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The Immediate Stabilizing Implant (ISI) is a one-piece threaded dental implant with the abutment incorporated into the design for a single stage surgical procedure. The implant is intended to be surgically placed in the bone of the upper or lower jaw arches providing support for prosthetic devices resulting in the restoration of the patient's chewing function. Immediate loading can be obtained if implants are rigidly splinted.

Self-tapping one-piece CP Titanium threaded dental implant, with a roughened surface treatment. Available in 3.25mm, 4.0mm, and 5.0mm diameter, and in lengths of 8mm 10mm, 12mm, 14mm & 16mm.

The provided document is a 510(k) Pre-Market Notification for a dental implant (Immediate Stabilizing Implant - ISI). This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with defined acceptance criteria and performance metrics.

Therefore, the document does not contain the requested information regarding acceptance criteria and a study proving the device meets those criteria, as it's not a clinical study report. The information about sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, ground truth, and training sets is typically found in documentation for devices that require extensive performance validation, often through clinical or non-clinical testing that directly measures performance against pre-defined criteria.

Instead, the document focuses on comparing the ISI device's design, function, labeling, material composition, and intended use to existing predicate devices to assert substantial equivalence.

Here's a breakdown of why the requested information is absent:

1. Acceptance Criteria and Reported Device Performance: These are usually established for new devices undergoing rigorous testing for safety and efficacy. For a 510(k), the "performance" is primarily assessed against the predicate device's characteristics and historical safety/effectiveness.
2. Sample Sizes and Data Provenance: This relates to clinical or analytical studies. The 510(k) summary provided does not describe such a study.
3. Number of Experts, Qualifications, Adjudication Method: These are elements of studies involving expert review, common for diagnostic or imaging devices. This is a physical implant, not a diagnostic tool.
4. MRMC Comparative Effectiveness Study: This is specific to diagnostic aids that influence human reader performance.
5. Standalone Performance: While aspects of a device's physical/mechanical performance might be tested, a "standalone" performance in the context of an algorithm's output (as typically asked) is not relevant here.
6. Type of Ground Truth: Ground truth (e.g., pathology, outcomes data) is used to validate the accuracy or effectiveness of a diagnostic or predictive device. For a dental implant, the "effectiveness" is determined by successful integration and function, which is typically demonstrated over time in clinical use, not usually by a single ground truth in a 510(k) submission.
7. Training Set Sample Size and Ground Truth for Training Set: These are concepts related to machine learning and AI, which are not applicable to the ISI dental implant.

In summary, the provided document demonstrates substantial equivalence based on a comparison to predicate devices, not through a study with defined acceptance criteria and performance metrics in the way a diagnostic or AI-powered device would.

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"O" Company's OCO Endosseous Implant is intended to be surgically placed in the bone of the upper or lower jaw arches providing support for prosthetic devices resulting in the restoration of the patient's chewing function.

OCO Dental Implant (5.0 mm Diameter)

I am sorry, but based on the provided text, I cannot extract any information regarding acceptance criteria, device performance, results of a study, sample sizes, expert qualifications, adjudication methods, or ground truth establishment.

The document is an FDA 510(k) clearance letter for a dental implant (OCO Dental Implant, 5.0mm Diameter). It primarily focuses on:

• Device Identification: Trade/Device Name, Regulation Number, Regulation Name, Regulatory Class, Product Code.
• Clearance Determination: States that the device is "substantially equivalent" to legally marketed predicate devices.
• Regulatory Compliance: Outlines requirements for annual registration, listing, good manufacturing practices, labeling, and prohibitions against misbranding and adulteration.
• Contact Information: Provides contacts for labeling regulations, promotion/advertising, and general responsibilities.
• Indications For Use: Briefly describes the intended use of the dental implant.

There is no mention of any specific study conducted by the manufacturer, acceptance criteria for performance, or any data to demonstrate the device meets such criteria. The FDA's substantial equivalence determination for this type of device (a Class III endosseous implant) typically relies on demonstrating that the new device has the same intended use, fundamental technological characteristics, and safety and effectiveness as a predicate device, often without requiring an entirely new clinical study with performance metrics in a 510(k) submission.

