(119 days)
The Captivator TM EMR Device is indicated for endoscopic mucosal resection in the upper GI tract.
The Captivator™ EMR Device is an endoscopic mucosal resection device consisting of a ligator cap with ligation bands, a band ligator handle, an electrosurgical snare, and a pathology kit. The ligator cap and band ligator handle are attached to an endoscope, and bands are deployed one at a time to capture mucosal tissue as pseudopolyps, which are clectrosurgically removed using the snare. The device is capable of performing multiple resections. The banding portion of the device is made up of a clear ligator cap with elastic bands stretched around the outer circumference of the cap. Bands are deployed by actuating the handle. The ligator device allows the introduction of an electrosurgical snare for endoscopic therapies. A pathology kit is also provided as a procedural aid which is used to handle tissue samples for histological processing.
The provided text describes a 510(k) premarket notification for the Captivator™ EMR Device. However, it does not contain information about acceptance criteria or a study proving the device meets specific performance metrics in relation to clinical outcomes or AI performance.
The document focuses on demonstrating substantial equivalence to existing predicate devices through non-clinical testing, primarily bench testing and biocompatibility assessments. Therefore, I cannot extract the requested information in the format you provided.
Here's what can be inferred from the text regarding the nature of the "performance data" presented, and why it doesn't align with your request:
- Acceptance Criteria & Reported Device Performance (Table): Not provided. The document states "Non-clinical comparative performance bench testing was successfully completed to establish substantial equivalence" and lists types of tests (e.g., system suction delivery efficiency with snare, band ultimate tensile force, and snare loop to pull wire tensile strength). However, it does not provide specific acceptance values for these tests or the measured performance of the Captivator™ EMR Device against those values. The goal was substantial equivalence, not meeting predefined clinical performance metrics.
- Sample Size for Test Set & Data Provenance: Not applicable in the context of clinical performance data. The "test set" here refers to components used in non-clinical bench testing.
- Number of Experts & Qualifications for Ground Truth: Not applicable. Ground truth for clinical performance or AI evaluation is not discussed.
- Adjudication Method: Not applicable.
- Multi Reader Multi Case (MRMC) Comparative Effectiveness Study: No MRMC study was performed or mentioned.
- Standalone (algorithm only) performance: Not applicable, as this is a physical medical device, not an AI algorithm.
- Type of Ground Truth Used: Not applicable in the requested sense (e.g., pathology, outcomes data). The "ground truth" for the non-clinical comparative bench testing would be the performance of the predicate device.
- Sample Size for Training Set: Not applicable.
- How Ground Truth for Training Set was established: Not applicable.
In summary: This 510(k) submission establishes substantial equivalence through non-clinical laboratory testing, not through clinical trials or studies involving AI performance, human readers, or specific clinical acceptance criteria with corresponding performance data. The "performance data" discussed are engineering and bench test results.
Therefore, I cannot fulfill your request to create a table of acceptance criteria and device performance based on the provided document alone, as this type of information is not present.
§ 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).