(67 days)
The Command2 MicroElectric System is intended for use in the cutting, drilling, reaming, decorticating, and smoothing of bone and other bone related tissue in a variety of surgical procedures including: ENT, dental, orthopedic, maxiofacial, spinal, and plastics. It is also usable in the placement or cutting of screws, wires, pins, and other fixation devices.
The Stryker Command2 MicroElectric System, consisting of electrically powered surgical instruments, controls, power source, and other system accessories
This document is a 510(k) premarket notification for a surgical instrument system (K961970 Stryker Command2 MicroElectric Surgical System). The primary purpose of this type of submission is to demonstrate substantial equivalence to a predicate device, not necessarily to provide detailed performance studies against specific acceptance criteria in the way a novel AI/software device would.
Therefore, many of the requested categories for AI/software device studies are not applicable to this 1996 surgical instrument submission. I will address the relevant points based on the provided text, and explicitly state when a category is not applicable.
1. A table of acceptance criteria and the reported device performance
Since this is a submission for substantial equivalence of a physical surgical instrument system, the "acceptance criteria" are primarily related to safety, intended use, and equivalence to existing devices. There isn't a table of quantifiable performance metrics in the way one would find for a software algorithm (e.g., sensitivity, specificity).
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Intended Use Equivalence: Cutting, drilling, reaming, decorticating, and smoothing of bone and other bone-related tissue in various surgical procedures (ENT, dental, orthopedic, maxiofacial, spinal, plastics), and placement/cutting of fixation devices. | The Stryker Command2 MicroElectric System is stated to be "equivalent in intended use, safety, and effectiveness to powered instruments, controls, and associated accessories that were marketed by Stryker prior to the 1976 Medical Devices Amendment." It also states the additional power source/console feature is "equivalent to existing power sources distributed by MicroAire. Intended use, function, and safety risks are all substantially equivalent." |
| Safety and Effectiveness Equivalence: Comparable safety and effectiveness to predicate devices. | The device "does not raise any new safety and efficacy concerns when compared to similar devices already being marketed." The cutting accessories are equivalent in materials, cutting action, and configuration to pre-1976 devices, offering "required precision for controlling the location and extent of the surgical contact." Safety warnings, malfunction troubleshooting, and operating duty cycles are listed in the Operator's Manual. |
| Standard Compliance: Meet relevant electrical and safety standards. | The Stryker Command2 MicroElectric System is "designed to meet the following Standards: CSA 22.2 No. 601.1-M90, UL 2601-1 First Edition, IEC 601-1 with amendments, IEC 601-1-2, CISPR 11, IEC 1000-4-2, IEC 1000-4-3, IEC 1000-4-4, IEC 1000-4-5." This indicates adherence to established electrical and safety benchmarks for medical devices. |
| Material/Configuration Equivalence of Cutting Accessories: Similar materials, cutting action, and surface configuration to predicate devices. | The cutting accessories are "equivalent to devices distributed by Stryker prior to the 1976 Medical Devices Amendment" regarding materials of construction, cutting action, and cutting surface configuration. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This submission is for a physical surgical instrument and relies on a comparison to predicate devices, not on a test set of data for an algorithm. There is no mention of a "test set" in the context of an algorithmic evaluation.
3. 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)
Not applicable. As noted above, there is no "test set" or ground truth established by experts in the context of an algorithmic evaluation for this device. The "ground truth" for a surgical instrument's performance is typically established through a history of its use in surgical procedures, adherence to engineering specifications, and compliance with standards. The document mentions that the predicate designs "proven in surgical procedures" offer the required precision.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set for algorithmic performance.
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. This is not an AI-assisted device, nor is it a diagnostic imaging device that would typically involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device does not involve a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the claims in this submission is primarily based on:
- Historical Performance of Predicate Devices: The document frequently refers to devices marketed by Stryker prior to the 1976 Medical Devices Amendment and existing power sources distributed by MicroAire as having established safety and effectiveness.
- Engineering Standards Compliance: Adherence to various CSA, UL, and IEC standards signifies that the device meets established benchmarks for safety and performance in its electrical and mechanical aspects.
- Implied Clinical Use: Claims that predicate designs were "proven in surgical procedures" suggest that historical clinical use and outcomes informed the understanding of their required precision and effectiveness.
8. The sample size for the training set
Not applicable. No training set as this is not an algorithm.
9. How the ground truth for the training set was established
Not applicable. No training set.
§ 878.4820 Surgical instrument motors and accessories/attachments.
(a)
Identification. Surgical instrument motors and accessories are AC-powered, battery-powered, or air-powered devices intended for use during surgical procedures to provide power to operate various accessories or attachments to cut hard tissue or bone and soft tissue. Accessories or attachments may include a bur, chisel (osteotome), dermabrasion brush, dermatome, drill bit, hammerhead, pin driver, and saw blade.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.