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The Sargon Non-Expandable Dental Implant is indicated for immediate placement or delayed placement in the bone of the upper or lower jaw to support prosthetic devices such as artificial teeth, crowns, bridges or overdentures in partially or fully edentulous patients and to restore the patient's chewing function. This device is not indicated for immediate loading.

The Sargon Non-Expandable implant is a root form endosseous dental implant (FDA classification code DZE). It has been placed in class 2 per (1 DA Classification code DEE). is fabricated from titanium alloy meeting the specifications of ASTM F136. It is available in lengths of 8, 10, 13, and 16mm and diameters of 4.3 and 5.1mm. The surface is grit blasted and acid etched. The device is provided sterile. Sterility is achieved by gamma radiation pursuant the devilos provide a sterility assurance level (SAL) of 10°.

The provided text is a 510(k) summary for a dental implant device (K082573). It details the device's description, intended use, and claims of substantial equivalence to predicate devices. However, it does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.

510(k) submissions typically demonstrate substantial equivalence to a legally marketed predicate device rather than presenting new performance studies against specific acceptance criteria. This means the device is deemed safe and effective because it is very similar to another device that has already been cleared by the FDA.

Therefore, I cannot provide the requested table or answer the questions related to studies, sample sizes, ground truth, or expert involvement, as this information is not present in the provided document.

To clarify, here's what is available in the document regarding how equivalence was established:

• Basis for Substantial Equivalence: The Sargon Non-Expandable Dental Implant is claimed to be substantially equivalent to certain Strauman implants (K012757, K003271, K033984) and previously cleared Sargon expandable implants (K930071, K961005, K981141).
• Equivalence Factors: This equivalence is based on "material composition, implant dimensions (e.g., Strauman K033984; lengths 8, 10, 13, 16; diameters 3.3, 4.1, 4.6), surface treatment and individual or abutment design." It also states "There are no new indications or materials as compared with the predicate devices."

This is the extent of the performance "proof" provided in this type of submission.

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Selected Brånemark System® implant products (those identified in the preceding section, "Device Name") are intended to be placed in the upper or lower jaw to support prosthetic devices, such as artificial teeth, and to restore a patient's chewing function. This may be accomplished using either a two stage surgical procedure or a single stage surqical procedure.

If a single stage surgical procedure is used, these implants may be loaded immediately following insertion - PROVIDED - at least four implants are placed, and are splinted with a bar. These implants must be placed predominantly in the anterior mandible (between the mental foramina) where good initial stability of the implants, with or without bi-cortical anchoragel can most often be obtained.

Brånemark System® dental implants are threaded, root-form implants fabricated from ASTM grade 1 "commercially pure" titanium. They are available in diameters of 3.75 mm and 4.0 mm, and are available in lengths ranging from 10 mm to 21 mm. Research studies have demonstrated that titanium is biocompatible.

The provided text is a 510(k) summary for Nobel Biocare's Brånemark System® Implants, seeking clearance for an immediate loading indication. This document details the device, its intended use, and a comparison to predicate devices, but does not contain any information about specific acceptance criteria or a study proving the device meets those criteria, as typically understood for AI/ML or diagnostic devices.

The 510(k) process for medical devices primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific quantitative acceptance criteria in the way a clinical trial for a drug or an AI diagnostic algorithm would.

Therefore, many of the requested items (e.g., sample size for test set, number of experts for ground truth, MRMC studies, standalone performance) are not applicable or cannot be extracted from this type of regulatory submission. The document explicitly states "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent...".

Here's a breakdown of what can and cannot be answered based on the provided text:

1. A table of acceptance criteria and the reported device performance

• Not applicable/Not provided. This document is a 510(k) summary for substantial equivalence, not a performance study against specific acceptance criteria. The "performance" assessment is based on demonstrating equivalence to predicate devices already cleared for immediate loading.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not applicable/Not provided. This document does not present results from a clinical test set with specific sample sizes. The regulatory submission relies on comparison to predicate devices and existing biocompatibility data for titanium.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable/Not provided. Ground truth establishment, typically for diagnostic accuracy or outcome prediction, is not described in this 510(k) summary.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable/Not provided. No test set or adjudication method is mentioned.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable/Not provided. MRMC studies are typically for evaluating the impact of AI algorithms on human reader performance, which is not the subject of this 510(k) for dental implants.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable/Not provided. This document is not about an algorithm, but a physical dental implant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not applicable/Not provided. This document does not refer to ground truth data in the context of device performance metrics. The implicit "ground truth" for the immediate loading indication is likely established clinical practice and safety/efficacy data already accepted for the predicate devices.

