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Inclusive® Titanium Abutments are premanufactured prosthetic components connected to endosseous dental implants in the edentulous or partially edentulous maxilla or mandible to provide support for cement-retained or screw-retained prosthetic restorations.

All digitally designed abutments for use with Inclusive Titanium Abutments for CAD/CAM are intended to be sent to a Prismatik Dentalcraft validated milling center for manufacture.

Compatible Implant System: Dentsply Implants Astra Tech Implant System® EV

Inclusive® Titanium Abutments compatible with: Dentsply Implants Astra Tech Implant System EV, which are the subject of this submission, are designed and fabricated to be compatible exclusively with Dentsply Implants Astra Tech Implant System EV, and have a prefabricated, precision interface (implant/abutment connection) compatible with the primary predicate device connection. The proposed product line includes stock abutments and abutments intended for fabrication of patient-specific custom abutments using CAD/CAM technology. Each patient-specific abutment is individually prescribed by the clinician and manufactured by an authorized milling center validated by Prismatik Dentalcraft.

The subject devices are manufactured from titanium alloy conforming to ASTM F136, and have a taper followed by a keyway connection feature that prevents rotation of the abutment. The abutments are compatible exclusively with the Astra Tech OsseoSpeed EV implant line (cleared under K120414) in the following diameters: 3.0S, 3.6S, 4.2S, 4.2C, 4.8S, 4.8C, 5.4S mm. The subject device includes the following components: Titanium Abutment Blanks, intended to fabricate all-titanium, patientspecific abutments using CAD/CAM technology; Titanium Abutment 4.5mmH and Titanium Abutment 6mmH, intended to be used for support of CAD/CAM fabricated crowns/bridges or zirconia copings; Titanium Esthetic Abutments, prefabricated abutments intended to be connected directly to an endosseous implant for retention of a prosthesis in straight and 15° angled designs; and Titanium Screws, indicated for the temporary or long-term retention of the abutments to the compatible dental implant fixtures. All subject device components are provided non-sterile.

Titanium Abutment 4.5mmH are two-piece abutments. The crowns/bridges or zirconia copings produced at the validated milling center compose the second part of the two piece abutment.

The provided text describes the 510(k) premarket notification for Inclusive® Titanium Abutments compatible with Dentsply Implants Astra Tech Implant System® EV. This document is a regulatory submission for a dental device, not an AI/ML medical device. Therefore, the information requested in your prompt regarding acceptance criteria and study proving performance for an AI/ML device (e.g., sample size for test set, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) is not applicable to this document.

The document focuses on demonstrating substantial equivalence to legally marketed predicate devices, primarily through non-clinical performance data.

Here's an analysis based on the information that is available in the document:

Device Type: Dental Implant Abutment (Hardware, not Software/AI)

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

Since this is a hardware device submission, the "acceptance criteria" are related to mechanical, material, and biological compatibility, and "performance" refers to demonstrating equivalence to a predicate device through non-clinical testing.

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

• Test Set Sample Size: Not explicitly stated as "sample size" in the context of statistical testing for AI/ML. For mechanical testing, it would refer to the number of abutments tested, which is not detailed in the summary (e.g., "Worst-case constructs were subjected to static compression and compression fatigue testing.").
• Data Provenance: The studies are non-clinical, likely conducted in a lab environment rather than on human patients. The document does not specify a country of origin for the testing data, beyond the manufacturer being in Irvine, CA, USA.
• Retrospective/Prospective: Not applicable, as this refers to non-clinical lab testing of a hardware device.

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

• Not Applicable. This is a hardware device not requiring human interpretation of medical images or data for "ground truth" establishment in the AI/ML sense. The "ground truth" here is adherence to engineering specifications and performance standards, validated by accredited testing methods.

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

• Not Applicable. No human adjudication process is described or implied for the performance validation of this hardware device.

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

• Not Applicable. This is a hardware device; no human reader or AI assistance is involved in its use or evaluation for regulatory purposes. The document explicitly states: "No clinical data were included in this submission."

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

• Not Applicable. There is no algorithm for standalone performance. This device is a physical component used in dental procedures.

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

• For Hardware Devices: The "ground truth" is defined by established engineering and material standards, validated through laboratory tests:
  • Mechanical Integrity: Conformance to ISO 14801 (static compression and fatigue limits).
  • Biocompatibility: Conformance to ISO 10993 series.
  • Sterilization: Conformance to ISO 17665-1.
  • Dimensional Accuracy: Verified through reverse engineering and dimensional analysis against OEM specifications.

