(94 days)
The DEFENDO™ Disposable Biopsy Valve is indicated for covering the endoscope biopsy port during an endoscopy procedure. The valve provides access for endoscopic device passage and exchange, helps maintain sufflation, and minimizes leakage of biomaterial from the biopsy port throughout the endoscopic procedure.
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Here's an analysis of the provided text regarding the DEFENDO Biopsy Valve, focusing on the requested information:
This document is a 510(k) clearance letter for a medical device (DEFENDO™ Biopsy Valve). It primarily focuses on the regulatory determination of substantial equivalence to a predicate device, rather than a detailed report of a clinical study with specific acceptance criteria and performance metrics for a novel algorithm or AI device.
Therefore, I cannot provide a complete answer to all your questions as the information is not present in the provided text. The document describes a device (biopsy valve), not a diagnostic algorithm or AI. The FDA letter states that the device is "substantially equivalent" to legally marketed predicate devices. This typically means the manufacturer performed a series of tests to demonstrate that their device functions similarly and is as safe and effective as existing, legally marketed devices. However, the details of these tests, specific acceptance criteria, or a "study that proves the device meets the acceptance criteria" in the context of an AI/algorithm are not described.
Let's address what can be extracted from the document:
1. A table of acceptance criteria and the reported device performance
This information is not provided in the document. The FDA letter is a regulatory clearance, not a detailed technical report of performance metrics. For a device like a biopsy valve, acceptance criteria would likely relate to biocompatibility, fluid sealing, ease of use, durability, and compatibility with specific endoscopes, but these specifics are not listed.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided. As this is a physical medical device, "test set" would likely refer to the number of devices tested or the number of simulated procedures performed, but no such details are given.
3. 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 information is not provided. This concept of "ground truth" and expert review is typically relevant for diagnostic algorithms or AI that interpret medical images or data. For a biopsy valve, the "ground truth" would be established through engineering specifications and functional testing, not expert consensus on medical findings.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. Adjudication methods are relevant for studies where multiple readers interpret data, which is not described here.
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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done as described in this document. This type of study is specific to AI or diagnostic imaging interpretation. The device being reviewed is a physical biopsy valve, not an AI system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, this is not applicable. The DEFENDO™ Biopsy Valve is a physical accessory used during an endoscopy procedure, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not explicitly stated in the document. For a physical device like a biopsy valve, "ground truth" would generally be established through engineering specifications, material safety standards, and functional performance benchmarks (e.g., ability to maintain insufflation, resist leakage, allow instrument passage).
8. The sample size for the training set
This information is not provided. This concept is relevant for machine learning models, which is not what the DEFENDO™ Biopsy Valve is.
9. How the ground truth for the training set was established
This information is not provided. This concept is relevant for machine learning models, which is not what the DEFENDO™ Biopsy Valve is.
In summary:
The provided document is an FDA 510(k) clearance letter for a physical medical device (biopsy valve). It confirms the device's substantial equivalence to existing devices but does not contain the detailed technical or clinical study data typically found in reports for AI or diagnostic algorithms, including specific acceptance criteria, performance metrics, ground truth establishment, or study designs like MRMC or standalone performance evaluations. For such a device, the "study" demonstrating its safety and effectiveness would involve engineering tests (e.g., mechanical durability, fluid integrity), biocompatibility testing, and functional assessments, which are not outlined in this regulatory letter.
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.