(29 days)
The Midas Rex Curved Burs are intended for use in surgical procedures for the following medical applications: Neurosurgical; Spine; Ear, Nose and Throat (ENT), Orthopedic Surgery, and General and Plastic Surgery including Maxillofacial, Craniofacial and Sternotomy. The Curved bur will be used to cut and/or remove bone and biomaterial.
Midas Rex Curved Bur is a sterile, single use, one piece device which includes the dissection tool (bur head, bur wire, bur tang) and the protective tube / cooling sleeve / hub. The hub connects and locks into the existing Legend telescoping attachment base. Legend telescoping attachment base connects to the Legend motor. The motor provides the power to rotate the dissecting tool / bur. The attachment / tube provide support and stability to the dissecting tool. The bur head which may be fluted or diamond coated, is the actual cutting tip on the device.
The provided document is a 510(k) summary for the Medtronic Midas Rex® Curved Burs. It focuses on establishing substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and performance metrics for the curved burs themselves. Therefore, much of the requested information regarding acceptance criteria, study design, and ground truth establishment is not present in this type of regulatory submission.
However, I can extract the information that is available and highlight what is missing.
Here's the analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
This information is not provided in the document. A 510(k) submission for substantial equivalence generally doesn't include specific performance acceptance criteria for the new device in the same way a clinical trial or a test report would. The "performance" being evaluated here is the claim that the new device (Curved Bur) is as safe and effective as the predicate device, not against specific measurement thresholds.
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. There is no mention of a "test set" or data provenance as this 510(k) is based on a technological comparison, not a new performance evaluation study in the traditional sense.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. As there's no "test set" or explicit ground truth establishment described, no experts for this purpose are mentioned.
4. Adjudication Method for the Test Set
This information is not provided in the document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
This information is not applicable and not provided in the document. This device (a surgical bur) is not an AI-assisted diagnostic or imaging device, so an MRMC study or AI-related effectiveness analysis is not relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable and not provided in the document. This is a physical surgical tool, not an algorithm.
7. The Type of Ground Truth Used
This information is not explicitly stated as there is no mention of a formal ground truth used for performance validation. The "ground truth" in a 510(k) context for substantial equivalence is often implicitly the established performance and safety profiles of the predicate device.
8. The Sample Size for the Training Set
This information is not provided in the document. No "training set" is mentioned as this is not a machine learning or AI device.
9. How the Ground Truth for the Training Set Was Established
This information is not provided in the document. No "training set" is mentioned.
Summary of Device and 510(k) Filing:
The document describes the Medtronic Midas Rex® Curved Burs, a sterile, single-use surgical dissecting tool. It's intended to cut and/or remove bone and biomaterials in various surgical procedures, including neurosurgical, spine, ENT, orthopedic, and general and plastic surgery.
The 510(k) filing (K072315) seeks to establish substantial equivalence to the predicate device, the Medtronic Midas Rex® Legend® Pneumatic High Speed System (K020069), specifically focusing on the Legend Telescoping System tools.
The core argument for substantial equivalence is that the device modification (Curved Bur) does not affect intended use, indication for use, device safety and effectiveness, and the fundamental scientific technology is the same as the previously cleared Legend Telescoping System. This implies that the safety and effectiveness are "proven" by virtue of being technologically equivalent to an already cleared and marketed product. The FDA's clearance letter confirms this determination of substantial equivalence.
§ 882.4310 Powered simple cranial drills, burrs, trephines, and their accessories.
(a)
Identification. Powered simple cranial drills, burrs, trephines, and their accessories are bone cutting and drilling instruments used on a patient's skull. The instruments are used with a power source but do not have a clutch mechanism to disengage the tip after penetrating the skull.(b)
Classification. Class II (performance standards).