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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:

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.

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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:

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.

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