(470 days)
The hekaDrill system is intended for use in surgical procedures involving incision / cutting, removal, drilling, and sawing of soft and hard tissue and bone. The system is specifically intended for use in Neurologic 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 provided text describes a 510(k) submission for the hekaDrill System. It includes details about performance testing, but it does not provide acceptance criteria in a quantitative format or a detailed study section with specific sample sizes, ground truth procedures, or expert involvement as requested.
However, based on the limited information available in the "Discussion of the Performance Testing" table, I can extract and infer some aspects related to acceptance criteria and reported device performance.
Here's an attempt to structure the answer based on the given information, with caveats about missing details:
Acceptance Criteria and Supporting Study for hekaDrill System
The K193630 submission for the hekaDrill System included performance testing to demonstrate the functionality and safety of the device compared to predicate devices. The following table summarizes the reported performance relative to general criteria.
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria Category | Specific Criteria (Inferred from "Conclusion" column in source) | Reported Device Performance |
|---|---|---|
| General Performance | Cutting performance (vibration, noise, control) equivalent or superior to predicate. | Cutting performance was equivalent or better to that of predicate device. |
| Electrical Performance | Adherence to IEC 60601-1:2005 for electrical safety. | Instruments conform to IEC 60601-1:2005 for electrical safety. |
| Electromagnetic Compatibility | Adherence to IEC 60601-1-2:2014 for electromagnetic compatibility. | Instruments conform to IEC 60601-1-2:2014 for electromagnetic compatibility. |
| Biocompatibility | Non-cytotoxic. | Non-cytotoxic (No biological reactivity - Grade 0). |
| Non-sensitizer (0% sensitization). | Non-sensitizer (elicited no reaction at challenge). | |
| Non-irritant. | Non-irritant (Test article sites did not show significantly greater biological reaction than control). | |
| Non-toxic (systemic). | Non-toxic (Test article did not induce a significantly greater biological reaction than control extracts). | |
| Non-pyrogenic. | Non-pyrogenic (Test article did not induce a Pyrogenic response). | |
| Non-hemolytic. | Non-hemolytic (Test article led to a hemolysis index above the negative control of 0.14%). |
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify the sample sizes used for any of the performance tests. For instance, for "Cutting performance," it does not state how many devices were tested or how many cutting tasks were performed. For biocompatibility tests, the number of samples or specimens analyzed is not provided.
- Data Provenance: The document does not explicitly state the country of origin of the data or whether the studies were retrospective or prospective. Given that these are bench and lab-based performance tests for a new device submission, they would typically be prospective studies conducted in a controlled lab environment by Zethon Ltd (a UK company) or its contracted testing facilities.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. The performance tests described (cutting performance comparison, electrical safety, EMC, biocompatibility) are primarily objective, quantitative measurements against established standards or predicate device performance, rather than requiring expert interpretation for ground truth.
4. Adjudication method for the test set:
- This information is not applicable/provided. The tests are objective measurements against standards or predicate performance, not subjective readings requiring adjudication for ground truth.
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:
- This information is not applicable. The device, hekaDrill System, is an electric cranial drill motor, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study or assessment of AI assistance would not be relevant to this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This information is not applicable. As stated above, the hekaDrill System is a surgical instrument, not an algorithm.
7. The type of ground truth used:
- For the General Performance (Cutting performance), the ground truth was based on a comparison to a predicate drill system (Midas Rex Drill Systems), implying the predicate's performance served as a benchmark for "equivalent or better."
- For Electrical Performance and Electromagnetic Compatibility, the ground truth was adherence to international consensus standards (IEC 60601-1:2005 and IEC 60601-1-2:2014, respectively).
- For Biocompatibility, the ground truth was established by recognized biocompatibility testing methods (e.g., L929 MEM Elution for cytotoxicity, Kligman Maximization for sensitization, etc.) where specific biological responses or lack thereof (e.g., "Non-cytotoxic," "Non-sensitizer") define compliance.
8. The sample size for the training set:
- This information is not applicable/provided. The device is a surgical instrument, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established:
- This information is not applicable. As there is no training set for a machine learning algorithm, there is no ground truth to establish for it.
§ 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).