8. The sample size for the training set:

• Not Applicable. This is a hardware device, not an AI/ML algorithm that requires a training set.

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

• Not Applicable. As above, no training set for an AI/ML algorithm is involved.

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Implants:

OsseoSpeed™ Plus implants of the Astra Tech Implant System Plus are intended to be used:

• · To replace missing teeth in single or multiple unit applications within the mandible or maxilla
• · For immediate placement in extraction sites and partially or completely healed alveolar ridge situations
• · For both one- and two-stage surgical procedures
• · Especially well in soft bone applications where implants with other implant surface treatments may be less effective
• · Together with immediate loading protocol in all indications, except in single tooth situations in soft bone (type IV) where implant stability may be difficult to obtain and immediate loading may not be appropriate.

Abutments:

Astra Tech Implant System Plus abutments are intended to be used in conjunction with the Astra Tech Implant System Plus in fully edentulous or partially edentulous maxillary and/or mandibular arches to provide support for crowns, bridges or overdentures.

OsseoSpeed Plus implants are straight, self-tapping, threaded, root-form dental implants provided in multiple diameters and lengths with the previously cleared OsseoSpeed™ surface. Implants are available in diameters of 3.6 mm, 4.2 mm and lengths of 9 mm, 11 mm and 13 mm. The neck portion of the implant includes the MicroThread™ design. A new anti-rotation interface with 6 keyway cross section connections allows for six abutment positions. All other features and procedures of OsseoSpeed Plus implants are the same as presently cleared OsseoSpeed implants.

OsseoSpeed Plus abutment components consist of cover screws, healing abutments and abutments with corresponding screws. Cover screws and healing abutments are provided in sizes to match the implant platform. Healing abutments are provided in sizes to match the implant platform and various gingival diameters and gingival heights. OsseoSpeed Plus abutments have three design types, cylindrical, asymmetric and angled (20°). Each abutment design type is provided in three platform diameters (3.6, 4.2 and 4.8 mm), two prosthetic margin diameters (4.5 and 5.5 mm or 5.5 and 7.0 mm) and two gingival heights (low = 1.5- 2.5 mm and high = 2.5-3.5 mm) for a total of eleven abutment design combinations.

To assist in preoperative treatment planning of position and direction of implant placement, transparent radiographic implant guide sheets are provided with magnifications from 1.0X to 1.8X. The radiographic implant guides are usable with all OsseoSpeed Plus implants.

Here's a breakdown of the acceptance criteria and study information based on the provided 510(k) summary for the Astra Tech Implant System Plus:

Important Note: This 510(k) summary is for a dental implant system. The information provided is typical for medical devices that aim to demonstrate substantial equivalence to previously cleared predicate devices, rather than a clinical study establishing efficacy from scratch. Therefore, many of the typical "AI/algorithm performance study" criteria you listed (like MRMC studies, training set details, or ground truth establishment for a test set in the AI context) are not applicable to this type of device submission.

The "study" in this context refers to performance testing designed to show that the new device's technological changes do not raise new issues of safety or efficacy compared to the predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria:
The primary acceptance criterion for this 510(k) submission is to demonstrate substantial equivalence to legally marketed predicate devices. This is achieved by showing that the subject device has the same intended use, technological characteristics, materials, and provides similar performance without raising new issues of safety or efficacy. The specific performance test mentioned is compliance with ISO 14801.

Reported Device Performance:
The document states: "Performance testing was provided to demonstrate substantial equivalence and included methods described in ISO 14801."

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

• Sample Size for Test Set: Not specified in the summary. For mechanical testing under ISO 14801, a specific number of implants would be tested, but this number is not disclosed in the provided text.
• Data Provenance: The testing was conducted by or for Astra Tech AB, a Swedish company. The summary doesn't specify if the testing itself was performed in Sweden or elsewhere, nor does it specify if human data (e.g., retrospective or prospective patient data) was used. Given it's ISO 14801, it is almost certainly bench-top mechanical testing, not human patient data.

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

This information is not applicable as the "test set" in this context refers to mechanical performance testing, not human-interpreted data requiring expert consensus or ground truth establishment in the way it would be for an AI algorithm.

4. Adjudication Method for the Test Set

This information is not applicable for mechanical performance testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC comparative effectiveness study was not performed. This type of study is typically done for diagnostic or screening devices, especially those involving human interpretation of images, to assess reader performance with and without an AI aid. This 510(k) is for a physical medical implant device.

