(90 days)
The Stryker Cassette Pump is intended as a general purpose suction and/or irrigation device for use in laparoscopic and open general surgery, laparoscopic and open gynecological surgery, laparoscopic and open urologic surgery, endoscopic and open nasal surgery, open otolaryncologic surgery, and open plastic surgery. This device provides sterile irrigant solution, serves as a conduit for suction, and functions as a cannula for accessory instrumentation, including electrosurgical devices.
The Stryker Cassette Pump is a modification of the currently marketed Stryker Strykeflow Suction Irrigator in that the batteries are rechargeable and relocated with the motor to a re-usable pump console. The single use tube set is equivalent to the Stryker Strykeflow Suction Irrigator.
The provided text is a 510(k) summary for the Stryker Cassette Pump, demonstrating its substantial equivalence to predicate devices, rather than a study with specific acceptance criteria and detailed performance results. Therefore, much of the requested information regarding acceptance criteria, sample sizes, expert involvement, and ground truth cannot be extracted directly from this document.
However, I can provide what is stated and highlight what is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety | Conforms to voluntary safety standards (IEC 60601-1, IEC 60601-1-1, etc.) |
| Effectiveness | Equivalent to predicate devices (Stryker Strykeflow K954726, Davol® X-Stream" K003790) |
| Conformity to relevant voluntary safety and performance standards | Conforms to IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-1-4, IEC 60529, ISO 10993, ANSI/AAMIHF-18 2003 |
Missing: Specific quantitative acceptance criteria (e.g., maximum flow rate, minimum suction pressure, battery life, seal integrity) and the exact measured performance values for the Stryker Cassette Pump are not detailed. The document only states that "Laboratory and performance testing demonstrate that the characteristics of the Stryker Cassette Pump are equivalent in Safety and Effectiveness to the referenced predicate devices."
2. Sample Size Used for the Test Set and Data Provenance:
Missing: The document does not specify any sample sizes for a "test set" in the context of device performance. The entire submission is about demonstrating substantial equivalence, not a standalone clinical or experimental study with a defined test set. Data provenance (country of origin, retrospective/prospective) is not applicable here as it's a device submission, not a study involving patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Missing: As there is no "test set" and ground truth in the context of an AI/human performance study, this information is not applicable. The assessment here is based on engineering and performance testing against established standards and predicate devices.
4. Adjudication Method for the Test Set:
Missing: Not applicable for this type of device submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
Missing: No MRMC study was done or mentioned. This is a medical device approval document, not related to AI comparative effectiveness.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
Missing: This is not applicable as the device is a physical pump, not an algorithm.
7. The Type of Ground Truth Used:
The "ground truth" in this context refers to the established safety and performance characteristics of the predicate devices and the compliance with recognized voluntary standards.
- Established Predicate Device Performance: The functional specifications, safety profiles, and clinical indications of the Strykeflow Suction Irrigator (K954726) and Davol® X-Stream" Laparoscopic Irrigation System (K003790) serve as benchmarks.
- Voluntary Safety and Performance Standards: The device's adherence to standards such as IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC 60601-1-4, IEC 60529, ISO 10993, and ANSI/AAMIHF-18 2003 forms the basis of its "ground truth" for safety and general performance.
8. The Sample Size for the Training Set:
Missing: Not applicable. This document describes a physical medical device, not a machine learning model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established:
Missing: Not applicable.
§ 880.6740 Vacuum-powered body fluid suction apparatus.
(a)
Identification. A vacuum-powered body fluid suction apparatus is a device used to aspirate, remove, or sample body fluids. The device is powered by an external source of vacuum. This generic type of device includes vacuum regulators, vacuum collection bottles, suction catheters and tips, connecting flexible aspirating tubes, rigid suction tips, specimen traps, noninvasive tubing, and suction regulators (with gauge).(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.