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Spectra-System Dental Implants 2008 are comprised of dental implant fixtures and prosthetic devices that compose a two-piece implant system. The implants are intended for use in the mandible and maxilla, in support of single unit or multiple unit cement or screw-receiving restorations and for the retention and support of overdentures. The implants are intended for immediate placement and function for the support of singletooth or multiple-tooth restorations, recognizing bone stability and appropriate occusal load requirements.

The Spectra-System Dental Implants 2008 system consists of implants, abutments, healing components, and screws for use in one or two-stage placement and restorations.

The provided text is a 510(k) summary for the Spectra-System Dental Implants 2008. This document outlines the device description, intended use, and comparison to predicate devices for regulatory approval. It does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement.

Therefore, I cannot provide the requested information. The text is a regulatory submission for a dental implant, focusing on demonstrating substantial equivalence to previously approved devices, rather than presenting a detailed study of its performance against specific acceptance criteria.

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Spectra-System Abutments are designed to be used in support of a dental implant(s) to provide support for prosthetic restorations such as crowns, bridges, overdentures or custom prosthetic fabrications in a partially or completely edentulous patient. Spectra-System Abutments are intended for use in the mandible or maxilla. Prostheses can be screw or cement retained to the abutment.

Spectra-System Abutments 2008 consist of a number abutment used in conjunction with dental implants for provisional, permanent or laboratory fabrication of a final dental prosthesis. The system includes Non-Engaging Titanium Temporary Abutments, Angled Screw-Receiving Abutments, Narrow ("N" Series) Abutments, Non-Engaging Plastic Abutments, Non-Engaging Gold Abutments and related components.

The provided text is a 510(k) summary for the "Spectra-System Abutments 2008" and a corresponding FDA clearance letter. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving a device meets specific acceptance criteria through a study with the detailed categories you've provided (e.g., sample size, expert ground truth, MRMC study, etc.).

Therefore, I cannot extract the information you requested because it is not present in the provided document. The document describes the device, its intended use, and compares it to predicate devices to establish substantial equivalence based on physical dimensions, material composition, indications for use, and manufacturing methods, rather than clinical performance metrics from a study as described in your prompt.

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The Spectra Dental Implant System consists of one-piece implants for single-stage or twostage surgical procedures that are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework. They may be placed in immediate function if initial implant stability can be established.

The ScrewDirect 3.0mm implant is indicated for:

1. An artificial root structure for single tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors.
2. Multiple tooth replacements or denture stabilization.

The Screw Redirect implant is intended for support and retention of fixed single tooth and fixed partial denture restorations in the premolar, cuspid, and incisor regions of the partially edentulous maxillary jaw. It is indicated for immediate functional loading when four or more implants are splinted together in the endentulous upper or lower jaw.

The Screw Indirect implant is indicated for the support and retention of bar overdentures or as a terminal or intermediary attachment for screw-retained fixed bridgework. It is indicated for immediate functional loading when four or more implants are splinted together in the edentulous upper or lower jaw. This implant model is not indicated for use with abutments, only with a 2mm extender.

Spectra-System is substantially equivalent to the predicate devices; has comparable technological characteristics, identical intended use and are similar in terms of material, size, and basic design features. The overall implant product designs of the Spectra System are similar to the predicate devices.

The provided text is a 510(k) summary for the Spectra-System dental implants. This type of submission focuses on demonstrating substantial equivalence to previously cleared devices rather than proving safety and effectiveness through clinical trials with specific acceptance criteria. Therefore, much of the requested information regarding acceptance criteria, study details, and performance metrics for a novel medical device is not applicable or cannot be extracted from this document.

However, I can provide information based on the comparison analysis presented to demonstrate substantial equivalence to predicate devices.

Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission based on substantial equivalence, there are no explicit "acceptance criteria" in the sense of predefined performance thresholds for a clinical study. Instead, the device's performance is demonstrated by its comparable technological characteristics to predicate devices. The "reported device performance" is essentially the alignment of the Spectra-System's features with those of the predicate devices.

The acceptance criteria here are implicitly:

1. Identical Intended Use: The Spectra-System must have the same intended use as the predicate devices.
2. Similar Technological Characteristics: The Spectra-System must be similar in terms of material, size, and basic design features to the predicate devices.

Here's a summary of the comparison analysis that serves as the "reported device performance" in this context:

• General Design: All are threaded, root form implants.
• Placement Method: Predominantly two or single-stage surgery, aligning with predicates.
• Material: Primarily Titanium alloy, identical or comparable to CP4 Titanium or commercially pure titanium of predicates.
• Implant Body Type: Threaded body, often with micro-threads at the collar section, similar to predicates (some predicates have smooth collars or grooves).
• Body Diameter: Ranges (e.g., 3.0mm to 6.0mm) are comparable to or overlap with predicate devices.
• Lengths: Ranges (e.g., 8mm to 19mm) are comparable to or overlap with predicate devices.
• Platform Diameter: Ranges are generally comparable.
• Implant Surface: Roughened (HA blasted) or plasma HA coated, comparable to predicate devices which use HA coated, roughened, or micro-roughened surfaces.
• Packaging: Inner sleeve/vial system with components (carrier, cover screw, extender, coping), consistent with predicate packaging (double vial, carrier-based).
• Sterilization: Gamma irradiation, consistent with predicate devices. |

1. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. This is a 510(k) based on substantial equivalence to predicate devices, not on a clinical "test set" with patient data. No clinical studies are presented in this summary document with sample sizes or data provenance.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. There was no clinical "test set" requiring ground truth establishment by experts.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. There was no clinical "test set" requiring adjudication.

4. 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

Not applicable. This document pertains to dental implants, not an AI-assisted diagnostic or imaging device. No MRMC study was conducted or presented.

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

Not applicable. This document pertains to dental implants, not a standalone algorithm.

6. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Not applicable. The "ground truth" in this context is the regulatory clearance status and established technological characteristics of the predicate devices, against which the new device is compared.

7. The sample size for the training set

Not applicable. There was no "training set" as this is not a machine learning or AI device submission.

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

Not applicable.

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