM/EDS Chemical Surface Analysis

These tests are stated to have "supported that the subject device is substantially equivalent to the predicate devices and it is in conformance with the FDA guidance document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments."

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CSM Implants are intended for use in support of single or multiple-unit restorations and partial or fully edentulous mandibles and maxilla. This system is intended for delayed loading.

The CSM submerged-L Implant System includes various one-stage Fixtures and two-stage Fixtures made of titanium. These implants are surgically inserted into the upper and/or lower jawbone and serve as a tooth root replacement providing a stable foundation for restorations. This product is a fixture and an abutment prosthetic dentistry material which are dental implant infrastructures. The connection with the abutment is inserted in bones as internal connection (the morse taper 11° and Hexagon type) method. A connection will restore mastication function of the patient who has difficulties due to damage of the natural tooth and function as a supporting the prosthetic dentistry material such as artificial tooth.

Here's a breakdown of the acceptance criteria and the study information for the "CSM submerged-L Implant System" based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document explicitly states that the study involved "mechanical testing" and "fatigue testing." However, it does not specify the sample size for the test set (number of implants tested) or the data provenance (e.g., country of origin of the data, retrospective or prospective). This type of information is typically detailed in a full testing report, which is usually not included in the publicly available 510(k) summary.

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

This information is not applicable to this type of device and study. The "CSM submerged-L Implant System" is a physical medical device (dental implant), and its performance is evaluated through mechanical engineering tests (fatigue testing, mechanical strength), not through interpretation of data by human experts to establish "ground truth" in the way it would be for an AI algorithm interpreting medical images.

4. Adjudication Method for the Test Set:

This information is not applicable for the same reasons as point 3. Mechanical testing results are objective measurements, not subject to expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness study was done:

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the performance of AI algorithms that assist human readers (e.g., in radiology). The "CSM submerged-L Implant System" is a physical implant, and its performance evaluation focuses on its mechanical properties and equivalence to predicate devices.

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

No, a standalone performance study in the context of an AI algorithm was not done. This device is a physical product, not an AI algorithm. Its "standalone performance" refers to its mechanical properties when tested independently.

7. The Type of Ground Truth Used:

The "ground truth" in this context is established through physical measurements and engineering standards, specifically:

• Mechanical strength (e.g., yield strength, ultimate tensile strength, fracture toughness)
• Fatigue life
• Dimensional accuracy
• These are compared against established benchmarks or the performance of a predicate device.

8. The Sample Size for the Training Set:

This information is not applicable. The "CSM submerged-L Implant System" is a manufactured product, not an AI model that requires a training set. The "training" for such a device involves design, material selection, and manufacturing processes, culminating in a final product that undergoes testing.

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

This information is not applicable as there is no "training set" in the context of an AI algorithm. For a physical device, the design and manufacturing process are iterative, informed by engineering principles, material science, and previous product data, rather than a specific "training set with ground truth."

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