Search Results

Straumann® dental 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 dental 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 implants of the Straumann Dental Implant System. The subject devices represent a full line of Straumann implants having the Ti-13Zr alloy (Roxolid®) and the SLA grit blast and acid etch surface finish in the same diameters, lengths, emergence profiles and implant-to abutment interfaces as previously cleared implants in the Straumann Dental Implant System.

This document (K150938) describes the Straumann® Dental Implant System - Roxolid® SLA Implants, which are dental endosseous implants. The primary purpose of this 510(k) submission is to demonstrate substantial equivalence to previously cleared devices. The key change is the use of a Titanium-13Zirconium alloy (Roxolid®) for the implants, compared to commercially pure Grade 4 Titanium in the predicate devices.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

The document does not explicitly state "acceptance criteria" for specific performance metrics in a tabular format. Instead, it relies on demonstrating that the new material change (Roxolid®) does not negatively impact the performance compared to the predicate devices which used commercially pure Grade 4 Titanium. The performance is assessed through various bench studies.

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 explicitly states that the substantial equivalence of the device is addressed via "bench studies" and "dynamic fatigue test data consistent with FDA guidance and ISO 14801." However, it does not provide specific sample sizes (e.g., number of implants tested), the exact test parameters beyond "ISO 14801," or the provenance of the data (country of origin, retrospective/prospective). This information would typically be detailed in the full test reports, which are not included in this summary.

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 is a medical device approval based on bench testing and material equivalence, not on clinical performance or interpretation of images by experts. Therefore, the concept of "experts used to establish the ground truth" for a test set (like in a diagnostic AI study) is not applicable here. The "ground truth" for the bench tests would be the results obtained following the specified standards (e.g., force values, cycles to failure).

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

Not applicable. As noted above, this submission relies on bench testing and material characterization, not human interpretation or adjudication of outputs.

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

Not applicable. This is not an AI-assisted diagnostic tool. It is a dental implant.

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

Not applicable. This is not an algorithm or software device.

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

The "ground truth" for this device's performance relies on engineering standards and scientific verification of material properties and mechanical performance. This includes:

• Material composition analysis: Verifying the Ti-13Zr alloy (Roxolid®) composition.
• Mechanical testing: Dynamic fatigue testing according to ISO 14801.
• Surface characterization: Analysis of the SLA grit blast and acid etch surface finish characteristics and surface chemistry.
• Sterilization validation: Conformance to ISO 11137-1 and ISO 11137-2 for sterility assurance level (SAL).

8. The sample size for the training set

Not applicable. There is no "training set" in the context of this traditional medical device approval process. The device's performance is not learned through data like an AI model; it's designed and verified through engineering principles and testing.

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

Not applicable, as there is no training set for this device.

Ask a specific question about this device

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. Multiple tooth applications may be rigidly splinted.

The subject Titamax Ti EX Acqua implants are provided in the same design variants as the predicate Titamax Ti EX implants. The only difference is the application of the Acqua hydrophilic surface treatment in place of the NeoPoros surface finish. The Titamax Ti EX Acqua are provided in two endosseous diameters (3.75 and 4.0 mm), one platform diameter (4.1 mm), and five lengths (9, 11, 13, 15, and 17 mm).
The subject Ti Drive Acqua implants have the same tapered, single thread design variants as the predicate CM Drive implants and the same external hex abutment interface and internal geometry as the predicate HE series implants. They also have the Acqua hydrophilic surface treatment in place of the NeoPoros surface finish. The Ti Drive Acqua implants are provided in three endosseous diameters (3.5, 4.3, and 5.0 mm), three platform diameters (3.3, 4.3, and 5.0 mm), and five lengths (8, 10, 11.5, 13, and 16 mm).

