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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® 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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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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3i dental implants are 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.

Let's break down the provided text to extract the requested information.

Analysis of the Provided Text:

The document is a 510(k) Premarket Notification for OSSEOTITE NT™ CERTAIN™ Implants. The core purpose of a 510(k) submission is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device. This process typically relies on comparing the new device's technological characteristics, indications for use, and performance to those of the predicate. It does not generally involve an extensive independent clinical study with predefined acceptance criteria and a detailed statistical analysis of performance metrics like accuracy, sensitivity, or specificity in the same way a PMA (Premarket Approval) submission would.

Instead, the "study" demonstrating the device meets acceptance criteria in a 510(k) is often a comparative analysis against the predicate device to show that it is as safe and effective.

Here's how to interpret the information and answer your questions given the context of a 510(k):

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

Explanation: In a 510(k), "acceptance criteria" are implicitly met by demonstrating substantial equivalence. The "reported device performance" is the manufacturer's assertion and justification that these criteria are met through comparison to predicate devices, rather than through independent clinical performance metrics.

Regarding the "Study that proves the device meets the acceptance criteria":

For a 510(k), the "study" is primarily the comparison to predicate devices. The document explicitly states: "The OSSEOTITE NT Certain Implants are substantially equivalent to the legally marketed OSSEOTITE NT Implants and 3i Innovative Implants and Cover Screws." This substantial equivalence is the proof for a 510(k). The basis for this determination is the comparative analysis of indications for use and technological characteristics against the identified predicate devices (K014235, K972444, K935544, K980549, K983347, K022009).

Now, let's address the specific numbered points based on the provided text, and acknowledge when the information is not present in this type of submission.

2. Sample sized 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. A 510(k) for a dental implant primarily relies on engineering specifications, material science, and comparison to predicate devices, not typically a "test set" in the context of clinical performance data collection. No patient data or clinical study data is presented.
• 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)

• Number of Experts: Not applicable/Not provided. This type of information is generally associated with clinical trials or diagnostic device performance studies, which are not detailed here. The "ground truth" for a 510(k) for a new version of an implant is typically established by engineering standards, biocompatibility testing (which is assumed to have been done, but not detailed here), and the prior approval status of the predicate devices.

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

• Adjudication Method: Not applicable/Not provided. This refers to methods for resolving discrepancies in expert opinion for diagnostic assessments, which is not relevant to this 510(k) submission as no such "test set" requiring expert adjudication is described for clinical performance.

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

• MRMC Study: No. This is a dental implant, not an imaging device or AI-assisted diagnostic tool. Therefore, an MRMC study is not relevant or described.
• Effect Size of AI: Not applicable.

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

• Standalone Performance Study: No. This device is a passive dental implant, not an algorithm or AI system.

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

• Type of Ground Truth: For a dental implant 510(k), the "ground truth" for demonstrating substantial equivalence is generally established by:
  • Engineering specifications and material properties: Ensuring the device meets accepted standards for strength, biocompatibility, and durability.
  • Successful historical use of predicate devices: The fact that the predicate devices are legally marketed and have a history of safe and effective use provides the "ground truth" for the new device's design principles and intended use.
  • (Implied) Biocompatibility testing: Not explicitly detailed here, but standard for implants.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable/Not provided. No "training set" in the context of machine learning or complex diagnostic algorithms is relevant to this submission.

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

• How Ground Truth for Training Set was Established: Not applicable/Not provided. As there is no training set described, this question is not relevant.

Summary of 510(k) Context:

It's crucial to understand that a 510(k) premarket notification, especially for a device like a dental implant that is similar to existing ones, focuses on demonstrating substantial equivalence to predicate devices. It typically does not involve new, extensive clinical trials with statistical endpoints, large test sets, expert adjudication, or AI performance metrics. The "proof" in this context is the detailed comparison of the new device's design, materials, manufacturing, and intended use against those of already-approved predicate devices to show that it is just as safe and effective. The provided document aligns perfectly with this 510(k) paradigm.

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OSSEOTITE NT™ Implant System is indicated for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment to restore a patient's chewing function.

