(207 days)
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.
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.