The subject Titamax CM EX Acqua implants are provided in the same design variants as the predicate Titamax CM EX implants. The only difference is the application of the Acqua hydrophilic surface treatment in place of the NeoPoros surface finish. The Titamax CM EX Acqua implants are provided in three endosseous diameters (3.5, 3.75, and 4.0 mm), three platform diameters (3.5, 3.75, and 4.0 mm), and five lengths (9, 11, 13, 15, 17 and 19 mm).

The subject CM Drive Acqua implants are provided in the same design variants as the predicate Titamax CM EX implants. The only difference is the application of the Acqua hydrophilic surface treatment in place of the NeoPoros surface finish. The CM Drive Acqua implants are provided in three endosseous diameters (3.5, 4.3, and 5.0 mm), three platform diameters (3.3, 4.3, and 5.0 mm), and five lengths (8, 10, 11.5, 13, and 16 mm).

The subject Titamax Smart EX Acqua implants are provided in the same design variants as the predicate. The only difference is the application of the Acqua hydrophilic surface treatment in place of the NeoPoros surface finish. The Titamax Smart EX Acqua implants are provided in two endosseous diameters (3.75 and 4.0 mm), one platform diameter (4.1 mm), and five lengths (9, 11, 13, 15, and 17 mm).

The subject device Drive Smart Acqua implants are provided in the same design variants as the predicate Drive Smart implants. The only difference is the application of the Acqua hydrophilic surface treatment in place of the NeoPoros surface finish. The Drive Smart Acqua implants are provided in three endosseous diameters (3.5, 4.3, and 5.0 mm), three platform diameters (3.3, 4.3, and 5.0 mm), and five lengths (8, 10, 11.5, 13, and 16 mm).

The Acqua surface finish is a traditional grit blast and acid etch surface that is further processed in a manner that renders it hydrophilic.

The subject implant devices are made of Grade 4 commercially pure titanium conforming to ASTM F67, Standard Specification for Unalloyed Titanium for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700), with a surface that is grit blasted, acid etched and subjected to a process that renders them hydrophilic. The subject Smart mount devices are made of titanium alloy conforming to ASTM F136 Standard for Titanium-6Aluminum-Specification 4Vanadium ELI (Extra Low Interstitial) Allov for Surgical Implant Applications (UNS R56401).

The provided text describes the Neodent Implant System's 510(k) summary (K133592) and its substantial equivalence determination by the FDA. However, it does not contain information about acceptance criteria, specifics of a study proving device performance against acceptance criteria, or details regarding ground truth establishment, sample sizes for test/training sets, expert qualifications, or adjudication methods in the context of an AI/algorithm-based device as requested in the prompt.

The document primarily focuses on demonstrating the substantial equivalence of the Neodent Implant System to legally marketed predicate devices based on design, materials, surface treatment, and intended use.

Here's a breakdown of what can be extracted and what is missing based on your specific questions:

1. Table of Acceptance Criteria and Reported Device Performance:

This information is not available in the provided text. The document states that "Non-clinical data submitted, referenced, or relied upon to demonstrate substantial equivalence include engineering analysis and dimensional analysis. Bench testing and animal testing were submitted to characterize the Acqua surface." However, it does not specify any quantitative acceptance criteria or the reported performance metrics against those criteria.

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

This information is not available. The document mentions bench testing and animal testing but provides no details on sample sizes or data provenance (country of origin, retrospective/prospective) for these tests.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

This information is not available. The document does not describe any process of establishing ground truth by experts, as it's not detailing a diagnostic AI/algorithm.

4. Adjudication Method for the Test Set:

This information is not available. Adjudication methods are typically relevant for human review of results, which is not described here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done and Effect Size:

No. The document explicitly states: "Clinical data were not submitted in this premarket notification." Therefore, an MRMC study comparing human readers with and without AI assistance was not performed or reported.

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

No. The device is a physical dental implant system, not a software algorithm. Therefore, "standalone" performance in the context of an algorithm is not applicable or discussed.

