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The Paltop Conical 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. Narrow diameter implants are intended for placement in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws where the horizontal space is limited by the adjacent teeth and roots. The Paltop Conical Implant System is also indicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

The Paltop Conical Implant System which comprises endosseous root-form dental implants, mating abutment screws, and other associated components for single-unit, multi-unit, and overdenture restorations. Endosseous dental implants are surgically implanted into a patient's mouth to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. Endosseous dental implant abutments are secured to dental implants with a retaining screw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. The Paltop Conical Implant System implants are one- and two-stage endosseous screw type dental implants with associated compatible abutments, screws, and other associated accessory components. The Paltop Conical Implant System prosthetic components include healing caps, and multi-unit abutments which are available in straight or angulated configurations. Prosthetic devices used with the dental implant abutments in this submission may be screw-retained or cemented. The implants, titanium abutment screws are fabricated from a Titanium-6 Aluminum 4 Vanadium ELI titanium alloy (Grade 23) which conforms to ASTM F136, Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401). The Subject device implants are surface treated with SLA (Sand-blasted, Large Grit, Acid Etched). Immediate temporary abutments include a PEEK (Polyether ether Ketone) material sleeve, and the SAS abutment includes a PEEK healing cap/coping. All implants and prosthetic components are one-time use device components are provided sterile and sterilized by gamma irradiation except for Single-Unit and Multi-Unit copings, SAS Abutment components and all replacement screws which are provided non-sterile. Devices provided as non-sterile are sterilized by steam.

The provided text describes the 510(k) submission for the "Paltop Conical Implant System." This document is a regulatory filing demonstrating substantial equivalence to previously cleared devices, not a study performing clinical validation against acceptance criteria for a new AI/CADx device.

Therefore, most of the requested information (acceptance criteria for clinical performance, sample sizes for test/training sets, expert adjudication, MRMC studies, standalone performance, ground truth establishment, etc.) is not present in this document, as it pertains to a different type of device and regulatory submission.

The document focuses on non-clinical performance testing (fatigue testing, biocompatibility, endotoxin testing, sterilization validation, and MRI compatibility) to demonstrate the device's mechanical and material properties are equivalent to the predicate devices.

However, I can extract the information that is present and explicitly state what is missing based on the document's content:

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

The document does not specify quantitative clinical performance acceptance criteria (e.g., sensitivity, specificity, AUC) because it's a dental implant, not a diagnostic AI device. Instead, it refers to non-clinical performance standards.

2. Sample sized used for the test set and the data provenance

• Test Set Sample Size: Not applicable. This document refers to non-clinical bench testing (e.g., mechanical fatigue, material properties), not a clinical trial with a test set of patient data.
• Data Provenance: Not applicable for a clinical test set. The non-clinical testing appears to be conducted by the manufacturer, Paltop Advanced Dental Solutions, Ltd.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable. No clinical ground truth was established as this was a 510(k) submission for a physical device, based on non-clinical testing and substantial equivalence to predicate devices.

4. Adjudication method for the test set

• Not applicable. No clinical test set.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

• No. This type of study is for evaluating medical imaging AI. This document is for a dental implant.

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

• Not applicable. This is not an AI algorithm.

7. The type of ground truth used

• Not applicable for clinical ground truth. The "ground truth" for this device's performance validation is based on engineering standards, material specifications, and regulatory guidelines (e.g., ISO 14801 for fatigue, ISO 10993 for biocompatibility).

8. The sample size for the training set

• Not applicable. There is no AI training set.

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

• Not applicable. There is no AI training set.

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