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The Surgical Drills are intended to cut into maxilla or mandible to create an osteotomy for endosseous dental implant placement.

The proposed Surgical Drills are reusable invasive surgical instruments designed to prepare an osteotomy for a dental implant procedure. The base material of the drill is made of surgical grade stainless steel. The bone cutting portion of the drill may be coated with diamond like coating (DLC) or laser marked to indicate the depth marks. The Surgical Drills consist of straight drills, and cortical drills. Straight drills are available in diameters 3.2 to 5.1 mm. Step drills are available in diameters 2.3/2.0 to 5.4/4.8 mm. Cortical drills are available in diameters 3.2 to 7.0 mm. The straight and step drills have osteotomy depth indicators and are intended to make osteotomies for Implant Direct endosseous dental implants.

The provided document is a 510(k) summary for a medical device called "Surgical Drills." It is a regulatory submission to the FDA for market clearance, demonstrating substantial equivalence to a predicate device, not an AI/ML device. Therefore, the questions related to AI/ML specific criteria, ground truth, experts, and training/test sets are not applicable here.

However, I can extract and present the acceptance criteria and the studies performed to demonstrate the device's conformance, as detailed in the document.

Acceptance Criteria and Device Performance for Surgical Drills (Non-AI/ML Device)

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state numerical sample sizes for each test in the way you would typically see for an AI/ML study. Instead, it refers to "worst-case drills" for corrosion and distribution testing, and "all three groups" for performance testing (referring to the subject device and predicate device, likely with multiple samples per group).

• Provenance: This is a regulatory submission for a medical device. The data provenance is from the manufacturing company, Implant Direct Sybron Manufacturing, LLC, specifically from their non-clinical testing performed to support the 510(k) submission. These are prospective tests conducted by the manufacturer.

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

Not applicable. This is a physical medical device (surgical drills), not an AI/ML system that requires expert-established ground truth for classification or prediction. The "ground truth" for these tests is based on objective measurements and established industry standards (e.g., ISO, ASTM, AAMI).

4. Adjudication Method for the Test Set

Not applicable, as this is not an AI/ML study requiring expert adjudication of results. The results are based on objective physical and chemical testing.

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. This is not an AI/ML device, and therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed.

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

The "ground truth" for the non-clinical tests is based on:

• International Standards: e.g., ISO 10993 series for biocompatibility, ISO 17665-1 for sterilization.
• Industry Standards: e.g., ASTM F1089 for corrosion testing, AAMI TIR30 and TIR12 for cleaning validation, ASTM D4169-16 for distribution testing.
• Objective Measurements: e.g., axial drilling force measurements, visual/SEM assessment for performance, TOC and protein levels for cleaning, absence of visible corrosion.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI/ML model that requires a training set.

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

Not applicable. There is no training set for a physical surgical device.

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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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