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BIOMET 3i Dental Implants are intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth utilizing delayed or immediate loading, or with a terminal or intermediary abutment for fixed or removable bridgework, and to retain overdentures.

OSSEOTITE® 2 Dental Implants are intended for immediate function on single tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function.

OSSEOTITE® 2 Dental Implants are similar to predicate BIOMET 3i OSSEOTITE Implants, currently being sold worldwide. OSSEOTITE 2® Dental Implants are provided with the proprietary OSSEOTITE dual acid-etched surface which has been in commercial distribution since market clearance in 1995 and are made of Commercially Pure Titanium. Implants have a straight wall design, with an External Hex Connection. OSSEOTITE® 2 Dental Implants are offered in diameters of 3.25, 3.75, 4.0, 5.0, and 6.0 in varying lengths from 3 mm to 15 mm. Size appropriate cover screws are provided with each implant.

The provided document is a 510(k) summary for the OSSEOTITE® 2 Dental Implants. This is a special 510(k) submission, meaning it's for a modification to a previously cleared device. Therefore, the "study" described is primarily focused on demonstrating substantial equivalence to predicate devices through bench testing and referencing existing clinical data rather than conducting a de novo clinical trial for the new device.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

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

The acceptance criteria for this device are based on demonstrating that the OSSEOTITE® 2 Dental Implants are substantially equivalent to legally marketed predicate devices (OSSEOTITE II MODEL XIFOSSXXX (K100724) and OSSEOTITE; OSSEOTITE NT; XP; TG Implant(s) (K063286)). This means they must share the same intended use, indications for use, technological characteristics, and principles of operation, and any differences must not raise new questions of safety or effectiveness.

The document directly compares the proposed device to its predicates across various characteristics. The "reported device performance" in this context refers to showing that these characteristics are either identical or that any modifications (specifically the abutment connection) do not negatively impact performance as demonstrated by bench 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: For the bench testing, the document states "All testing conducted met the acceptance criteria and evaluated the worst case scenario including 30° pre-angled abutments as compared to predicate BIOMET 3i designs." It does not specify the numerical sample size for the fatigue testing according to ISO 14801:2007. For the clinical reports cited, specific sample sizes are also not provided in this summary document.
• Data Provenance:
  • Bench Testing: The geographical origin is not specified, but it was conducted by "BIOMET 3i" implying internal company testing or contracted to a lab.
  • Clinical Data: The summary mentions two clinical reports ("Insertional Torque Force, Osseotite 2 Placement Data, Pressure Necrosis" dated September 21st, 2011, and "BIOMET 3i Insertion Torque Report" dated November 10, 2011). These reports summarize clinical projects and "implant placement experience data". The summary doesn't explicitly state if they are retrospective or prospective, nor does it specify the country of origin. However, given they are reports on existing data, they are likely retrospective analyses of clinical experience.

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)

• For the bench testing (ISO 14801:2007), ground truth is established by the standard itself and objective mechanical measurements. No human experts are involved in establishing ground truth in terms of diagnostic assessment.
• For the clinical reports, the "ground truth" relates to clinical outcomes (insertion torque, success, failure). These would have been established by the dental practitioners involved in the implant placement and follow-up. The document does not specify the number or qualifications of these experts; it only cites the reports.

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

• There is no mention of an adjudication method for either the bench testing or the clinical data in this 510(k) summary. Bench testing results are objective measurements against a standard. Clinical outcomes would typically be derived from patient records and the assessment of the treating clinicians, not through a separate adjudication panel described in this 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

• No MRMC comparative effectiveness study was done or is relevant for this submission. This device is a dental implant, a physical product, not an AI or imaging device that would involve "human readers" or AI assistance in interpretation.

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.

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

• For bench testing, the "ground truth" is defined by the acceptance criteria of the ISO 14801:2007 standard and the objective mechanical properties measured.
• For the clinical data cited, the ground truth is derived from clinical outcomes data (e.g., measured insertion torque values, implant success/failure at follow-up).

