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Straumann® Screw Retained Abutments are indicated to be placed into the implants of the Straumann® Dental Implant System to provide support for prosthetic reconstructions such as crowns, bridges and bars. The final processed devices have the purpose of restoring chewing function. Straumann® Screw Retained Abutments are indicated for screw-retained restorations.

Straumann® Screw Retained Abutments include one-piece straight and angled (17° and 30°) abutments, basal screws and abutment carrier pin. The subject device is identical to the primary predicate, K133421, and subsequent premarket notification submissions K141871, K150814 and K151247 with the exception that the subject device will be delivered to the user sterile as opposed to non-sterile and a change in packaging to ensure sterility of the devices.

This document is a 510(k) premarket notification for the Straumann® Screw Retained Abutments. It aims to demonstrate substantial equivalence to previously cleared predicate devices. Since this is not a diagnostic device and doesn't involve an AI algorithm, the information requested in your prompt (acceptance criteria, study details, expert input, MRMC study, standalone performance, training set) typically applies to AI/ML-based medical devices or diagnostic tools.

This submission focuses on engineering, material, and sterilization equivalence for a dental implant component. Therefore, the detailed AI/ML-specific questions in your prompt are not applicable to this document.

However, I can extract information related to the device's technical characteristics and the claim of substantial equivalence.

Here's a breakdown of what is applicable from your prompt, based on the provided text:

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

The document doesn't explicitly state "acceptance criteria" in the format typically used for performance metrics of diagnostic algorithms. Instead, it relies on demonstrating substantial equivalence to predicate devices. This means that the device's characteristics must be similar enough to the predicate to ensure equivalent safety and effectiveness.

The table provided (pages 5-6) serves as the primary evidence for this. It compares the Subject Device (Straumann® Screw Retained Abutments) to several Predicate Devices across various technical characteristics. The "performance" in this context is demonstrating that these characteristics are either identical or sufficiently similar to the legally marketed predicates.

The study proving the device meets its "acceptance criteria" (i.e., substantial equivalence) is the comparison to predicate devices and the verification/validation activities for the changes (primarily sterilization and packaging). The document explicitly states: "The subject device is identical to the primary predicate, K133421, and subsequent premarket notification submissions K141871, K150814 and K151247 with the exception that the subject device will be delivered to the user sterile as opposed to non-sterile and a change in packaging to ensure sterility of the devices." And "Packaging materials and configuration is equivalent to reference predicate device, Straumann® Healing Abutments, Healing Caps, Closure Screws, K130808."

The substantial equivalence is primarily based on:

• Identical Indications for Use.
• Identical fundamental operating principles.
• Identical materials (Ti-6Al-7Nb titanium alloy).
• Comparable design features (Implant-to-Abutment Connection, Interface Type, Platform Diameter(s), Abutment Angulation(s), Gingival Height(s), Orientation of Angulation to Engagement Features).
• Validation of the sterilization process according to recognized standards (ISO 11137-1 and ISO 11137-2) and equivalence of packaging to a previously cleared sterile device (K130808).

The following points are not applicable to this 510(k) submission for a non-AI/ML dental abutment:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
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)
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
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
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
8. The sample size for the training set
9. How the ground truth for the training set was established

These points would be relevant for devices that involve algorithms, image interpretation, or diagnostics where a "ground truth" needs to be established and performance metrics (e.g., sensitivity, specificity, AUC) are calculated based on a test set. This submission is for a physical medical device (dental abutment) where the primary evaluation is based on engineering design, material properties, and manufacturing processes, demonstrated through comparison to legally marketed predicate devices and validation of changes like sterilization.

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Prosthetic components directly or indirectly connected to the endosseous dental implant are intended for use as an aid in prosthetic rehabilitations.

The subject devices represent a line extension of the Straumann Dental Implant System (SDIS). The subject devices are an assembly of a noble metal alloy (Ceramicor®) Abutment Base and a polymer (POM) Modeling Aid. The Modeling Aid is attached to the abutment base by means of a friction fit. The subject devices employ the same Modeling Aid (catalog no. 049.217) as the identified predicate devices. The subject devices use the same Basal Screw for fixing the finished restoration to the implant (catalog no. 049.128) as the identified predicate devices. The subject devices interface with Straumann Tissue Level (TL) implants having the Regular Neck (RN) or Wide Neck (WN) implant-to-abutment interface. The subject devices do not engage the anti-rotation features within the TL implants. The non-engaging design makes these devices suitable for the fabrication of bar and bridge superstructures by the dental laboratory using either casting or soldering techniques.

