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Intra-Lock® Implants have been designed to restore partially or fully edentulous patients. The implants have been designed to be used in either the mandible or the maxilla and to support removable or fixed prostheses, from single tooth replacement to full arch reconstruction. Intra-Lock® Implants are intended for immediate function on single tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore normal teeth functions.

The Intra-Lock® Dental Implants are titanium screw-type threaded root-form endosseous implants ranging in diameters from 3.75mm - 5.0mm and length from 8mm - 15mm. The implants in this submission include tapered and straight body implants with short and 2mm collars that have horizontal micro-threads and an internal connection to interface with the abutment.

The provided document is a 510(k) Summary for Intra-Lock® Dental Implants. It focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific performance criteria through a study with a test set, ground truth, or expert review.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, and training set ground truth cannot be extracted from this document.

The key phrases that indicate the nature of this submission are:

• "No new performance testing was conducted." This explicitly states that no new studies (clinical or non-clinical) were performed to establish performance metrics against acceptance criteria for this specific submission.
• "Mechanical bench testing of two previously identified Intra-Lock Dental Implant System worst-case scenario (i.e. smallest diameter implant / angled abutments), which remains applicable for the implants contained in this submission and was previously reviewed in K103194, April 21, 2011 and/or K111199, August 8, 2011." This indicates that any relevant performance testing was conducted for previous submissions (K103194, K111199) and is being referenced, not newly presented or detailed here.
• "Conclusion: Based on the data within this submission, the Intra-Lock dental implants are substantially equivalent to the predicate dental implants identified. The minor differences between proposed devices and the predicate devices raise no new issues of safety, risk to health or effectiveness." This reinforces that the goal is to demonstrate substantial equivalence, not to meet specific quantitative performance criteria through a new study.

In essence, this 510(k) submission relies on the established safety and effectiveness of its predicate devices and argues that the new device's differences do not introduce new risks, rather than providing new performance data against acceptance criteria.

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