(49 days)
Bone cutting instruments are intended for use during 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 Straumann P.004 Dental Implant System is an integrated system of endosseous dental implants, which are designed to support prosthetic devices for partially or fully edentulous patients. The system consists of a variety of dental implants, abutments and surgical and prosthetic parts and instruments.
This document, K082532, is a 510(k) premarket notification for the Straumann Guided Instruments, specifically drill bits, for use in oral surgery. As a 510(k) submission, the primary goal is to demonstrate substantial equivalence to a legally marketed predicate device, not to prove meeting specific performance "acceptance criteria" through a clinical study in the way a novel AI device might. Therefore, the information typically found in an AI device submission regarding acceptance criteria, performance metrics, and clinical study details (like sample sizes, ground truth establishment, or expert reviews for AI model performance) is not applicable or present in this type of submission.
Here's a breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable in this 510(k) submission.
510(k) submissions for devices like these typically rely on demonstrating that the new device has the same technological characteristics and intended use as a predicate device and does not raise new questions of safety or effectiveness. There are no explicit performance "acceptance criteria" stated as numerical targets that need to be met by the device's performance, nor is there a report of device performance against such criteria in the context of an efficacy study.
The submission states: "The proposed Straumann Guided Instruments are substantially equivalent to the currently marketed devices. The intended use is identical to the predicate devices. The proposed drill bits have the same material composition, basic design and fundamental operating principles to the currently marketed devices." This is the core "acceptance criteria" for a 510(k) and the "performance" is demonstrated through this comparison.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable.
This submission does not involve a "test set" of data or a study to evaluate a device's performance against ground truth in the way an AI/ML device would. The evaluation is based on engineering and material characteristics compared to a predicate device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable.
There is no "ground truth" establishment in the context of a clinical performance study described here, as this is a device based on established technology.
4. Adjudication Method for the Test Set
Not applicable.
No test set requiring adjudication is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No.
This is not an AI/ML device, and therefore, an MRMC comparative effectiveness study is not relevant or described.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop)
No.
This is not an algorithm-based device.
7. Type of Ground Truth Used
Not applicable.
As this is a 510(k) for surgical instruments, the "ground truth" for showing substantial equivalence generally involves showing that the device meets material specifications, design tolerances, and performs as expected in bench or animal testing (if applicable and novel), rather than clinical outcomes or expert consensus on diagnostic accuracy. No such ground truth data is explicitly presented here.
8. Sample Size for the Training Set
Not applicable.
This is not an AI/ML device, and therefore, no "training set" is used.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
No training set is used.
Summary of the Study that Proves the Device Meets the (Implicit) Acceptance Criteria:
The "study" in this 510(k) context is primarily a comparison to a legally marketed predicate device (K894844, Bone Cutting Instruments) rather than a clinical trial with performance metrics. The core argument for acceptance is the demonstration of substantial equivalence to the predicate device.
- Rationale for Equivalence: The submission asserts that the Straumann Guided Instruments (drill bits) are substantially equivalent to the predicate device because:
- They share the identical intended use (bone cutting during oral surgery to drill or cut into the upper or lower jaw to prepare bone for wires, pins, or screws).
- They have the same material composition.
- They have a basic design that is the same.
- They operate on the fundamental operating principles that are the same.
The FDA's decision to clear the device (as indicated by the letter from the FDA) signifies that they agreed with this assessment of substantial equivalence. This type of submission relies on established safety and effectiveness of the predicate device, assuming the new device, by being substantially equivalent, also shares those characteristics.
§ 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.