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

Not Applicable. This device is a physical dental implant, not an algorithm. Therefore, "standalone" algorithm performance is not relevant.

7. The Type of Ground Truth Used

For the mechanical performance testing (ISO 14801), the "ground truth" would be the objective measurements of force, cycles to failure, or displacement as defined by the standard, measured by calibrated equipment. It is not expert consensus, pathology, or outcomes data in the usual sense.

8. The Sample Size for the Training Set

Not Applicable. This 510(k) is for a physical medical device, not an AI algorithm. Therefore, there is no "training set."

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

Not Applicable. As there is no training set for an AI algorithm, this question is irrelevant to this device submission.

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Astra Tech Implant System abutments are intended to be used in conjunction with the Astra Tech Implant System in fully edentulous or partially edentulous maxillary and/or mandibular arches to provide support for crowns, bridges or overdentures. Highly angled abutments on small diameter implants are not recommended for use in the molar region. ZirDesign is not recommended for use in the molar regions.

The Astra Tech Implant System has been modified to increase treatment options by adding new abutment shapes in titanium and zirconia. Both abutment designs are provided in multiple sizes with straight and angled versions. The hex interlocking anti-rotation mechanism for indexing with the implant remains unchanged from the predicate devices. As with the predicate devices, Astra Tech's Conical Seal Design™ is used for the internal connection with the implant to achieve a tight and stable interface.

The provided text describes modifications to the Astra Tech Implant System, specifically the addition of new abutment shapes, and asserts their substantial equivalence to predicate devices, but it does not contain acceptance criteria for device performance or a study proving that the device meets such criteria.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than detailing performance against specific acceptance criteria for a novel device.

Here's why the requested information cannot be extracted from the provided text:

• No Acceptance Criteria: The document does not define any specific numerical or categorical acceptance criteria for performance metrics (e.g., strength, durability, fit).
• No Performance Study Details: While it states "Performance testing was provided to demonstrate substantial equivalence and included methods described in ISO 14801," it does not provide any results from this testing, nor does it detail the study design elements requested (sample size, data provenance, ground truth establishment, expert qualifications, etc.).
• Focus on Substantial Equivalence: The entire submission hinges on the argument that the modified device is "substantially equivalent" to existing predicate devices, implying that its performance is expected to be similar, rather than proving it meets new, pre-defined acceptance criteria.

Therefore, I cannot populate the table or provide the requested details because the input text does not contain this information.

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The OsseoSpeed implants are intended to be used:

• to replace missing teeth in single or multiple unit applications within the mandible or . maxilla
• for immediate placement in extraction sites and partially or completely healed alveolar . ridge situations
• for both one- and two-stage surgical procedures o
• especially well in soft bone applications where implants with other implant surface . treatments may be less effective
• together with immediate loading protocol in all indications, except in single tooth ● situations in soft bone (type IV) where implant stability may be difficult to obtain and immediate loading may not be appropriate
• together with immediate loading protocol for single-tooth restorations on implants 8 mm . or longer
• with its 3.0 S product line for maxillary lateral incisors and mandibular lateral and . central incisors.

Astra Tech Implant System implants are intended to support prosthetic devices in edentulous or partially edentulous patients to restore esthetics and chewing function. The new components of the Astra Tech Implant System included in this submission are OsseoSpeed TX implants which have a narrower tapered apex design compared to OsseoSpeed implants (K053384). They are placed using a modified drilling protocol with new conical drill sizes. The modified drilling protocol is specifically designed for soft bone applications. All other features and procedures of OsseoSpeed TX implants remain the same as those for OsseoSpeed implants.

The purpose of this submission is to add the OsseoSpeed TX implants to the present product line and expand device claims regarding primary stability of Astra Tech Implant System implants.

The provided text describes a 510(k) premarket notification for the Astra Tech Implant System. The submission focuses on demonstrating substantial equivalence to predicate devices, rather than establishing new performance criteria for a novel device. Therefore, the "acceptance criteria" and "study proving the device meets acceptance criteria" as typically understood for a new therapeutic or diagnostic device (e.g., specific clinical endpoints, sensitivity/specificity thresholds) are not explicitly present in the document in the format requested.

Instead, the submission's goal is to show the new OsseoSpeed TX implants (with a narrower tapered apex design and modified drilling protocol for soft bone) are substantially equivalent to existing legally marketed devices. The "acceptance criteria" in this context would be the successful demonstration of this substantial equivalence, and the "study" is the comparison testing performed to support this claim.

