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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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