Implant Innovation's dental implant systems include screw-form (i.e. threaded) titanium implants with a machined, external HEX to assist in placement and to provide antirotation features for the restoration. The OSSEOTTE® Brand implants have a special dual acid-etched treatment process to increase surface roughness.

The OSSEOTITE NTTM Dental Implants are tapered implants designed to mimic the shape and form of a natural tooth. The taper aspect ratio varies depending upon the length and diameter. The NT implants will be available in diameters of 3.25, 4.0, 5.0 and 6.0 mm and lengths of 8.5, 10.0, 11.5, 13.0 and 15.0 mm.

The provided document, K014235 for OSSEOTITE NT™ Implants and Accessories, is a 510(k) premarket notification. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving device effectiveness through clinical trials with specific acceptance criteria, as might be seen with a PMA (Premarket Approval) application.

Therefore, the document does not contain the detailed information requested regarding acceptance criteria, specific study designs (test set sample size, data provenance, expert adjudication, MRMC studies, standalone performance), or ground truth establishment for a training set.

However, I can extract the information that is present concerning performance data and substantial equivalence:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• The document mentions "mechanical testing of the implants." This implies in vitro testing.
• Sample Size: Not specified.
• Data Provenance: In vitro testing (laboratory-based), not specified geographical origin. This is not human data.

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

• Not applicable. The performance data is based on mechanical testing, not a human-interpreted ground truth.

4. Adjudication Method for the Test Set:

• Not applicable. The performance data is based on mechanical testing, not a human-interpreted ground truth.

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

• No, an MRMC study was not done. This device is not an AI/imaging device where human reader performance would be assessed.

6. If a Standalone (Algorithm Only Without Human-in-the Loop Performance) Was Done:

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

7. The Type of Ground Truth Used:

• For the mechanical performance, the "ground truth" would be the measured mechanical properties (e.g., strength, fatigue resistance) of the predicate device, against which the new device was compared. This is a scientific measurement, not an expert-derived ground truth.

8. The Sample Size for the Training Set:

• Not applicable. This is a physical medical device, not an AI model requiring a training set.

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

• Not applicable. This is a physical medical device, not an AI model.

In summary, this 510(k) filing relies on demonstrating substantial equivalence primarily through comparison of physical characteristics and mechanical testing to existing predicate devices, rather than clinical efficacy studies with specific acceptance criteria or expert-based ground truth evaluations.

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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 to restore a patient's chewing function.

The proposed OSSEOTITE® implants are identical to the predicate implants currently on the market, K983347, K980549, K935544.

The provided 510(k) summary for the OSSEOTITE® Dental Implants does not describe an AI/ML powered device, therefore, many of the requested details about acceptance criteria, study methods, and ground truth are not applicable. This document is a summary for a traditional medical device (dental implants) and focuses on substantial equivalence to predicate devices rather than performance metrics typically associated with AI.

However, I can extract the relevant information presented in the document pertaining to the closest equivalent of "acceptance criteria" and the study that supports it.

Acceptance Criteria and Reported Device Performance

Detailed Study Information (where applicable and extractable)

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

   • Sample size: Not explicitly stated. The document refers to a "meta-analysis of clinical data" and "a second analysis" but does not provide the number of patients or implants included in these analyses.
   • Data provenance: Not explicitly stated. It is inferred that the data is clinical, but the country of origin, whether retrospective or prospective, is not mentioned.

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

   • Not applicable/Not provided. The "ground truth" here is implied to be clinical outcomes (implant survival), which would be derived from patient data, not expert consensus on an image or diagnostic output.

3. Adjudication method for the test set:

   • Not applicable/Not provided. Adjudication methods like 2+1 or 3+1 are typically used for expert review of images or diagnostic assessments. This study relies on clinical outcomes data.

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

   • Not applicable. This is not an AI/ML device, and no MRMC study was performed or is relevant to this submission.

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

   • Not applicable. This is not an AI/ML device.

6. The type of ground truth used:

   • Clinical outcomes data (specifically, long-term cumulative survival of dental implants).

