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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, freestanding bridges and to retain overdentures.

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

This 510(k) requests an expansion of the indications for use of all externally and internally hexed 3i dental implants to include immediate loading procedures in the mandible when using a minimum of four (4) splinted implants ≥ 10mm in length. Standard, commercially available 3i abutments and screws can be used with 3i dental implants in immediate loading procedures. Several new components will complement the standard line for the clinicians use as necessary in immediate occlusal loading.

The provided 510(k) summary for K030614 describes the acceptance criteria and supporting studies for the 3i Dental Implants, specifically for the expansion of indications to include immediate loading procedures in the mandible.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state numerical acceptance criteria in a clear, tabulated format for the clinical performance. Instead, it relies on substantiating "clinical success" and "osseointegration" based on existing literature and previous clearances.

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

The submission primarily relies on a literature review of previously published clinical studies, rather than a single, dedicated prospective clinical trial for this specific 510(k) submission. Therefore, "test set" sample sizes are derived from these referenced studies.

• Tarnow et al.: 107 implants (in 10 edentulous cases).
• Testori et al.: 12 Osseotite implants (in 1 patient).
• Defrancq et al.: 417 Osseotite implants in 68 mandibular procedures; 309 Osseotite implants in 34 maxilla procedures.
• Ibanez and Jalbout: 87 Osseotite implants in 11 patients.
• Data Provenance: The studies are published clinical literature. The country of origin is not explicitly stated for all, but given the names and journals, they are likely international, possibly with an emphasis on European and North American research. All are retrospective analyses of cases or small prospective case reports/series.

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

This information is not provided. The summarized studies are clinical publications, and the ground truth (e.g., osseointegration, implant success/failure) would have been established by the clinicians/researchers involved in those individual studies based on standard dental and surgical assessment methods (clinical examination, radiographs, and for one study, histologic analysis). There is no mention of an independent panel of experts establishing a ground truth for a unified "test set" for this 510(k) specifically.

4. Adjudication Method (e.g. 2+1, 3+1, none) for the Test Set

Not applicable in the context of this submission. Since the submission relies on published literature, there's no mention of a formal adjudication method for a specific test set. The outcomes in the referenced studies were assessed by the respective study authors.

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 submission is for dental implants, not an AI-powered diagnostic device. Therefore, no MRMC study or AI-related comparative effectiveness is presented.

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

Not applicable. This is a medical device (dental implant), not an algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the referenced clinical studies was primarily:

• Outcomes Data: Clinical success/failure, implant survival rates, absence of mobility, absence of periimplant radiolucency.
• Clinical Examination: Assessment of implant stability and health.
• Radiographic Examination: To check for periimplant radiolucency and bone levels.
• Histology/Pathology: Testori et al. specifically mention "histologic analysis after 4 months of occlusal loading" and "histomorphometric evaluation revealed 78%-85% bone-to-implant contact."

8. The Sample Size for the Training Set

Not applicable. This is a medical device, not a machine learning algorithm.

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

Not applicable. This is a medical device, not a machine learning algorithm.

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

The submission leverages a combination of non-clinical (mechanical) testing and a literature review of clinical studies to demonstrate that the 3i Dental Implants, when used for immediate loading, are "substantially equivalent" to predicate devices and clinically successful.

Non-clinical Testing:

• Mechanical tests (Static Load Compression, Cyclic Fatigue) were performed on 3i implants and the new single-piece abutment. These tests simulated biting and chewing forces and passed established criteria, showing the components' physical integrity. Insertion torque for the new abutment also passed, exceeding recommended levels.

Clinical Performance (Literature Review):
The submission relies on a review of existing clinical literature, specifically highlighting four studies:

• Tarnow et al. (1997): A case series involving various implant types (including 3i) for immediate loading in edentulous arches, reporting high osseointegration rates.
• Testori et al. (2001): A case report on Osseotite implants in the mandible, demonstrating clinical and histologic osseointegration during immediate loading, with good bone-to-implant contact.
• Defrancq et al. (2002): A report on successful immediate loading techniques using Osseotite implants in both maxilla and mandible, with very low implant loss rates (e.g., 0.48% in mandibular procedures).
• Ibanez, JC, Jalbout,ZN (2002): A two-year follow-up study on Osseotite implants for immediate loading, reporting 100% success with no implant mobility or periimplant radiolucency.

