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Intra-Lock® 15° Angled Abutments are intended for use with Intra-Lock® dental implants to support a prosthetic device in partially or fully edentulous patients. The abutments may be used in single and/or multiple tooth application in the mandible or maxilla.

The subject Intra-Lock® 15° Angled Abutment has a narrow prosthetic interface (SQ Platform) and therefore only mates with implants having SQ Platform. The SQ Platform abutments are anodized a magenta color.

The provided text describes the 510(k) summary for the Intra-Lock® 15° Angled Abutment, a dental device, and does not contain information about an AI/ML powered medical device. Therefore, I cannot extract the acceptance criteria and study details as requested for an AI/ML device.

The document focuses on:

• Device Identification: Name, common name, classification, and predicate devices.
• Intended Use/Indications: To support prosthetic devices with Intra-Lock® dental implants in partially or fully edentulous patients.
• Technological Characteristics: Narrow prosthetic interface (SQ Platform), magenta anodization.
• Mechanical Testing: Static and dynamic fatigue testing in accordance with ISO 14801:2007.
• Substantial Equivalence: Claim that the device is substantially equivalent to predicate devices based on design, materials, intended use, and operational principles, raising no new safety or effectiveness issues.

There is no mention of acceptance criteria related to algorithms, performance metrics like accuracy, sensitivity, specificity, or any studies involving AI/ML models, human readers, or ground truth establishment for such models.

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