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Atlas Implant Systems are designed for use in dental implant surgery. They are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including, cement retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. They are not intended for use of immediate loading.

The Atlas Implant System includes a variety of precision-machined fixtures manufactured from titanium. These implants are surgically inserted into the upper and/or lower jawbone and serve as a replacement for a patient's tooth root providing a stable foundation for restorations.

The provided document, K071148, is a 510(k) Pre-market Notification for the Atlas Implant System. This type of submission focuses on proving substantial equivalence to a predicate device rather than undergoing a de novo clinical trial with comprehensive acceptance criteria and detailed performance studies typical of AI/software medical devices.

Therefore, the document does not contain the information requested regarding acceptance criteria related to device performance in the context of an AI/software medical device.

Specifically, the document states:

• 14-8. Performance: "Laboratory testing was conducted to determine device functionality and conformance to design input requirements." This refers to mechanical and material testing of a physical implant, not a software algorithm's performance.
• No mention of sample sizes for test sets, data provenance, number or qualifications of experts, adjudication methods, MRMC studies, standalone performance, type of ground truth, or training set details.

The document discusses substantial equivalence for a dental implant, comparing its physical and material characteristics (e.g., material, design, dimensions, surface treatment) to a predicate device (ALLFIM IMPLANT SYSTEM K050635). The "acceptance criteria" for a 510(k) for a physical implant like this are primarily about demonstrating that it is as safe and effective as a legally marketed predicate device, typically through bench testing and comparison of technical specifications, not through clinical performance metrics against a defined ground truth.

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