Here's a breakdown based on the information provided, reinterpreting "acceptance criteria" and "study" for a 510(k) submission:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document mentions "Testing was performed to compare OsseoSpeed TX implants using the new soft bone drilling protocol with OsseoSpeed implants using the standard drilling protocol. Calculations also were made to determine bone to implant contact for the two implant/drilling protocol combinations."

• Sample Size: The exact sample size for this comparative testing is not specified in the provided text.
• Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective. It is implied to be laboratory/non-clinical testing given the nature of comparing drilling protocols and bone-to-implant contact for implants.

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

This type of information (expert review for ground truth) is typically relevant for diagnostic devices interpreting medical images or data. For a dental implant's mechanical stability and bone-to-implant contact, the "ground truth" would be established through direct physical measurements, imaging, or histological analysis, rather than expert consensus on interpretation. Therefore, this information is not applicable and not provided in the document for an implant device.

4. Adjudication Method for the Test Set

Adjudication methods (e.g., 2+1, 3+1) are primarily used in studies where multiple human readers interpret data, and discrepancies need to be resolved. Since the "testing" described involves comparing implant performance characteristics (mechanical stability, bone-to-implant contact) through presumably laboratory or animal studies, an adjudication method in this sense is not applicable and not provided.

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

No. An MRMC study is relevant for comparing the performance of human readers, typically with and without AI assistance for diagnostic tasks. This submission is for a dental implant, which is a therapeutic device, not a diagnostic one involving human interpretation of cases. Therefore, this type of study was not done and is not applicable.

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

No. This question is also relevant for diagnostic devices, specifically AI algorithms. The Astra Tech Implant System is a physical dental implant, not an algorithm. Therefore, a standalone algorithm performance study was not done and is not applicable.

7. The Type of Ground Truth Used

For the performance testing described ("compare OsseoSpeed TX implants... with OsseoSpeed implants... Calculations also were made to determine bone to implant contact"), the ground truth would be based on:

• Direct measurements/experiments: For primary mechanical stability and bone-to-implant contact, this would typically involve biomechanical testing (e.g., insertion torque, removal torque, pull-out strength tests) and potentially histological analysis or micro-CT imaging to quantify bone-to-implant contact in animal models or ex vivo samples.
• The document implies these were obtained through calculations and comparative testing, which points to direct experimental data rather than expert consensus, pathology (in the clinical sense for a patient), or outcomes data (long-term clinical results).

8. The Sample Size for the Training Set

This question is applicable to machine learning algorithms. Since the Astra Tech Implant System is a physical medical device (dental implant) and not an AI/ML algorithm, there is no training set and therefore no specified sample size for it.

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

As there is no training set for an AI/ML algorithm, this question is not applicable.

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The Multi-Unit Abutments for Straumann and Astra Tech Implant Systems are premanufactured prosthetic components directly connected to endosseous dental implants and are intended for use as an aid in prosthetic rehabilitation.

Nobel Biocare's Multi-Unit Abutments for Straumann and AstraTech Implant Systems are endosseous dental implant abutments. The Nobel Biocare Multi-Unit Abutments for Straumann and AstraTech Implant Systems attach directly to endosseous dental implants and provides a platform for restoration.

Nobel Biocare's Multi-Unit Abutments for Straumann and AstraTech Implant Systems are made entirely of titanium/vanadium alloy.

This document is a 510(k) Summary of Safety and Effectiveness for Nobel Biocare's Multi-Unit Abutments for Straumann and AstraTech Implant Systems. This device is an endosseous dental implant abutment. The submission demonstrates substantial equivalence to previously cleared devices.

Here's the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a numerical sample size for the test set. It mentions "worst-case test samples" were identified and tested. The data provenance is within a laboratory setting, as it refers to "fatigue testing" of the physical devices. No country of origin for the data is explicitly stated beyond Nobel Biocare USA LLC's address in California. The study is prospective in the sense that the testing was performed on the new device to demonstrate its equivalence.

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

Not applicable. This is a submission for a physical medical device (dental implant abutment) that undergoes mechanical and material testing, not a diagnostic or AI-driven device requiring expert-established ground truth. The "ground truth" for this type of device is compliance with specific mechanical and material standards as outlined in FDA guidance documents.

4. Adjudication Method for the Test Set

Not applicable. As noted above, this is mechanical testing of a physical device against established standards, not a diagnostic or AI study requiring adjudication of interpretations.