8. The sample size for the training set

• This is a special 510(k) for a physical medical device, not a machine learning or AI algorithm. Therefore, the concept of a "training set" in the context of AI is not applicable. The device's design and manufacturing rely on established engineering principles and prior predicate devices.

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

• As the concept of a "training set" for an AI algorithm is not applicable here, there is no ground truth established for a training set. The device's safety and effectiveness are established through comparison to predicates and bench testing against industry standards.

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BIOMET 3i Dental Implants are intended for surgical placement in either jaw and used for anchoring or supporting single- and multiple-unit prostheses. BIOMET 3i Dental Implants can be immediately loaded when primary stability and proper occlusion have been established.

Full OSSEOTITE® Certain® II Dental Implants are substantially equivalent to BIOMET 3i's OSSEOTITE® Dental Implants which have been previously cleared in K063286 and K063341. The device is an endosseous dental implant made of Commercially Pure Titanium. It is available in various lengths and diameters with a straight-walled implant body, Incremental Cutting Edge (I.C.E.) with apical taper, and a Full OSSEOTITE® surface. It has an Internal Hexagon Connection for mating with BIOMET 3i Certain® Restorative Components. The implants are packaged in a sterile tray with a cover screw and sterilized by Gamma Irradiation with a shelf life of 5 years.

This document describes the 510(k) summary for the Full OSSEOTITE® Certain® II Dental Implant, focusing on its substantial equivalence to predicate devices rather than a study with a traditional AI-specific acceptance criteria framework. Therefore, many of the typical categories for AI/ML performance studies (like sample size for test sets, expert ground truth, MRMC studies, or training set details) are not directly applicable or reported in this type of submission.

Here's an analysis of the provided text based on your request, with a focus on what can be extracted and what is not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are primarily based on design verification testing, ensuring proper device functioning and substantial equivalence to legally marketed predicate devices. The performance is demonstrated by meeting these engineering and material standards, rather than statistical performance metrics for diagnostic accuracy.

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

• Sample Size: The document does not specify a "test set" in the context of clinical or data-driven validation. The testing performed is "design verification testing," likely involving a set number of implants for mechanical and material property assessments, as per engineering and regulatory standards (e.g., ISO, ASTM, or specific FDA guidance for dental implants). However, the exact sample sizes for these engineering tests are not provided in this 510(k) summary.
• Data Provenance: Not applicable in the context of clinical data for AI/ML. The "data" here refers to engineering test results and manufacturing specifications.

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

• This is not applicable as the device is not an AI/ML diagnostic or assistive tool requiring expert-labeled ground truth from medical images or clinical data. The "ground truth" for device performance is based on established engineering standards and regulatory guidance for dental implants.

4. Adjudication Method for the Test Set

• Not applicable for this type of device submission. Adjudication methods are typically relevant for clinical studies where human reviewers assess diagnostic outputs, which is not the case here.

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

• No, an MRMC study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance for diagnostic tasks, which is not the purpose of a dental implant submission.

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 algorithm is not applicable. This device is a physical dental implant, not a software algorithm. Its performance is assessed through physical and material property tests.

7. The Type of Ground Truth Used

• The "ground truth" here is based on engineering standards, material specifications, and regulatory guidance documents (specifically, the "FDA Guidance Document - Special Control Class II Root-Form Dental Implants (May 2004)"). This includes established benchmarks for mechanical strength, biocompatibility, and dimensions of dental implants.

8. The Sample Size for the Training Set

• Not applicable. This device is a physical product, not a machine learning model, so 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 a machine learning model.

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BIOMET 3i dental implants are intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth utilizing delayed or immediate loading, or as a terminal or intermediary abutment for fixed or removable bridgework, and to retain overdentures.

BIOMET 3i Osseotite and NanoTite dental implants are intended for immediate function on single tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function.

BIOMET 3i Dental Implants are provided with the proprietary OSSEOTITE acid-etched surface, both with and without the additional proprietary NanoTite treatment. Implants are offered in both tapered and parallel-walled/straight designs, and each design provides offerings for either external hex or internal connections. Implants are also offered in various diameters and length.

