(37 days)
The XPS Drill System is primarily intended for the controlled incision or removal of bonc in the ear, nose, throat and other areas of the head and neck.
The XPS Drill System is made up of a console, electric motor, exchangable handpieces, foot pedal and accessories as described below. It has the ability to operate one handpiece and incorporates irrigation capability. The handpiece speed range is 0 - 90,000 RPM and the stall torque is 3.5 oz-in.
This document describes a medical device submission (K983224) for the XOMED XPS Drill System. It is a 510(k) summary, which means the manufacturer is asserting substantial equivalence to a predicate device rather than conducting new clinical studies to prove effectiveness or safety. Therefore, the device does not have acceptance criteria or a study proving it meets them in the traditional sense of a clinical trial.
However, I can extract information related to the device's intended use, performance characteristics (as described for substantial equivalence), and the regulatory process which implicitly serves as the "acceptance criteria" for marketing the device as substantially equivalent.
1. A table of acceptance criteria and the reported device performance
Since this is a 510(k) for substantial equivalence, formal acceptance criteria and reported performance from specific studies are not detailed. Instead, the "acceptance criteria" here are defined by the predicate devices and the changes made.
| Acceptance Criteria (Implied by Predicate & Device Description) | Reported Device Performance (as described for Substantial Equivalence) |
|---|---|
| Intended Use: Controlled incision or removal of bone in the ear, nose, throat, and other areas of the head and neck. | The XPS Drill System is primarily intended for the controlled incision or removal of bone in the ear, nose, throat and other areas of the head and neck. (Same as intended use) |
| Operating Speed Range: Similar to existing ENT drills. | Handpiece speed range is 0 - 90,000 RPM. |
| Stall Torque: Sufficient for intended bone removal. | Stall torque is 3.5 oz-in. |
| Irrigation Capability: Present in comparable ENT drills. | Incorporates irrigation capability. |
| Configuration: Console, electric motor, interchangeable handpieces, foot pedal, and accessories. | Made up of a console, electric motor, exchangable handpieces, foot pedal and accessories. Ability to operate one handpiece. |
| Software: No software involved in operation. | NOTE: There is no software involved with the operation of this device. |
| Safety and Effectiveness: Demonstrated by substantial equivalence to K904850 and K960853. | "The new XPS Drill System is the same drill system that was previously cleared by K904850 Xomed now intends to market this system for ENT and Head and Neck surgery... As an ENT drill, the XPS Drill System is also substantially equivalent to the MPS Powerforma currently marketed by Xomed (K960853)." Minor changes to labeling (instruction manual and console) are not considered significant. |
The "study" proving it meets these "acceptance criteria" is the 510(k) Substantial Equivalence submission itself, which argues that the device is as safe and effective as legally marketed predicate devices.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for test set: Not applicable (N/A). This is a 510(k) submission based on substantial equivalence to predicate devices, not a clinical study with a test set of data.
- Data provenance: N/A.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Number of experts: N/A. No a specific "ground truth" was established by experts for a test set in the context of this 510(k). The regulatory body (FDA) reviews the submitted information and makes a determination of substantial equivalence.
- Qualifications of experts: N/A.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication method: N/A.
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
- MRMC study: No. This device is a surgical drill and does not involve AI or human readers for diagnostic interpretation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Standalone performance: No. This device is a physical surgical drill and does not involve algorithms or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of ground truth: N/A. The "ground truth" for a 510(k) is the established safety and effectiveness of the predicate devices (K904850 and K960853), determined through their original clearance process.
8. The sample size for the training set
- Sample size for training set: N/A. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
- Ground truth establishment: N/A.
§ 874.4250 Ear, nose, and throat electric or pneumatic surgical drill.
(a)
Identification. An ear, nose, and throat electric or pneumatic surgical drill is a rotating drilling device, including the handpiece, that is intended to drive various accessories, such as an ear, nose, and throat bur (§ 874.4140), for the controlled incision or removal of bone in the ear, nose, and throat area.(b)
Classification. Class II.