(346 days)
The Karl Storz ARTHROPUMP POWER Irrigation/Suction Pump is intended for use by qualified surgeons to provide irrigation/aspiration to the surgical site during arthroscopic surgical procedures in the joints of the shoulder, knees, ankle, elbow, wrist, and hip.
The Karl Storz ARTHROPUMP POWER is a combined irrigation and suction pump for dilation and irrigation of joint capsules with a fluid. Both roller pumps are software controlled and automatically manage fluid and joint pressure based on settings chosen by the user. If desired, both flow and manage hald and joint proodividually adjusted. The device is used as part of a system that includes the unit, a footswitch and tubing, and can support integrated use of a shaver.
The provided document is a 510(k) summary for the KARL STORZ ARTHROPUMP POWER Irrigation/Suction Pump. This type of document typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with detailed acceptance criteria and performance metrics for a novel AI/software device.
Based on the information available in the document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states: "Test results show that all specifications have been met." However, it does not provide a table of
specific acceptance criteria or quantitative performance metrics (e.g., accuracy, precision, etc.) for the device. The focus is on functional, performance, and safety testing to demonstrate that the device meets its design specifications, but these specifications are not detailed in the summary.
2. Sample size used for the test set and the data provenance:
Not applicable. The document does not describe a test set in the context of an AI/software device evaluation. Performance testing mentioned is for the physical device's function, performance, and safety, not for evaluating an algorithm's output on a dataset.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This information is relevant for AI/software devices where human experts establish ground truth for testing.
4. Adjudication method for the test set:
Not applicable. This is typically used in the context of expert review of AI/software outputs.
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:
No, an MRMC study was not done. The device is an irrigation/suction pump, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an AI/software algorithm. The device itself is a physical pump with software control. The document mentions "microprocessor controlled dual peristaltic pump technology" and that "both roller pumps are software controlled," but this refers to the operational control of the pump, not an AI algorithm performing a diagnostic or analytical task.
7. The type of ground truth used:
Not applicable. The "ground truth" concept as applied to AI/software performance (e.g., pathology, outcomes data) is not relevant for this device. The "ground truth" for this device would be its correct physical function, pressure maintenance, and flow rates according to engineering specifications.
8. The sample size for the training set:
Not applicable. This device is not an AI/software algorithm that requires a training set.
9. How the ground truth for the training set was established:
Not applicable.
Summary:
The KARL STORZ ARTHROPUMP POWER is a medical device (an irrigation/suction pump) that utilizes microprocessor-controlled software to manage its mechanical functions. The provided 510(k) summary focuses on demonstrating its substantial equivalence to existing predicate devices (FMS Duo and Karl Storz Arthropump Plus).
The "study" or testing described within this document is typical for a hardware device with embedded software:
- Non-Clinical Performance Data: "The KARL STORZ ARTHROPUMP POWER has been tested for function, performance and safety. Test results show that all specifications have been met."
This statement indicates that the device underwent engineering and functional testing to verify that it meets its pre-defined design specifications for parameters like pressure control, flow rates, and safety mechanisms. However, the exact specifications and the detailed results of these tests are not provided in this summary. The acceptance criteria would be those specific engineering and functional specifications, and the "study" is the internal design verification and validation testing conducted by the manufacturer.
§ 888.1100 Arthroscope.
(a)
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.