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Lifecore Biomedical Dental Implants are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including: cement retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework.

The PrimaConnex™ Internal Connection Implant is a threaded implant that is intended for immediate placement and can be restored with a temporary prosthesis in single tooth and multiple tooth applications with good quality bone.

The PrimaConnex Internal Connection Implant is intended for immediate placement, where immediate implant placement is defined by the International Congress of Oral Implantologists (ICOI) as the placement of an implant at the time of tooth extraction into the extraction socket.

The PrimaConnex Internal Connection Implant is intended for immediate provisionalization with non-occlusal load. Immediate Provisionalization is described by the International Congress of Oral Implantologists (ICOI) as a clinical protocol or the placement of an interim prosthesis with or without occlusal contact with the opposing dentition at the same critical visit of implant placement. The PrimaConnex Internal Connection Implant can be restored with a temporary prosthesis in single tooth and multiple tooth applications with good quality bone.

The Lifecore Biomedical PrimaConnex Internal Connection Implant System consists of two-stage, root-form tapered and straight-walled threaded dental implants and associated abutment systems, which provide the clinician with screw-retained, cement-retained, and overdenture abutments. The system also includes surgical and restorative instrumentation: twist drills, surgical taps, surgical depth probe, depth gauges, abutment drivers, latch-type drivers, and hand-piece adapters. Lifecore PrimaConnex implants are available with a Resorbable Blast Media (RBM) roughened surface. All implants have an internal connection as an anti-rotational feature for the prosthetics.

This 510(k) premarket notification for the Lifecore PrimaConnex™ Internal Connection Implant System does not include a study with acceptance criteria and device performance results as typically requested for AI/ML device submissions. Instead, it demonstrates substantial equivalence to previously cleared predicate devices.

Therefore, many of the requested sections (e.g., acceptance criteria, test set sample size, ground truth details, MRMC study, standalone performance) are not applicable or cannot be extracted from the provided text. The document focuses on comparing the new device's design, materials, intended use, and general characteristics to existing FDA-cleared dental implants to show that no new questions of safety or effectiveness are raised.

Here's an attempt to address the prompts based on the available information, noting the limitations:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the 510(k) summary. For a device showing substantial equivalence, specific "acceptance criteria" and direct "device performance" in the context of a new study are typically not presented in this format. The acceptance is based on demonstrating similarity to predicates.

2. Sample Size Used for the Test Set and Data Provenance

This information is not applicable/not provided. There is no "test set" in the context of a new performance study described. The 510(k) relies on comparison to predicate devices, not on new clinical performance data with a specific test cohort.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable/not provided. Since no new clinical study with a "test set" is described, there's no ground truth established by experts for performance evaluation.

4. Adjudication Method for the Test Set

This information is not applicable/not provided. There is no "test set" or adjudication process described.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done or described in this 510(k) submission. The submission is based on demonstrating substantial equivalence to predicate devices, not on a new comparative effectiveness study.

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

This information is not applicable/not provided. The device is an endosseous dental implant system, which is a physical medical device, not an AI/ML algorithm. Therefore, "standalone algorithm performance" is not relevant here.

7. The Type of Ground Truth Used

This information is not applicable/not provided. As no new performance study is described, there is no "ground truth" established for the device's performance in the context of this 510(k) summary. The "truth" for substantial equivalence is based on established safety and effectiveness of the predicate devices.

8. The Sample Size for the Training Set

This information is not applicable/not provided. This device is a physical dental implant, not an AI/ML system. Therefore, there is no "training set."

9. How the Ground Truth for the Training Set Was Established

This information is not applicable/not provided. As explained above, there is no "training set" for this device.

Summary of the 510(k) Submission:

The provided document is an Abbreviated 510(k) Premarket Notification for the PrimaConnex™ Internal Connection Implant System. This type of submission aims to demonstrate substantial equivalence to legally marketed predicate devices, rather than providing extensive new clinical study data with detailed performance metrics and acceptance criteria.

Key points from the document indicating an equivalence approach:

• Section 5. Substantial Equivalence Comparison: This section explicitly states the purpose is to compare the new device to identified predicates.
• The document highlights similarities in:
  • Intended Use: "The PrimaConnex Internal Connection Implant System has a substantially equivalent intended use as the identified predicates."
  • Fundamental Scientific Technology: All are "threaded, root form implants constructed of titanium."
  • Size and Materials: "similar in size and materials."
  • Sterilization: "sterilized via gamma irradiation and intended for single use only."
  • Instrumentation: "include instruments to assist with the implant procedure."
• Conclusion: "When compared with the predicate devices, no new questions of safety or effectiveness have been raised for the PrimaConnex Internal Connection Implant System."

The FDA's response (SEP - 9 2005 letter) confirms this: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent...".

Therefore, the "study" proving the device meets "acceptance criteria" here is the comparison to established predicate devices, and the "acceptance criteria" is essentially demonstrating that the new device is as safe and effective as the predicates, raising no new safety or effectiveness concerns. No specific quantitative performance metrics beyond this comparison are presented in the provided text.

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