(127 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 solely for use with the ELAN 4 Electro Motor System. The ELAN 4 Electro Motor System 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 either a diamond coated or tungsten carbide head. The ELAN 4 Tools are components of the ELAN 4 Electro Motor System.
This document describes the premarket notification for the Aesculap ELAN 4 Tools (K182527), which are intended for high speed cutting, sawing, and drilling of bone. The information provided focuses on demonstrating substantial equivalence to a predicate device, rather than a study proving performance against specific acceptance criteria for an AI/ML powered device.
Therefore, many of the requested details about acceptance criteria, study design for AI, expert involvement, and ground truth are not applicable or cannot be extracted from this document, as this is a traditional medical device submission, not an AI/ML device submission.
Here's a breakdown of the information that can be extracted and where details are not applicable (N/A) or not provided (NP) given the nature of this submission:
1. A table of acceptance criteria and the reported device performance
For this traditional medical device, the "acceptance criteria" are based on demonstrating substantial equivalence to a legally marketed predicate device through design, materials, and performance testing (like biocompatibility and bench testing, rather than clinical performance metrics for an AI algorithm).
| Acceptance Criteria Category | Specific Test/Comparison Point | Reported Device Performance (Summary) |
|---|---|---|
| Biocompatibility | Cytotoxicity, Sensitization, Intracutaneous Irritation, Acute Systemic Toxicity, Hemolysis, Pyrogen testing per ISO 10993-1 | All tests passed, demonstrating biological safety and substantial equivalence to predicate devices. |
| Bench Testing - Rotational Performance | Determine suitability for speeds up to 100,000 rpm (for burrs and disc) | Passed ("Design not suitable, suitable for speeds up to 100,000 rpm" - Note: The wording here is a bit ambiguous, but implying it meets the capability.) |
| Bench Testing - Temperature Measurement | Evaluate bone temperature increase after milling, drilling, or cutting with constant pressure and regular irrigation | Passed ("With constant pressure and regular irrigation, evaluated bone temperature increase after milling, drilling or cutting") |
| Technological Characteristics Comparison to Predicate (Anspach Dissection Tools K113476) | Indications for Use | Substantially equivalent ("The ELAN Tools are intended for high speed cutting, sawing, and drilling of bone in the fields of Spine, ENT, Neuro, and Maxillofacial Surgery." vs. "Dissection tools are intended for cutting and shaping bone including spine and cranium.") |
| Regulation number, Product Code, Regulatory Panel | Identical (882.4310, HBE, Neurology) | |
| Burrs & drills - Size | Similar (0.6 mm to 25 mm for subject vs. 0.5 mm to 24.5 mm for predicate) | |
| Burrs & drills - Type | Identical (fluted, ball, conical, oval, barrel, acorn, pin, twist, drills, cutters, and discs) | |
| Materials | Similar (Stainless steel, diamond, tungsten carbide for subject vs. Stainless steel, diamond, carbide for predicate) | |
| Attachment mechanism | Yes for both | |
| Sterile Single Use | Yes for both | |
| Sterilization | GAMMA irradiation for subject, unknown for predicate (but implies predicate is sterile) |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: N/A (This is a traditional mechanical device, not an AI/ML system that uses a 'test set' in the same way for performance evaluation on predictive tasks.) The "tests" here refer to physical product testing (e.g., biocompatibility on samples, bench testing on devices).
- Data Provenance: N/A (Not relevant for this type of device submission.)
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- N/A (Ground truth in the context of an AI/ML test set is not applicable here. The "truth" is established through physical/material properties and mechanical performance specifications.)
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A (Not applicable for this type of device testing.)
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
- No. This is not an AI/ML device, and thus no MRMC study or human-in-the-loop performance evaluation was performed or is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- N/A. This is a surgical tool, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device's performance is based on engineering specifications, material science standards (e.g., ISO for biocompatibility), and direct physical measurements (e.g., temperature, rotational speed tolerances).
8. The sample size for the training set
- N/A. This is not an AI/ML device; there is no 'training set' in this context.
9. How the ground truth for the training set was established
- N/A. Not applicable.
§ 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).