7. The Type of Ground Truth Used:

This information is not available. For a physical device, "ground truth" often refers to established engineering specifications, material properties, or biological outcomes. While the document mentions demonstrating substantial equivalence through "engineering analysis and dimensional analysis" and characterizing the "Acqua surface" through "bench testing and animal testing," it does not explicitly define what "ground truth" was used or how it was established for these tests.

8. The Sample Size for the Training Set:

This information is not available. As the device is not an AI/algorithm, there is no concept of a "training set" in the context of the provided document.

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

This information is not available (not applicable, as there's no training set).

Summary of what is present:

• Device Name: Neodent Implant System
• Intended Use: "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. Multiple tooth applications may be rigidly splinted."
• Basis for Approval: Substantial equivalence to previously cleared predicate devices (K101207, K101945, K123022, K133510, and K033984 for the SLActive surface).
• Performance Data Submitted: Non-clinical data including engineering analysis, dimensional analysis, bench testing, and animal testing to characterize the Acqua surface.
• Clinical Data: "Clinical data were not submitted in this premarket notification."

The provided text describes a regulatory submission for a physical medical device (dental implants), not a diagnostic AI or algorithm. Therefore, many of the questions related to AI/algorithm validation (ground truth, expert adjudication, MRMC studies, training/test sets) are not addressed in this document.

Ask a specific question about this device

The Synthes Radial Head Prosthesis System is intended for:

1. The replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepitation, and decreased motion at the radio-humeral and/or proximal radio-ulnar joint with
   a. Joint destruction and/or subluxation visible on x-ray
   b. Resistance to conservative treatment
2. Primary replacement after fracture of the radial head.
3. Symptomatic sequelae after radial head resection
4. Revision following failed radial head arthroplasty.

The Synthes Radial Head Prosthesis is a two-piece modular system comprised of titanium alloy stem and cobalt chrome head components with an integral screw and side-loading application to allow for in situ assembly. The system consists of a range of lengths and diameters for the stem in both straight and curved configurations as well as heads in a range of diameters and heights to accommodate the surgical need.

This document is a 510(k) Summary for the Synthes Radial Head Prosthesis System. It is focused on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria and conducting a study to prove performance against those criteria in the way one might for a novel diagnostic or AI device.

Therefore, many of the specific questions regarding acceptance criteria, device performance metrics (e.g., sensitivity, specificity), sample sizes, ground truth establishment, expert qualifications, and MRMC studies are not directly applicable or explicitly detailed in this type of submission for a medical implant device.

However, I can extract the relevant information regarding the performance testing and the approach to demonstrating substantial equivalence.

Here's an analysis based on the provided text, addressing the applicable points and explaining why others are not present:

Context: The Synthes Radial Head Prosthesis System is a medical implant (a modular radial head prosthesis) intended for the replacement of the radial head in specific orthopaedic conditions. The 510(k) submission aims to demonstrate that this new device is "substantially equivalent" to existing, legally marketed predicate devices. This means it has the same intended use, fundamental technological characteristics, and similar materials, and that performance testing shows it is as safe and effective as the predicates.

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

The document does not explicitly present a table of quantitative acceptance criteria for performance metrics typical of, for example, diagnostic accuracy (like sensitivity, specificity, AUC). Instead, the "acceptance criteria" are implied by the demonstration of substantial equivalence to predicate devices through various tests and analyses.

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

• Sample Size: The document does not specify a "sample size" in terms of patients or anatomical specimens as one would for a clinical trial or diagnostic study. The "test set" here refers to the actual physical devices (or components thereof) that underwent in vitro performance testing and surface analysis. The number of such devices or samples tested is not disclosed in this summary.
• Data Provenance: The tests are described as "in vitro performance testing," "Macro Surface Analysis," "Scanning Electron Microscopy (SEM)," and "X-Ray Photoelectron Spectroscopy (XPS)." These are laboratory-based studies, not clinical studies involving patient data from specific countries or populations. The data provenance is controlled laboratory conditions.

