(29 days)
These products are used in combination with an applicable endoscope to perform the endoscopic treatments for the target site in the gastrointestinal tract, such as ablation, incision, cauterization, coagulation and avulsion of tissue and arrest of bleeding, and to inject saline or submucosal injection agent for endoscopic surgery into the submucosal layer in the gastrointestinal tract, which is exposed after dissection, under the management of physicians in medical facilities. Never use this product for any other purpose.
FUJIFILM Diathermic Slitter (FlushKnife) is an electrosurgical instrument that removes tissue and controls bleeding by use of high-frequency ("HF") electrical current. The device is available with either a needle or ball tip slitter and comes in a variety of sizes.
This document is a 510(k) Premarket Notification from the FDA regarding a medical device. It does not contain information about an AI/ML medical device or a clinical study with human subjects, therefore, most of the requested information cannot be extracted from the document. The document describes a Diathermic Slitter (FlushKnife) used for endoscopic treatments in the gastrointestinal tract. This is a physical, electrosurgical instrument, not an AI or software-based device.
Therefore, many of the requested fields related to AI/ML device performance, such as sample size for test sets, ground truth establishment, expert adjudication, MRMC studies, and training set details, are not applicable to this document.
However, I can provide information based on the "Performance Data" section regarding the device's technical validation.
Here's what can be extracted based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document states that the device met pre-defined acceptance criteria for all tests. Specific numerical acceptance criteria or performance metrics are not detailed in this summary; rather, it refers to compliance with standards and successful completion of tests.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Electrical Safety & Electromagnetic Compatibility | Device evaluated using ANSI/AAMI ES60601-1:2005/(R)2012, IEC 60601-1-2:2014, IEC 60601-1-6:2013, IEC 60601-2-2:2017, and IEC 60601-2-18:2009. Met pre-defined acceptance criteria. |
| Biocompatibility | Device evaluated using ISO 10993-1:2018, ISO 10993-5:2009, ISO 10993-7:2008, ISO 10993-10:2010, and ISO 10993-11:2017, in accordance with FDA guidance. Met pre-defined acceptance criteria. |
| Sterility | Device evaluated according to ISO 11135:2014 and FDA guidance "Submission and Review of Sterility Information...". Met pre-defined acceptance criteria. |
| Device Specific Testing (ISO 8600-1:2015) | Bench testing conducted to validate compatibility with submucosal injection agent. Met pre-defined acceptance criteria. |
| Additional Performance Testing (Bench Testing) | Maximum diameter of insertion portion, Working length, Slitter length, Conductivity, Liquid delivery amount. Met pre-defined acceptance criteria in all cases. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified for any of the performance tests. The document refers to "bench testing" and evaluations against standards, which typically involve a specified number of samples, but these numbers are not disclosed.
- Data Provenance: The testing appears to be conducted by the manufacturer as part of their submission for regulatory clearance. The document doesn't specify country of origin for data but states the manufacturer is FUJIFILM Corporation, located in Japan. The tests are described as "bench testing," implying a laboratory, likely prospective testing for the purpose of the submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This document describes a traditional electrosurgical device, not an AI/ML device that requires expert-established ground truth for image interpretation or diagnosis. Ground truth, in this context, refers to the physical properties and performance characteristics of the device being measured against engineering specifications and regulatory standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. As this is not an AI/ML device relying on human interpretation, an adjudication method for test set ground truth is not relevant.
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 not an AI/ML device and therefore no MRMC study or assessment of human reader improvement with AI assistance was conducted or is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is not an algorithm or software device. Its performance is evaluated intrinsically as a physical piece of medical equipment.
7. The type of ground truth used
- Technical Specifications and Consensus Standards: The "ground truth" for this device's performance relies on its ability to meet engineering design specifications and comply with recognized consensus standards for electrical safety, biocompatibility, sterility, and device-specific functionalities (e.g., slitter length, conductivity). This is established through laboratory testing and verification against pre-defined performance metrics, rather than expert consensus on diagnostic interpretations or clinical outcomes data in a comparative study.
8. The sample size for the training set
- Not Applicable. This device uses traditional engineering principles, not machine learning, and therefore has no "training set."
9. How the ground truth for the training set was established
- Not Applicable. There is no training set for this type of device.
§ 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).