(288 days)
The Stryker Auto Irrigation System is intended for use with the Maestro Pneumatic System for providing controlled, cooling irrigation during cutting, shaping, and removal of bone.
The Stryker Auto Irrigation System provides on-demand irrigation using a peristaltic pump. The system consists of an enclosure containing the pump, an attachable irrigation cassette and a sensor plug.
The provided document is a 510(k) summary for the Stryker Auto Irrigation System. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study with acceptance criteria and device performance metrics in the way modern AI/ML device submissions do.
Therefore, much of the requested information (such as specific performance metrics, sample sizes for test/training sets, expert qualifications, ground truth establishment, or human-in-the-loop studies) is not available in this type of submission.
Here's a breakdown of what can be extracted and what cannot:
1. Table of acceptance criteria and the reported device performance
The submission demonstrates substantial equivalence based on intended use and technological characteristics being similar to predicate devices. It does not present specific quantitative acceptance criteria or performance metrics for the device itself.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Intended Use: Same as predicate device (Anspach Irrigation Pump and Irrigation Pump II) | The Stryker Auto Irrigation System has the same intended use: "providing controlled, cooling irrigation during cutting, shaping and removal of bone." |
| Technological Characteristics: Same as predicate device | "This device and the predicate device have the same technological characteristics, the same operating principles and have similar performance characteristics." (Specific characteristics are not detailed, but imply similarity in pump mechanism, control, etc., without providing quantitative data). |
| Operating Principles: Same as predicate device | "This device and the predicate device have the same technological characteristics, the same operating principles and have similar performance characteristics." |
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 / Not provided. This submission does not include a specific "test set" in the context of an AI/ML device. The evaluation is based on a comparison to existing predicate devices, implying engineering design verification and validation, but not a clinical study or a data-driven performance study in the modern sense.
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 / Not provided. Ground truth establishment is not relevant for this type of device and submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not provided.
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 / Not provided. This is not an AI/ML device; it's an electromechanical surgical irrigation pump.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable / Not provided. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable / Not provided. Ground truth is not relevant for this type of device and submission. The "ground truth" for demonstrating substantial equivalence is the existing performance and safety profile of the predicate devices.
8. The sample size for the training set
- Not applicable / Not provided. This is not an AI/ML device.
9. How the ground truth for the training set was established
- Not applicable / Not provided. This is not an AI/ML device.
Study Proving Device Meets Acceptance Criteria:
The document states: "Based upon the comparison to the predicate devices, the Stryker Auto Irrigation System is substantially equivalent to a legally marketed device."
This means the "study" proving the device meets the "acceptance criteria" (which in this context is "substantial equivalence") is a comparison to predicate devices (K030576 Anspach Irrigation Pump and Irrigation Pump II). The comparison asserts that the Stryker Auto Irrigation System has:
- The same intended use.
- The same technological characteristics.
- The same operating principles.
- Similar performance characteristics.
The supporting evidence would typically be engineering design specifications, bench testing results, and perhaps biocompatibility testing (which are not detailed in this summary). There is no clinical trial data or performance study as we would see for a novel therapeutic or diagnostic device, especially not one involving AI/ML.
§ 880.5725 Infusion pump.
(a)
Identification. An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.(b)
Classification. Class II (performance standards).