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K Number
K024145
Device Name
AIGIS-XO
Manufacturer
SB LUCIUS, INC.
Date Cleared
2003-03-07

(81 days)

Product Code
EJT
Regulation Number
872.3060
Type
Traditional
Panel
DE
Reference & Predicate Devices
K960104
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

AIGIS-XO is intended for manufacturing

  • Inlay / Onlays -
  • Crowns -
  • Short span bridges "
  • Long span bridges -
  • Removable partials -
Device Description

AIGIS-XO is an inlay, onlay, crown and bridge alloy. This device is dependable 82% gold alloy with a high gold appearance. AIGIS-XO is excellent for inlays, three-quarter crowns, long and short-span bridges.

AI/ML Overview

The provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria in the context of a medical AI device.

Instead, the document is a 510(k) summary for a dental casting alloy named "AIGIS-XO," seeking market clearance as a Class II medical device. The 510(k) process is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving performance against specific acceptance criteria for AI algorithms.

Here's why the requested information cannot be extracted from this document:

  • Device Type: The device is "AIGIS-XO, Dental casting alloy" (a physical material), not an AI-powered diagnostic or assistive tool.
  • Study Type: The document describes a comparison of the new device (AIGIS-XO) to a predicate device (BIOCLUS 4) based on composition and physical/mechanical properties (e.g., melting point, hardness, yield strength, elongation, density), not performance metrics like sensitivity, specificity, or reader agreement that would be relevant for an AI study.
  • No AI Component: There is no mention of any AI algorithm, machine learning, deep learning, or digital imaging analysis.
  • No Human Reader Studies: Since it's a dental alloy, there are no human reader studies (MRMC or standalone) involved.
  • No Training/Test Sets: The concepts of training sets, test sets, ground truth established by experts, or adjudication methods are not applicable to the documentation of a dental alloy's properties.

Therefore, I cannot provide the requested table and study details as they pertain to AI device evaluation. The document focuses on demonstrating chemical and physical property similarities to an existing device to establish substantial equivalence.

§ 872.3060 Noble metal alloy.

(a)
Identification. A noble metal alloy is a device composed primarily of noble metals, such as gold, palladium, platinum, or silver, that is intended for use in the fabrication of cast or porcelain-fused-to-metal crown and bridge restorations.(b)
Classification. Class II (special controls). The special control for these devices is FDA's “Class II Special Controls Guidance Document: Dental Noble Metal Alloys.” The devices are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9. See § 872.1(e) for availability of guidance information.