(57 days)
The Stryker® Consolidated Operating Room Equipment (CORE™) Maestro Air Pneumatically operated surgical instrument system. The pneumatic motor provides power to operate removable rotating surgical cutting. tools and their accessories intended for use in neurosurgery, including craniotomy and spinal surgery; as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial and sternotomy surgeries.
The Stryker® Maestro Air™ Motor(s) is a pneumatic motor powered by a regulated gas source. When connected to a gas source via tubing, the pneumatic motor operates at a normal operating pressure up to 150-psi (per square inch). The motor speed is controlled by a handswitch or a footpedal that connects to the motor and to a regulated gas source.
This 510(k) summary describes a medical device, the Stryker® Maestro™ Air Motors, which is a pneumatic cranial drill motor. It does not involve any AI/ML components or describe a study related to AI/ML device performance. Therefore, the specific questions regarding AI/ML acceptance criteria, sample sizes for test and training sets, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance cannot be answered from the provided text.
The document primarily focuses on demonstrating substantial equivalence to a predicate device (Stryker Maestro Pneumatic System, K041754) based on non-clinical performance testing.
Here's an analysis of the provided text, addressing what can be answered:
1. Table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" with numerical targets for each performance metric in a pass/fail sense. Instead, it states that "The results of the performance testing demonstrate that the functionality, integrity and safety and effectiveness of the Stryker Maestro Air Motors are sufficient for their intended use and support a determination of substantial equivalence to the predicate device."
However, we can infer performance comparisons from Table 6-1, which compares the subject device to the predicate device. These comparisons implicitly serve as "performance criteria" for demonstrating substantial equivalence.
| DESCRIPTION | Predicted Acceptance Criteria (Based on Predicate) | Reported Device Performance (Stryker® Maestro Air™ Motors) |
|---|---|---|
| Classification of Device | Class II | Class II |
| Regulation | 21 CFR 882.4370; Pneumatic Cranial Drill Motor | 21 CFR 882.4370; Pneumatic Cranial Drill Motor |
| Product Code | HBB | HBB |
| Power source | Dry, Filtered, Compressed air or nitrogen | Dry, Filtered, Compressed air or nitrogen |
| Patient Population | General | General |
| Contraindications | None known | None known |
| Motor Type | High Speed, High Torque, Pneumatic Vane | High Speed, High Torque, Pneumatic Vane |
| Mode of Action | Footpedal and Handswitch | Footpedal and Handswitch |
| Operating Speed | Up to 75,000 rotations per minute | Up to 75,000 rotations per minute |
| Stall Torque | 5.6 in-oz. @ 150 psi (per square inch) | 6.7 in-oz. @ 150 psi (per square inch) |
| Maximum Operating Pressure | 120 psi (per square inch) | Up to 150 psi (per square inch) |
| Grip Design | Smooth | Knurled (Different, but likely considered acceptable as a design feature, not functional) |
| Router Retention Mechanism | Friction | Spring Collar (Different, but likely considered acceptable as a design feature) |
| Method of Sterilization | Moist Heat (Steam) | Moist Heat (Steam) |
| Sterility Assurance Level (SAL) | 10-e (likely 10^-6) | 10-e (likely 10^-6) |
| Method of Packaging | Packaged in a polybag case configuration | Packaged in a sealed air Korrvu retention Insert configuration (Different packaging method) |
| Cleaning Method | Manual | Manual and Mechanical (automated) (Expanded cleaning method) |
| Weight of the Motor and Hose | 2.05 lb. | 1.65 lb. (Lighter) |
| Housing Material | Stainless Steel | Stainless Steel and Aluminum (Different materials) |
| Pneumatic Hose Assembly | Exhaust Hose: Flurosilicone Inlet Hose: Nitrile rubber | Exhaust Hose: Flurosilicone with silicone jacket and Slick Sil coating Inlet Hose: Nitrile rubber and neoprene (Different hose materials/coatings) |
Study that proves the device meets the acceptance criteria:
The study performed was a set of non-clinical verification tests. These tests included:
- Reliability Testing (Motor body, Handswitch mounting, Router Retention, Pneumatic Hose assembly and automated washing)
- Packaging Testing
- Cleaning Testing
- Sterilization Testing
The results of these tests demonstrated that the functionality, integrity, and safety and effectiveness of the Stryker Maestro Air Motors are sufficient for their intended use and support a determination of substantial equivalence.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify exact sample sizes for the non-clinical tests (e.g., how many motors were tested for reliability). It only lists the types of tests performed. It also does not provide information on data provenance in terms of country of origin or retrospective/prospective nature, as these are non-clinical engineering tests, not patient studies.
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. This is a submission for a mechanical device based on non-clinical engineering tests, not an AI/ML device requiring expert-established ground truth from medical images or clinical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as ground truth establishment by experts for a test set is not relevant to this type of device submission.
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/ML device and no MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. For this mechanical device, the "ground truth" for performance is established through engineering specifications, validated test methods (e.g., measuring torque, speed, pressure resistance), and established industry standards for sterilization, packaging, and cleaning.
8. The sample size for the training set
Not applicable. This is not an AI/ML device, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device.
§ 882.4370 Pneumatic cranial drill motor.
(a)
Identification. A pneumatic cranial drill motor is a pneumatically operated power source used with removable rotating surgical cutting tools or drill bits on a patient's skull.(b)
Classification. Class II (performance standards).