(47 days)
The PolyCatch Retrieval Device is intended for capture and retrieval of excised polyps, foreign bodies, tissue samples and calculi during flexible or rigid endoscopy procedures.
The PolyCatch Retrieval Device is a complete one-piece device for retrieval of polyps and foreign bodies from the gastrointestinal and respiratory tracts and is a disposable instrument intended for single patient use only. The PolyCatch Retrieval Device is used through the working channel of a legally marketed endoscope. The PolyCatch Retrieval Device consists of a handle, outer sheath and a snare wire/loop to which a non-Latex pouch is attached. As the snare wire is advanced from of the outer sheath of the device, it expands to its full circumference thereby deploying the non-Latex pouch. The pouch can then be manipulated by the clinician to engage a polyp or foreign body. After the polyp or foreign body is captured within the pouch the handle is used to draw the snare wire and pouch back against the device sheath. The endoscope along with the PolyCatch is then removed together from the patient to complete the retrieval procedure.
This document is a 510(k) premarket notification for a medical device called the "PolyCatch Retrieval Device." It is a submission to the FDA (Food and Drug Administration) for clearance to market the device. The document states that the device is substantially equivalent to a legally marketed predicate device.
Here's an analysis based on your request, keeping in mind that this type of regulatory submission often focuses on demonstrating equivalence to an existing device rather than presenting extensive de novo clinical trials with AI components.
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A table of acceptance criteria and the reported device performance
This document does not specify "acceptance criteria" in terms of performance metrics (like sensitivity, specificity, accuracy) that would typically be associated with an AI-enabled device's diagnostic or predictive capabilities. This is a conventional medical device a "PolyCatch Retrieval Device" which is used for the physical retrieval of polyps, foreign bodies, tissue samples, and calculi. Its "performance" would relate to its mechanical function, biocompatibility, and ability to effectively retrieve objects as intended.
The document states:
"Design verification data and biocompatibility testing has demonstrated that the proposed PolyCatch Retrieval Device is safe and effective."
"Bench performance testing was conducted using a specially designed test fixture intended to simulate actual device use of the PolyCatch Retrieval Device."
"Medi-Globe Corporation has demonstrated that the proposed PolyCatch Retrieval Device is as safe and effective as the predicate device, (Roth Net Retriever, K122462)."Without the full design verification and bench test reports, specific quantitative acceptance criteria and their corresponding results cannot be extracted from this summary. This document operates under the premise of "substantial equivalence" to a predicate device, meaning its performance is considered comparable to the predicate.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "Design verification data and biocompatibility testing" and "bench performance testing." These typically involve studies in vitro or on test fixtures, not human patient data in the way an AI study would. Therefore, concepts like sample size of a patient test set, country of origin, retrospective/prospective classification, or human data provenance are not applicable here. The "test set" in this context refers to the materials and conditions used in the bench testing. No specific sample sizes for these tests are provided in this summary.
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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 is not an AI-enabled device. The "ground truth" for a device like this would be its mechanical integrity, effective capture/retrieval of test objects under simulated conditions, and biocompatibility. This does not require human expert interpretation of images or data to establish a ground truth.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as this is not an AI-enabled diagnostic or predictive device requiring adjudication for ambiguous cases.
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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 is not an AI-enabled device, and no human reader studies are mentioned or implied.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a physical medical instrument, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for a physical retrieval device like this would be defined by engineering specifications and successful mechanical operation under test conditions, as well as satisfactory biocompatibility results. This does not involve expert consensus, pathology, or outcomes data in the way a diagnostic AI would.
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The sample size for the training set
Not applicable, as this is not an AI-enabled device, and therefore no "training set" in the context of machine learning is used.
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How the ground truth for the training set was established
Not applicable, for the same reason as 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).