(418 days)
Endoscopic Surgical Instruments are intended for cutting, grasping, dissecting and coagulation of soft tissue in endoscopic surgical procedures. They are intended for single patient use.
The Endoscopic Surgical Instruments are disposable,single use,individually packaged devices that are composed of biocompatible materials. The instruments are 5mm in diameter as well as 330mm (or 420mm) in length.
The instruments consist of handle, shaft and dissector /grasper/scissor jaw.
The provided text is a 510(k) summary for the Kingston Endoscopic Surgical Instruments. This document focuses on demonstrating substantial equivalence to a predicate device based on material, design, dimensions, and sterilization, supported by electrical safety and functional bench testing. It does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of clinical performance or diagnostic accuracy.
Therefore, I cannot provide the requested information in the format specified because the document does not contain:
- A table of acceptance criteria and reported device performance related to a clinical outcome or diagnostic accuracy study. The performance data mentioned are for electrical safety and bench testing, not clinical effectiveness.
- Sample size used for a test set and data provenance related to clinical performance. Bench testing doesn't typically involve a "test set" in this context.
- Number of experts used to establish ground truth or their qualifications. Ground truth is not established for clinical outcomes in this document.
- Adjudication method for a test set.
- Multi-reader multi-case (MRMC) comparative effectiveness study information.
- Standalone (algorithm-only) performance information. This is a physical device, not an algorithm.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for clinical performance.
- Sample size for a training set. This is not an AI/ML device requiring training data.
- How ground truth for the training set was established.
The "Performance Data" section solely refers to:
- Electrical safety testing: In accordance with IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-2.
- Function bench testing: Including Transverse holding force, Longitudinal holding force, Ratchet holding force, Cutting efficacy, and Thermal effects on Tissue.
These are engineering and safety tests, not clinical studies demonstrating performance against a specific clinical acceptance criterion. The conclusion of the 510(k) is about substantial equivalence, stating the device is "as safe, as effective, and performs as well as the predicate device" based on these engineering and design similarities and bench tests.
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.