5. If a Multi-reader Multi-case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-reader Multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that involve human interpretation of medical images, often with AI assistance. This submission is for a physical dental implant abutment.

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

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

7. The Type of Ground Truth Used

The "ground truth" for this device's safety and effectiveness is established by physical standards and performance requirements for endosseous dental implant abutments, as outlined in the "FDA guidance Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments." This involves demonstrating mechanical properties (like fatigue strength) are equivalent to legally marketed predicate devices.

8. The Sample Size for the Training Set

Not applicable. As this is not an AI or machine learning device, there is no "training set."

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

Not applicable.

Summary of the Study:

The study conducted was a fatigue testing of "worst-case test samples" of the Multi-Unit Abutments for Straumann and AstraTech Implant Systems. The objective was to demonstrate that these abutments meet the safety and effectiveness requirements by being substantially equivalent to legally marketed predicate devices (listed in the "Legally Marketed Device(s)" section of the document). The criteria for "substantial equivalence" were based on the FDA's Class II Special Controls Guidance Document for Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments, which sets out performance standards, particularly related to fatigue life. The testing results indicated that the new device met these criteria, thereby proving its substantial equivalence to the predicates.

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Astra Tech Implant System is intended to be used to replace missing masticatory functional units (teeth) in single or multiple unit applications within the mandible or maxilla. The device may be used equally well in a single-stage or two-stage surgical procedure. It is indicated for immediate implantation in extraction sites or implantation in partially healed or completely healed alveolar ridge situations. When a one-stage surgical approach is applied, the implant may be immediately loaded when good primary stability is achieved and the functional load is appropriate. The OsseoSpeed Narrow product line shall be used only to replace maxillary lateral incisors and mandibular lateral and central incisors.

The fluoride-modified implant surface, though having a fluoride ion level far below that needed for caries prevention in teeth, provides a favorable substrate for bone attachment and osseointegration. Astra Tech Implant System is especially indicated for use in soft bone applications where implants with other implant surface treatments may be less effective. Because initial stability may be difficult to obtain in Type IV bone, immediate loading of single tooth restorations may not be appropriate in such situations. Immediate loading of single tooth restorations is not recommended for the OsseoSpeed™ 4.0S - 6 mm implant.

Astra Tech Implant System implants, abutments, prosthetic components and accessories are intended for supporting prosthetic devices in edentulous or partially edentulous patients to restore esthetics and chewing function. All components of the Astra Tech Implant System are identical to those presently marketed. The purpose of this submission is to expand device claims.

This 510(k) summary for the Astra Tech Implant System (K091239) does not contain information on acceptance criteria or a study proving device performance against such criteria.

The document is a standard 510(k) submission summary, which focuses on demonstrating substantial equivalence to a predicate device. It defines the intended use and describes the device, but does not present specific performance metrics, clinical study data, or acceptance criteria that would typically be found in a study proving device performance.

Therefore, I cannot populate the table or answer the specific questions about sample sizes, ground truth establishment, expert qualifications, or MRMC studies, as that information is not present in the provided text.

The document states: "Astra Tech AB demonstrated that, for the purposes of FDA's regulation of medical devices, the Astra Tech Implant System is substantially equivalent in indications and design principles to predicate devices..." This implies that the 'study' conducted was a comparison to existing, legally marketed devices, rather than a de novo clinical trial with defined acceptance criteria and performance metrics. Substantial equivalence does not require new performance data if the new device is sufficiently similar to a predicate.

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Astra Tech Implant System abutments are intended to be used in conjunction with Astra Tech Implant System implants in fully edentulous or partially edentulous maxillary and/or mandibular arches to provide support for crowns, bridges or overdentures.

The Astra Tech Implant System has been modified to increase treatment options by adding a new component, an additional abutment for provisional restorations.

The provided text describes a 510(k) summary for a medical device modification, specifically the "Astra Tech Implant System, New Component." However, it does not contain information about acceptance criteria, the study that proves device meets acceptance criteria, detailed performance data, sample sizes, ground truth establishment, or expert involvement.

