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The intended use of the Replace HA Coated Implants is for restoring chewing function by serving as anchorage for dental restorations. The Replace HA Coated Implant is both for single-stage or two-stage surgical procedures and cement or screw retained restorations. The Replace HA Coated Implant is intended for immediate placement and function on single tooth and/or multiple tooth applications in good quality bone (type I or type II bone), to restore chewing function. Multiple tooth applications may be splinted with a bar.

The Replace™ HA Coated Implant is to serve as a support for prosthetic devices to restore a patient's chewing function. The available diameters are 3.5 mm, 4.3 mm, 5.0 mm and 6.0 mm with lengths of 10 mm, 13 mm, and 16 mm. The titanium alloy implant has an HA coating on the root form portion to within approximately 2 mm of the top.

The provided text describes a 510(k) summary for the Replace™ HA Coated Implant by Nobel Biocare USA, Inc. The document focuses on establishing substantial equivalence for an expanded Indications for Use of an already marketed device, rather than introducing a completely new device or new technology. Therefore, the information regarding acceptance criteria and a detailed study proving the device meets those criteria, as typically seen in efficacy studies for novel devices, is not present in this submission.

Here's a breakdown of the available information in relation to your request, highlighting what is present and what is not:

• Acceptance Criteria and Reported Device Performance: This section is not applicable in the traditional sense of a clinical performance study with predefined primary and secondary endpoints. The submission is for an expanded indication of an existing device.

  • Acceptance Criteria: No specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy targets) are stated. The "acceptance criterion" in this context is the FDA's determination of substantial equivalence, meaning the expanded indications are "as safe and effective as the original Indications for Use."
  • Reported Device Performance: The document states, "Clinical results show that the expanded Indications for Use is as safe and effective as the original Indications for Use." No specific performance metrics (e.g., success rates, complication rates) are provided in this summary.

• Sample Size, Ground Truth, and Adjudication for Test Set: This information is not provided in the 510(k) summary. A 510(k) summary for an expanded indication, particularly for a device like a dental implant, often relies on existing clinical data from the predicate device and potentially post-market surveillance data, rather than a new, dedicated, prospective clinical trial with a specific test set.

• MRMC Comparative Effectiveness Study: An MRMC study is not applicable here as this is a physical medical device (dental implant), not an AI/software-based diagnostic tool.

• Standalone Performance: Not applicable for a physical medical device.

• Type of Ground Truth Used: The term "ground truth" is not explicitly used or defined in the context of this submission. The "clinical results" mentioned imply a reliance on real-world outcomes associated with the predicate device and potentially additional clinical observations supporting the expanded indications.

• Sample Size for Training Set: Not applicable in the context of a 510(k) for a physical medical device's expanded indications.

• How Ground Truth for Training Set Was Established: Not applicable.

Summary of available information as per your request:

In conclusion, this 510(k) summary focuses on demonstrating that an expanded indication for an existing dental implant is as safe and effective as the original indication, relying on existing "clinical results" rather than a new, detailed clinical study with specific acceptance criteria and performance metrics for a novel technology.

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