This looks like a 510(k) premarket notification for a dental implant. 510(k)s generally demonstrate substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria with detailed studies like those of an AI/ML device.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication, MRMC studies, standalone performance, ground truth, and training data is not applicable to this type of submission.

Instead, the submission focuses on demonstrating that the BIOMET 3i Dental Implants have technological characteristics and intended uses that are substantially equivalent to already legally marketed predicate devices. The "Performance Testing" section mentions:

• Laboratory testing: Conducted to determine device functionality and conformance to design input requirements and FDA's Class II special controls guidance document.
• Risk analysis: Conducted in accordance with ISO 14971.
• Results: Included in the premarket notification submissions for the predicate device.

The FDA's decision letter also confirms that they have determined the device is "substantially equivalent" to legally marketed predicate devices.

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3i dental implants are intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth, or as a terminal or intermediary abutment for fixed or removable bridgework, and to retain overdentures.

In addition, when a minimum of 4 implants, ≥ 10mm in length, are placed in the mandible and splinted in the anterior region, immediate loading is indicated.

The 3i OSSEOTITE® Certain® Dental Implants are provided with the proprietary OSSEOTITE acid-etched surface which has been in commercial distribution since market clearance in 1995. Implants are offered in tapered and parallel-walled/straight designs, each design providing offerings for internal hex connections. Additionally, the implants are offered in an expanded platform, lateralized design with an internal connection Implants are offered in diameters of 3.25, 3.75, 4.0, 5.0, and 6.0 in varying lengths from 7 mm to 20 mm. Size appropriate cover screws are offered with each implant.

The provided text does not contain specific acceptance criteria or a detailed study description with performance metrics for the 3i OSSEOTITE® Certain® Dental Implants in the format requested.

Instead, the document is a 510(k) Premarket Notification summary, which focuses on demonstrating substantial equivalence to previously cleared predicate devices. The "Performance" section explicitly states: "Performance standards have not been established by the FDA under Section 514 of the Federal Food, Drug and Cosmetic Act."

The document mentions "Laboratory testing was conducted to determine device functionality and conformance to design input requirements, as well as FDA's Class II special controls guidance document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments." However, no specific results, acceptance criteria, or a detailed study design from this laboratory testing are provided.

The text also refers to previous 510(k) clearances for specific performance claims (enhanced performance in poor bone, early loading, use in smokers, immediate loading) based on "OSSEOTITE clinical data in the respective submissions." However, the details of these studies and their acceptance criteria are not included in this document.

Therefore, I cannot populate the table or answer the specific questions about sample size, ground truth, expert opinions, or MRMC studies because this information is not present in the provided text. The document's purpose is to show substantial equivalence, not to present a detailed performance study against specific acceptance criteria.

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3i dental implants are intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth, or as a terminal or intermediary abutment for fixed or removable bridgework, and to retain overdentures.

In addition, when a minimum of 4 implants, ≥ 10mm in length, are placed in the mandible and splinted in the anterior region, immediate loading is indicated.

The 3i OSSEOTITE® Dental Implants are provided with the proprietary OSSEOTITE acid-etched surface which has been in commercial distribution since market clearance in 1995. Implants are offered in tapered and parallel-walled/straight designs, each design providing offerings for external hex connections. Additionally, the implants are offered in a trans-gingival design with an internal connection Implants are offered in diameters of 3.25, 3.75, 4.0, 5.0, and 6.0 in varying lengths from 7 mm to 20 mm. size appropriate cover screws are offered with each implant.

The provided text is related to a 510(k) premarket notification for "3i OSSEOTITE® Dental Implants." However, it does not contain information about acceptance criteria or a study proving the device meets specific performance criteria with numerical results.

