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The 5.0 x 6.0mm locking-taper Bicon dental implant is intended to be surgically placed in the maxilla or mandible to provide support for prosthetic devices to restore the patient's chewing function.

The 5.0 x 6.0mm Dental Implant

I am sorry, but the provided text is a 510(k) clearance letter for a dental implant and does not contain the information requested regarding acceptance criteria, device performance studies, or details about AI algorithms. This document is a regulatory approval letter, not a technical study report.

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Synthograft is designed for:

• the filling and or reconstruction of either traumatic or degenerative multi-wall bone defects
• the augmentation of the sinus floor
• the augmentation of the alveolar ridges
• the augmentation of the alveblar hagos
• the filling of periodontal or other alveolar bone defects and tooth sockets and osteotomies
• the preservation of the alveolus for the preparation of an implant site.

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This document is a 510(k) substantial equivalence letter for a device named "Synthograft," a bone grafting material. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria, as it is a regulatory clearance document rather than a performance study report.

Therefore, I cannot provide a response filling in the requested information as the source text does not contain such details. The document primarily focuses on the FDA's determination of substantial equivalence to a predicate device and outlines regulatory conditions for marketing.

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The 4.5 x 6.0mm and the 6.0 x 6.0mm implants are designed for use in edentulous sites in the mandible or maxilla for support of a complete denture prosthesis, a terminal or intermediate abutment for fixed bridgework, partial dentures, or a single tooth replacement.

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This document is a 510(k) clearance letter for a dental implant. It does not contain information about acceptance criteria or a study proving device performance in the context of an AI/ML or diagnostic device.

Therefore, I cannot provide the requested information. The document focuses on regulatory approval and substantial equivalence to legally marketed predicate devices, not on performance metrics of the device itself beyond its stated indications for use.

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The Bicon Orthodontic Implant System is intended for those cases where a clinician desires to provide a fixed point of anchorage to which orthodontic appliances may be attached to orthodontically move teeth. The system consists of a small implant that is screwed into the jawbone that will be removed after completion of treatment.

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I am sorry, but this document contains a medical device approval letter from the FDA. It does not include information about acceptance criteria, study details, sample sizes, ground truth establishment, or expert qualifications for a device's performance. Therefore, I cannot fulfill your request based on the provided text.

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The Bicon implant is designed for use in edentulous sites in the mandible or maxilla for support of a completed denture prosthesis, a terminal or intermediate abutment for fixed bridgework, partial dentures, or a single tooth replacement.

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The provided text is a 510(k) clearance letter from the FDA for the Biconite Surface Treatment, a component of the Bicon implant system. This document is a regulatory clearance and does not contain information about acceptance criteria or a study proving device performance against such criteria.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent... to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..."

This means the device was cleared based on its substantial equivalence to an existing device, not through a study demonstrating its performance against specific acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, ground truth, and expert involvement is not present in this document.

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The 5.0 x 6.0mm Bicon dental implant is intended to be surgically placed in the maxilla or mandible to provide support for prosthetic devices to restore the patient's chewing function.

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I am sorry, but the provided text does not contain the detailed information necessary to answer your request regarding acceptance criteria and a study proving a device meets them. The document is a 510(k) clearance letter from the FDA for a dental implant.

It informs Dr. Vincent Morgan that their device, "The 5.0 x 6.0mm Dental Implant," has been found substantially equivalent to a legally marketed predicate device. This letter approves the marketing of the device, but it does not include the underlying study data, acceptance criteria, or performance metrics.

Specifically, the document does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for a test set.
3. Information on experts used to establish ground truth or their qualifications.
4. Adjudication methods.
5. Details about multi-reader multi-case (MRMC) comparative effectiveness studies or effect sizes.
6. Results of standalone algorithm performance.
7. The type of ground truth used.
8. Sample size for a training set.
9. How ground truth for a training set was established.

This FDA letter is a regulatory approval document based on a review of submitted information, not a publication of the study data itself.

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The BTI System will be used to provide immediate or interim stability for new/existing dental prosthetics in partially or fully edentulous jaws.

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The provided text is a Food and Drug Administration (FDA) 510(k) premarket notification letter for the Bicon Transitional Implant (BTI) System. It confirms that the device is substantially equivalent to legally marketed predicate devices.

However, the document does not contain specific information regarding:

• Acceptance criteria for device performance
• Details of any study (sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance) that proves the device meets acceptance criteria.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." This type of FDA clearance (510(k)) focuses on substantial equivalence to a predicate device rather than requiring extensive clinical trials or performance studies with detailed acceptance criteria as would be the case for a PMA (Premarket Approval Application) or De Novo classification for novel devices.

Therefore, I cannot provide the requested information from the given text.

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The 4.5mm diameter implants are designed for use in edentulous sites in the mandible or maxilla for support of a complete denture prosthesis, a terminal or intermediate abutment for fixed bridge work , partial dentures, and / or a single tooth replacement.

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It appears the provided text is a 510(k) clearance letter from the FDA for a dental implant system. This type of document does not typically contain the detailed technical study information required to answer your specific questions about acceptance criteria, device performance, and study methodologies for an AI/algorithm-based device.

The document grants clearance for a physical medical device (Bicon Dental Implants), not a software or AI-driven diagnostic tool. Therefore, information such as sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types for training/test sets, and training set information are not relevant to this specific FDA letter.

To answer your questions accurately, I would need a different type of document, such as a clinical study report, a technical performance report for a software device, or an FDA submission (PMA, De Novo, or 510(k)) specifically for a device involving AI or complex algorithms.

Based on the provided text, I cannot extract the information you've requested.

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The Bicon Bone Screws are indicated for those cases where a clinician desires to have a temporary prosthesis attached to bone.

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I am sorry, but the provided text is a 510(k) clearance letter for the "Bicon Bone Screw System" and an "Indications for Use" statement. This type of document from the FDA does not contain information about acceptance criteria for a device's performance, nor does it detail studies proving that the device meets such criteria.

The letter confirms that the device is substantially equivalent to legally marketed predicate devices, meaning it has met the regulatory requirements for market clearance, primarily based on demonstrating similarity to existing devices. It does not include performance metrics or study details in the way typically found in a clinical trial report or scientific publication.

Therefore, I cannot provide the requested information about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment based on the provided text.

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