(90 days)
These devices are intended to endoscopically transect polyps in the gastrointestinal tract (sessile or perdunctuated) using electrocautery. During the same maneuver the polyp is captured, retrieved and submitted for pathological analysis.
This disposable product consists of a handle equipped with a male plug for connection to a standard ESU, a flexible sheath and a cable to which a snare loop fitted with a net is attached distally. Upon resection, the device and scope is removed from the patient and the polyp removed from the net together in a continuous retrograde motion. The Snare II version is disposed after one use. The Snare III version may be reused with the same patient. The device is available with different loop sizes and the sheath/cable lengths to accommodate different polyp sizes and endoscope types.
The provided document is a 510(k) summary for the Nakao Snare II and Nakao Snare III. This type of regulatory submission is for demonstrating substantial equivalence to a predicate device, rather than proving a device meets specific performance criteria through extensive clinical studies.
Therefore, the document does not contain the detailed information requested regarding acceptance criteria, specific device performance metrics, study designs (sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance), or training set details.
Here's what can be inferred and what is explicitly missing:
1. A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated in terms of measurable performance metrics (e.g., success rates, safety profiles, specific dimensional tolerances beyond typical design).
- Reported Device Performance: Not explicitly reported as an outcome of a specific study against acceptance criteria.
2. Sample size used for the test set and the data provenance:
- Sample Size (Test Set): Not mentioned.
- Data Provenance (Country of Origin, Retrospective/Prospective): Not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This type of detail is not provided as there is no indication of a clinical validation study using expert ground truth in this document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not mentioned, as no such test set or adjudication process is 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, an MRMC study was not done. This device is a medical instrument (polypectomy snare), not an AI-driven diagnostic or assistive technology for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, a standalone performance study was not done. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable/Not mentioned, as no explicit study using ground truth is described. The intended use states "the polyp is captured, retrieved and submitted for pathological analysis," implying pathology as a definitive diagnostic outcome for the resected tissue, but this isn't described as the ground truth for a device performance study.
8. The sample size for the training set:
- Not applicable/Not mentioned. There is no mention of a "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established:
- Not applicable/Not mentioned.
Summary from the 510(k) document:
The basis for market clearance is substantial equivalence to a predicate device (K926103 - U. S. Endoscopy Group Inc.). The document states:
- "The subject device has the same technological characteristics, is composed of the same type of materials and is of a similar design to the predicate device."
This means that the device's safety and effectiveness were established by arguing its similarity to an already legally marketed device, not by performing new detailed performance studies against specific acceptance criteria. The regulatory approval is based on this comparison, implying that if the predicate device was safe and effective, the substantially equivalent subject device will also be.
§ 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).