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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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