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The I Macro 6.0mm X 6.0mm Implant system is intended for implantation in the maxillary or mandibular molar region where bone exists. This Macro implant provides support for fixed or removable dental prostheses in a single tooth, partially edentulous prostheses, or complete arch prostheses. It further adds the option for immediate loading on single and splinted multiple unit restorations when good primary stability is achieved and with proper occlusal loading, to restore the chewing function.

The I Macro 6.0mm X 6.0mm implants are self-tapping: commercially pure, CP Titanium or Titanium Alloy threaded screws, with light grit blasting or roughened surface treatment. These materials and procedures are exactly the same as cleared in the OCO Biomedical submission K 110337. The I Macro 6.0mm X 6.0mm Implant is available in a 6.0mm diameter and a 6.0mm length.

The provided document is a 510(k) summary for a dental implant (I Macro 6.0mm X 6.0mm) and focuses on establishing substantial equivalence to previously marketed devices. It does not contain information about acceptance criteria, device performance metrics, or details of a specific study to prove the device meets such criteria in the way typically expected for an AI/ML medical device.

The study referenced in the document is a non-clinical testing data used to demonstrate substantial equivalence to predicate devices, rather than proving a novel device meets specific performance acceptance criteria for diagnostic or clinical tasks.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set and data provenance.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study results or effect size with AI assistance.
6. Standalone algorithm performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

This document describes a regulatory submission for a physical medical device (dental implant), not an AI/ML software device, and thus the type of information requested (e.g., test sets, ground truth, expert adjudication, AI performance metrics) is not applicable or present.

The document states:
"Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence included: engineering analysis, dimensional analysis, pull-out testing, and static and dynamic compression-bending testing according to ISO 14801."

This indicates that the "study" conducted was a series of engineering and biomechanical tests to ensure the physical properties of the new implant were comparable to existing ones, which is standard for substantial equivalence for physical devices. It does not involve "performance" in the context of diagnostic accuracy, sensitivity, specificity, etc., which would require a clinical dataset and ground truth.

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The I Macro Implant system is intended for implantation in the mandibular molar region where bone exists and the surgeon has determined that placement of a narrower diameter implant would increase the chance of failure due to poor primary stability, or increased surgical procedures leading to complications. This I Macro implant provides support for fixed or removable dental prostheses in a single tooth, partially edentulous prostheses, or complete arch prostheses. It further adds the option for immediate loading on single and splinted multiple unit restorations when good primary stability is achieved and with proper occlusal loading, to restore the chewing function.

The I Macro implants are self-tapping; commercially pure; Titanium Alloy threaded screws, with light grit blasting or roughened surface treatment. These materials and procedures are exactly the same as cleared in the OCO Biomedical submission K090174. The I Macro Implant is available in a 6.0, 7.0, 8.0 & 9.0mm diameter and is available in 8, 10, and 12mm lengths.

The provided text describes a medical device submission (K110337) for the "I Macro Implant System," a dental implant. The submission primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices through comparisons of materials, design, processing, packaging, sterilization methods, and indications for use.

Based on the provided information, the device is a dental implant, and the "study" mentioned refers to various testing standards used to demonstrate the device's properties. These are not clinical studies in the typical sense of evaluating AI performance or diagnostic accuracy. Instead, they are engineering and biological evaluations.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that the fundamental scientific technology, including materials, processing, packaging, and sterilization methods, is "identical or very similar to referenced predicate devices." The acceptance criteria are largely met by demonstrating compliance with established international standards for medical device manufacturing and testing, rather than explicit numerical performance targets from a clinical trial.

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

This information is not applicable and not provided in the document. The document describes engineering and biological testing of the device itself (fatigue, biocompatibility, surface analysis), not a "test set" of patient data for evaluating an AI algorithm's performance.

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

This information is not applicable and not provided. This document does not describe the evaluation of an AI algorithm requiring a ground truth established by experts.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. This document does not describe an AI evaluation requiring an adjudication method.

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

There is no mention of an MRMC comparative effectiveness study, or any AI component, in this document.

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

There is no mention of a standalone algorithm performance study or any AI component in this document.

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

This information is not applicable and not provided. The "ground truth" in this context would likely refer to the physical and chemical properties of the implant meeting the specifications outlined in the standards (e.g., fatigue strength exceeding a certain threshold, materials matching composition specifications).

8. The sample size for the training set

This information is not applicable and not provided. This document describes a medical device, not an AI algorithm that requires a training set.

