(164 days)
The Phasor Drill is a sterile, single-use, disposable device intended for use on adult patients during neurosurgical procedures for drilling of cranial bone.
The Phasor™ Drill is a handheld single unit drill that is a sterile, single use device. The drill includes an ergonomically designed outer shell for ease and maneuverability, a thumbscrew drill stop to ensure the product drills to the preset required depth, and a fixed drill bit made from 440A stainless steel. The Phasor™ Drill is powered by six primary lithium CR2 cells electrically connected in series to provide 18 V. The motor used in the Phasor™ Drill is a brushed DC motor which is designed to be run from a direct current power source, via batteries. The gearbox is integrated into the motor to reduce the rotational speed. The drill bit forms the shaft of the motor eliminating the need for a coupling, chuck or other clutching mechanism. The Phasor™ Drill product family includes various drill sizes depending on the drill bit diameter (0.75-3.2 mm), number of flutes (2 or 3), drill bit length (75-210 mm), and Thumb Screw Drill stop diameters (1.5-3.2 mm). As seen in Figure 1, the Phasor™ Drill has two switches. The ON/OFF button in the front is a momentary push button switch which activates the drill when pressed. The blue slider switch on the top is used for reversing the direction of rotation. The slider switch is a DPDT (double pole; double throw) which reverses the polarity of the drill motor when moved in forward or rearward direction.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Phasor Drill. It's important to note that this document is a 510(k) summary for a medical device and typically focuses on demonstrating substantial equivalence to a predicate device rather than comprehensive clinical effectiveness studies with explicit acceptance criteria for diagnostic performance metric. The "acceptance criteria" here relate more to engineering performance and regulatory compliance for a mechanical device.
Acceptance Criteria and Reported Device Performance
The document describes several performance tests, but it doesn't explicitly state numerical "acceptance criteria" in the format of a typical diagnostic AI/imaging study (e.g., sensitivity, specificity thresholds). Instead, it states that tests were conducted to "verify suitability of the design characteristics" and that "Results of the testing confirmed the Phasor™ meets design requirements."
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Bench Performance | Confirmed the Phasor™ meets design requirements after Compression Test, Torque, and Drill Stop (Pull) tests. Specific quantitative results are not provided in this summary but are referenced as being in Appendix C. |
| Biocompatibility | Performed according to ISO 10993-17:2002 and ISO 10993-18:2005 on drill bits and thumbscrew drill stop. 440A Stainless Steel (drill bit material) is noted as having known biocompatibility with human tissue. Complete biocompatibility testing was also completed by the plastics supplier of the thumbscrew drill stop (referenced in Appendix F). Biotex, Inc. states they met necessary biocompatibility requirements. |
| Shelf Life/Integrity | Product successfully passed the equivalent of one year of aging from Distribution Challenge Testing and Accelerated Aging Studies. All testing performed was conformal. Real-time aging protocol for one and three-year shelf life is planned. |
| Material | Drill bits made from 440A stainless steel, manufactured under standard ASTM F899 (for biocompatibility). |
| Sterility | Provided sterile for single use. Passed conformity after Distribution/Aging Packaging Integrity tests. |
| Power Source | Powered by six primary lithium CR2 cells (18V) and a brushed DC motor. (Functional specification, not performance criterion explicitly stated). |
Study Details
Given that this is a 510(k) for a mechanical surgical drill, the "study" described is a series of engineering and material performance tests, not a clinical trial or an AI algorithm performance study. Therefore, many of the typical questions for an AI device are not directly applicable.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: Not explicitly stated how many devices or components were tested for each performance test (e.g., compression, torque, drill stop pull, aging). The document mentions "results from the performance testing are provided" and "All testing performed was conformal," implying sufficient samples were evaluated to ensure design requirements were met.
- Data Provenance: Not specified. These are likely internal bench tests conducted by Biotex, Inc. or a contracted testing laboratory. The document focuses on regulatory compliance, not geographical data origin. The testing is prospective for the purpose of demonstrating device performance.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- This question is not applicable as the "ground truth" for a mechanical device like a drill is related to its physical performance characteristics (e.g., torque, compression strength, sterility maintenance) which are measured by engineering standards and equipment, not by expert interpretation like in image-based diagnostic AI.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This question is not applicable for the type of engineering performance testing described. Results are based on objective physical measurements against established engineering specifications and standards.
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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 question is not applicable. The Phasor Drill is a mechanical surgical tool, not an AI-assisted diagnostic device. No human-in-the-loop performance or comparison with AI assistance is relevant.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This question is not applicable. The Phasor Drill is a mechanical surgical tool, not an AI algorithm. Its standalone performance is its mechanical function.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" here is based on engineering specifications and recognized standards for mechanical performance (e.g., torque values, pull-out forces), biocompatibility (ISO 10993 standards), and packaging integrity (ASTM standards). These standards define acceptable ranges or outcomes for the device's physical properties and sterility.
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The sample size for the training set
- This question is not applicable. The Phasor Drill is a mechanical device, not an AI algorithm that requires a "training set." Its design and manufacturing are based on engineering principles and material science, not machine learning data.
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How the ground truth for the training set was established
- This question is not applicable for the same reason as question 7.
§ 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).