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The SM® Implant System is an endosseous dental implant is indicated for surgical placement in the upper and lower jaw arches, to provide a root form means for single or multiple units' prosthetic appliance attachment to restore a patient's chewing function. Implants can be placed with a conventional two stage surgical process with an option for transmucosal healing or they can be placed in a single stage surgical process for immediate loading. Immediate loading is restricted to the anterior mandible, based on four splinted interforminal placed implants, and not indicated for single, unsplinted implants.

The SM Implant System is a root-form threaded dental implant made of Grade 4 titanium. The implant is produced by machining process, followed by grit blasting and cleaning. It is available in diameters 3.8, 4.5, and 5.3 mm, and lengths from 8mm to 14 mm. It is placed via one or two stage surgery and the functional loading can be from immediate to delay.

The provided text describes a 510(k) premarket notification for the "SM Implant Systems" (K061797), an endosseous dental implant. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed clinical study data with specific acceptance criteria and performance metrics typically found in efficacy studies for novel devices.

Therefore, the input document does not contain the information requested in points 1, 2, 3, 4, 5, 6, 7, 8, and 9. The document explicitly states that "Laboratory testing was conducted to determine device functionality and conformance to design input requirements" (Section 13-8. Performance), but it does not elaborate on the specific acceptance criteria, study design, sample sizes, ground truth establishment, or expert involvement for device performance.

The 510(k) summary (and the FDA's response letter) confirms that the device is "substantially equivalent" to predicate devices, meaning it has the same intended use and technological characteristics as a device already on the market, or if there are differences, those differences do not raise new questions of safety and effectiveness.

Based on the provided text, I cannot complete the table or answer the specific questions related to acceptance criteria and a study proving those criteria were met.

Summary of what is possible to extract from the provided text:

• Device Name: SM Implant Systems
• Classification Name: Endosseous Dental Implant System
• Predicate Device: ANKYLOS® DENTAL IMPLANT SYSTEM (K012087)
• Performance information: "Laboratory testing was conducted to determine device functionality and conformance to design input requirements." (No details provided)
• Type of Study (implied by 510(k)): Substantial equivalence determination based on comparison to a predicate device, supported by laboratory testing for functionality and conformance to design requirements. This is not a clinical efficacy study with acceptance criteria as requested in the prompt.

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