(148 days)
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
| Acceptance Criteria Category | Specific Criteria/Test | Reported Device Performance |
|---|---|---|
| Biocompatibility | Tested in accordance with ISO 10993-1, ISO 10993-5, ISO 10993-10, and ISO 10993-11. | Successfully tested against the specified ISO standards for biocompatibility. |
| Performance Testing (Drilling) | No significant changes in axial drilling thrust forces after repeated use. | Results indicate no significant changes in axial drilling thrust forces in all three groups (subject device and predicate device) after repeated use and processing. |
| Visual Assessment (Cutting Surfaces) | Cutting surfaces assessed visually using SEM images. | (Implicitly, the visual assessment supported the performance, as no negative findings were reported, and the device was deemed substantially equivalent.) |
| Corrosion Testing | No sign of corrosion after processing according to Instructions for Use (ASTM F1089). | All tested Surgical Drills showed no sign of corrosion without magnification after being boiled for 30 minutes and allowed to cool and air dry. |
| Cleaning Validation | Cleaning efficiency demonstrated in accordance with AAMI TIR30 and AAMI TIR12, meeting acceptable levels for residual soil markers (TOC and protein). | Cleaning efficiency successfully conducted. Extracts analyzed for total organic carbon (TOC) and protein as residual soil markers, implying acceptable levels were achieved. |
| Sterilization Validation | Sterilization demonstrated with a Sterility Assurance Level (SAL) of 10^-6 in accordance with ISO 17665-1 (overkill approach). | Sterilization validation successfully conducted to demonstrate an SAL of 10^-6 using the overkill approach as per ISO 17665-1. |
| Distribution Testing | Passed QA inspection before and after simulated shipping (ASTM D4169-16) with no impact on the device. | All drills subjected to the distribution testing passed the QA inspection prior to and after the distribution simulation, indicating no impact from distribution. |
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.
§ 872.4120 Bone cutting instrument and accessories.
(a)
Identification. A bone cutting instrument and accessories is a metal device intended for use in reconstructive oral surgery to drill or cut into the upper or lower jaw and may be used to prepare bone to insert a wire, pin, or screw. The device includes the manual bone drill and wire driver, powered bone drill, rotary bone cutting handpiece, and AC-powered bone saw.(b)
Classification. Class II.