(71 days)
RZ Endoscopic (Minimally Invasive) Instruments and Accessories are indicated for various endoscopic procedures and include both electrical and non-electrical accessories.
RZ Endoscopic (Minimally Invasive) Instruments and Accessories consist of 1. Modular Forceps (reusable) 2. Single-Piece Forceps 3. Modular Forceps with Disposable Tips 4. Electrodes 5. Resectoscopic Instruments & Electrodes (reusable & disposable) 6. Electrosurgical Cables
The provided text is a 510(k) Summary for "RZ Endoscopic (Minimally Invasive) Instruments and Accessories". It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria.
Specifically, the document states: "Performance Data: Testing was performed to support substantial equivalence to the predicate devices. The RZ Endoscopic (Minimally Invasive) Instruments and Accessories met all specified design and performance requirements." This is a general statement that confirms performance testing was done and the device passed, but it does not provide any specific details about:
- A table of acceptance criteria and the reported device performance: No specific metrics, thresholds, or results are presented.
- Sample size used for the test set and the data provenance: No information on how many devices were tested or where the test data came from.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as this is for medical image analysis or diagnostic devices, not surgical instruments. The "ground truth" for surgical instruments typically involves engineering specifications and direct performance measurements (e.g., tensile strength, insulation integrity, cutting efficiency).
- Adjudication method: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
- Standalone performance study (algorithm only): Not applicable, as this is a physical medical device, not an algorithm.
- Type of ground truth used: Implied to be engineering specifications and functional testing, but not explicitly detailed.
- Sample size for the training set: Not applicable, as this is not an AI/ML device.
- How the ground truth for the training set was established: Not applicable.
The document's purpose is to establish substantial equivalence to predicate devices based on design and general performance requirements, not to detail the specific performance criteria and study results in the manner requested for AI/ML or diagnostic devices.
§ 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.