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The implants are intended for both one- and two-stage surgical procedures in the following situations and with the following clinical protocols:

• · Replacing missing teeth in single or multiple unit applications in the mandible or maxilla.
• · Immediate placement in extraction sites and in situations with a partially or completely healed alveolar ridge.
• · Especially indicated for use in soft bone applications with other implant surface treatments may be less effective.
  • Immediate and early loading for all indications, except in single tooth situations on implant shorter than 8 mm or in soft bone (type 4) where implant stability may be difficult to obtain, and immediate loading may not be appropriate.
  · The intended use for PrimeTaper EV Ø3.0 is limited to replacement of maxillary lateral incisors and mandibular incisors.

DS Implants abutments provided with the EV connection are intended to be used in conjunction with implants with the EV connection in fully edentulous or partially edentulous maxillary and/or mandibular arches to provide support for crowns, bridges or overdentures.

MultiBase Abutments EV:
DS Implants abutments provided with the EV connection are intended to be used in conjunction with implants with the EV connection in fully edentulous or partially edentulous maxillary and/or mandibular arches to provide support for bridges or overdentures.

The proposed (A) PrimeTaper EV Dental Implant Ø3.0 is a root form endosseous implant which is intended for use by a dental clinician in the prosthetic restoration of chewing function in edentulous human jaws. It represents an additional extra small implant diameter implant) to reference device PrimeTaper EV Dental Implants (K210610).

The proposed (A) PrimeTaper EV Dental Implant Ø3.0 has the identical implant-abutment connection geometry as the predicate (A) Astra Tech EV Implant (K120414), and is therefore compatible with the reference device Astra Tech EV Abutments (K120414) with 3.0 mm diameter of the Astra Tech Implant System EV (K120414).

The proposed (B) DS Implant abutments with EV connection XS include the following abutments and accessories:

• TiDesign EV (XS) ●
• MultiBase Abutment EV (XS) ●
• . TempAbutment EV (XS)
• Healing Abutment EV (XS) ●
• HealDesign EV (XS) ●
• Cover Screw EV (XS)
• Abutment Screw EV (XS) ●

The proposed (B) DS Implants abutments with EV connection XS are used in conjunction with an endosseous dental implant with EV connection to aid in prosthetic rehabilitation in fully edentulous or partially edentulous maxillary and/or mandibular arches. They are prosthetic abutments compatible with the proposed (A) PrimeTaper EV Dental Implant Ø3.0 and represent an additional extra small abutment-implant diameter (XS, 3 mm diameter) to the Predicate (B) DS Implants abutments with EV Connection in sizes S (small), M (medium) and L (large) (K213449).

The proposed (B) abutments have the identical implant-abutment connection geometry as the reference device Astra Tech EV Abutments (K120414) and are therefore compatible with the predicate (A) Astra Tech EV Implants (K120414) with 3.0 mm diameter.

The proposed (A) PrimeTaper EV Dental Implant Ø3.0 and proposed (B) DS Implants abutments with EV connection XS are single-use devices and are provided sterile by electron-beam irradiation except for TiDesign EV (XS). TempAbutment EV (XS) and Abutment Screw (XS), which are provided non-sterile. Devices provided as non-sterilized by the end user via steam sterilization.

The document provided is a 510(k) summary for Dentsply Sirona's PrimeTaper EV Dental Implants Ø3.0 and DS Implants abutments with EV connection (XS). It describes the devices, their intended use, and substantial equivalence to predicate and reference devices based on non-clinical performance data and published literature.

Here's a breakdown of the requested information:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in a quantitative manner with specific thresholds. Instead, it relies on demonstrating that the proposed devices (PrimeTaper EV Dental Implants Ø3.0 and DS Implants abutments with EV connection XS) are substantially equivalent to legally marketed predicate devices. The performance is assessed by confirming that the proposed devices satisfactorily meet the requirements of non-clinical bench testing and aligning with published clinical data on similar devices.

However, based on the non-clinical testing performed, we can infer performance criteria against established standards:

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

• Non-clinical Testing (Bench Tests): The document refers to "worst-case implant-abutment combination" for fatigue testing but does not specify the exact number of samples tested for each non-clinical performance test (e.g., fatigue, biocompatibility, sterilization validation, MRI). It is implied that sufficient samples were tested to meet the requirements of the respective ISO and ASTM standards.
• Clinical Literature:
  • Sample Size: 200 narrow diameter implants (OsseoSpeed 3.0 mm, Astra Tech Implant System (K080396)) were evaluated. These implants were placed in "over 160 patients."
  • Data Provenance: The data is from "six peer-reviewed scientific publications" presenting "1 to 5 years of clinical follow-up data from four (4) different clinical trials." The country of origin is not specified but it relates to published peer-reviewed scientific literature. The studies were prospectively followed up.

