(77 days)
SPI® VECTOdrill™ Ceramic Drills are for use in the preparation of the implant site for all SPI® System implants.
SPI® VECTOdrill™ ceramic drills are reusable zirconia dental implant drill bits for use with the SPI Dental Implant System. SPI VECTOdrill ceramic drills include a pilot drill and three progressive twist drills. The pilot drill has a sler, highly efficient tip that initiates the pilot hole without the need for a round bur. The pilot drill also has the ability to cut laterally, in order to allow slight axial correction. The twist drills do not cut laterally, which helps to avoid enlarging the diameter of the osteotomy site. Each twist drill has an integrated guide at the tip, which is the same diameter as the preceding drill, in order to provide automatic axial quidance.
The pilot drill has a diameter of 2.0 mm and is available in 29.0 mm and 34.0 mm lengths. The twist drill is available in three diameters (2.8 mm, 3.5 mm and 4.3 mm) and two lengths for each diameter (29.0 mm and 34.0 mm).
Both the pilot drill and the twist drill have the proximal end configured to fit into a dental handpiece latch. All SPI VECTOdrills have a length 0.5 mm longer than the corresponding SPI Dental Implants. Each drill has depth markings that correspond to the VECTOdrill depth gauge in increments of 1.5 mm, from 8.0 mm to 17.0 mm. SPI VECTOdrill ceramic drills are intended to be resterilized and reused up to 20 times.
SPI VECTOdrill ceramic drills are made of alumina toughened zirconia (ATZ). SPI VECTOdrill ceramic drills are packed individually in a transparent plastic tube contained in a sealed plastic sleeve and are provided non-sterile.
Testing of SPI VECTOdrill ceramic drills established their ability to retain their cutting ability under aggressive cutting conditions. Testing also resulted in the conclusion that the mechanical properties of SPI VECTOdrill ceramic drills are appropriate for their safe use.
Here's an analysis of the provided information regarding the acceptance criteria and study for the SPI® VECTOdrill™ Ceramic Drills:
Crucially, the provided document does not contain detailed information about specific acceptance criteria, a formal study protocol, or quantitative performance metrics typically found in a comprehensive medical device validation study report.
The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a full performance validation report. Therefore, many of the requested sections will state "Not provided" or explain that the information is not present in this summary.
1. Table of Acceptance Criteria and Reported Device Performance
As noted, specific quantitative acceptance criteria are not explicitly stated in this 510(k) summary. The summary broadly states that "Testing... established their ability to retain their cutting ability under aggressive cutting conditions" and "resulted in the conclusion that the mechanical properties... are appropriate for their safe use." Without specific metrics (e.g., minimum cutting efficiency, maximum wear per use, fracture strength thresholds), it's impossible to create a table with numerical acceptance criteria and corresponding reported performance.
| Acceptance Criteria Category | Specific Acceptance Criterion | Reported Device Performance |
|---|---|---|
| Cutting Ability | (Not explicitly stated in terms of quantifiable metrics) | "established their ability to retain their cutting ability under aggressive cutting conditions" |
| Mechanical Properties | (Not explicitly stated in terms of quantifiable metrics or thresholds) | "appropriate for their safe use" |
| Reuse | Designed for "up to 20 times" | (Implied that testing supports this, but no specific data presented) |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated. The document refers to "Testing of SPI VECTOdrill ceramic drills" but does not give a number of drills tested or the extent of the testing.
- Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not explicitly stated. Given the manufacturer is Thommen Medical AG (Switzerland) and the representative is in the USA, the testing could have occurred in either region, or elsewhere. The nature of the testing (bench testing for mechanical properties and cutting ability) suggests it was likely prospective, but this is not confirmed.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This type of information is generally not applicable to a device like a dental drill. Ground truth for a drill's performance would typically be based on objective physical measurements (e.g., torque, force, wear, cutting depth, material analysis) rather than expert interpretation of images or clinical outcomes. Therefore, no experts would be needed to establish "ground truth" in the way described for diagnostic devices.
4. Adjudication Method for the Test Set
- Not applicable, as ground truth typically refers to clinical or diagnostic assessment, not objective mechanical property 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
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices involving human interpretation, often with AI assistance. The SPI® VECTOdrill™ Ceramic Drills are surgical instruments, and their performance is assessed through mechanical and material testing, not through human reader interpretation. There is no AI component mentioned.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Not applicable. This device is a physical surgical instrument, not an algorithm. Therefore, "standalone" performance in the context of AI algorithms is irrelevant. The performance of the drill itself, without a human operator, cannot be meaningfully assessed, as its function inherently requires human use.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
- For this device, the "ground truth" would be established through objective, standardized engineering and material science testing. This would involve:
- Mechanical Property Testing: Measuring tensile strength, bending strength, hardness, fracture toughness, etc., against predefined material specifications.
- Cutting Performance Testing: Assessing cutting speed, efficiency, and wear under simulated clinical conditions (e.g., drilling into bone substitutes).
- Durability/Fatigue Testing: Simulating repeated sterilization and use to evaluate structural integrity and performance over its intended lifespan (up to 20 uses).
- Visual Inspection/Metrology: Checking for physical defects, dimensions, and tolerances.
8. The Sample Size for the Training Set
- Not applicable. This device is not an AI/machine learning model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
- Not applicable. As there is no training set for an AI model, this question does not apply.
§ 872.3980 Endosseous dental implant accessories.
(a)
Identification. Endosseous dental implant accessories are manually powered devices intended to aid in the placement or removal of endosseous dental implants and abutments, prepare the site for placement of endosseous dental implants or abutments, aid in the fitting of endosseous dental implants or abutments, aid in the fabrication of dental prosthetics, and be used as an accessory with endosseous dental implants when tissue contact will last less than 1 hour. These devices include drill bits, screwdrivers, countertorque devices, placement and removal tools, laboratory pieces used for fabrication of dental prosthetics, and trial abutments.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.