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The INNO SLA Submerged Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, screw-retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework.

The INNO SLA Submerged Implant System offers Healing Abutment (Type A and Type B), Angulated Abutment, Temporary Abutment, Sonator S Abutment, Sonator A Abutment, and Screws. These components are used with the fixtures and cover screws cleared under K132242.

The provided text is a 510(k) summary for the INNO SLA Submerged Implant System. It describes the device, its intended use, and argues for its substantial equivalence to previously cleared predicate devices.

However, the document does not contain the information requested regarding acceptance criteria and a study proving a device meets those criteria, particularly in the context of an AI/ML-driven device performance study. The device described, the "INNO SLA Submerged Implant System," is a physical dental implant system and not an AI/ML-based medical device. Therefore, the questions related to AI/ML device performance (like sample size for test/training sets, data provenance, expert ground truth, MRMC studies, standalone performance) are not applicable to this document.

The document does mention "Non-Clinical Testing" which includes:

• Surface Modification: Leveraging specifications and processes from a predicate device (K132242) for TiN coating.
• Cytotoxicity Testing: Performed on representative abutments with TiN coating according to ANSI/AAMI/ISO 10993-5 and ISO 10993-12. This type of testing ensures the material is not harmful to cells.
• Mechanical performance testing: Conducted according to ISO 14801. This test establishes the fatigue limit to ensure structural integrity and sufficient strength for intended use. The "worst-case scenario" was chosen based on FDA Guidance.
• End-user sterility validation: Conducted according to ISO 17665-1 and ISO 17665-2 for a prior clearance (K132242) and leveraged for the subject devices.

These tests are standard for physical medical devices and confirm material compatibility, mechanical robustness, and effective sterilization, which are relevant "acceptance criteria" for such devices. The document explicitly states that the mechanical performance test demonstrated "sufficient strength for their intended use and are substantially equivalent to predicate devices with regard to mechanical performance."

In summary, the requested information regarding AI/ML device performance cannot be extracted from this document because it pertains to a physical dental implant system, not an AI/ML system.

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The INNO SLA Submerged Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including: cemented retained, screw retained, or overdenture restorations, and terminal or intermediate abulment support for fixed bridgework, this system is intended for delayed loading.

The implants with diameters larger than 5.0mm are intended to be surgically placed in the maxillary or mandibular molar areas for the purposed of providing prosthetic support for dental restorations (Crown, bridge, and overdentures) in partially or fully edentulous individuals. These implants are intended to be used where smaller implants have failed.

The INNO SLA Submerged Implant System is a dental implant made of titanium(Grade 4) metal intended to be surgically placed in the bone of the upper and / or lower jaw arches. This system is similar to other commercially available products based on the intended use, the technology used. the claims, the material composition employed and performance characteristics. The differences between the subject device and the predicate device are shape and surface treatment. The INNO SLA Submerged Implant System has one-stage and two-stage surgery. The surface treatment method of the subject device is S.L.A(Sand-blasted Large grit Acid-etched).

The fixture diameters are 3.7. 4.2, 4.6, 5.1, and 6.0mm and the implant lengths are 7.0, 7.5, 8, 9.5. 10. 11.5. 12. and 14mm in this system. The available lengths for each diameter of the fixtures are the following:

• 03.7mm with lengths of 8mm, 10mm, 12mm, and 14mm
• 04.2mm with lengths of 8mm, 10mm, 12mm, and 14mm .
• 04.6mm with lengths of 8mm, 10mm, 12mm, and 14mm ●
• 5. 1mm with lengths of 7mm, 8mm, 12mm, 12mm, and 14mm .
• 06.0mm with lengths of 7mm, 7.5mm, 9.5mm, and 11.5mm .

The abutments are made of titanium alloy and plastic and it is intended for use to made temporary prosthesis. It consists of Abutment and Coping Screw. The Abutment diameters are 3.7 ~ 6.5mm, and lengths 7.9 ~ 17.7mm.

The provided text describes a 510(k) submission for the "INNO SLA Submerged Implant System" and focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study proving the device meets specific acceptance criteria through performance data.

Here's a breakdown of why the requested information cannot be fully provided from the given text:

• Nature of 510(k) Submission: A 510(k) submission primarily aims to demonstrate that a new device is as safe and effective as a legally marketed predicate device (substantial equivalence), without requiring new studies to establish specific performance criteria like those often seen in AI/software device submissions. It often relies on comparisons of design, materials, indications for use, and possibly non-clinical bench testing.
• "No additional testing was performed for the subject device." This explicit statement means there isn't a performance study for the INNO SLA Submerged Implant System as requested.
• "Only the difference between the subject device and the predicate is the surface treatment method and the Fixture's external design." The submission argues that these differences do not raise new questions of safety or effectiveness.

Therefore, many of the requested fields related to a performance study will be marked as "Not Applicable" or "Not Provided" based on the content.

Acceptance Criteria and Device Performance

Since no specific performance study was conducted for the subject device to quantify its performance against pre-defined acceptance criteria, this table cannot be populated as requested in the context of typical AI/software device evaluation.

Study Details

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 applicable. No clinical or non-clinical performance study with a test set was performed for the subject device to demonstrate new performance metrics. The submission relies on demonstrating substantial equivalence to predicate devices that are already marketed.
   • Data Provenance: Not applicable.

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):

   • Not applicable. No test set requiring expert ground truth was used for this submission. The submission is based on engineering and material comparisons, and the established safety and effectiveness of predicate devices.

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

   • Not applicable. No test set requiring ground truth adjudication was used.

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 device is a dental implant, a physical medical device, not an AI software. Therefore, an MRMC study related to AI assistance is irrelevant.

5. 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 or software. Therefore, standalone algorithm performance is irrelevant.

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

   • Not applicable. The submission is for a physical dental implant and relies on established regulatory pathways for devices of similar design, materials, and intended use, rather than requiring ground truth for diagnostic or predictive performance.

7. The sample size for the training set:

   • Not applicable. This device is a physical dental implant, not a machine learning model.

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

   • Not applicable. This device is a physical dental implant, not a machine learning model.

Summary of the 510(k) Submission:

The provided text describes a 510(k) submission (K132247) for the INNO SLA Submerged Implant System. The submission itself explicitly states: "No additional testing was performed for the subject device."

Instead of conducting a new study to establish acceptance criteria and performance, the manufacturer, Cowellmedi Co., Ltd., is seeking clearance by demonstrating substantial equivalence to two predicate devices:

• Cowell Implant System by Cowellmedi Co., Ltd. (K100850)
• Implantium II by Dentium Co., Ltd. (K060501)

The grounds for substantial equivalence are based on:

• Identical intended use
• Identical material composition: CP Titanium, Gr.4 ASTM F67
• Similar design: Submerged
• Similar components and sterilization method (Gamma)
• Compliance with FDA's Class II special controls guidance document for root-form endosseous dental implants.

The noted differences between the subject device and the predicates are:

• Surface treatment method: INNO SLA uses SLA (Sand-blasted Large grit Acid-etched), while one predicate uses RBM (Resorbable Blast Medium) and the other uses SLA.
• Fixture's external design
• Specific implant diameters and lengths offered, which overlap significantly with the predicate devices' ranges.

The submission concludes that these differences do not raise new questions of safety or effectiveness, and therefore the device is substantially equivalent to the predicate devices. The FDA concurred with this assessment and cleared the device for market.

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