3. 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)

This section is not applicable to this submission. The "ground truth" in this context is established through compliance with recognized international standards (ISO, ASTM) for non-clinical testing and clinical outcomes reported in peer-reviewed literature, rather than expert adjudication of a test set in the way one might see for an AI algorithm.

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

Not applicable. This is not an AI/imaging device where expert adjudication for ground truth establishment is typically performed.

5. 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 submission is for dental implants and abutments, not an AI-assisted diagnostic or therapeutic device.

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

Not applicable. This is not an AI/algorithm-based device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Non-clinical Testing: The "ground truth" for non-clinical performance (sterilization, biocompatibility, fatigue, MRI safety, pyrogenicity, packaging) is defined by established international standards (ISO, ASTM) and FDA guidance documents. The device's performance is measured against these technical standards.
• Clinical Performance (via literature): The "ground truth" is based on outcomes data (survival rates, marginal bone maintenance) reported in peer-reviewed clinical literature.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set.

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

Not applicable. This is not an AI/machine learning device.

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The Tatum Surgical Integrity Tapered, "T" and "S" Dental Implant Systems are intended to be surgically placed in the bone of the upper or lower jaw to provide support for removable or fixed prothesis to restore chewing function. It may be used with single-stage or two- stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading.

The Tatum Surgical Dental "P" Plateau Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for removable or fixed prosthesis to restore chewing function. It may be used for single or multiple unit restorations and is indicated for delayed loading, placed with conventional two-stage surgical process with secondary and transmucosal healing.

The Tatum Surgical One-Piece Dental Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for removable or fixed prosthesis to restore chewing function. It may be used for single or multiple unt restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. The 3.0 mm diameter Tatum Surgical One-Piece Implant must be splinted if two or more are used adjacent to each other.

The subject device includes three (3) two-piece implant systems that have connections and prosthetic components in multiple designs unique to each system, including straight and angled abutments intended for single-unit and multiple-unit restorations. The subject device also includes one (1) one-piece implant system, in which the abutment portion is integral with the implant portion.

This document describes the Tatum Surgical Dental Implant System, a Class II medical device, and its substantial equivalence to previously cleared predicate devices. It focuses on the technical specifications and performance data rather than diagnostic or AI-assisted performance for an acceptance criterion.

Therefore, the requested information regarding acceptance criteria and studies proving the device meets them, particularly concerning human reader improvement with AI assistance, standalone algorithm performance, number of experts for ground truth, sample sizes for training and test sets, and data provenance, cannot be extracted from this document.

The document details the following technical and performance aspects:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not present acceptance criteria in a quantitative table format with corresponding reported device performance, as would be typical for an AI/diagnostic device. Instead, it provides:

• Indications for Use (IFU) Statement Comparison: (Pages 9-10) This section compares the IFU of the subject device (Tatum Surgical Dental Implant System) against several predicate devices (e.g., Neodent Implant System, Blue Sky Bio Dental Implant System, MIS Internal Hex Dental Implant System). The acceptance criterion implicitly is "substantial equivalence" of the IFU. The reported performance is that "The IFUS for the subject device is substantially equivalent to that of the primary predicate K133510 and the additional predicate devices."

• Technological Characteristics Comparison: (Pages 11-15) This extensive table compares various features of the subject device (Tatum Surgical Dental Implant System) across its different implant lines (Integrity Tapered, "T" and "S" Implants, "P" Plateau Implant System, One-Piece Implant System) with numerous predicate devices. The features compared include:

  • Product Code
  • Implant Placement (Bone Level, Tissue Level)
  • Prosthetic Interface Connection (Internal pentagon, Internal hex, Morse taper)
  • Body/Platform Diameter (mm)
  • Total Lengths (mm)
  • Endosseous Length (mm)
  • Apical Hole (Yes/No)
  • Implant Material (Titanium alloy (Ti6Al-4V), CP Titanium, Gr.4, Titanium TI-6Al-4V ELI, Zirconia)
  • Implant Endosseous Surface (Aluminum oxide blasted and passivated, Grit blasted and acid etched, Blasted with resorbable medium, etched, Sand blasted and acid etched, MTX Blasted, Sand-blasted, Large grit, Acid-etched (SLA), Roughened - blasted and acid Etched, Blasted and clean, None)
  • Healing Components (Coronal Ø, Gingival Height, Connection, Material)
  • Abutments (Coronal Ø, Gingival Height, Angulation, Connection, Material)
  • Ball Abutments (Coronal Ø, Gingival Height, Connection, Material)
  • Abutment Type (Straight)
  • Sterility
  • Usage (Single patient, single-use)

  The reported device performance for these features is stated directly in the table, demonstrating the similarities or minor differences to the predicate devices, thereby supporting the claim of substantial equivalence.

