(168 days)
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:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Functionality | Passed functionality testing |
| Reliability | Passed reliability testing |
| Duty cycle | Passed duty cycle testing |
| Wear of couplings, valves, hoses, and seals | Passed wear testing |
| Leakage of couplings, valves, hoses, and seals | Passed leak testing |
| Endurance of switches and valve control | Passed endurance testing |
| Noise | Passed noise testing |
| Temperature | Passed temperature testing |
| Output torque | Comparable to predicate device (Synthes Electric Pen Drive (EPD) System (K043310) and Midas Rex Legend System (K020069)) |
| Power | Comparable to predicate device (Synthes Electric Pen Drive (EPD) System (K043310) and Midas Rex Legend System (K020069)) |
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.
§ 882.4370 Pneumatic cranial drill motor.
(a)
Identification. A pneumatic cranial drill motor is a pneumatically operated power source used with removable rotating surgical cutting tools or drill bits on a patient's skull.(b)
Classification. Class II (performance standards).