Instead, the document focuses on:

• Substantial Equivalence: The primary assertion is that the new device is substantially equivalent to previously cleared predicate devices (K874590, K935544, K972444, K980549, K983347, K992334, K014235, K022009, K030164, K033430, K051461).
• Performance Testing: It states that "Laboratory testing was conducted to determine device functionality and conformance to design input requirements, as well as FDA's Class II special controls guidance document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments. Risk analysis was conducted in accordance with ISO 14971."
• Previous Clinical Data: It mentions that "Specific performance claims for enhanced performance in poor bone (K980549), early loading (K983347), and use in smokers (K022009), and immediate loading (K030164) have received market clearance based on the OSSEOTITE clinical data in the respective submissions." This indicates that clinical data from previous submissions was used to support specific claims, but no new study details or acceptance criteria for this specific 510(k) submission are presented..

Therefore, I cannot populate the requested table and details because the information is not present in the provided text. The document relies on substantial equivalence to previously cleared devices and refers to prior clinical data from those predicate devices for performance claims, rather than presenting new acceptance criteria and a study to meet them for this specific 510(k).

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31 dental implants are intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth, or as a terminal or intermediary abutment for fixed or removable bridgework, and to retain overdentures.

In addition, when a minimum of 4 implants, ≥ 10 mm in length, arc placed in the maxilla and/or the mandible and splinted in the anterior region, immediate loading is indicated.

The 3i Nano CaP OSSEOTITE Dental Implants are provided with the proprietary OSSEOTITE acid-etched surface further treated with a deposition of nano-crystals of calcium phosphate. Implants are offered in both tapered and parallel-walled /straight designs, and each design provides offerings for either external hex or internal connections.

This is a 510(k) premarket notification for a modification to a dental implant, the 3i Nano CaP OSSEOTITE® Dental Implants. The provided document does not contain acceptance criteria for device performance in the form of specific quantitative metrics or a study demonstrating that the device meets such criteria.

Instead, the submission focuses on demonstrating substantial equivalence to legally marketed predicate devices based on:

• Similar Design Features and Functions: The device is stated to have similar design features and functions to existing OSSEOTITE, OSSEOTITE NT, OSSEOTITE Certain, OSSEOTITE Certain NT, Prevail Implants, and 3i Innovative Implants and Cover Screws. The specific enhancement, the deposition of nano-crystals of calcium phosphate, is compared to already available Hydroxylapatite (HA) Coated Endosseous Dental Implants.
• Performance Testing: The document briefly states that "Laboratory testing was conducted to determine device functionality and conformance to design input requirements, as well as FDA's Class II Special Controls Root-form Endosseous Dental Document: Guidance Implants and Endosseous Dental Abutments." It also mentions "Risk analysis was conducted in accordance with ISO 14971."

Therefore, many of the requested criteria cannot be extracted from this particular 510(k) summary. This type of 510(k) relies heavily on comparing the new device's characteristics and performance to existing, legally marketed devices, rather than establishing new, specific acceptance criteria for performance in a clinical study.

Here's a breakdown of what can and cannot be answered:

1. Table of acceptance criteria and reported device performance:

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

• Not provided. The document refers to "Laboratory testing" but does not specify sample sizes or data provenance.

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

• Not applicable/Not provided. This type of information is typically relevant for studies involving subjective assessment (e.g., image interpretation). For a dental implant, performance testing would likely involve mechanical, material, and biocompatibility testing, not expert interpretation of data in the way, for example, a diagnostic AI would.

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

• Not applicable/Not provided.

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. This is not an AI/software device; it's a physical dental implant.

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

• No. This is not an AI/software device.

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

• For the "Performance testing" mentioned, the ground truth would typically be established by engineering specifications, material standards, and biocompatibility testing protocols. This would involve objective measurements against predefined limits for mechanical strength, fatigue resistance, surface characteristics, and biological response, rather than expert consensus on a clinical outcome in this context.

8. The sample size for the training set:

• Not applicable/Not provided. There is no "training set" in the context of this device's regulatory submission.

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

• Not applicable/Not provided. There is no "training set" in the context of this device's regulatory submission.

