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The Lifecore Single Tooth Abutment is intended to attach to an endosseous implant and provide support and retention for a single-tooth restoration in the mandible or maxilla.

The Lifecore Single Tooth Abutment System is designed for use with an endosseous dental implant and provides support and retention for cement-retained, single tooth restorations in the mandible or maxilla. The system consists of the single tooth abutments, abutment screws, healing caps, impression posts, and associated laboratory components. Most components are packaged separately to allow the clinician to choose only those components required for each clinical situation. The Lifecore Single Tooth Abutment System has been designed to be dimensionally compatible with the Nobel Biocare CeraOne® Abutment System gold and ceramic sleeves. The single tooth abutments and healing caps are manufactured from titanium allov (Ti 6Al-4V E.L.I.).

This document describes a 510(k) premarket notification for the "Lifecore Single Tooth Abutment System". This submission focuses on demonstrating substantial equivalence to predicate devices, rather than establishing de novo safety and effectiveness through a clinical study with acceptance criteria.

Therefore, the requested information elements related to acceptance criteria, device performance tables, sample sizes for test/training sets, expert qualifications, ground truth establishment, adjudication methods, and MRMC/standalone studies are not applicable in this context.

Here's an explanation based on the provided document:

The 510(k) submission (K993894) for the Lifecore Single Tooth Abutment System is a premarket notification aiming to demonstrate substantial equivalence to legally marketed predicate devices. This regulatory pathway does not typically involve setting acceptance criteria and conducting studies to prove the device meets those criteria in the same way a de novo device would for establishing safety and effectiveness. Instead, it relies on demonstrating that the new device has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness compared to the predicate devices.

Here's what the document does provide relevant to your request:

• Type of Study Conducted: This was a nonclinical study focused on demonstrating dimensional compatibility and material properties. The document states:

  • "The Lifecore Single Tooth Abutment System has been tested to ensure that all design specifications have been met."
  • "Dimensional inspections are routinely performed."
  • "Electrochemical Corrosion Evaluation... has been performed..."
  • "To ensure the Lifecore Single Tooth Abutment System design is compatible with the Nobel Biocare CeraOne® Abutment System Ceramic and Gold Sleeves, the critical mating dimensions of the CeraOne abutment, ceramic, and gold sleeves were measured using a Mycrona Video Measuring Machine and micrometers."

• Implicit "Acceptance Criteria" (based on equivalence): While not explicitly stated as "acceptance criteria" for performance, the goal of the nonclinical tests was to show that:

  • Design specifications were met.
  • Corrosion properties were "within acceptable limits" when exposed to artificial saliva.
  • Dimensions were compatible with the predicate Nobel Biocare CeraOne® Abutment System Ceramic and Gold Sleeves, meaning the Lifecore system was designed to "match or to be within the dimensional ranges identified" from the predicate device.

• Data Provenance: The data is internally generated from Lifecore Biomedical, Inc. based on their testing, and it is "retrospective" in the sense that it's a submission for a new device based on existing technological understanding and comparison to already marketed devices. The country of origin of the data would be the USA (Lifecore Biomedical, Inc. is located in Chaska, MN, USA).

• Ground Truth: For the nonclinical tests, the "ground truth" was established by engineering specifications, material science standards, and measurements of the predicate device's dimensions.

Why the other points are not applicable:

• Table of acceptance criteria and reported device performance: Not provided because this isn't a performance study against specific clinical criteria.
• Sample size for test set and training set, data provenance (for clinical data): No clinical test set or training set for an AI/algorithm is described. The "test set" here refers to the physical components tested for dimensional compatibility and corrosion.
• Number of experts and qualifications, adjudication method: Not relevant as this is not a diagnostic device involving expert interpretation of results.
• MRMC comparative effectiveness study: Not conducted, as this is a dental implant component, not a diagnostic algorithm where human readers assess performance.
• Standalone (algorithm only) performance: Not applicable, as this is a physical medical device, not an algorithm.
• Type of ground truth (e.g., pathology, outcomes data): While real-world outcomes are the ultimate measure of clinical success for implants, for a 510(k) for an abutment, "ground truth" for the nonclinical tests is based on engineered specifications and comparison to predicate device characteristics.
• How ground truth for the training set was established: No training set in the context of AI/machine learning.

In summary, the provided document describes a 510(k) submission where substantial equivalence is demonstrated through nonclinical testing (dimensional compatibility, material characteristics) rather than clinical performance studies with predefined acceptance criteria for a novel therapeutic or diagnostic outcome.

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