Search Results

The Synthes Air Pen Drive (APD) is indicated for screw insertion, pin and wire placement, cutting of bone and metal, drilling, reaming, decorticating, shaping and smoothing of bones and teeth in a wide variety of surgical procedures, including general orthopedic trauma, foot, hand, maxillofacial, neurosurgical, oral, otolaryngological, reconstructive and spine surgery

The Synthes Air Pen Drive (APD) System is a pneumatic powered system that consists of a Foot Pedal, Drive Unit, Hand Switch and Irrigation Control Unit that may be used with various commercially available attachments and cutting tools. The Drive Unit is pen-shaped and is connected to the Foot Pedal via a sterilizeable air hose. The rotation speed of the Drive Unit may be controlled from 0 to 60,000 rpm at 8 bar and from 0 to 80,000 at 12 bar via the Foot Pedal or the removable Hand Switch. Multiple attachments are available that have a quick-connect coupling to attach to the Drive Unit. The attachments accept various cutting tools including drill bits, burrs and saw blades.

This document describes a 510(k) summary for the Synthes Air Pen Drive (APD) System, a pneumatic powered surgical drill system. The entire document focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing, rather than presenting a study to prove a device meets specific performance acceptance criteria for an AI/ML powered device.

Therefore, many of the requested categories about acceptance criteria and AI/ML study design cannot be extracted from the provided text.

Here is the information that can be extracted or explicitly stated as not present:

1. Table of acceptance criteria and the reported device performance:

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not applicable. This is a medical device (surgical drill) and the testing involved non-clinical performance and engineering evaluations, not studies on a test set with patient data.

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):
Not applicable. Ground truth for a diagnostic AI/ML device is not relevant here as this is a surgical drill. The evaluation was based on engineering performance and adherence to standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable.

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 powered device for diagnostic or analytical purposes.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable. The "ground truth" for this device's evaluation was based on established engineering principles, industry standards for medical devices, and performance characteristics of predicate devices.

8. The sample size for the training set:
Not applicable. This is not an AI/ML powered device.

9. How the ground truth for the training set was established:
Not applicable.

Ask a specific question about this device

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.

Ask a specific question about this device