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The IBS Implant System is intended to replace missing teeth to restore chewing function. The IBS Implant can be placed in support of single or multiple-unit restorations including; cement retained, or overdenture restorations, and terminal or immediate abutunent support for fixed bridgework. This system is for one or two stage surgical procedures and not for immediate loading. This system is intended for delayed loading.

The IBS Implant System consists of dental implants, abutments, and screws for use in one or two-stage dental implant placement and restorations. The implant-abutment connection is tight and precise fitting with internal hex and Morse taper bevel. The surface of the system has been treated with RBM (Resorbable Blasted media). This submission is to add implants and abutments to the previously cleared device, IBS Implant System (K153350).

The provided document is a 510(k) Premarket Notification from the U.S. FDA, which focuses on demonstrating substantial equivalence of a new device (IBS Implant System) to existing predicate devices. It does NOT describe a study that proves the device meets predefined acceptance criteria for AI/ML performance.

Instead, the document primarily discusses:

• The Indications for Use for the IBS Implant System (dental implants).
• A detailed comparison of the subject device with predicate devices, highlighting similarities and differences in design, materials, dimensions, and manufacturing processes.
• The non-clinical data leveraged from predicate devices (e.g., sterilization validation, biocompatibility, fatigue testing) to support the substantial equivalence claim for the new components being added.

Therefore, I cannot fulfill your request as it pertains to acceptance criteria and performance studies for an AI/ML powered medical device. The provided document is for a traditional dental implant system and does not involve AI/ML.

To answer your question meaningfully, I would need a document related to an AI/ML medical device submission.

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AR N Type Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. AR N Type Implant System is for two stage surgical procedures. It is intended for delayed load.

The AR_N Type Implant System is a dental implant system made of CP TiGr 4 per ASTM F67, intended to be surgically placed in the bone of the upper or lower jaw arches for loading after a conventional healing period. The implants may be used to replace one or more missing teeth. The surface of the implants has been treated with RBM (Resorbable Blast Media). Each product line includes corresponding abutments in multiple designs (Cover Screws, Healing Abutments, Angled Abutments, Cemented Abutments (Hex, Non-hex), and Solid Abutments) for restorations. Small diameter implants and angled abutments are not recommended for the posterior region. They are made of Titanium Grade 4 / ASTM F67, and provided as non-sterile.

The document provided is a 510(k) summary for a medical device called "AR N Type Implant System." It details the device's characteristics and its substantial equivalence to a predicate device. However, it does not contain specific acceptance criteria, reported device performance metrics against those criteria, or the details of a study setup as requested in the prompt (e.g., sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC study results).

The document rather states that non-clinical tests were performed to evaluate the device's performance and establish substantial equivalence to the predicate device, but it does not provide the specific numerical acceptance criteria or the precise results obtained from those tests in a table format. It broadly states that "The result of the above tests have met the standard, and proved the substantial equivalence with the predicate device."

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance or details about the ground truth, sample sizes, expert qualifications, or adjudication methods for a study proving the device meets acceptance criteria, as this information is not present in the provided text.

Based on the available text, here is what can be extracted regarding the types of tests performed to demonstrate performance for substantial equivalence:

Types of Non-Clinical Tests Performed (Not acceptance criteria or performance numbers):

• Sterilization Validation:
  • For sterile devices (fixtures): In accordance with ISO 11137, ISO 11737-1 & ISO 11737-2 for gamma sterilization.
  • For non-sterile devices (abutments): In accordance with ANSI/AAMI ST79 for steam sterilization.
• Surface Characteristics Test:
  • Chemical and SEM image analyses to verify no residual after RBM treatment on fixtures.
• Comparative Fatigue Testing:
  • Performed in accordance with ISO 14801:2007.
• Biocompatibility Testing:
  • Cytotoxicity Test: Performed according to ISO 10993-5:2009.
  • Sensitization Test: Performed according to ISO 10993-10:2010.

The document concludes that "Those tests have been performed to evaluate the substantial equivalence in the surface characteristics compared to the predicate device. The result of the above tests have met the standard, and proved the substantial equivalence with the predicate device." However, no specific numerical acceptance criteria or quantitative performance data are presented in the document itself.

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