In summary: This 510(k) primarily demonstrates substantial equivalence through similarity to predicate devices and general statements about laboratory testing confirming functionality and conformance to design requirements and special controls guidance, rather than presenting specific quantitative acceptance criteria or detailed study results.

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Intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment to restore a patient's chewing function.

The OSSEOTITE NT Certain Implants are internally connected, tapered implants designed to mimic the shape and form of a natural tooth

The provided text is a 510(k) premarket notification for a medical device called OSSEOTITE NTTM Certain™ Implants. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study with detailed statistical outcomes.

Therefore, many of the requested sections about acceptance criteria, detailed study design, sample sizes for training/test sets, expert qualifications, and specific performance metrics cannot be directly extracted from the provided text.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document explicitly states: "Performance standards have not been established by the FDA under Section 514 of the Federal Food, Drug and Cosmetic Act."

This indicates that there are no pre-defined quantitative acceptance criteria against which the device's performance is measured in this submission. The submission relies on demonstrating substantial equivalence to existing legally marketed devices.

Therefore, a table of acceptance criteria and reported device performance, as typically understood in a study proving performance, cannot be generated from this document. The "performance" demonstrated is that the device has "features and functions which are similar to the currently available OSSEOTITE NT Certain Implants and the OSSEOTITE NT Implants."

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

• Sample Size for Test Set: Not applicable. The submission is not based on a new performance study with a test set of patient data to validate against specific metrics. It is an equivalence claim to existing devices.
• Data Provenance: Not applicable. No new patient data study is described for this submission.

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

• Not applicable. There is no described test set requiring ground truth established by experts.

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

• Not applicable. There is no described test set requiring adjudication.

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

• No. This submission is for a dental implant (hardware), not an AI-powered diagnostic device. Therefore, an MRMC study is not relevant here.

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

• No. This submission is for a dental implant, not an algorithm.

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

• Not applicable. The submission is based on demonstrating substantial equivalence to predicate devices, not on proving device performance against a specific ground truth.

8. The sample size for the training set:

• Not applicable. No new performance study or algorithm training is described.

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

• Not applicable. No new performance study or algorithm training is described.

Summary of what the document does provide regarding safety and effectiveness:

The core of this 510(k) submission is to establish substantial equivalence to predicate devices. The arguments for safety and effectiveness are based on the premise that because the new device's technological characteristics, materials, and intended use are "similar" to or the same as legally marketed predicate devices (OSSEOTITE NT Certain Implants K031475, OSSEOTITE NT Dental Implants K014235, 3i Implants K030614), it can be considered equally safe and effective.

The conclusion states: "The proposed OSSEOTITE NT Certain Implants are substantially equivalent to the legally marketed OSSEOTITE NT Certain Implants and the OSSEOTITE NT Implants." This is the "study" and "proof" presented in this type of submission when explicit performance standards are not established for the device type.

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3 i dental implants are indicated for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment.

The 3i TG OSSEOTITE® Wide Implants are trans-gingival implants designed with an internal morse-taper. The wider dimension of the seating surface provides a realistic size proportion of a natural tooth of the posterior area.

The provided document is a 510(k) summary for a medical device, the 3i TG OSSEOTITE® Wide Implants. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through a clinical study.

Therefore, the document does not contain the information requested in the prompt regarding acceptance criteria and a study proving the device meets them. It explicitly states under "Performance": "Performance standards have not been established by the FDA under Section 514 of the Federal Food, Drug and Cosmetic Act."

The purpose of a 510(k) is to show that a new device is "substantially equivalent" to an already legally marketed device – meaning it has the same intended use and the same technological characteristics, or if it has different technological characteristics, that these do not raise new questions of safety and effectiveness. It does not typically involve the presentation of acceptance criteria or a dedicated study to prove performance against those criteria in the same way a PMA (Pre-Market Approval) or a clinical trial for a novel device would.

Based on the document, here's what can be extracted, and what cannot:

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

• Not available. The document states "Performance standards have not been established by the FDA under Section 514 of the Federal Food, Drug and Cosmetic Act." The submission is based on substantial equivalence to predicate devices, not on meeting specific performance criteria.

