(266 days)
The SmartBand® EMR Device is intended for endoscopic mucosal resection in the upper G1 tract.
The SmartBand® EMR Device is an endoscopic mucosal resection device that is provided as a Kit or a Pack that is designed for ligation assisted endoscopic mucosal resection (EMR) in the upper gastrointestinal (GI) tract. The SmartBand® EMR Kit consists of the SmartBand Ligator Kit, supplied non-sterile and the SmartSnare™ EMR Hexagonal Snare, supplied sterile. The ligator kit contains a ligation handle, loading device, connector tube, and a cylindrical barrel with 5 bands separated by a deployment cord. The SmartBand® EMR Pack consists of a cylindrical barrel with 5 bands separated by a deployment cord, which can be used when more bands are needed to complete the procedure.
This looks like a 510(k) premarket notification for a medical device called "SmartBand EMR Kit." The document describes the device, its intended use, and performance testing, but it does not appear to be a study about AI/ML device performance or include acceptance criteria directly related to AI/ML device performance metrics like sensitivity, specificity, or AUC.
The document mainly focuses on demonstrating substantial equivalence to a predicate device (Captivator™ EMR Device (K140726)) by comparing their design features, intended use, and functional performance through bench testing and biocompatibility assessments.
Therefore, many of the specific details requested in your prompt (e.g., acceptance criteria for AI models, sample size for test sets with ground truth, expert qualifications for ground truth, MRMC studies, standalone algorithm performance, training set details) are not present in this document because it's not a submission for an AI-powered device.
However, I can extract information related to the device's overall performance testing as described in the document, which serves as the "study that proves the device meets the acceptance criteria" in the context of this 510(k) submission.
Here's a breakdown of the available information based on your prompt:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria with corresponding performance values for specific metrics relevant to AI/ML. Instead, it describes general performance testing conducted to ensure safe and effective function.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safe and effective function | "All components have been performance bench tested to ensure safe and effective function of the device." |
| Substantial equivalence to predicate device | "The non-clinical comparative performance testing successfully determined that the SmartBand® EMR Device is substantially equivalent to the predicate." |
| System suction delivery efficiency | Testing included "system suction delivery efficiency with the snare." (Result: Implied to be acceptable and comparable to predicate for substantial equivalence) |
| Band ultimate tensile force | Testing included "band ultimate tensile force." (Result: Implied to be acceptable and comparable to predicate for substantial equivalence) |
| Snare loop to pull wire tensile strength | Testing included "snare loop to pull wire tensile strength." (Result: Implied to be acceptable and comparable to predicate for substantial equivalence) |
| Sterilization effectiveness (for SmartSnare™) | "Testing according to ENISO 11135-1 and EN ISO 11138-2, sterilization of health care products, verifies that the ETO sterilization method and parameters that are used to sterilize the SmartSnare™ EMR Hexagonal Snare." (Result: Effective) |
| Biocompatibility | "The patient contacting components of the device (the barrel, bands, cord and snare) were subjected to and showed acceptable results to Cytotoxicity, Sensitization, Acute Systemic Toxicity, and USP Physicochemical testing." (Result: Acceptable) |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample size: Not explicitly stated as a number of "cases" or "patients" in the context of an observational study. Performance testing was conducted on "representative production units" and "components" of the device. This implies bench testing of physical units rather than a clinical dataset.
- Data provenance: Not applicable in the context of bench testing on physical devices.
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 bench testing of a physical medical device, not an AI/ML diagnostic or prognostic tool that requires expert-established ground truth from medical images or patient data.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. See point 3.
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 because this is not an AI-assisted device.
6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done
- No. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable in the AI/ML sense. The "ground truth" for the bench testing would be the engineering specifications, relevant ISO standards (e.g., for sterilization, biocompatibility), and the performance of the predicate device for comparative purposes.
8. The sample size for the training set
- Not applicable. This device does not involve a training set as it is not an AI/ML product.
9. How the ground truth for the training set was established
- Not applicable. See point 8.
§ 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).