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The drill is used to pre-drill into the maxilla or mandible to create an initial osteotomy for the later endosseous dental implant placement. The drills are used with a handpiece.
CeraDrill is a ceramic drill for the dental implantology made of a modern high performance ceramic. The drills are intended to be used with a handpiece. The intended use for this device is to cut into the maxilla or mandible to create an osteotomy for endosseous dental implant placement.

CeraDrills within the new "CeraLine" is intended for use in implantology. These are made of high efficiency ceramics featuring an excellent cutting performance. The new CeraDrill offers the possibility of working without any metal, thus guaranteeing a biocompatible operation. Damages, as they occur in particular when disinfecting and cleaning steel burs with inappropriate agents, are now a thing of the past. The multifunctional ceramic drills are suited for initial preparation of the implant site axis and depth. The drills feature high initial sharpness and optimal cutting efficiency, thus achieving an effective material reduction. Due to their high efficiency toothing and the distinct tip-transversing blade, the drill has very good axial drilling properties for precise cutting without the need for prior use of a centering bur. The special twist drill blade geometry ensures smooth and precise operation. Moreover, the depth markings, which are lasered on to the working part in 2 mm intervals guarantee precise and safe control of the penetration depth. The CeraDrill family is available in diverse dimensions and shapes for the individual preparation on the osteotomy.

This is a submission for a 510(k) premarket notification for a dental device, specifically a bone-cutting instrument. These types of devices generally rely on demonstrating substantial equivalence to a predicate device rather than undergoing extensive clinical trials as typically seen for novel medical devices or diagnostic algorithms. Therefore, the information provided focuses on non-clinical performance and technological characteristics.

1. Table of Acceptance Criteria and Reported Device Performance

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

The submission does not specify a "test set" in the context of an AI/ML algorithm or a diagnostic test with patient data. Instead, it refers to non-clinical tests conducted on the CeraDrill devices themselves to evaluate their physical and biological characteristics. The data provenance is internal testing by the manufacturer (Gebr. Brasseler GmbH & Co. KG), and the studies are prospective in the sense that they were designed and executed to test the characteristics of the new device. No geographical origin of patient data is relevant here as it's not a clinical study involving patients.

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

Not applicable. This is not a study that involves expert review for ground truth in the context of diagnostic accuracy. The "ground truth" for the non-clinical tests would be the measured physical and biological properties of the device, assessed using established engineering and laboratory standards.

4. Adjudication Method for the Test Set

Not applicable. As noted above, this submission describes non-clinical performance data, not a study evaluating human interpretation or a diagnostic outcome requiring adjudication.

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

No MRMC comparative effectiveness study was done. This device is a surgical instrument, not an AI-assisted diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No standalone algorithm performance study was done. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the evaluation of the CeraDrill's performance is based on engineering and laboratory test results for mechanical stability, thermal safety, corrosion resistance, material composition, and biocompatibility, as determined by internal testing and adherence to relevant standards (e.g., ISO 7405 for biocompatibility).

8. The Sample Size for the Training Set

Not applicable. There is no training set as this is not an AI/ML device.

9. How the Ground Truth for the Training Set Was Established

Not applicable. There is no training set.

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Surgical drills, taps and burs are used in dental, oral/maxillofacial surgery for preparing the bone (osteotomy), to receive an implant(s) or other device for bone fracture repair for restorative reconstruction. Trephine burs are used harvest bone material for autologous bone grafting procedures and to remove fractured surgical and implantable devices from the bone.

The purpose of this submission is to request marketing clearance for all drills, taps and burs (hereinafter referred to simply as "drills") manufactured and/or distributed by 3i, with an Amorphous Carbon (AC) coating applied to the cutting surfaces of the devices. This submission is for clearance of AC as a coating for current and future drill designs.

3i currently manufactures and distributes a wide range of reusable and disposable machine, electro-polished and titanium nitride (TiN) surface finished drills for the oral/maxillofacial surgical market. Current drill designs are essentially the same as others constructed of Stainless Steel with machined, electro-polished or applied TiN finishes.

The provided document is a 510(k) summary for Implant Innovations, Inc.'s (3i) surgical drills, taps, and burs with an Amorphous Carbon (AC) coating. It focuses on demonstrating the substantial equivalence of these AC-coated devices to previously cleared 3i devices (with polished or Titanium Nitride coatings) and other similar devices on the market. The primary purpose of the submission is to obtain marketing clearance for the AC coating, highlighting its improved durability and performance characteristics.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a formal, quantifiable sense as a pass/fail threshold. Instead, it presents performance testing results that demonstrate the superior durability of the AC coating compared to uncoated and TiN-coated alternatives, implying these results are sufficient for substantial equivalence.

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

The document does not specify the exact sample sizes (number of drills, burs, or taps) used for each performance test (Rolling Contact Fatigue, Sliding Wear, Scratch, Micro-Blast). The results are presented as single values or ranges, without detailing the number of units tested to achieve those results or any statistical measures.