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

• Not available. No clinical study or test set data is presented to demonstrate performance against acceptance criteria. The submission relies on demonstrating substantial equivalence to predicate devices.

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)

• Not applicable. No test set or ground truth establishment based on expert consensus for performance evaluation is described.

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

• Not applicable. No test set requiring adjudication in the context of performance evaluation is described.

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

• Not applicable. This device is an endosseous dental implant, not an AI-powered diagnostic tool, so an MRMC study is not relevant to its regulatory submission type.

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

• Not applicable. This device is an endosseous dental implant, not an algorithm.

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

• Not applicable. The submission relies on substantial equivalence, not on establishing ground truth for performance evaluation.

8. The sample size for the training set

• Not applicable. No machine learning algorithm or training set is involved in the submission for this type of device.

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

• Not applicable. No machine learning algorithm or training set is involved.

Summary of the Document's Content:

The document is a 510(k) premarket notification for the "3i TG OSSEOTITE® Wide Implants." Its primary conclusion is that the device is substantially equivalent to legally marketed predicate devices (TG OSSEOTITE® Dental Implants K972444 and OSSEOTITE® IOL Implants K031632). It describes the device as trans-gingival implants designed with an internal morse-taper and a wider seating surface, intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment. The technological characteristics are stated to be similar to the currently available TG OSSEOTITE® Implants. The FDA's letter confirms this substantial equivalence determination, allowing the device to be marketed.

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3i dental implants are indicated for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment.

The 3 i IOLTM Dental Implants are offered in both externally hexed and internally connected designs. The devices are tapered implants designed to mimic the shape and form of a natural tooth.

The provided document, K031632 for the 3i IOL™ Dental Implants, is a 510(k) Premarket Notification. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than detailed clinical performance studies with specific acceptance criteria as you might find for a PMA (Pre-Market Approval).

Therefore, much of the requested information regarding acceptance criteria, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, and standalone performance studies is not explicitly present or applicable in this type of regulatory document.

Here's what can be extracted and inferred based on the provided text:

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

The document does not specify quantitative acceptance criteria. Instead, it relies on demonstrating substantial equivalence to predicate devices. The "performance" described is in terms of the device's characteristics being "similar" to these predicate devices.

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 for Test Set: Not applicable/not provided. This 510(k) does not present a clinical test set with performance data.
• Data Provenance: Not applicable/not provided.

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)

• Not applicable/not provided. Ground truth establishment with experts is typically associated with performance studies, which are not detailed here.

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

• Not applicable/not provided.

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/not provided. This is a dental implant, not an imaging AI device.

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

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

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

• Not applicable/not provided in the context of a performance study. The "ground truth" for this 510(k) is the successful long-term performance and safety of the predicate devices to which the 3i IOL™ Dental Implants are compared.

8. The sample size for the training set

• Not applicable/not provided. This document does not describe an AI/ML device that requires a training set.

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

• Not applicable/not provided.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The "study" or evidence provided in this K031632 510(k) filing for the 3i IOL™ Dental Implants is the demonstration of substantial equivalence to several legally marketed predicate devices. The core argument is:

• The 3i IOL™ Dental Implants are designed for surgical placement in the upper or lower jaw for prosthetic attachment.
• They are available in externally hexed and internally connected designs and are tapered to mimic natural teeth.
• Crucially, the document states: "The 3i IOL Dental Implants contain features and functions which are similar to the currently available OSSEOTITE NT Implants and 3i Innovative Implants and Cover Screws."

The FDA's decision to clear the device implies they agreed with the submitter's assertion that the new device shares sufficient technological characteristics and indications for use with the predicate devices to be considered "substantially equivalent" in terms of safety and effectiveness, without requiring new clinical performance data. The listed predicate devices (K014235, K972444, K935544, K980549, K983347, K022009) serve as the existing proof of concept and safety/effectiveness for similar designs and functionalities.

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