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The Prima Plus™ Conical Implant System is intended for use in single-stage or two-stage surgical procedures for replacing single or multiple missing teeth in partially or fully edentulous mandibles and/or maxillae. The Prima Plus™ Conical Implant System supports single or multiple-unit restorations to re-establish patient chewing function and aesthetics. Prima Plus™ Conical implants are intended for placement following natural tooth loss or for immediate placement into an extraction socket. Immediate function may be achieved when good primary stability is established, and appropriate occlusal loading is applied.

All digitally designed custom abutments for use with Prima Plus™ Conical Implants are to be sent to a Keystone Dental validated milling center for manufacture.

The purpose of this submission is for the marketing clearance for Prima Plus Conical Implants, an endosseous root-form dental implant. The overall system is designed to be used with compatible components and are indicated for single-unit, multi-unit and overdenture restorations. No new prosthetic components were designed as part of this submission, with these implants designed to be compatible with previously cleared prosthetic components.

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. Prosthetic devices used with the dental implant abutments in this submission may be screw-retained or cement-retained.

The Prima Plus Conical Implant System includes endosseous screw type dental implants which can be used in either single- or two-stage surgeries with associated compatible abutments, screws, and other associated accessory components. The Prima Plus Conical Includes previously marketed abutments with fifteen (1 5) designs: Healing Abutments, Straight (with and without TiPink), Angled (with and without TiPink), Straight Multi-Unit, Angled Multi-Unit, PEEK Straight Temporary, PEEK Angled Temporary, Temporary Cylinder (with and without TiPink), Titanium Temporary Immediate (with and without TiPink), Titanium Blank. There are four minor variations of the Titanium Base design: Ti-Base, C-Base®, and ELLIPTIBase®. Prosthetic devices used with the dental implant abutments in this submission may be screw-retained or cemented.

lmplants are fabricated from a Titanium 4 Vanadium ELI titanium alloy which conforms to ASTM F136, Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI Alloy for Surgical Implant Applications (UNS R56401). They have a Sandblasted, Large grit and Acid-etched (SLA) surface treatment.

All implants are one-time use devices All Subject device components are provided sterilized by gamma irradiation.

The provided text is a 510(k) summary for a medical device (Keystone Dental Inc.'s Prima Plus Conical Implant System). It describes the device, its intended use, and how it is substantially equivalent to previously marketed devices based on non-clinical performance testing.

However, the document does not contain information typically found in a study proving device performance against acceptance criteria for AI/ML-enabled devices, especially regarding clinical performance, human-in-the-loop studies, or the establishment of ground truth by experts.

The key phrases from your request which are not addressed in the provided text are:

• "Acceptance criteria and the study that proves the device meets the acceptance criteria."
• "Table of acceptance criteria and the reported device performance." (beyond static mechanical testing)
• "Sample sized used for the test set and the data provenance." (There's no clinical test set described)
• "Number of experts used to establish the ground truth for the test set and the qualifications of those experts."
• "Adjudication method for the test set."
• "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."
• "If a standalone (i.e. algorithm only without human-in-the-loop performance) was done."
• "The type of ground truth used (expert consensus, pathology, outcomes data, etc)."
• "The sample size for the training set."
• "How the ground truth for the training set was established."

The document explicitly states: "No clinical data were included in this submission." This means there are no studies involving human patients or complex data analysis that would require features like AI models, human readers, or ground truth establishment by medical experts.

The "acceptance criteria" and "device performance" mentioned are limited to:

• Non-Clinical Performance Testing:
  • Fatigue testing per ISO 14801:2016 (Dentistry – Implants – Dynamic loading test for Endosseous Dental Implants). This is a mechanical test.
  • Biological Evaluation per ISO 10993-1.
  • Sterilization information leverage (from a reference device, K220200).
  • MRI review (non-clinical, using scientific rationale and published literature).

The "study" that proves the device meets the acceptance criteria is primarily benchtop mechanical performance testing (ISO 14801) on "worst-case constructs" to demonstrate "suitability for intended use."

Therefore, I cannot provide a table or details on the ground truth, expert involvement, or clinical study design as requested for an AI/ML device, because this 510(k) filing for a dental implant does not involve such elements. It is a physical medical device, and its equivalency is based on material properties, design comparisons, and mechanical durability.

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