7. The sample size for the training set:

   • Not applicable/Not provided. Dental implants do not typically have "training sets" in the context of AI/ML. The "meta-analysis of clinical data" would represent the overall dataset analyzed for the study.

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

   • Not applicable. The "ground truth" (clinical survival) would have been established through follow-up observations of patients who received the implants in clinical studies. The details of how this was measured (e.g., specific criteria for survival, follow-up period) are not provided in this summary.

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An endosseous dental implant is indicated for surgical placement in the upper or lower jaw arches, to provide a root form means for prosthetic appliance attachment and to restore a patient's chewing function.

With use of OSSEOTITE® implants, the time between surgical implant placement and evaluation for prosthetic loading may be reduced from previously recommended four months (mandible) and six months (maxillary) to, two months for either mandibular or maxillary sites, when such evaluation confirms appropriate conditions for prosthetic attachment and masticatory loading.

Not Found

The provided document is a 510(k) summary for the OSSEOTITE® Dental Implant System, detailing its substantial equivalence to previously marketed devices and a performance claim for reduced healing time. It describes the scientific basis for this claim but does not provide specific details about a formal study with acceptance criteria and statistical analysis as would typically be found in a clinical trial report.

Therefore, many of the requested sections below cannot be fully answered or will be marked as "Not Applicable" or "Not Provided" based on the information available in this 510(k) summary.

Acceptance Criteria and Device Performance for OSSEOTITE® Dental Implant System

The acceptance criteria for the OSSEOTITE® Dental Implant System, as presented in this 510(k) summary, revolve around demonstrating a reduced healing time for prosthetic loading compared to historical recommendations. The document focuses on achieving "adequate healing" within two months, regardless of the implant site.

Study Details (Based on the provided K983347 510(k) Summary):

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

   • Sample Size: Not explicitly stated. The document refers to "numerous academic and clinical researchers," "ongoing evaluations," "animal studies," and "clinical trials." No specific numbers for human subjects or animal models are provided.
   • Data Provenance: Not explicitly stated. The document mentions "numerous academic and clinical researchers" which implies varied sources, but no specific countries or locations are given.
   • Retrospective or Prospective: "Ongoing clinical studies" and "interim results from various ongoing evaluations" suggest a prospective nature, but details are lacking.

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

   • Number of Experts: Not provided. The evaluation of "adequate healing" and "clinical evaluation" would typically involve dental professionals, but no details on their number or qualifications are mentioned in this summary.
   • Qualifications of Experts: Not provided.

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

   • Adjudication Method: Not provided. The document refers to "clinical evaluation" and "radiographic examination" to confirm healing, but there is no description of an adjudication process for conflicting clinical assessments or interpretations.

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

   • MRMC Study: Not applicable. This document pertains to a dental implant device and its healing properties, not an AI-assisted diagnostic or interpretation tool.
   • Effect Size of AI assistance: Not applicable.

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

   • Standalone Performance: Not applicable. This document is about a physical medical device (dental implant), not an algorithm or software.

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

   • Type of Ground Truth: The ground truth for successful integration and healing appears to be based on clinical evaluation (assessment by dental professionals) and radiographic examination (absence of radiolucency suggestive of bone-implant interface issues). The mention of "resistance to countertorque extraction" from animal studies suggests a mechanical measure as well, likely correlating with bone-implant integration.

7. The sample size for the training set:

   • Sample Size for Training Set: Not applicable in the context of this 510(k) summary. The document describes clinical experience and ongoing studies with the OSSEOTITE® implant, which would contribute to understanding its performance, but it doesn't refer to a "training set" in the machine learning sense. The development of the OSSEOTITE® surface itself was likely informed by extensive research and prior observations, but specific "training set" data for a statistical model is not mentioned.

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

   • Ground Truth for Training Set: Not applicable, as no "training set" is described in the context of this device's submission. The understanding of the device's performance evolved from "market introduction," "numerous academic and clinical researchers," "ongoing evaluations," and "animal studies."

