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The Stern Micro ERA System is a resilient retention device for dental prosthesis, designed to be used in restoration of removable dentures.

Device consists of a series of nylon male attachments in six variable sizes to provide six levels of retention. The six levels of retention are color coded - white, orange, blue, gray, yellow, and red (in order of increasing degrees of retention). Variations in the degree of retention are incorporated to facilitate requirements of individual patients. It also includes a black processing (also referred to as fabricating) male that is not used in the mouth for retention of the finished denture, but only used as a tool to incorporate the final snap-in male into the finished dental appliance. A resin female is also incorporated in this system, along with stainless steel and titanium alloy instruments.

The provided document is a 510(k) summary for the Stern Micro ERA Attachment System, a dental device. It does not contain information about acceptance criteria or a study proving that the device meets such criteria.

Instead, this document is a regulatory submission for premarket notification, demonstrating substantial equivalence to a predicate device. It explicitly states: "This submission is a Special 510(k): Abbreviated 510(k) as described in FDA's guidance document entitled 'The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications.' In support of this 510(k), Sterngold has provided information to demonstrate conformity with FDA's guidance document entitled Premarket Notification 510(k): Regulatory Requirements for Medical Devices."

The conclusion further clarifies: "Based on the indications for use, technological characteristics, and comparison to predicate devices, the Stern Micro ERA System has been shown to be safe and effective for its intended use."

Therefore, I cannot provide the requested information. The document focuses on demonstrating substantial equivalence to a previously approved device (Stern ERA System – 510(k) No. K 913348) rather than presenting a performance study against specific acceptance criteria.

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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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The Lifecore Sustain and Restore Dental Implant Systems are intended for use in either partially or fully edentulous mandibles or maxillae in the following areas:

• Support of fixed (cemented) restorations utilizing multiple abutments; .
• Support of fixed detachable (screw retained) prosthetics utilizing multiple abutments; ●
• Overdenture retention by means of a ball overdenture attachment, o-ring attachment, dalla bona or hader bar;
• Terminal or interniedlate abutment support for fixed bridgework; .
• Free standing restorations without involvement of adjacent dentition.

The abutment is designed for use with an endosseous implant which is implanted in the lower or upper jaw. The abutment is used as an attachment solution to overdentures.

This document is a 510(k) summary for the Lifecore O-Ring Abutment and Lifecore Dalla Bona Abutment, overdenture abutments used with endosseous implants. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the way a modern AI/Software as a Medical Device submission would.

Based on the provided text, the device is a physical medical device (dental abutment) and the submission is a premarket notification (510(k)) seeking clearance for substantial equivalence to a predicate device. This type of submission relies on demonstrating that the new device has the same intended use and technological characteristics as a legally marketed predicate device, and does not raise new questions of safety and effectiveness.

Therefore, the specific information requested about acceptance criteria, study details, sample sizes, ground truth, and AI performance metrics is not available in the provided document.

However, I can extract what is explicitly stated about the basis for market clearance, which effectively serves as the "proof" for this type of medical device submission:

1. Table of Acceptance Criteria and Reported Device Performance
This document does not specify formal, quantitative acceptance criteria or detailed performance metrics in the way a software or diagnostic device would.
Instead, the "acceptance criteria" for a 510(k) in this context are based on demonstrating "substantial equivalence."

2. Sample Size used for the test set and the data provenance: Not applicable. This submission is based on demonstrating substantial equivalence to a predicate device through description of technological characteristics, not on a clinical "test set" in the context of performance evaluation.

3. Number of experts used to establish the ground truth for the test set and qualifications: Not applicable. Ground truth as typically understood for diagnostic or AI devices is not part of this 510(k) submission for a physical implant accessory.

4. Adjudication method for the test set: Not applicable.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, this is not an MRMC study. It is a 510(k) submission for a physical device, not an AI or diagnostic tool requiring such a study.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm or software device.

7. The type of ground truth used: Not applicable in the context of clinical performance data. The "ground truth" for this submission is the established safety and effectiveness of the predicate device(s) through their prior market clearance and historical use.

8. The sample size for the training set: Not applicable. This is not a machine learning or AI device.

9. How the ground truth for the training set was established: Not applicable.

In summary: The provided text is a standard 510(k) summary for a physical medical device (dental abutments). It seeks market clearance by demonstrating substantial equivalence to already cleared predicate devices. The "study" proving the device meets the (implicit) acceptance criteria is the comparison of its technological characteristics and intended use to those of legally marketed predicate devices, and the conclusion that no new questions of safety or effectiveness are raised. There are no performance data, clinical trials, or AI-related metrics discussed because the device, and the regulatory pathway chosen, do not require them.

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Implant systems are for use in single tooth, partially edentulous, completely edentulous, mandibles and maxillae as a support or attachment for prosthetic restoration. The restoration can be detachable (screw relained) prosthetics in multiple, free standing or terminal restorations.

The conical abutment is designed for use with an endosseous implant which is implanted in the lower or upper jaw. The conical abutment provides a base for the restorative crown or bridgework.

The provided text is a 510(k) Summary for a medical device called "Lifecore Conical Abutment." This document focuses on demonstrating substantial equivalence to previously cleared devices rather than providing detailed acceptance criteria and study results for device performance in the way a clinical study report would.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment cannot be extracted from this document, as it is not present. The summary states:

• "The technological characteristics of the modified version of the conical abutment and the earlier versions are identical. The titanium used in both devices is the same. Manufacturing processes are also the same as is general shape and structure. Therefore, no new types of technology and no new technological questions are involved."

This statement indicates that the submission is based on the premise that the new device is essentially the same as a previously cleared version, and thus does not require new performance studies with specific acceptance criteria that would typically be detailed in a clinical trial report.

To provide the requested information, a document describing a de novo approval process or a clinical study for a novel device would be necessary.

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