(40 days)
The eMax 2 Plus System is intended for Cutting and shaping bone including spine and cranium.
The eMax 2 Plus System is an electrically powered drill motor with a series of attachments designed for use on the bones of the cranium and spine. The system components include a control console, the motor hand piece and foot control switch. The control console supplies power to the motor through a detachable cable. This system is non-sterile.
The provided text is a 510(k) summary for the eMax 2 Plus System, which is an electrically powered drill motor designed for cutting and shaping bone in cranium and spine. This document does not describe acceptance criteria or a study proving the device meets acceptance criteria in the way a clinical performance study for an AI/CADe device would.
Instead, this 510(k) summary focuses on demonstrating "Substantial Equivalence" to a legally marketed predicate device (the eMax Drill System, K011444). The FDA's 510(k) pathway is for devices that are "substantially equivalent" to predicate devices, meaning they have the same intended use and technological characteristics, or if there are differences, those differences do not raise new questions of safety and effectiveness.
Therefore, many of the requested categories (acceptance criteria table, sample size, data provenance, expert ground truth, adjudication, MRMC study, standalone performance, training set details) are not applicable or not present in this type of regulatory submission. The assessment here is primarily based on comparing the new device's specifications and performance to an already cleared predicate device, rather than an independent clinical study against a predefined set of performance metrics.
Here's an analysis based on the provided document:
1. Table of acceptance criteria and the reported device performance:
- Acceptance Criteria: No explicit acceptance criteria or target performance values are defined in this document for the eMax 2 Plus System itself. The entire premise of a 510(k) is to demonstrate "substantial equivalence" to a predicate device.
- Reported Device Performance: The document states that the eMax 2 Plus System is made of the same materials and contains features and functions similar to the currently available eMax Drill System (K011444). The same cutters, attachments, and accessories will interface with both systems. This implies that its performance is expected to be equivalent to the predicate device.
2. Sample size used for the test set and the data provenance: Not applicable for this type of submission. There is no "test set" in the context of a performance study for the eMax 2 Plus System. The evaluation is based on comparing its design and specifications to the predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no ground truth, as it's not a diagnostic AI/CADe device being evaluated.
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 device is a surgical drill, not an AI/CADe system for image interpretation.
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.
8. The sample size for the training set: Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established: Not applicable.
Summary based on the document:
The eMax 2 Plus System is cleared based on its substantial equivalence to the predicate eMax Drill System (K011444). The performance demonstration is implicitly through the assertion that the new device has technological characteristics similar to the predicate device, including materials, features, functions, and compatibility with accessories. The FDA's role in this 510(k) process is to confirm that these similarities allow the new device to be marketed without raising new questions of safety and effectiveness, assuming it meets general controls and manufacturing practices.
§ 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).