(263 days)
Aesculap ELAN 4 Tools are intended for high speed cutting, sawing, and drilling of bone in the fields of Spine, ENT, Neuro, and Maxillofacial Surgery
The ELAN 4 Tools are cutting devices designed for use with the ELAN 4 Electro Motor System. The ELAN 4 Tools are designed for cutting, sawing and drilling of bone. The ELAN 4 Tools have an attachment mechanism designed specifically for the type of motors and attachments with which they will be used. The ELAN 4 Tools are manufactured from stainless steel with some tools containing a coated layer of diamond chips. The ELAN 4 Tools are components of the ELAN 4 Electro Motor System (K152960).
Based on the provided text, the device in question is Aesculap ELAN 4 Tools, which are instruments for high-speed cutting, sawing, and drilling of bone. This document is an FDA 510(k) summary, which focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than establishing de novo clinical efficacy or performance of a novel AI/software medical device.
Therefore, the information required for explaining acceptance criteria and a study proving device performance, particularly related to AI performance metrics, clinical studies, reader studies, and large datasets for training/testing, is not present in this document. The document details testing related to the physical device's characteristics and safety.
Here's what can be extracted and why other sections cannot be completed:
1. Table of Acceptance Criteria and Reported Device Performance & 2. Sample Size and Data Provenance (for test set):
Since this is a physical medical device (drills, burrs, trephines) and not an AI/software device, the "acceptance criteria" and "reported device performance" in an AI context (e.g., AUC, sensitivity, specificity, F1-score) are not applicable. The performance evaluated here relates to the mechanical function and biocompatibility of the tools.
| Acceptance Criteria (Bench Testing) | Reported Device Performance |
|---|---|
| Design suitable for speeds up to 80,000 rpm for 2 minutes (Rotating performance test for rotating tools) | Pass |
| With constant pressure and regular irrigation, evaluated bone temperature increase after milling, drilling or cutting (Measurement of temperature) | Pass |
| Biocompatibility in accordance with ISO 10991-1 (Cytotoxicity, Sensitization, Intracutaneous Irritation, Acute Systemic Toxicity, Hemolysis, Pyrogen testing) | All testing met acceptance criterion |
| Endotoxin testing in accordance with ISO 10993-5 | Met acceptance criterion |
| Sterilization validation in accordance with ANSI/AAMI/ISO 11137-1:2006 and ISO 11137-2:2006 (Gamma irradiation) | Validated |
| Packaging validation per ISO 11607 | Validated |
| Shelf life (5 years) validated per ASTM F1980 (Accelerated aging data) | Supported |
Sample Size and Data Provenance:
- For Rotating performance test and Measurement of temperature: The document does not specify the sample size used for these bench tests (e.g., how many tools were tested). The data provenance is implied to be from the manufacturer's internal testing.
- For Biocompatibility, Sterilization, Packaging, and Shelf-life testing: These typically involve standardized protocols where the "sample size" refers to the number of units tested to achieve statistical confidence for validation. Specific numbers are not provided in this summary but are part of the underlying validation reports. The data provenance is internal lab testing by the manufacturer or their contractors.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is not applicable as the studies described are bench tests and biocompatibility tests for a physical device, not a diagnostic or AI-driven system requiring expert ground truth for interpretation (e.g., radiologist reads).
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable for the same reason as above.
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 tool, not an AI diagnostic or assistance system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the physical device testing:
- Bench Testing (Rotating performance, Temperature Measurement): Ground truth is based on engineering specifications and physical measurements, demonstrating the device performs as designed under specified conditions.
- Biocompatibility, Sterilization, Packaging, Shelf-life: Ground truth is established by adherence to recognized international standards (ISO, ASTM) and achieving specified pass/fail criteria (e.g., no cytotoxicity, acceptable endotoxin levels, sterility assurance level).
8. The sample size for the training set & 9. How the ground truth for the training set was established:
Not applicable. This device does not involve a "training set" in the context of machine learning or AI. The development process would involve iterative design and testing, but not in the same sense as an AI model's training phase.
In summary: The provided document is a 510(k) clearance letter and summary for a conventional surgical instrument. The "acceptance criteria" and "study" described pertain to the manufacturing, material science, and mechanical performance of the physical tools, and their biological safety (biocompatibility and sterilization). It does not involve any AI, software, or diagnostic imaging components, thus many of the requested fields are not relevant to this specific submission.
§ 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).