(264 days)
The Captura® Disposable Hot Biopsy Forceps is used endoscopically in conjunction with monopolar electrosurgical current to obtain gastrointestinal mucosal tissue biopsies and for removal of sessile polyps. This device is indicated for adult use only.
The Captura® Disposable Hot Biopsy Forceps is a sterile, single use device compatible with the accessory channel of endoscopes. The device consists of stainless steel forceps cups joined to a spool handle by a Pebax-coated stainless steel coilspring catheter and stainless steel drive cable. The handle's spool actuates the opening and closing of the forceps cups and its brass electrosurgical pin is intended for connection to an electrosurgical generator.
The provided document is a 510(k) premarket notification for the Captura® Disposable Hot Biopsy Forceps. This type of submission focuses on demonstrating substantial equivalence to an existing legally marketed device, not necessarily extensive clinical trials proving novel performance or the use of AI.
Therefore, the specific information requested, such as acceptance criteria, sample sizes for test and training sets, number and qualifications of experts for ground truth, adjudication methods, multi-reader multi-case studies, and standalone algorithm performance, is not available in this document. This document is for a medical device (biopsy forceps), not an AI/software as a medical device (SaMD).
Here's what can be inferred from the document regarding performance and validation:
1. A table of acceptance criteria and the reported device performance:
The document broadly states that the device meets performance criteria required for its intended use, but does not provide specific acceptance criteria values or detailed performance metrics in numerical form.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Sterilization | Meets performance criteria |
| Shelf life | Meets performance criteria |
| Biocompatibility | Meets performance criteria |
| Electrical safety | Meets performance criteria |
| Non-clinical bench testing | Meets performance criteria |
| Endoscope & Active Cord Compatibility | Confirmed compatibility for intended use |
| Biopsy Obtainment & Removal | Demonstrated functionality |
| Tensile Testing | Demonstrated appropriate strength |
| Flexibility Testing | Demonstrated appropriate flexibility |
| Post-Aging Functional Testing | Demonstrated maintained functionality after aging |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This information is not provided. The testing mentioned is primarily non-clinical bench testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
This information is not applicable and not provided. The device is a physical tool, and its performance is assessed through engineering and bench tests, not expert interpretation of diagnostic data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not provided and not applicable for the type of testing 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:
Not applicable. This device is not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an algorithm or SaMD. The performance assessment is for a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For physical and electrical performance tests, the "ground truth" would be established by validated test methods, adherence to relevant standards, and engineering specifications. For example, a tensile test would measure a force against a specific standard for material strength. Biocompatibility would be assessed against ISO standards.
8. The sample size for the training set:
Not applicable. There is no AI model or training set described in this document.
9. How the ground truth for the training set was established:
Not applicable. There is no AI model or training set described in this document.
In summary: The provided document describes the regulatory submission for a physical medical device (biopsy forceps). The assessment of this device's safety and effectiveness relies on non-clinical bench testing, electrical safety, biocompatibility, sterilization, and shelf-life data, demonstrating substantial equivalence to a predicate device. It does not involve AI, clinical efficacy studies with human subjects for diagnostic accuracy, or associated ground truth establishment methods typically found in AI/SaMD submissions.
§ 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).