This document is a 510(k) Premarket Notification for a dental abutment, specifically the "Straumann® synOcta Gold Abutments for Bridge." The purpose of this notification is to demonstrate that the new device is substantially equivalent to existing predicate devices already on the market, rather than proving a new medical claim or performance characteristic that would require extensive clinical trials. Therefore, the information provided focuses on the device's design, material, and mechanical performance compared to a predicate, not on complex acceptance criteria for a diagnostic algorithm or a clinical outcome.

Here's an analysis of the provided text in the context of the requested information, understanding that this is for a physical medical device (dental abutment) and not an AI/diagnostic tool:

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

The document does not present a formal table of "acceptance criteria" in the way one would for a diagnostic device (e.g., sensitivity, specificity, accuracy thresholds). Instead, it relies on demonstrating substantial equivalence to a predicate device through conformity to existing standards and showing comparable mechanical performance.

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

The document mentions "Dynamic fatigue test data" in support of the submission. However, it does not specify:

• The sample size for these tests.
• The specific data provenance (country of origin, retrospective or prospective).
• Details about a "test set" in the context of diagnostic performance. The testing here is mechanical (fatigue).

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 submission. The device is a physical dental abutment, and its "performance" is evaluated through mechanical bench testing and material characterization, not by expert interpretation or ground truth establishment in a clinical imaging or diagnostic context.

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

This question is not applicable. There is no "adjudication" in the sense of reconciling expert opinions for a diagnostic outcome. Mechanical tests are typically performed according to standardized protocols.

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. MRMC studies are used for diagnostic devices involving human readers and AI. This submission is for a physical dental abutment.

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

This question is not applicable. This is not an algorithm or AI device.

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

For this device, "ground truth" is established through:

• Mechanical standards: Adherence to international standards like ISO 14801 for dynamic fatigue testing.
• Material specifications: Conforming to material standards like ISO 22674 for metallic dental materials.
• Biocompatibility and Sterilization: Relying on the established safety of the materials and manufacturing methods used in the predicate devices.

8. The sample size for the training set

This question is not applicable. There is no "training set" as this is not an AI/machine learning device. The design, materials, and manufacturing processes are developed through engineering and materials science, not by training an algorithm on data.

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

This question is not applicable for the reasons stated above.

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CAMLOG® and CONELOG® Abutments for Screw-retained Restorations (ASR) are intended to support occlusal screw- retained prosthetic restorations in the upper jaw and lower jaw in conjunction with CAMLOG® and CONELOG® Implants.

Abutment for Screw-retained Restorations (ASR) is available with the Camlog or the Conelog implant/abutment interface. ASR Straight is provided in five platform diameters (3.3. 3.8. 4.3. 5.0 and 6.0 mm) and three gingival heights (0.5, 2.0 and 4.0 mm), for a total of 15 abutment options. ASR Angled is provided in four platform diameters (3.3, 3.8, 4.3, and 5.0 mm), four gingival heights (2.5, 3.5, 4.0 and 5.0 mm), and two angles (17° and 30°). Each of the angled designs is provided in a Type A option (anti-rotation cam alignment away from the abutment cone angle) or Type B option (anti-rotation cam alignment in the direction of the abutment cone angle), for a total of 32 abutment options. A healing cap, and a titanium cap for temporary or permanent restoration fabrication are available for all sizes. All ASR components are made from titanium alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401).

This document describes the premarket notification (510(k)) for the CAMLOG® and CONELOG® Abutments for Screw-retained Restorations (ASR). This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving direct clinical effectiveness against specific acceptance criteria. Therefore, the information typically requested regarding acceptance criteria and a study proving those criteria are met is not directly applicable in the same way as for a novel device or a clinical trial.

However, based on the provided text, we can infer the equivalence criteria and the studies performed to demonstrate substantial equivalence, which serves a similar purpose in the 510(k) process.

Here's the breakdown of the information related to acceptance criteria and supporting studies, interpreted within the context of a 510(k) submission:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) submission, the "acceptance criteria" are predominantly related to demonstrating substantial equivalence to predicate devices in terms of intended use, technological characteristics, and material. The "reported device performance" is the comparison made against the predicate devices.

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

For a 510(k) submission focused on substantial equivalence through non-clinical testing, there isn't a "test set" in the traditional sense of a clinical study with a patient cohort.

• Non-Clinical Tests: The sample sizes for each non-clinical test (sterilization, biocompatibility, mechanical fatigue) would be determined by the specific ISO standards referenced (e.g., ISO 14801 for fatigue testing often specifies sample sizes for statistical significance). These details are not provided in the document.
• Data Provenance: The data provenance is from non-clinical laboratory testing conducted by the manufacturer (Altatec GmbH). The country of origin for the data is Germany (manufacturer's location). The data is prospective in the sense that these tests were conducted specifically for this submission.

