(59 days)
The Hubly Electric Drill is a single-use, sterile, disposable device intended for use on adult patients during neurosurgical procedures for drilling of cranial bone.
The Hubly Electric Drill is a battery powered cranial drill. It is single-use disposable and provided ethylene oxide sterilized. The drill is designed to create optimal burr holes, in the emergency room, at the bedside, or in the operating room. The system is designed to streamline bedside intracranial access and facilitate the treatment of emergent conditions in adult patients.
The device is a battery-powered hand drill which can be used one-handed using either hand. The drill is trigger-activated after removal of the battery pull tab. The drill has a single speed and turns off when the trigger is released. The drill bit has depth indicators at 5 and 10mm depth, which the physician may use to visually gauge depth of penetration while drilling.
The drill also has an auto-stop feature which detects when the bit breaks through the inner table of the skull and immediately stops the drill. The device has an LED indicator which indicates to the user (green) when they are applying enough force and (red) when the drill stops.
The drill features mechanical plunge prevention with a tapered stainless steel drill may be reactivated any number of times using the trigger if the physician desires.
The provided text describes performance testing for the Hubly Electric Drill. However, it does not contain specific numerical acceptance criteria or numerical reported device performance in a table format, nor does it detail a study proving the device meets specific acceptance criteria in the way requested.
Instead, the document outlines various tests conducted to demonstrate the device's substantial equivalence to a predicate device and its safety and effectiveness.
Here's an attempt to extract and synthesize the information based on the request, noting where information is not explicitly provided in the text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a table with explicit numerical acceptance criteria and corresponding reported device performance values. It generally states that the device "meets all design specifications and requirements" for bench tests and "all in vivo requirements were met" for the animal study.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not specify a numerical sample size for any of the performance tests (bench testing, animal study).
- Data Provenance:
- Bench Testing: Conducted by Hubly Inc. (implied, as they are the applicant).
- Animal Study: Conducted in a GLP (Good Laboratory Practice) compliant setting using a sheep model. The location/country is not specified.
- Retrospective/Prospective: The tests described (bench, animal) are prospective studies conducted to support the 510(k) submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
- This information is not provided in the document. The studies described are performance tests and an animal study, not studies relying on expert review for ground truth establishment.
4. Adjudication Method for the Test Set
- This information is not applicable/provided. The described tests are instrumental/procedural performance tests and an animal study, not studies involving human reader interpretation requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The document explicitly states: "Clinical testing was not performed on human subjects." The studies focused on bench performance and an animal model.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- The Hubly Electric Drill is a physical medical device (a drill), not an AI algorithm. Therefore, a standalone algorithm performance study is not applicable. The "software verification testing" was conducted on firmware responsible for the automatic stopping feature, but this is an embedded system, not a standalone AI application. The software implements "additional safety features" and has a "Moderate" level of concern.
7. Type of Ground Truth Used
- Bench Testing: Ground truth was implicitly based on engineering design specifications and requirements (e.g., battery life, depth of penetration, trigger performance).
- Animal Study: Ground truth was based on observational outcomes in the sheep model, specifically demonstrating that "Users (Test Device Evaluators) could safely use the Hubly Electric Drill for intracranial access without damaging the dura or brain tissue."
8. Sample Size for the Training Set
- This information is not applicable/provided. The device is a physical drill with embedded firmware, not a machine learning model that requires a training set in the conventional sense. The "software" mentioned is firmware, which is typically developed through traditional software engineering processes, not trained on data.
9. How the Ground Truth for the Training Set Was Established
- This information is not applicable/provided for the reasons stated in point 8.
§ 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).