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The Paltop Dental Implant System Internal Hex Standard and Wide Platforms implants (implant diameters 3.75 and above and lengths 8mm and above) as well as Conical Connection implants (implant diameters 3.75 and above and lengths 8mm and above), are indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. The Paltop Dental Implant System is indicated also for immediate loading, when good primary stability is achieved and with appropriate occlusal loading.

The Paltop Narrow Implant (Internal Hex and Conical Connections, for implant diameters 3.25 and lengths 10mm and above) is indicated for use in surgical and restorative applications for placement in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws where the interdental spaces are limited by the adjacent teeth and roots, to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. The Paltop Narrow Implant is indicated also for immediate loading, when good primary stability is achieved and with appropriate occlusal loading.

The purpose of this submission is to add components and update previously cleared to the Paltop Advanced Dental Solutions, Ltd product line of endosseous dental implants, abutments, and prosthetic components. Specifically, this submission seeks marketing clearance for dental implants with body diameters of 3.25 mm, 3.75 mm, 4.2 mm, 5 mm, and 6 mm various compatible abutments, two (2) cover screws, and one (1) additional abutment screw.

The subject device dental implants are self-tapping, threaded, root-form dental implants intended for the functional and aesthetic rehabilitation of the partial or fully edentulous mandible or maxilla. Once osseointegrated, the implants act as an anchor for various fixed or removable prosthetic solutions. All subject device implants are intended to be placed at the bone level (crestal position). All implants with diameters of 4.2 mm and 5.0 mm diameters allow for the option of platform switching.

Advanced, Advanced +, Dynamic, PAI, and PAI TC dental implants have an internal hex connection. Each implant line is provided with a body diameter of 3.25 mm, and interface with the Paltop Narrow Platform (NP) prosthetic components, with an interface diameter of 2.90 mm. Implants with the 3.25 mm body diameter are provided in lengths of 10, 11.5, 13, and 16 mm. Each implant line also is provided with body diameters of 3.75, 4.2, and 5 mm; these implants are provided in lengths of 8, 10, 11.5, 13, and 16 mm and interface with the Paltop Standard Platform (SP) prosthetic components, with an interface diameter of 3.65 mm.

The Advanced +, Dynamic, PAI, and PAI TC dental implant lines also are provided in a body diameter of 6 mm, in lengths of 8, 10, 11.5, 13, and 16 mm. Implants with the 6 mm body diameter interface with the Paltop Wide Platform (WP) prosthetic components, with an interface diameter of 4.4 mm. The Advanced +, Dynamic, PAI, and PAI TC dental implants have an internal threaded section (UNF 1-72) for connection to the corresponding cover screw, healing cap, abutment, or abutment screw.

The subject device conical connection implants (Dynamic Conical MC, and PCA) are provided in body diameters of 3.25, 3.75, 4.2, and 5 mm. Conical implants with the 3.25 mm body diameter are provided in lengths of 10, 11.5, 13, and 16 mm; all other body diameter sizes are provided in lengths of 8, 10, 11.5, 13, and 16 mm. All conical implants have a recessed internal section for abutment indexing, and an internal threaded section for connecting with corresponding compatible healing caps, abutments, and screws. Subject device implants with a conical geometry connect to conical connection prosthetic components. The conical connection prosthetic interface diameter is 2.9 mm.

The subject device conical connection implants (Dynamic Conical MC, and PCA) have a recessed 22° internal conical taper and a section for abutment indexing, as well as a threaded section (M1.6 x 0.35) for connection to the corresponding cover screw, healing cap, abutment, or abutment screw.

All subject device titanium abutments and screws are manufactured from titanium alloy conforming to ASTM F136.

The subject device endosseous dental abutments provide a range of cement-retained and screw-retained prosthetic solutions for dental implant restoration. Subject device abutments include seven (7) compatible implant abutment designs: Healing Caps, Straight Abutments, Angulated Abutments, Multi-Unit Abutment, Temporary Abutments, Snap-On Abutment System (SAS), and Ball Abutments for subject and non-subject device implants of the same families (Advanced, Advanced +, Dynamic, PAI, and PAI TC dental implants) and the conical healing caps are compatible with conical subject and non-subject devices (PCA, Dynamic Conical, Dynamic Conical MC). Abutments are offered in either indexed (engaging) or non-indexed (non- engaging) external connections that are compatible with the subject device implants.

Subject device abutments are compatible with the subject device implants with the internal hex connection, and the conical connection implants (subject device healing cap), as well as previously cleared compatible implants as described in Table 4 Subject Device Component Compatibilities. Subject device abutments are compatible with subject device implants according to their appropriate internal connection and platform. Subject device implants with an internal hex connection and diameter size of 3.25 mm (Advanced, Advanced +, Dynamic, PAI, and PAI TC) are compatible with subject device Narrow Platform (NP) Abutments, as well as abutments cleared in K210117. Subject device implants with an internal hex connection and diameter size of 3.75 mm, 4.2 mm and 5.0 mm (Advanced, Advanced +, Dynamic, PAI, and PAI TC) are compatible with subject device Standard Platform (SP) Abutments, as well as abutments cleared in K232740. The 6.0 mm diameter internal hex implants of all lengths (Advanced +, Dynamic, PAI, and PAI TC) are compatible with subject device Wide Platform (WP) Abutments, as well as abutments cleared in K232740. Subject device implants with a conical connection (Dynamic Conical MC and PCA) are compatible with the subject device conical connection healing cap, as well as conical connection abutments cleared in K220200. The 5.0 mm diameter conical connection implants of all lengths (Dynamic Conical MC and PCA) are compatible with conical connection abutments cleared in K232740.