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

This information is not applicable and not provided. This document describes a medical device, not an AI algorithm.

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The TSI and ERI Dental Implants are artificial root structures intended for permanent surgical implantation in the bone for the purpose of single or multiple tooth replacements (splinted or free standing), or for stabilization of a prosthetic system, such as artificial teeth in order to restore the patient's chewing function. The TSI and ERI can be placed in the anterior or posterior mandible/maxilla for immediate or delayed loading purposes. Immediate loading is only intended when good primary stability is achieved and appropriate occlusal loading.

The TS1 & ERI implants are self-tapping, commercially pure. CP Titanium or Titanium Alloy threaded screws. with light grit blasting or roughened surface treatment. The TSI includes a 2mm collar and is available in 3.25, 4.0. 5.0mm diameters and each are available in 8. 10. 12. 14. and 16mm len gths. The ERI includes a 1 mm collar and is available in 3.25. 4.0. 5.0mm diameters and each are available in 8. 10. 12. 14. and 16mm lengths.

The provided text (K090174) is a 510(k) summary for a dental implant called TSI & ERI. It outlines the device description, indications for use, and claims substantial equivalence to previously cleared predicate devices.

However, the provided document does not contain information about acceptance criteria or a study that proves the device meets those criteria, as typically seen for AI/ML-based devices or complex diagnostic tools.

Dental implants like TSI & ERI are cleared through the 510(k) pathway by demonstrating substantial equivalence to existing, legally marketed predicate devices. This means the new device has the same intended use, similar technological characteristics, and raises no new questions of safety and effectiveness. Clinical studies or performance data with acceptance criteria are generally not required if substantial equivalence can be demonstrated through non-clinical means (e.g., comparison of materials, design, manufacturing processes, and published literature on the predicate devices).

Therefore, I cannot provide the requested information because it is not present in the provided text.

Here's a breakdown of why each point cannot be addressed:

1. A table of acceptance criteria and the reported device performance: Not applicable for this type of 510(k) clearance. Performance is inferred through substantial equivalence to predicates.
2. Sample size used for the test set and the data provenance: No test set or associated data for performance evaluation is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method: Not applicable.
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, as this is a physical medical device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The 510(k) summary for TSI & ERI focuses on demonstrating that its materials, design, intended use, packaging, and sterilization processes are similar enough to existing cleared devices (Immediate Stabilizing Implant (ISI) K033392, OCO 5.0mm Taper Implant K023336, and MegaGen ExFeel K052369) such that it does not require new efficacy or safety studies.

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As an artificial root structure for single tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors. The implant may be immediately restored with a temporary prosthesis that is not in functional occlusion.

When splinted together as an artificial root structure for multiple tooth replacement of mandibular incisors. The implants may be restored after a period of time or placed in immediate function.

For denture stabilization using multiple implants in the anterior mandible and maxilla. The implants may be restored after a period of time or placed in immediate function when good primary stability is achieved and with appropriate occlusal loading.

A self-tapping CP Titanium or Titanium Alloy threaded screw, with light grit blasting or roughened surface treatment.

Device Acceptance Criteria and Performance Study Analysis

The provided document describes the 510(k) submission for the I-Mini Dental Implant. However, it does not contain any information about specific acceptance criteria, a study proving the device meets those criteria, or performance data related to such criteria.

The document is a 510(k) summary and FDA clearance letter, which focuses on demonstrating substantial equivalence to legally marketed predicate devices, not on presenting performance data against defined acceptance criteria.

Therefore, I cannot provide the requested information for the following sections as they are not present in the provided text:

• A table of acceptance criteria and the reported device performance
• Sample sizes used for the test set and the data provenance
• Number of experts used to establish the ground truth for the test set and their qualifications
• Adjudication method for the test set
• Multi-Reader Multi-Case (MRMC) comparative effectiveness study, if any, and its effect size
• Standalone (algorithm only) performance study, if any
• Type of ground truth used
• Sample size for the training set
• How the ground truth for the training set was established

Key takeaway from the document:

The I-Mini Dental Implant received 510(k) clearance based on its substantial equivalence to existing predicate devices (IMTEC Sendax MDI and BioHorizons Maestro System 3.0mm) in terms of design, function, labeling, material composition, and intended use, rather than on the basis of new performance data against specific acceptance criteria. This is a common pathway for medical device clearance when a new device is similar enough to previously approved devices.

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