(156 days)
For Endoscopic removal of polyps and obtaining samples in the gastrointestinal tract.
Not Found
The provided documents are a 510(k) clearance letter and an Indications For Use statement for "Hot Biopsy Forceps, Models 1592, 1594, 1596 and 1598." These documents do not contain any information regarding the acceptance criteria, device performance, or any studies conducted to prove the device meets acceptance criteria.
The 510(k) clearance process by the FDA is primarily about demonstrating substantial equivalence to a legally marketed predicate device, not necessarily proving performance against specific acceptance criteria through clinical studies in the same way a Premarket Approval (PMA) would.
Therefore, I cannot fulfill your request for the following information based on the provided text:
- A table of acceptance criteria and the reported device performance: Not present.
- Sample sized used for the test set and the data provenance: Not present.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present.
- Adjudication method: Not present.
- 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 relevant to this device; this is not an AI-assisted device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not relevant to this device; this is not an AI algorithm.
- The type of ground truth used: Not present.
- The sample size for the training set: Not relevant to this device; this is not an AI algorithm.
- How the ground truth for the training set was established: Not relevant to this device; this is not an AI algorithm.
The documents indicate that the device is "Hot Biopsy Forceps" for "Endoscopic removal of polyps and obtaining samples in the gastrointestinal tract." The clearance is based on substantial equivalence to a predicate device, as opposed to de novo pre-market clinical study data demonstrating specific performance metrics.
§ 876.4300 Endoscopic electrosurgical unit and accessories.
(a)
Identification. An endoscopic electrosurgical unit and accessories is a device used to perform electrosurgical procedures through an endoscope. This generic type of device includes the electrosurgical generator, patient plate, electric biopsy forceps, electrode, flexible snare, electrosurgical alarm system, electrosurgical power supply unit, electrical clamp, self-opening rigid snare, flexible suction coagulator electrode, patient return wristlet, contact jelly, adaptor to the cord for transurethral surgical instruments, the electric cord for transurethral surgical instruments, and the transurethral desiccator.(b)
Classification. Class II (performance standards).