All subject device titanium abutments and screws are manufactured from titanium alloy conforming to ASTM F136.

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The Paltop Dental Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. The Paltop Dental Implant System is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

Paltop Advanced Dental Solutions Implant System consists of a one and two stage endosseous screw type implant with internal hexagonal connection, intended for single use. Each implant is accompanied by standard cover screws, healing caps, abutment system superstructures and surgical instruments. The Paltop dental implant system is composed of the following implant families: Paltop Advanced screw type implants and Paltop Dynamic screw type implants. Each implant is accompanied by a standard cover screw. Paltop dental implants are made of Ti 6Al 4V ELI, and shall meet the requirements of ASTM F136. "Paltop Advanced" are screw type implants, with double leaded "V" shape progressive external thread profile along the implants body, and fine threads at its neck. It has an internal hex. connection and a domed apex. The implant is available in 3.75mm, 4.2mm and 5mm diameter and lengths of 8mm, 10mm, 11.5mm, 13mm and 16mm. The implants are suitable for both one and two stage implant procedures. "Paltop Dynamic" are screw type implants, with 3 different thread geometries: double leaded "V" shape progressive external thread profile at the apical portion, modified reverse buttress along its body and fine thread at the neck. It has an internal hex. connection. The implant is available in 3.75mm, 4.2mm and 5mm diameter and lengths of 8mm, 10mm, 11.5mm, 13mm and 16mm. The implants are suitable for both one and two stage implant procedures. The Paltop Advanced Dental Implant System includes a variety of abutments having a central bore and a lower mating surface that is configured to mate with the mating surface of the Paltop implant. A collar portion is located at a coronal end of the dental implant. A central bore extends through the collar portion and into the implant body portion. The central bore includes a threaded section for receiving a threaded portion of a screw and post receiving section. The post receiving section consists of hex geometry for antirotational features and a conical section (above the hex) which interfaces with the abutment. The designed threads provides secure primary fixation. This design is responsible for transferring the load from the abutment/prosthesis to the implant body.

The provided document is a 510(k) summary for the Paltop Advanced Dental Solutions Implant System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive clinical study data for acceptance criteria.

Therefore, the document does not contain a detailed study proving the device meets specific acceptance criteria in the format requested by the user for an AI/ML device.

Here's a breakdown of the available information in relation to the requested points:

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

This information is not explicitly provided in the document in the context of acceptance criteria and performance metrics typically expected for an AI/ML device. The document primarily focuses on demonstrating substantial equivalence to predicate dental implants through technological characteristics and compliance with established standards for dental implants.

The "performance" described is in the context of mechanical, material, and biological properties, not a predictive or diagnostic AI/ML performance.

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

This information is not provided. The non-clinical tests mentioned are fatigue, corrosion resistance, surface analysis, and biocompatibility, which are standard tests for physical medical devices, not AI/ML systems.

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)

This information is not applicable and therefore not provided. The device described is a dental implant, not an AI/ML diagnostic or predictive tool that requires expert-established ground truth from images or other data.

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

This information is not applicable and therefore not provided. As the device is a physical dental implant, there is no "test set" in the context of AI/ML performance evaluation requiring adjudication.

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

This information is not applicable and therefore not provided. The device is a dental implant and does not involve AI assistance for human readers/clinicians, nor does it present "cases" for interpretation.

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

This information is not applicable and therefore not provided. The device is a physical dental implant and does not involve an algorithm.

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

This information is not applicable in the context of AI/ML ground truth. For the physical dental implant, ground truth is implicitly established by compliance with international standards for material properties, mechanical performance (e.g., fatigue), and biocompatibility. Clinical effectiveness is generally inferred from the substantial equivalence to existing devices with a long history of safe and effective use.

8. The sample size for the training set

This information is not applicable and therefore not provided. The device is a physical dental implant and does not involve a training set for an AI/ML algorithm.

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

This information is not applicable and therefore not provided. The device is a physical dental implant and does not involve a training set for an AI/ML algorithm.

Summary regarding the provided document:

The 510(k) submission for the Paltop Advanced Dental Solutions Implant System focuses on demonstrating substantial equivalence to predicate dental implant devices, as opposed to providing detailed acceptance criteria and a study for an AI/ML device. The "study" referenced in the document for clinical aspects is a literature review, which concludes that titanium-based dental implants are safe and effective. The "acceptance criteria" are implied by compliance with various international standards for biocompatibility, material properties, and mechanical performance relevant to dental implants (e.g., ISO, ASTM standards listed on pages 4, 6, and 7). There are no AI/ML specific details in this document.

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