(46 days)
The Anspach eG1 High Speed Electric System is intended for cutting and shaping bone including spine and cranium.
The Anspach eG1 High Speed System, which consists of a control console, handpiece, and various attachments, is an electrically powered surgical drill that handles a range of surgical procedures ranging from power-demanding applications to delicate dissection.
This submission is for a 510(k) premarket notification for a Class II medical device, the Anspach eG1 High Speed Electric System, an electrically powered surgical drill. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting new clinical trials to prove safety and effectiveness. Therefore, the information typically found in acceptance criteria documentation for novel devices (e.g., studies with test sets, ground truth establishment, MRMC studies) is generally not present in such FDA documents.
Based on the provided text, here's a breakdown of what can and cannot be extracted:
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
Acceptance Criteria (Derived from Substantial Equivalence to Predicate): The device must perform as intended, utilizing similar materials, features, and functions as the predicate device (Anspach eMax Drill System, K011444), and raise no new safety or effectiveness issues.
Reported Device Performance:
| Performance Aspect | Claimed Performance |
|---|---|
| Functional | "The Anspach eG1 High Speed Electric System and attachments perform as intended." |
| Safety | "Raises no new safety or effectiveness issues." |
| Materials | "Designed utilizing the same materials... as the predicate devices." |
| Features/Functions | "Contains features and functions which are similar to the predicate devices." |
| Intended Use | "Intended for cutting and shaping bone including spine and cranium." (Same as predicate implied by substantial equivalence) |
Study Information
For a 510(k) submission, the "study" is primarily a "Design Verification" and "Performance Testing" against the design requirements, not a clinical study on human subjects or an AI algorithm performance study.
2. Sample size used for the test set and the data provenance: Not applicable. This submission describes physical and functional testing of the device itself, not an algorithm using a dataset.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically understood for diagnostic or AI/ML algorithm evaluation (e.g., radiologist consensus) is not relevant here. The "ground truth" for the device's functional integrity would be engineering specifications and standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. The testing described is design verification, likely performed by engineers, not subjective human assessment needing adjudication.
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 device or a diagnostic imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical surgical drill system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this type of device would be engineering specifications, functional requirements, and performance standards. Testing would be against these predefined technical parameters.
8. The sample size for the training set: Not applicable. This is not an AI/ML algorithm with a training set.
9. How the ground truth for the training set was established: Not applicable. There is no training set for this device.
§ 882.4360 Electric cranial drill motor.
(a)
Identification. An electric cranial drill motor is an electrically operated power source used with removable rotating surgical cutting tools or drill bits on a patient's skull.(b)
Classification. Class II (performance standards).