The data provenance is from Implant Innovation's own "initial testing" for the specific AC coating to be used on their drills, as well as being consistent with "results published by several other related suppliers and applications" and "well documented in literature and marketing materials by others in the industry." The studies appear to be retrospective in the sense that they are laboratory performance tests conducted specifically for this 510(k) submission, not clinical trials. The country of origin for the data is not explicitly stated, but the company (Implant Innovations, Inc.) is based in the United States (Palm Beach Gardens, FL).

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

This type of information is generally relevant for studies involving qualitative assessments, such as image interpretation or diagnosis. The studies described are laboratory-based performance tests (e.g., fatigue, wear, friction, scratch, blast tests) measuring physical properties of the coating. For such tests, the "ground truth" is typically the quantitative measurement obtained through standardized testing procedures and equipment. Therefore, independent expert review for ground truth establishment, in the context of interpretation, is not applicable or described.

4. Adjudication Method for the Test Set

As the tests are objective, quantitative measurements of material properties, there is no "adjudication method" described or needed in the context of resolving disagreements between human expert interpretations. The tests yield direct numerical results.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study is mentioned. The submission focuses on the material properties and durability of the coating, not the interpretative performance of human readers, with or without AI assistance.

6. Standalone (Algorithm Only) Performance Study

Not applicable. The device is a physical surgical tool with a coating, not an algorithm or AI system. The performance tests are for the physical properties of the device and its coating.

7. Type of Ground Truth Used

The ground truth used for the performance tests consists of objective, quantitative measurements of material properties (e.g., hours for fatigue, coefficient of friction, critical load for scratching, seconds for blast removal) obtained through standardized laboratory testing. These are not based on expert consensus, pathology, or outcomes data in the usual sense.

8. Sample Size for the Training Set

Not applicable. The device is a physical product, and the testing described relates to the performance of its coating. There is no "training set" in the context of machine learning algorithms.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no "training set" for an AI algorithm.

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The proposed pre-sterilized, single-use, disposable drills, taps and burs (3i UniSystem) will be of the same design as previous products but will be constructed of "High Speed Surgical Steel" per AISI M2. All 3i drills are marked at the appropriate depth lengths to assist the clinician in proper drilling and are labeled with the correct drill diameter(s). Each drill is also identified as a "3i" device.

This document is a 510(k) summary for a medical device (pre-sterilized, single-use, disposable drills, taps, and burs) and does not contain the kind of study information requested. The document describes the device, its intended use, packaging, sterilization methods, contraindications, warnings, precautions, adverse effects, and substantial equivalence to previously cleared devices.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving those criteria are met, as that information is not present in the provided text.

Here is an explanation for each point, indicating why the information is not present:

1. A table of acceptance criteria and the reported device performance: This document does not define specific performance acceptance criteria for the drills, taps, and burs. It discusses features like "sharper cutting edge" and "improved drilling efficiency with less trauma to remaining bone" as benefits, but these are not quantified or presented as acceptance criteria.
2. Sample size used for the test set and the data provenance: No performance testing data or a "test set" is mentioned. The device is being cleared based on substantial equivalence to existing devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: As there is no "test set" or performance data, this information is not applicable.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable as no test set or performance study is described.
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: This device is a surgical tool, not an AI diagnostic or assistive device. Therefore, an MRMC study is not relevant, and no such study is mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical surgical tool, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable as no performance study is described. The "ground truth" for this device's efficacy relies on its design, material, and proven sterilization methods, and its substantial equivalence to other legally marketed devices.
8. The sample size for the training set: Not applicable as this is not an AI/algorithm-based device and no "training set" is used.
9. How the ground truth for the training set was established: Not applicable for the same reasons as above.

The document focuses on demonstrating that the new disposable, pre-sterilized drills are substantially equivalent to existing, legally marketed drills, primarily by detailing the material change (from stainless steel to "High Speed Surgical Steel" per AISI M2) and the addition of pre-sterilization. The only "performance" discussed is the sterility assurance level (SAL).

Specifically, regarding sterility, the document states:

• Acceptance Criteria (Implied): A Sterility Assurance Level (SAL) of ten to the minus six (10^-6).
• Reported Device Performance (Implied): Achieved by using Co60 Irradiation at a minimum dose of 25.0 kGy (2.5 mRads).
• Study Proving Acceptance: "Validation of sterilization process shall be accomplished as specified by the Association for the Advancement of Medical Instrumentation. Irradiation sterilization shall be accomplished by an FDA registered irradiation sterilization facility." This indicates that the sterilization process itself is validated according to established standards, rather than a performance study on the device's cutting ability. This validation procedure is the study that proves the device meets the sterility acceptance criteria, although specific raw data or sample sizes from this validation are not included in this summary.

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