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An Endosseous dental implant is indicated for surgical placement in the upper or lower jaw arches, to provide a root form means for prosthetic appliance attachment to restore a patient's chewing function. This submission provides information and animal/clinical data to support a clinical performance claim of "Enhanced Performance in Poor Quality Bone".

Screw type implant with a "Defined Surface Structure".

The provided text describes a 510(k) submission for the "Osseotite" Dental Implant System, focusing on a claim of "Enhanced Performance in Poor Bone" due to a "Defined Surface Structure." It does not present acceptance criteria in the typical sense of quantitative targets for performance metrics from a formal validation study. Instead, it relies on demonstrating that the "Osseotite" surface performs at least as well as, and in some cases better than, other "non-Osseotite" surfaced implants, particularly in areas with poor quality bone.

Here's an attempt to extract and interpret the information based on your request, understanding that the structure of a 510(k) summary is different from a clinical trial report.

Acceptance Criteria and Reported Device Performance

The document doesn't define explicit numerical acceptance criteria for a new, unproven device's safety and efficacy because it's a 510(k) submission seeking substantial equivalence to a predicate device. The primary "acceptance criterion" for marketing approval through 510(k) is demonstrating substantial equivalence to a legally marketed predicate device, which the "Osseotite" implants had already achieved in terms of design and materials in an earlier K submission (K935544).

This particular submission (K980549) is to support a marketing claim of "Enhanced Performance in Poor Bone" based on new data, not to re-establish fundamental safety and efficacy. Therefore, the "acceptance criteria" here implicitly relate to the sufficiency of evidence to support this performance claim rather than a predefined set of performance thresholds for device approval.

However, we can infer performance indicators and reported findings:

Study Details to Support "Enhanced Performance" Claim

The document describes several types of studies and data used to support the "Enhanced Performance" claim:

1. Sample size for the test set and data provenance:

   • Animal studies: Unspecified number of animals. Likely from research institutions where the studies were "published." Provenance not specified, but typically animal studies are prospective.
   • Clinical trials: Two ongoing prospective clinical trials. The sample size for the clinical trials is not explicitly stated in this summary, but they track "Osseotite" vs "non-Osseotite" (machined surface) implants. The "8.8% greater" outcome is reported for "similar implants at 24 months" in areas of poor quality bone. The specific countries of origin for these clinical trials are not mentioned.

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

   • The document mentions "Numerous academic and clinical researchers are involved with a variety of studies." It does not specify the exact number of experts involved in establishing ground truth for individual animal or clinical study outcomes.
   • Expert qualifications are inferred from the context of "academic and clinical researchers" but are not explicitly detailed (e.g., years of experience, specific certifications).

3. Adjudication method for the test set:

   • Not specified. This level of detail is typically found in full study protocols or publications, not a 510(k) summary.

4. Multi-Reader Multi-Case (MRMC) comparative effectiveness study:

   • No, an MRMC comparative effectiveness study in the typical sense (e.g., human readers interpreting images with and without AI assistance) was not done. The "Osseotite" is a physical dental implant, and the studies assess its direct performance (e.g., osseointegration, stability, survival rates) rather than observational interpretations.

5. Standalone (algorithm only without human-in-the-loop performance) study:

   • This is not applicable as the device is a physical dental implant, not an AI algorithm. The studies assess the implant's standalone biological and mechanical performance in vivo.

6. Type of ground truth used:

   • Animal studies: Likely direct measurement of biological response (e.g., histology for bone-to-surface contact, mechanical testing for countertorque extraction).
   • Clinical trials: Clinical outcomes directly observed and measured (e.g., implant survival, success/failure based on established dental implant criteria, which might include absence of mobility, absence of pain/infection, etc.). These outcomes serve as the ground truth.

7. Sample size for the training set:

   • Not applicable in the typical sense of a machine learning model's training set. The "training" for this physical device would be the iterative design, manufacturing, and preclinical testing phases, which are not specifically quantified as a "training set" here.

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

   • Not applicable as described above. The ground truth for evaluating the device's performance (as described in points 1 and 6) is based on direct biological and clinical measurements and observations.

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