(75 days)
May be used in conjunction with an electrosurgical generator for endoscopic resection of a polypoid lesion.
The ConMed Deuce Polypectomy Snare is a sterile, single patient use, disposable device used in conjunction with an electrosurgical generator for the delivery of electrosurgical current through a flexible endoscope to a stainless steel wire snare at the operative site for endoscopic resection of a polypoid lesion.
The snare consists of a non-detachable handle with a sliding finger ring mechanism for retracting/extending the distal snare loop. An external sheath covers the snare loop cable and is attached to the distal portion of the snare handle. Within the handle, an electrode completes the circuit between the electrosurgical unit and the snare loop.
The polypectomy snares are manufactured in 230cm sheath lengths with a 2.3mm outer diameter in a variety of different loop configurations.
The provided document describes the 510(k) premarket notification for the ConMed Deuce Polypectomy Snares. It states that "Bench testing has been performed to demonstrate equivalence of the ConMed Polypectomy Snares to their predicate devices. All testing passed the predetermined performance specifications." However, it does not provide details on the specific acceptance criteria, reported performance, sample sizes, ground truth establishment, or any advanced study designs such as MRMC comparative effectiveness or standalone performance studies.
Therefore, most of the requested information cannot be extracted from this document.
Here's a summary of what can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Predetermined performance specifications for equivalence to predicate devices. | All testing passed the predetermined performance specifications. |
2. Sample size used for the test set and the data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned. (Bench testing typically does not involve expert ground truth in the same way clinical studies do.)
4. Adjudication method for the test set: Not applicable for bench testing as described.
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: No, this is a medical device (polypectomy snare), not an AI diagnostic tool. An MRMC study is not relevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is hardware. "Bench testing" can be considered a form of standalone performance measurement for the device itself.
7. The type of ground truth used: For bench testing, the "ground truth" would be the engineering specifications and performance standards of the predicate devices or general industry standards for such devices. The document implies comparison to predicate devices as the basis for equivalence.
8. The sample size for the training set: Not applicable, as this is a hardware device; there is no "training set" in the context of machine learning.
9. How the ground truth for the training set was established: Not applicable.
§ 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).