8. The sample size for the training set

• Not applicable/Not provided. This is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established

• Not applicable/Not provided. This is not an AI/ML device.

Summary of Device Acceptance (based on 510(k) Substantial Equivalence):

The device (Brånemark System® Implants with immediate loading indication) achieved acceptance through the FDA's 510(k) clearance process by demonstrating substantial equivalence to legally marketed predicate devices, specifically the Straumann ITI Implant (K984104) and the Sargon Cylindro-Blade Implant (K930071), both of which already had an immediate load indication.

The key aspects considered for substantial equivalence, as detailed in the comparison table, included:

• Intended Use: Functionally the same (support prosthetic devices, restore chewing function).
• Indication: Immediate Load.
• Design: Threaded, root-form implants (similar to Straumann ITI Implant, different but accepted from Sargon).
• Placement Method: Single stage surgery.
• Material: Commercially pure titanium (similar to Straumann, different but accepted from Sargon's titanium alloy).
• Coating: None.
• Dimensions: Within acceptable ranges relative to predicate devices.

The FDA concluded that the device is substantially equivalent to the predicate devices for the stated indications for use (immediate loading under specific conditions: at least four implants placed, splinted with a bar, predominantly in the anterior mandible, with good initial stability). This substantial equivalence determination allowed the device to be marketed.

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For immediate load use, without an abutment, in either partially or fully edentulous mandibles and maxillae, for fixed or detachable prosthesis and for use in support of free-standing restorations with or without the involvement of adjacent dentition.

The product is an endosseous dental implant for prosthetic attachment; trade name: Sargon Immediate Load Implant™. It is substantially equivalent to previously marketed models of this device described in premarket notifications K930071 and K961005. In this design, the collar is longer and allows the direct fixation of a prosthesis to the implant with or without the use of an abutment. The material is the same as the predicate devices; i.e., titanium alloy conforming to ASTM standard F136 "Standard Specification for Wrought Titanium 6Al-4V Ell Alloy for surgical Implant Applications."

The provided text describes a 510(k) summary for the Sargon Immediate Load Implant, but it does not contain information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

The document is a regulatory submission for a dental implant, focusing on its substantial equivalence to previously marketed devices. It details the device's material, indications for use, and confirms FDA clearance. Regulatory letters and forms are included, but there is no technical study data or performance metrics.

Therefore, I cannot provide the requested information based on the given input.

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ITI One Part octa implants are intended for surgical placement in the maxillary and/or mandibular arches to provide support for prosthetic restorations in edentulous or partially edentulous patients.

ITI one-part octa implants are for use in edentulous jaws in conjunction with barborne superstructure on 4 implants. If ITI one-part implants are splinted with a bar, they can be loaded immediately.

ITI one-part implants can also be used for indications requiring endosseous implants for functional rehabilitation in regions where an ITI two part implant and an Octa abutment would normally be used.

The All-in-O re implants are screw type dental implants made from CP titanium. Grade 4. They are available in various insertion lengths. The implants have the same rough surface as cleared ITI endosseous implants. The transmucosal part has a smooth machined surface to allow for the attachment of epithelial tissue.

The provided document is a 510(k) summary for a dental implant system (ITI Dental Implant System®) seeking substantial equivalence to existing devices. It does not contain information on the acceptance criteria, study details, or performance of an AI/ML powered device. The document is primarily focused on the device description, intended use, and a comparison to predicate devices, which are all traditional medical devices and not AI-based.

Therefore, I cannot extract the requested information from the given text as it pertains to AI/ML device performance.

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