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 to this type of device submission. The "ground truth" for a mechanical implant is its physical and mechanical properties, not expert-derived diagnostic labels. The performance is assessed through engineering and materials science testing, not clinical diagnosis by experts.

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

• This question is not applicable. Adjudication methods are typically used to resolve discrepancies in expert interpretations of clinical data or images. This submission focuses on the objective physical and mechanical properties of an implant.

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 implant, not a diagnostic imaging or AI algorithm that would involve human readers or AI assistance.

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

• This question is not applicable. The device is a physical implant, not an algorithm.

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

• The "ground truth" for this device's performance is established by engineering and materials science standards and measurements. This includes:
  • Mechanical properties: The ability to withstand clinical loads.
  • Material properties: Chemical composition and physical and macro/micro surface characteristics.
  • Peer-reviewed literature: Used to demonstrate how these material and surface characteristics relate to physiological responses.

8. The sample size for the training set

• This question is not applicable. There is no concept of a "training set" in the context of this 510(k) submission for a physical implant. The design and manufacturing processes are based on engineering principles and prior knowledge from predicate devices, rather than machine learning training.

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

• This question is not applicable, as there is no training set. The "ground truth" for the device's design and material selection would be established through established engineering principles, materials science, and conformity to relevant ASTM/ISO standards (though specific standards are not named in this summary).

Ask a specific question about this device

DEFCON TSA/TSH implants are suitable for the treatment of oral endosteal implantation in the upper and lower jaw and for the functional and esthetic oral rehabilitation of edentulous and partially dentate patients.

DEFCON TSA/TSH implants are for single-stage or two-stage surgical procedures and cement or screw retained restorations.

Implants are intended for immediate loading on single-tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function if the requirement detailed in the surgical manual is satisfied. When placing implants in the posterior region, we recommend using only large diameter (Ø6.0 mm and above) implants.

Specific indications for small diameter (Ø3.3 mm) implants: Because of their reduced mechanical stability, small diameter implants are only used in cases with a low mechanical load. Placement in the molar region is not recommended.

DEFCON TSA / TSH dental implant systems are threaded, root-form endosseous implants of various diameters and lengths and corresponding abutments. Implants are composed of Titanium commercially pure, feature different implant to abutment connection options and are available with modified surfaces to promote improved osseointegration. Implant abutments are composed of Titanium commercially pure, Titanium alloy 6Al 4V and POM-C.

Primary stability, adequate osseointegration and mechanical performance of the implant connection are fundamental to implant success. Device design characteristics including the thread profile, geometry, surface finish and crestal characteristics are based on these concepts.

The provided text describes the "IMPLADENT DEFCON TSA/TSH Dental Implant Systems," a root-form endosseous dental implant. The document is a 510(k) premarket notification summary, which focuses on demonstrating substantial equivalence to already marketed predicate devices rather than providing detailed acceptance criteria and a study to prove performance against those criteria in the way a clinical trial might.

Therefore, the information requested regarding acceptance criteria, device performance, study characteristics (sample size, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance), and training set details for an AI/CAD device is not available in the provided text.

The document explicitly states:

• "No clinical studies are submitted." (Section 5: 510(k) SUMMARY)
• The device was subject to "bench testing to determine conformance to performance [requirements]... specifically including mechanical performance... and biological testing in accordance with the level and duration of contact with the human body, surface finish evaluation including chemical analyses, and sterilization process validation." (Section 5: 510(k) SUMMARY - NON-CLINICAL TEST SUMMARY)

This indicates that compliance was demonstrated through non-clinical, laboratory bench testing, not through human clinical studies where acceptance criteria for diagnostic accuracy (common in AI/CAD systems) would typically be evaluated.