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"0" Company's OCO Endosseous Implant is intended to be surgically placed in the bone of the upper or lower jaw surgically praced in the bone of the or still devices resulting arches providing bart the patient's chewing function.

OCO Dental Implant (3.25mm diameter)

I apologize, but the provided text from the FDA 510(k) summary for the "OCO Dental Implant" does not contain information about acceptance criteria, device performance metrics, or details of a study involving AI or human readers.

The document is a traditional 510(k) clearance letter confirming that the device is substantially equivalent to a predicate device for its stated indications for use. It primarily focuses on regulatory compliance and does not include the type of performance study data that would be relevant to AI-based medical devices or even detailed clinical performance data for traditional devices beyond what is necessary to establish substantial equivalence.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based solely on the provided text.

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"O" Company's Titanium CP Endosseous Implant is intended to be surgically placed in the bone of the upper of lower jaw arches providing support for prosthetic devices resulting in the restoration of the patient's chewing function.

A cylinder shaped commercially pure titanium dental implant with external threads and a Hydroxylapatite Coating.

The provided text is a 510(k) premarket notification for a medical device called the "O" Butment HS Implant, a type of dental implant. It focuses on demonstrating substantial equivalence to previously marketed devices rather than presenting a study for meeting specific acceptance criteria for performance.

Therefore, most of the requested information regarding acceptance criteria, performance studies, sample sizes, expert ground truth, adjudication methods, and MRMC studies is not available in the provided document. The document describes a regulatory process for market clearance, not an evaluation of device performance against pre-defined acceptance criteria through a clinical or non-clinical study designed for that purpose.

Here's a breakdown based on the information that is available:

1. Table of Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

• Not applicable / Not provided. No test set in the sense of patient data or clinical images was used for performance evaluation against acceptance criteria. The "test" mentioned relates to non-clinical stress analysis.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

• Not applicable / Not provided. No ground truth established by experts is mentioned, as there was no test set of clinical cases.

4. Adjudication Method for the Test Set:

• Not applicable / Not provided.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No. An MRMC study was not done. The submission focuses on substantial equivalence based on design, materials, and non-clinical testing.

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

• Not applicable. This device is a physical dental implant, not an algorithm.

7. The Type of Ground Truth Used:

• Not applicable / Not provided. The evaluation was based on design comparison and non-clinical engineering stress analysis, not clinical ground truth.

8. The Sample Size for the Training Set:

• Not applicable / Not provided. This is not a machine learning device; therefore, no training set is relevant.

9. How the Ground Truth for the Training Set was Established:

• Not applicable / Not provided.

Summary of Relevant Information from the Document:

• Non-clinical tests: Lateral and vertical stress analysis performed by Rocky Mountain Testing.
• Finding: "It has been determined that the physical integrity of the implant has not been compromised by the modifications."
• Basis for Substantial Equivalence: Design, function, labeling, material composition, and intended use compared to predicate devices ("O" Butment ES Implant and Screw-Vent Implant).

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The titanium endosseous implant is a device intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices.

A cylinder shaped commercially pure titanium dental implant with external threads.

The provided text describes a 510(k) summary for a dental implant, "O" Butment ET Implant, seeking substantial equivalence to predicate devices. It does not contain information about acceptance criteria or a study proving device performance in the context of AI/software or a diagnostic device.

Therefore, I cannot fulfill the request as the provided input does not contain any of the required information regarding:

• A table of acceptance criteria and reported device performance.
• Sample size used for the test set or data provenance.
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method for the test set.
• MRMC comparative effectiveness study.
• Standalone algorithm performance study.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

The document discusses:

• Device Type: Dental Implant
• Purpose of 510(k): Substantial Equivalence
• Comparison Basis: Design, function, labeling, material composition, and intended use compared to predicate devices.
• Non-clinical tests: Lateral and vertical stress analysis, concluding physical integrity has not been compromised by modifications.

This is a traditional medical device approval document, not one related to software or AI performance assessment.

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