(191 days)
Aesculap's HiLan Motor System for Neurosurgery is a pneumatic motor system intended for use in surgical procedures to provide power to operate removable cutting tools or drill bits on a patient's skull. It is indicated for use in neurosurgery.
The HiLan Motor System for Neurosurgery consists of a small hand held motor, an air hose, a foot control, a pneumatic motor hose, and various cranial handpieces (craniotome and perforator). The system components connect to each other via a proprietary coupling system.
The provided text describes a 510(k) submission for the Aesculap HiLan Motor System for Neurosurgery. This document primarily focuses on demonstrating substantial equivalence to a previously cleared device, rather than presenting a study with specific acceptance criteria and performance data for a new, AI-powered device.
Therefore, many of the requested sections about acceptance criteria, study design, and AI-specific details cannot be fulfilled from the provided text. The device described, a pneumatic motor system for surgery, predates common AI applications in medical devices.
Here's an attempt to address the points based on the available information, with clear indications where the information is not present:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Not Explicitly Stated for this Device as a "New" Performance Study) | Reported Device Performance (Based on Substantial Equivalence Claim) |
|---|---|
| Technological Characteristics: Identical to predicate device (K973736). | The HiLan Motor System for Neurosurgery is identical in all technological characteristics to the HiLan Pneumatic Motor System which was cleared in K973736. |
| Intended Use: For use in surgical procedures to provide power to operate removable cutting tools or drill bits on a patient's skull, indicated for neurosurgery. | Intended use matches the described function. |
| Safety: Manufactured in accordance with relevant standards (ISO, German Din). | Manufactured in accordance with ISO and German Din Standards; Aesculap AG has ISO 9001 certification. |
| Functionality: Shares similar features and function with predicate and other marketed devices. | Shares similar features and function with corresponding devices distributed by Aesculap, Hall/Zimmer, and Midas Rex. |
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/Not provided. This document does not describe a performance study with a test set of data. The submission relies on demonstrating substantial equivalence to a prior device clearance (K973736).
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/Not provided. No ground truth establishment is described as this is not a performance study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided. No adjudication method is described.
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 device is a pneumatic motor system, not an AI or diagnostic imaging device. No MRMC study or AI assistance is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical surgical tool, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable/Not provided. No ground truth is established as this is not a performance study comparing a new device feature or diagnostic capability. The "ground truth" for substantial equivalence is the previously cleared device itself.
8. The sample size for the training set
- Not applicable/Not provided. No training set is involved for this type of device submission.
9. How the ground truth for the training set was established
- Not applicable/Not provided. No training set or ground truth for it is relevant to this device submission.
Summary of Device Acceptance:
The Aesculap HiLan Motor System for Neurosurgery was accepted for market clearance based on a 510(k) Substantial Equivalence pathway. The primary "study" (or justification) provided was the demonstration that the device is identical in all technological characteristics to a previously cleared predicate device, the HiLan Pneumatic Motor System (cleared under K973736). Additionally, it was stated to be manufactured in accordance with ISO and German Din Standards, and the manufacturer holds ISO 9001 certification, indicating adherence to quality management systems. The intended use also matched. Therefore, the FDA determined it was substantially equivalent to legally marketed predicate devices.
§ 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).