The document is a regulatory submission discussing the device's administrative information, intended use, description, and equivalence to a predicate device. It explicitly states that the modification "has the same intended use, uses the same operating principle, incorporates the same basic design, and is packaged using the same materials and processes" as the unmodified predicate device. This implies that the modification is considered substantially equivalent based on these similarities, rather than requiring a new, comprehensive performance study against specific acceptance criteria.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets or data provenance.
• Number of experts or their qualifications for ground truth.
• Adjudication method for the test set.
• MRMC comparative effectiveness study details.
• Standalone performance data.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

This type of information is typically found in a clinical study report or a more detailed performance evaluation, which is not present in the provided 510(k) summary. The 510(k) process for device modifications often focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring new, extensive performance studies with detailed acceptance criteria if the changes are minor and do not alter the fundamental safety or effectiveness of the device.

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Fixture MicroThread™ OsseoSpeed™ is intended to be used to replace missing masticatory functional units (teeth) in single or multiple unit applications within the mandible or maxilla where immediate implant stability may be obtained.. The device may be used equally well in a single-stage ) or two-stage surgical procedure. It is indicated for immediate implantation in extraction sites or implantation in partially healed or completely healed alveolar ridge situations. When a one-stage surgical approach is applied, the implant may be immediately loaded after implantation where immediate implant stability may be obtained.

The fluoride-modified surface, though having a fluoride ion level far below that needed for caries prevention in teeth, provides a favorable substrate for bone attachment and osseointegration. Fixture MicroThread OsseoSpeed is especially indicated for use in soft bone applications where implants with other implant surface treatments may be less effective. Because initial stability may be difficult to obtain in Type IV bone, immediate loading of single tooth restorations may not be appropriate in such situations.

Fixture MicroThread OsseoSpeed is a threaded, root-formed dental implant intended for supporting prosthetic devices in edentulous or partially dentate patients to restore their esthetics and chewing function. Fixture MicroThread OsseoSpeed is made from titanium with a micro-roughened and fluoride-modified surface, designated OsseoSpeed.

The implant is available with a straight or tapered contour at the implant neck and comes in different diameters and lengths. The abutments are screw-retained.

This 510(k) summary describes a dental implant and does not include an AI/ML device or a study with acceptance criteria and device performance as typically understood for such devices (e.g., sensitivity, specificity, AUC).

Instead, the document focuses on demonstrating substantial equivalence to a previously cleared predicate device, which is the primary regulatory pathway for many medical devices. The core argument for acceptance is that the device, "Fixture MicroThread™ OsseoSpeed™," is similar enough to existing, legally marketed devices that it doesn't raise new questions of safety and effectiveness.

Here's an analysis based on the provided text, using the structure of your request but acknowledging that some sections will be non-applicable due to the nature of the submission:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not present acceptance criteria or reported device performance in the form of quantitative metrics (e.g., sensitivity, specificity, accuracy) typically associated with AI/ML or diagnostic device studies.

Instead, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to a predicate device. The "performance" is described qualitatively as:

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

• Sample Size: Not applicable. This submission does not describe a "test set" in the context of an AI/ML algorithm or diagnostic study. The "data" mentioned refers to pre-clinical and clinical data supporting the biological performance of the implant surface.
• Data Provenance: The document states "previously submitted data and additional pre-clinical and clinical data with Fixture MicroThread OsseoSpeed." Specifics about country of origin or whether it was retrospective/prospective are not provided in this summary.

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

• Not applicable. There is no mention of a "test set" requiring ground truth established by experts in the context of evaluating an AI/ML device's performance. The review and approval process involved FDA scientific review, not expert consensus on image interpretation.

4. Adjudication Method for the Test Set

• Not applicable. There is no test set or adjudication method described for performance evaluation in this 510(k) summary.

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 device. The submission pertains to a physical 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

• The "ground truth" here is biological and clinical evidence of bone attachment, osseointegration, and implant stability. This is inferred from pre-clinical (e.g., animal studies, in-vitro) and clinical data (human studies) demonstrating the properties of the implant's surface and overall function. It is not an "expert consensus" or "pathology" in the diagnostic sense, but rather a demonstration of medical efficacy through biological response and clinical outcomes.

8. The Sample Size for the Training Set

• Not applicable. There is no "training set" for an AI/ML model described in this submission. The "previously submitted data and additional pre-clinical and clinical data" would be analogous to the evidence base considered for justifying substantial equivalence.

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

• Not applicable. As there is no AI/ML training set, this question is not relevant to the provided text. The "ground truth" for the device's claims (e.g., "fluoride-modified surface promotes increased and more rapid bone formation") would be established through scientific methods in pre-clinical studies (e.g., histological analysis, biomechanical testing) and clinical trials (e.g., radiographic assessment, implant stability measurements, clinical follow-up), typically evaluated by dental and medical professionals specializing in implantology.

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