(90 days)
The hekaDrill system is intended for use in surgical procedures involving incision / cutting, removal, drilling and sawing of soft and hard tissue, bone and biomaterials. The system is specifically intended for use in Neurosurgical (Cranial including craniotomy); Ear, Nose and Throat (ENT), Maxillofacial, Orthopedic, Arthroscopic, Spinal, Stemotomy, and General Surgical Procedures.
The hekaDrill System consists of electric and pneumatic drill handpieces, a power console, footswitches, attachments, connection cables, irrigation tube kits, cutting tools, and system accessories. The handpieces, attachments, and system accessories are provided non-sterile and are reusable. The console and footswitches are reusable and are not intended to be sterilised. The cutting tools and irrigation tube kits are provided sterile and are single use.
The hekaDrill device primarily consists of various components for surgical procedures involving cutting, drilling, and sawing of soft and hard tissues. The performance assessment focused on comparing the device's cutting performance, electrical safety, electromagnetic compatibility, and biocompatibility with predicate devices and relevant standards.
Here's a breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Acceptance Criteria / Standard Met | Reported Device Performance |
|---|---|---|
| General Performance | Equivalent or better cutting performance compared to predicate drill system (vibration, noise, control, and performance) | Cutting performance was equivalent or better to that of the predicate device. |
| Electrical Performance | Electrical safety according to IEC 60601-1:2005 | Instruments conform to IEC 60601-1:2005 for electrical safety. |
| Electromagnetic compatibility according to IEC 60601-1-2:2014 | Instruments conform to IEC 60601-1-2:2014 for electromagnetic compatibility. | |
| Biocompatibility | Non-cytotoxic (L929 MEM Elution) | No biological reactivity (Grade 0) of cells exposed to test article extract. |
| Non-sensitizer (Kligman Maximization) | Test article extracts elicited no reaction at challenge (0% sensitization). | |
| Non-irritant (Intracutaneous Injection) | Test article sites did not show a significantly greater biological reaction than the control article. | |
| Non-toxic (Systemic Toxicity) | Test article did not induce a significantly greater biological reaction than the control extracts. | |
| Non-pyrogenic (Pyrogenicity) | Test article did not induce a pyrogenic response. | |
| Non-hemolytic (Indirect Hemolysis) | Test article led to a hemolysis index above the negative control of 0.14%. |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the specific sample sizes for each performance test (e.g., number of cutting trials, number of biological samples). It also does not specify the country of origin for the data or whether the studies were retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
The document does not mention the use of experts to establish a "ground truth" in the traditional sense for the performance tests described. The assessment relied on objective measurements and comparisons against established standards and predicate device performance. For the biocompatibility tests, the "ground truth" is determined by the specific reaction observed (e.g., cytotoxicity, sensitization), not expert consensus on an image or diagnosis.
4. Adjudication Method for the Test Set:
Not applicable in this context. The performance tests involve objective measurements and comparisons to standards, not subjective interpretations requiring adjudication among experts.
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. The hekaDrill is a surgical drill system, not an AI-powered diagnostic or assistive device that would involve human readers or image interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable, as this is a physical medical device, not a software algorithm.
7. The Type of Ground Truth Used:
For the performance tests:
- General Performance: The "ground truth" was established by comparing direct measurements of performance characteristics (vibration, noise, control, cutting effectiveness) against those same characteristics of a predicate device.
- Electrical Performance: The "ground truth" was the adherence to established international safety standards (IEC 60601-1:2005 and IEC 60601-1-2:2014).
- Biocompatibility: The "ground truth" was dictated by the specific biological responses observed in standardized tests, such as the absence of biological reactivity in cytotoxicity assays or no significant reaction in sensitization tests.
8. The Sample Size for the Training Set:
Not applicable. This is a physical medical device. The concept of a "training set" is typically associated with machine learning or artificial intelligence models.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for this type of device.
§ 874.4250 Ear, nose, and throat electric or pneumatic surgical drill.
(a)
Identification. An ear, nose, and throat electric or pneumatic surgical drill is a rotating drilling device, including the handpiece, that is intended to drive various accessories, such as an ear, nose, and throat bur (§ 874.4140), for the controlled incision or removal of bone in the ear, nose, and throat area.(b)
Classification. Class II.