The "acceptance criteria" in this context are related to the mechanical, biological, and material properties of the implant, which were likely evaluated against industry standards or internal specifications during bench testing. However, the specific metrics and comparison to reported performance are not detailed in the summary provided.

In summary, as this is a 510(k) for a physical medical device (dental implant) and not an AI/CAD system, the requested information on acceptance criteria, clinical study design, and performance metrics (like sensitivity, specificity, reader improvement, etc.) is not applicable or present in the provided document.

Ask a specific question about this device

SLActive implants are for single-stage or two-stage surgical procedures. SLActive implants are intended for immediate placement and function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. Multiple tooth applications may be rigidly splinted. In the case of edentulous patients, 4 or more implants must be used in immediately loaded cases.

The Straumann solid screw dental implants are of various diameters and lengths with an anchorage surface that is grit blasted and acid etched and modified as described in K033984. No changes to overall implant design or dimensions were made. This submission involved additional studies to support the benefits of the SLActive implant surface.

This is an interesting case where the provided text is a 510(k) summary for a dental implant, which is a medical device. However, 510(k) summaries, especially from 2006, often do not contain detailed information about specific acceptance criteria and the results of studies in the way one might expect for a diagnostic AI device. They primarily focus on demonstrating substantial equivalence to a predicate device.

Based on the provided text, the device in question is the "Straumann Dental Implant System®" with the "SLActive implant surface." The submission focuses on the benefits of this new surface.

Here's an analysis based on the provided text, highlighting the absence of some requested information due to the nature of the 510(k) submission:

1. Table of Acceptance Criteria and Reported Device Performance

It is important to note that the provided 510(k) summary from 2006 does not explicitly state specific quantitative acceptance criteria or corresponding reported device performance metrics in a table format, as one would typically find for a diagnostic AI device aiming for performance targets like sensitivity, specificity, or AUC.

Instead, the "acceptance criteria" can be inferred from the basis for substantial equivalence, which focuses on demonstrating improved performance compared to the existing SLA surface and equivalence to the predicate device in other aspects.

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

The summary states: "The subject device with the modified SLActive surface demonstrates increased osteoblast activity and increased angiogenesis within the first several days after placement when compared to the SLA implant surface in animal studies."

• Sample Size for Test Set: The sample size for the animal studies is not specified in this 510(k) summary.
• Data Provenance (Country of Origin, Retrospective/Prospective): The summary indicates "animal studies." The country of origin and whether the studies were retrospective or prospective are not specified.

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

This information is not applicable and therefore not provided in the 510(k) summary for this type of device. The "ground truth" for an implant's biological performance in animal studies would be derived from histological analysis, biomechanical testing, and other laboratory-based assessments, not typically expert panel consensus on interpretations of images.

4. Adjudication Method for the Test Set

This is not applicable and therefore not provided. Adjudication methods like 2+1 or 3+1 are typically used in clinical imaging studies where human readers are assessing diagnostic output. The animal studies described would involve objective measurements and histological analysis.

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, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic AI devices that assist human readers. The SLActive implant is a physical medical device, not an AI diagnostic tool.

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

• No, a standalone performance study as described (for an algorithm) was not done. This concept is also not applicable to a dental implant product. The "standalone" performance here refers to the implant's biological and mechanical performance.

7. The Type of Ground Truth Used

Based on the description of the studies ("increased osteoblast activity and increased angiogenesis... in animal studies," "faster implant secondary stability"), the ground truth would be established through a combination of:

• Pathology/Histology: For observing osteoblast activity and angiogenesis.
• Biomechanical Testing/Measurement of Stability: For assessing implant secondary stability.
• Physiological Outcome Data: Direct measurement of biological responses in animal models.

8. The Sample Size for the Training Set

• Not applicable/Not provided. This device is a physical implant, not an AI algorithm that requires a training set. The "studies" mentioned are performance evaluations, not algorithm training.

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

• Not applicable/Not provided for the same reasons as point 8.

Ask a specific question about this device