The submission argues that these studies, along with prior animal studies (K983347) and general current clinical practice, provide sufficient evidence of "substantial clinical success with early loading" for implants similar in design and materials to the 3i implants, thereby supporting the expanded indication for immediate loading. The overall argument for acceptance is based on the substantial equivalence of the 3i implants to other legally marketed devices indicated for immediate loading, supported by safety and performance data from both non-clinical testing and clinical literature review.

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Selected Brånemark System® implant products (those identified in the preceding section, "Device Name") are intended to be placed in the upper or lower jaw to support prosthetic devices, such as artificial teeth, and to restore a patient's chewing function. This may be accomplished using either a two stage surgical procedure or a single stage surqical procedure.

If a single stage surgical procedure is used, these implants may be loaded immediately following insertion - PROVIDED - at least four implants are placed, and are splinted with a bar. These implants must be placed predominantly in the anterior mandible (between the mental foramina) where good initial stability of the implants, with or without bi-cortical anchoragel can most often be obtained.

Brånemark System® dental implants are threaded, root-form implants fabricated from ASTM grade 1 "commercially pure" titanium. They are available in diameters of 3.75 mm and 4.0 mm, and are available in lengths ranging from 10 mm to 21 mm. Research studies have demonstrated that titanium is biocompatible.

The provided text is a 510(k) summary for Nobel Biocare's Brånemark System® Implants, seeking clearance for an immediate loading indication. This document details the device, its intended use, and a comparison to predicate devices, but does not contain any information about specific acceptance criteria or a study proving the device meets those criteria, as typically understood for AI/ML or diagnostic devices.

The 510(k) process for medical devices primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific quantitative acceptance criteria in the way a clinical trial for a drug or an AI diagnostic algorithm would.

Therefore, many of the requested items (e.g., sample size for test set, number of experts for ground truth, MRMC studies, standalone performance) are not applicable or cannot be extracted from this type of regulatory submission. The document explicitly states "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent...".

Here's a breakdown of what can and cannot be answered based on the provided text:

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

• Not applicable/Not provided. This document is a 510(k) summary for substantial equivalence, not a performance study against specific acceptance criteria. The "performance" assessment is based on demonstrating equivalence to predicate devices already cleared for immediate loading.

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

• Not applicable/Not provided. This document does not present results from a clinical test set with specific sample sizes. The regulatory submission relies on comparison to predicate devices and existing biocompatibility data for titanium.

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, typically for diagnostic accuracy or outcome prediction, is not described in this 510(k) summary.

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

• Not applicable/Not provided. No test set or adjudication method is mentioned.

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. MRMC studies are typically for evaluating the impact of AI algorithms on human reader performance, which is not the subject of this 510(k) for dental implants.

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

• Not applicable/Not provided. This document is not about an algorithm, but a physical dental implant.

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

• Not applicable/Not provided. This document does not refer to ground truth data in the context of device performance metrics. The implicit "ground truth" for the immediate loading indication is likely established clinical practice and safety/efficacy data already accepted for the predicate devices.

8. The sample size for the training set

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

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

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

Summary of Device Acceptance (based on 510(k) Substantial Equivalence):

The device (Brånemark System® Implants with immediate loading indication) achieved acceptance through the FDA's 510(k) clearance process by demonstrating substantial equivalence to legally marketed predicate devices, specifically the Straumann ITI Implant (K984104) and the Sargon Cylindro-Blade Implant (K930071), both of which already had an immediate load indication.

The key aspects considered for substantial equivalence, as detailed in the comparison table, included:

• Intended Use: Functionally the same (support prosthetic devices, restore chewing function).
• Indication: Immediate Load.
• Design: Threaded, root-form implants (similar to Straumann ITI Implant, different but accepted from Sargon).
• Placement Method: Single stage surgery.
• Material: Commercially pure titanium (similar to Straumann, different but accepted from Sargon's titanium alloy).
• Coating: None.
• Dimensions: Within acceptable ranges relative to predicate devices.

The FDA concluded that the device is substantially equivalent to the predicate devices for the stated indications for use (immediate loading under specific conditions: at least four implants placed, splinted with a bar, predominantly in the anterior mandible, with good initial stability). This substantial equivalence determination allowed the device to be marketed.

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