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The Rescue Internal Implant System is intended to be surgically placed in the maxillary or mandibular molar areas for the purpose providing prosthetic support for dental restorations (Crown, These implants are bridges, and overdentures) in partially or fully edentulous individuals. These implants can be used where smaller implants have failed.

Rescue Internal Implant System consists of machined titanium, screw-form, root-form endosseous dental implants. It is intended to be surgically placed in the maxillary or mandibular molar areas for the purpose of providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. These implants can be used where smaller implants have failed.

Rescue Internal Implant System is an integrated system of endosseous dental implants which designed to support prosthetic devices for partially or fully edentulous patients. Rescue Internal Implant Fixture Systems consist of two-stage, root-form dental implants, associated with abutment systems, and the instruments.

This document is a 510(k) Premarket Notification Summary for the Rescue Internal Implant System, which is a dental implant device. It does not contain information about acceptance criteria or a study proving the device meets performance criteria in the way a medical device utilizing an algorithm or AI would.

The document primarily focuses on establishing "substantial equivalence" of the new Rescue Internal Implant System components to previously cleared predicate devices (Rescue Internal Implant System K063216 and BIOCON Dental Implants K010185 and K050712). Substantial equivalence in this context means that the device is as safe and effective as a legally marketed device.

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

• Type of Device: This is a physical, endosseous dental implant system, not a software or AI-driven diagnostic or treatment device. The performance of such devices is typically assessed through aspects like material biocompatibility, mechanical strength, and clinical outcomes over time, rather than metrics like sensitivity, specificity, or predictive accuracy.
• Regulatory Pathway: A 510(k) submission primarily demonstrates substantial equivalence to a predicate device. It doesn't typically require a clinical study demonstrating performance against specific acceptance criteria for algorithm performance.
• Lack of Performance Data: The document states, "FDA has not established a performance standard applicable to endosseous implants. The materials in the Rescue Internal Implant System meet applicable standards." This indicates that the regulatory pathway for this physical device does not require a study with performance metrics as would be expected for a device using an algorithm. The "standards" referred to are likely material and manufacturing standards, not performance metrics related to diagnostic accuracy.

Therefore, I cannot provide the requested information because the provided text describes a physical medical device (dental implant) approved through the 510(k) pathway by demonstrating substantial equivalence, and not a device that would typically have acceptance criteria and a study design focused on algorithm performance, such as sensitivity/specificity, sample sizes for test/training sets, expert ground truth, or MRMC studies.

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The Rescue Internal Implant System is intended to be surgically placed in the maxillary or mandibular molar areas for the purpose providing prosthetic support for dental restorations (Crown, bridges, and overdentures) in partially or fully edentulous individuals. These implants are intended to be used where smaller implants have failed.

Rescue Internal Implant System is an integrated system of endosseous dental implants which designed to support prosthetic devices for partially or fully edentulous patients. Rescue Internal Implant Fixture Systems consist of two-stage, root-form dental implants, associated with abutment systems, and the instruments.

The provided text does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria for the "Rescue Internal Dental Implant System."

Instead, the document is a 510(k) Premarket Notification Summary for the device, which aims to establish substantial equivalence to a predicate device. This type of submission generally focuses on comparing the new device's design, materials, and indications for use to an already legally marketed device, rather than presenting new performance data against specific acceptance criteria.

The relevant sections of the document explicitly state:

• "FDA has not established a performance standard applicable to endosseous... The materials in the Rescue Internal Implant System meet applicable implants." (Section 8, page 1) This indicates that there are no specific FDA-mandated performance standards or acceptance criteria for this type of device that would necessitate a study to meet them.
• "The noted difference in the design and material does not effectively change the performance of the device." (Section 11, page 1) This statement, along with the comparison table, emphasizes that the justification for market clearance is based on the new device being substantially equivalent to a predicate, implying that its performance is presumed to be similar without requiring new performance studies against specific criteria.

Therefore, I cannot extract the requested information as it is not present in the provided text.

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