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The Star/Vent Internal Hex Screw Implant is intended for placement in the bone of the upper or lower jaw to support prosthetic devices such as artificial teeth, crowns, bridges or overdentures in edentulous or partially edentulous patients and to restore the patient's chewing function. It is intended for immediate loading when good primary stability has been achieved and with appropriate occlusal loading,

The Park Star/Vent Internal Hex Screw Implant is a root form endosseous dental implant (FDA classification code DZE). It has been placed in class 2 per 21 CFR 872.3640. The device is fabricated from titanium alloy meeting the specifications of ASTM F136. It is available in lengths of 8, 10, 11.5, 13, and 16mm and diameters of 3.3, 3.75, 4.2, 5.0 and 6.0mm. The surface is treated with resorbable blast media. The device is provided sterile. Sterility is achieved by gamma radiation pursuant to ISO 11137 to provide a sterility assurance level (SAL) of 10-. This device includes straight abutments with a 1, 2, 3, or 4mm collar and a straight UCLA cast abutment with a titanium base. These abutments are composed of titanium alloy meeting the specifications of ASTM F-136.

The provided text is a 510(k) summary for a dental implant device (K082800). It focuses on establishing substantial equivalence to predicate devices based on material composition, implant dimensions, surface treatment, and indications for use.

Crucially, this document does not contain information about acceptance criteria for device performance studies, nor does it detail any studies conducted to prove the device meets specific performance criteria.

A 510(k) summary for a device like a dental implant typically demonstrates substantial equivalence to a legally marketed predicate device rather than presenting new clinical study data with acceptance criteria. The FDA determined that the device is substantially equivalent based on the provided information, meaning it performs as safely and effectively as previously cleared devices.

Therefore, I cannot populate the table or answer the subsequent questions regarding acceptance criteria, study details, ground truth, or sample sizes, as this information is not present in the provided text.

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BioPlant Systems refer to sets of root form endosseous dental implants and compatible implant abutment systems. BioPlant Systems are designed for use in dental implant surgery and are intended to be used in a manor in which they (the implants) integrate with the bone (osseointegration). The BioPlant abutment systems include various abutments designed to enable the implant process from healing thru final restoration. Clinical studies have demonstrated that, when surgically implanted under controlled conditions, a successfully osseointegrated implant will achieve a firm and direct connection between the living bone and surface of the titanium implant. BioPlant implants are for single or two-stage surgical procedures. Bio Plant Systems are intended for immediate placement in partially or fully edentulous mandibles and maxillae (type I or II bone), in support of single or multiple-unit restorations including; cemented retained, screw retained, or over-denture restorations, and terminal or intermediate abutment support for fixed bridgework. Multiple tooth applications may be splinted with a bar.

The Bio Plant System includes a variety of types and sizes of precision-machined self-tapping root-form implants, abutments and accessory fixtures manufactured from biocompatible, commercially pure (CP) titanium or biocompatible, wrought titanium or gold alloy. The implants are available with hex-lock features and either smooth (bright) or textured (abrasive blasted) surface finish. Implants range in diameter from 3.3 mm to 6.0 mm and in length from 7 mm to 18 mm. The implants are intended to be surgically inserted into the upper and/or lower jawbone and serve as a substitute or replacement tooth while providing a stable and secure foundation for restorations. Drill sequences, arms and insertion instruments, as specified, are available.

The provided text describes the Cowell Medi BioPlant System, an endosseous dental implant system, and its acceptance criteria as defined for its 510(k) submission to the FDA. The submission relies heavily on demonstrating substantial equivalence to predicate devices and provides non-clinical testing data to support this claim, rather than new clinical trials.

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

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the Cowell Medi BioPlant System are primarily based on demonstrating substantial equivalence to existing legally marketed predicate devices (Nobel Biocare's Brånemark System and Implant Innovations, Inc. (3i) Dental Implant Systems). The performance criteria are therefore linked to matching or being functionally equivalent to these predicates across various attributes.

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

• Test Set (Non-clinical): For the mechanical fatigue and static shear testing, the document states: "BioPlant System production unit implant-abutment system samples, considered physically representative of the design most prone to worst-case mechanical loading following implantation, were subjected to testing per part 5 of ISO 14801."

  • The exact sample size (number of units tested) is not explicitly stated in the provided text, beyond "All samples survived" and "All samples exhibited acceptable yield points."
  • Data Provenance: The document does not specify the country of origin for the non-clinical testing data directly. Given that the manufacturer is Cowell Medi Co., Ltd. from Busan, Korea, it's reasonable to infer the testing was likely conducted in Korea or by an accredited lab on behalf of the manufacturer. The testing adheres to ISO 14801, an international standard. The data is prospective in the sense that custom tests were performed on the BioPlant System samples to demonstrate performance against established standards.

• Test Set (Clinical): No new clinical test set was used for the BioPlant System itself. The submission explicitly states: "Cowell Medi perceives the adequacy of such existing documentation substantiates the exclusion of both animal and human clinical studies protocols or data." Instead, they rely on "Abundant, significant, peer reviewed documentation supporting the successful clinical performance of root-form endosseous dental implants and abutment systems exists." This refers to retrospective evidence from the wider body of literature and the predicate devices.

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

• Non-clinical Testing: For the mechanical and static shear testing, ground truth is established by objective engineering standards (ISO 14801) and the physical properties of the materials and design, not by expert consensus. There are no "experts" establishing unique ground truth in this context; rather, the tests measure objective performance metrics.
• Clinical Ground Truth: No new clinical ground truth was established by experts for the BioPlant System specifically. The submission relies on existing "peer-reviewed documentation" and the clinical history of the predicate devices. The "ground truth" for clinical performance, in this case, is derived from the established safety and effectiveness of similar devices in the medical literature.

4. Adjudication Method for the Test Set

• Non-clinical Testing: Not applicable. The mechanical and static shear tests have objective pass/fail criteria (e.g., survival after 5 million cycles, acceptable yield points, no fractures prior to yield). There's no human adjudication of ambiguous results.
• Clinical Testing: Not applicable, as no new clinical studies were performed.

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. The document describes a dental implant system, not a diagnostic AI device requiring multi-reader, multi-case studies or assessment of human reader improvement with AI assistance.

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

• Not applicable. The device is a physical medical device (dental implants and abutments), not an algorithm or AI system.

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

• Non-clinical: Objective physical and mechanical standards (ISO 14801), laboratory measurements of fatigue resistance and yield strength.
• Clinical: The clinical ground truth for showing "successful osseointegration" and "firm and direct connection between the living bone and surface of the titanium implant" is based on the general body of "Abundant, significant, peer reviewed documentation" for root-form endosseous dental implants. This implies reliance on historical outcomes data and expert consensus within the dental community regarding the performance of similar, established devices.

8. The Sample Size for the Training Set

• Not applicable. This is not an AI or machine learning device requiring a training set. The device design and manufacturing processes are likely informed by years of engineering knowledge and clinical experience with dental implants, rather than a quantifiable training dataset in the AI sense.

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

• Not applicable. As stated above, this is not an AI device.

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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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