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510(k) Data Aggregation
(63 days)
DENTAL/SURGICAL DRILLS, BURS, TAPS
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.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Rolling Contact Fatigue Resistance: Extended useful life/durability in high-friction environments. | AC Coated: 120 hours (demonstrates superior performance compared to Uncoated: 8.0 hrs and TiN/Ti Coated: 102 hrs). |
| Sliding Wear Resistance: Minimal wear under frictional conditions. | AC Coated: No detectable wear after 5 hours of testing. |
| Coefficient of Friction: Lower friction for enhanced efficiency and reduced trauma. | AC Coated: 0.090 and 0.080 (demonstrates lower friction than TiN/Ti Coated: 0.110 and 0.124). |
| Coating Adhesion/Integrity (Scratch Test): Resistance to flaking/chipping under stress. | Critical load to coating failure: 33.7 lbs. (The document states this confirms the gas deposition process applies the coating such that it will not flake or chip off under normal handling and surgical use conditions). |
| Coating Durability (Micro-Blast Test): Resistance to removal/abrasion. | Time to full coating removal: 78.1 seconds. (The document states this confirms the gas deposition process applies the coating such that it will not flake or chip off under normal handling and surgical use conditions). |
| Biocompatibility & Sterilizability: Consistent with medical device standards. | Biocompatibility: AC coatings provide excellent biocompatibility and chemical inertness. (This is stated as a known benefit of AC coatings in general medical device use and is implicitly accepted for this specific application based on the general knowledge). |
| Sterilizability: Sterilizable by autoclave or chemclave, or any other normal manufacturing sterilization means (e.g., ETO, Co60 Irradiation, Plasma). (This is explicitly stated for the AC coating). |
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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