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

This information is not applicable as there was no clinical test set requiring expert ground truth establishment. The ground truth for the non-clinical tests is based on the specific requirements and methodologies outlined in the referenced ISO standards.

4. Adjudication Method for the Test Set

This information is not applicable as there was no clinical test set.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical data were not submitted in this premarket notification."

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

This question is not applicable as the device is a physical dental abutment and not an AI algorithm.

7. The Type of Ground Truth Used

For the non-clinical tests, the "ground truth" is defined by the established international standards (ISO standards) referenced. For example:

• For sterilization, the ground truth is achieving the specified Sterility Assurance Level (SAL) per ISO 11137.
• For biocompatibility, the ground truth is demonstrating no unacceptable biological responses based on ISO 10993-1.
• For dynamic fatigue, the ground truth is withstanding specified loads for a defined number of cycles, as per ISO 14801.

8. The Sample Size for the Training Set

This question is not applicable as the device is a physical dental abutment and not an AI algorithm.

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

This question is not applicable as the device is a physical dental abutment and not an AI algorithm.

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

The subject Neodent Implant System implants are threaded, self-tapping, root form, endosseous dental implants with a Morse taper abutment interface. The proposed CM Drive implants come in three diameters (3.5, 4.3 and 5.0 mm) and a length of 18.0 mm. They are made of commercially pure and acid etched surface finish or the Acqua grit blasted, acid etched and hydrophilic, chemically active surface finish.

The CM Drive implants (K123022) have been shown to be compatible with the previously cleared angled abutments (K101945) having the CM implant-to-abutment interface.

The addition of the 18mm lengths to the previously cleared CM Drive Implants has no detrimental impact on device indications or performance. All other attributes are identical. No modifications were made to the coronal features of the implant that would impact dynamic fatigue performance.

A groove has been added to the conic portion of six (6) CM Mini Conical Abutments to ensure that the abutments do not release from the transfer tool during transfer from the package until secured in the implant. This feature also assures secure retention of the abutment in the package during storage and shipment.

The pilot hole depth of the CM Abutments was reduced in order to increase the minimum wall thickness of the abutment. The length of the internally threaded portion of the abutment was not changed, so engagement between the occlusal screw and the abutment is also unchanged.

This document is a 510(k) Pre-market Notification for the Neodent Implant System. It primarily addresses the substantial equivalence of the new device to previously cleared predicate devices, rather than detailing a study with specific acceptance criteria for a novel AI/software device. As such, most of your requested information (related to AI performance, sample sizes for test/training sets, expert adjudication, MRMC studies, standalone performance, and ground truth establishment) is not present in this document.

However, I can extract information related to the performance data presented and the comparison to predicate devices, which serves a similar function to acceptance criteria in the context of a 510(k) submission for a physical medical device.

1. Table of Acceptance Criteria and Reported Device Performance

In the context of this 510(k) for a dental implant system, "acceptance criteria" are implicitly defined by the demonstration of substantial equivalence to predicate devices. The primary performance criterion mentioned is dynamic fatigue testing, consistent with FDA guidance and ISO 14801. The "reported device performance" is that the device demonstrated substantial equivalence through these tests.

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

• Sample Size for Test Set: The document does not specify the exact number of implants or tests performed for the dynamic fatigue testing. It generally states that "Dynamic fatigue test data consistent with FDA guidance and ISO 14801 have been referenced." ISO 14801 typically involves mechanical testing of multiple samples, but the exact count is not given here.
• Data Provenance: The data is presented as "bench studies" performed by the manufacturer (JJGC Industria e Comercio de Materiais Dentarios SA or Instradent USA, Inc.). The country of origin of the data is not explicitly stated in terms of where the tests were physically conducted. The submission is from New Hampshire, USA on behalf of a Brazilian company.

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. The "ground truth" for this medical device submission is based on engineering and material science standards (e.g., ISO 14801) and the performance of predicate devices, not on expert consensus or clinical outcomes from a test "set" in the way an AI algorithm test set would be adjudicated.

4. Adjudication method for the test set

This information is not applicable for a physical device's substantial equivalence review. Testing is based on pre-defined engineering standards.

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. This is not an AI/software device.

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

This information is not applicable. This is not an AI/software device.

7. The type of ground truth used

The "ground truth" in this context is the mechanical performance standards (specifically dynamic fatigue strength as per ISO 14801) and the established safety and effectiveness profile of the legally marketed predicate devices. The new device's performance is compared against these engineering standards and the characteristics of the predicate devices.

8. The sample size for the training set

This information is not applicable. This is not an AI/software device. No training set is mentioned or implied.

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

This information is not applicable. This is not an AI/software device. No training set or ground truth establishment method for a training set is mentioned.

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