2. Sample size used for the test set and the data provenance:

• This information is not provided in the document. The document describes a medical device (dental implants) and its substantial equivalence based on material properties, design, and mechanical testing, not a diagnostic algorithm or AI.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• This information is not applicable and not provided as this document does not concern a diagnostic device requiring expert-established ground truth.

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

• This information is not applicable and not provided.

5. 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:

• This information is not applicable and not provided.

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

• This information is not applicable and not provided.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• This information is not applicable and not provided. The ground for this device's acceptance is based on demonstrating substantial equivalence to predicate devices through technical characteristics and mechanical performance testing, not through diagnostic accuracy against a ground truth.

8. The sample size for the training set:

• This information is not provided. The acceptance of this device is based on "substantial equivalence" to existing cleared devices, supported by performance testing (mechanical, surface analysis, sterilization, shelf-life, biocompatibility), rather than a machine learning training and test set paradigm.

9. How the ground truth for the training set was established:

• This information is not applicable and not provided as there is no mention of a training set or ground truth in the context of an AI/diagnostic device.

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NobelProcera Zirconia Implant Bridge (previously cleared per K202452) The NobelProcera® Zirconia Implant Bridge are indicated for use as a bridge anatomically shaped and/or framework in the treatment of partially edentulous jaws for the purpose of restoring chewing function.

TiUltra Implants and Xeal Abutments (previously cleared per K202344) NobelActive TiUltra NobelActive TiUltra implants are endosseous implants intended to be surgically placed in the upper or lower jaw bone for anchoring or supporting tooth replacements to restore patient esthetics and chewing function. Nobel Active Tilltra implants are indicated for single or multiple unit restorations in splinted applications. This can be achieved by a 2-stage or 1-stage surgical technique in combination with immediate, early or delayed loading protocols, recognizing sufficient primary stability and appropriate occlusal loading for the selected technique. NobelActive TiUltra 3.0 implants are intended to replace a lateral incisor in the maxilla and/or a central incisor in the mandible. Nobel Active TiUltra 3.0 implants are indicated for single-unit restorations only. NobelReplace CC TiUltra NobelReplace CC TiUltra implants are endosseous dental implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. The NobelReplace CC TiUltra implants are indicated for single or multiple unit restorations. The NobelReplace CC Tilltra implants can be used in splinted or non-splications. The NobelReplace CC TiUltra implant may be placed immediately and put into immediate function provided that initial stability requirements detailed in the manual are satisfied. NobelParallel CC TiUltra NobelParallel CC TiUltra implants are endosseous implants intended to be surgically placed in the upper or lower jaw bone for anchoring or supporting replacements to restore patient esthetics and chewing function. NobelParallel CC TiUltra implants are indicated for single or multiple restorations in splinted applications. This can be achieved by a 2-stage or 1-stage surgical techniques in combination with immediate, early of delayed loading protocols, recognizing sufficient primary stability and appropriate occlusal loading for the selected technique. Implants with

Not Found

This document is a 510(k) premarket notification decision letter from the FDA to Nobel Biocare AG regarding their Dental Implant Systems Portfolio - MR Conditional. It explicitly states that the letter covers indications for use and general controls, but does not contain information about acceptance criteria or performance studies for the device itself.

Therefore, I cannot provide the requested information for the following reasons:

1. Acceptance Criteria and Performance Data: The document is a regulatory clearance letter, not a clinical study report. It does not contain acceptance criteria for device performance, nor does it present any data from studies proving the device meets particular criteria. The letter confirms substantial equivalence to legally marketed predicate devices, which means the FDA has determined the device is as safe and effective as a previously cleared device, not that specific performance metrics were tested and met in a new study.
2. Study Details (Sample size, data provenance, experts, adjudication, MRMC, Standalone, Ground Truth, Training Set): Since no performance study data is included in this FDA 510(k) clearance letter, none of these details can be extracted. The document refers to various previously cleared predicate devices (e.g., K202452, K202344, K181869), but it doesn't describe the studies that led to their clearance.

In summary, the provided text does not contain the information necessary to describe acceptance criteria or a study proving the device meets those criteria.

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