(288 days)
The ORISE™ ProKnife has been designed to be used with endoscopes and electrosurgical units to cut tissue within the gastrointestinal tract using high-frequency current. The electrosurgical knife also has the capability of delivering saline/ submucosal lifting agent into submucosal tissue layers under direct visualization through an endoscope.
The ORISE™ ProKnife is an electrosurgical knife intended for use in Endoluminal surgery procedures, including but not limited to Endoscopic Submucosal Dissection (ESD). The ProKnife can deliver high frequency monopolar energy to facilitate incision of tissue. The ORISE™ ProKnife also has the capability of delivering saline/submucosal lifting agent through the electrode to maintain a submucosal fluid cushion without the need for a device exchange.
The provided text is a 510(k) summary for the ORISETM ProKnife, an electrosurgical knife. This document primarily focuses on establishing substantial equivalence to predicate devices through bench and ex-vivo testing, electrical safety, and biocompatibility. It does not describe a study involving a "device that uses AI" or "human readers," as indicated by the context of your request.
Therefore, I cannot extract the information requested for "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/human reader study because the provided document does not contain such a study design.
The performance data section (Section 8) describes:
- Bench Testing: Functional and performance tests to satisfy design verification requirements, including knife operation with compatible endoscopes, dimension, general durability, and injection capability. All results were "passing" and demonstrated the device met "pre-defined performance specifications."
- Electrical Testing: Evaluated according to IEC 60601 series standards for medical electrical equipment and high-frequency surgical equipment.
- Biocompatibility Testing: Evaluated according to ISO 10993-1 and FDA Guidance.
The document concludes that the non-clinical testing results "demonstrate that the ORISETM ProKnife is considered safe and effective for its intended use" and that it is "substantially equivalent" to predicate devices.
To directly address your specific points based on the provided text's limitations:
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A table of acceptance criteria and the reported device performance:
The document states: "All results were passing and demonstrate that the proposed device meets its pre-defined performance specifications." However, it does not provide a table with specific quantitative acceptance criteria or detailed reported performance values for each test. It only broadly states that the tests passed. -
Sample size used for the test set and the data provenance:
The document does not specify the sample sizes for the bench or ex-vivo tests. It also does not mention data provenance in terms of country of origin or whether the studies were retrospective or prospective, as these are non-clinical tests. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable, as this was not a study involving human interpretation of data or images where expert ground truth would be established. The tests were objective performance evaluations (e.g., durability, electrical safety). -
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable for non-clinical bench and ex-vivo tests. -
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, as this is not an AI-assisted device. -
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable, as this is an electrosurgical knife, not an algorithm. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the non-clinical tests described, the "ground truth" would be established engineering specifications and compliance with recognized standards (IEC, ISO). For example, a "passing" result for electrical safety means the device met the requirements of the cited IEC standards. -
The sample size for the training set:
Not applicable, as this is not a machine learning device that requires a training set. -
How the ground truth for the training set was established:
Not applicable, as this is not a machine learning 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).