(62 days)
The Stryker CrossFlow Integrated Arthroscopy Pump is a dual arthroscopic pump system intended to provide fluid distension and irrigation of the knee, shoulder, hip, elbow, ankle and wrist joint cavities and fluid suction during diagnostic and operative arthroscopic procedures.
The Stryker CrossFlow Integrated Arthroscopy Pump is a microprocessor-controlled dual (inflow and outflow) pump system designed to provide liquid distention and irrigation of joint cavities and aspiration of liquids out of the joint cavities during diagnostic and operative arthroscopy. Both the irrigation and aspiration pump of the device function according to the peristaltic principle. The Stryker CrossFlow Integrated Arthroscopy Pump consists of the following main components: console housing, power supply, two peristaltic pumps, three pinch valves, and a touch-screen display panel. The device is to be used with specially designed irrigation and aspiration tube sets and can be operated by remote hand and foot controls. A constantly-performed pressure sensing algorithm controls the value of the actual pressure in the joint cavity as compared to the set pressure determined by the user.
The Stryker CrossFlow Integrated Arthroscopy Pump is a medical device, and the provided 510(k) summary focuses on demonstrating its substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and a study to prove its performance in the same way one would for a diagnostic AI device.
Therefore, the requested information elements (acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication, MRMC studies, standalone performance, ground truth types, training set details) are generally not applicable or not explicitly provided in the context of this 510(k) submission for a physical pump system.
Here's a breakdown of what can be extracted and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance
- Acceptance Criteria: Not explicitly stated as pass/fail thresholds for clinical performance metrics in the provided document. Instead, the "acceptance criteria" are related to conformance with design specifications and voluntary external standards.
- Reported Device Performance: The document states that "bench performance testing performed on the Stryker CrossFlow Integrated Arthroscopy Pump verifies that the device satisfies design specifications and their acceptance criteria." However, specific numerical performance results (e.g., flow rates, pressure accuracy, ranges) are not detailed in this summary.
2. Sample size used for the test set and the data provenance
- Not Applicable/Not Provided. This type of information is typically for studies involving clinical data or imaging for AI/diagnostic devices. The testing mentioned in the document is bench testing of the physical pump system.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable/Not Provided. Ground truth established by experts is relevant for diagnostic or AI systems. For a physical pump, "ground truth" would relate to engineering specifications and measurements.
4. Adjudication method for the test set
- Not Applicable/Not Provided. Adjudication methods are used in clinical studies, particularly for interpreting ambiguous cases or establishing ground truth from multiple expert opinions.
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 a type of study specifically for AI-assisted diagnostic or interpretative tasks. The Stryker CrossFlow is a surgical pump.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable/Not Provided. This is relevant for AI algorithms. The "algorithm" in this device controls the pump's mechanical function, and its performance is assessed as part of the overall device's bench testing.
7. The type of ground truth used
- Not Applicable/Not Provided (in the AI/clinical sense). For this device, the "ground truth" for performance would be objective measurements against engineering specifications and validated test methods (e.g., pressure sensors, flow meters).
8. The sample size for the training set
- Not Applicable/Not Provided. This applies to AI/machine learning models.
9. How the ground truth for the training set was established
- Not Applicable/Not Provided. This applies to AI/machine learning models.
Summary of relevant information from the document related to "acceptance criteria" and "study":
The document highlights the following performance testing:
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Bench Performance Testing: "Bench performance testing performed on the Stryker CrossFlow Integrated Arthroscopy Pump verifies that the device satisfies design specifications and their acceptance criteria."
- Nature of "Acceptance Criteria": These relate to the device's adherence to its design specifications (e.g., maintaining set pressure, achieving specified flow rates, proper functioning of peristaltic pumps, pinch valves, software controls, etc.). Specific numerical values for these criteria are not disclosed in this summary.
- Nature of "Study/Testing": This refers to internal bench testing. Details about the methodology, exact test protocols, or raw data are not provided in this 510(k) summary. These would reside in the full 510(k) submission.
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Conformance to Voluntary External Standards:
- Biocompatibility: Verified per ISO 10993-1:2009/Cor 1:2010 for patient contacting materials.
- Software: Developed, tested, and verified per FDA guidance documents and IEC 62304:2006.
- Electrical Safety: Tested to IEC 60601-1:1988/A1:1991/A2:1995.
- Electromagnetic Compatibility: Verified by testing to IEC 60601-1-2:2007.
Conclusion stated by Stryker:
"The submitted information in this premarket notification is complete, and based on the indications for use, technological characteristics, performance testing and comparison to the predicate device, the Stryker CrossFlow Integrated Arthroscopy Pump raises no new questions of safety and effectiveness. The proposed device is substantially equivalent to the predicate device."
In essence, for this specific device and document, the "study" is the described bench performance testing and conformance to recognized standards, and the "acceptance criteria" are the device's internal design specifications and requirements of those standards. This is typical for a premarket notification (510(k)) for a device like an arthroscopic pump, which is demonstrating substantial equivalence to a predicate device based on similar technology and performance. It does not involve the elaborate clinical validation studies, expert ground truth establishment, or AI-specific metrics you've outlined, which are more common for diagnostic software or AI devices.
§ 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.