(15 days)
The 7 mm Extended Length Endoscope is intended for visualization of a surgical working cavity in minimally invasive surgery allowing access for vessel harvesting, and is primarily indicated for patients undergoing endoscopic vessel harvesting for arterial bypass. It is indicated for patients undergoing endoscopic surgery requiring tissue separation of the extraperitoneal or subcutaneous extremity and thoracic space. Extremity procedures include tissue dissection/ vessel harvesting along the saphenous vein and the femoral vessels. Thoracoscopic procedures include exposure and dissection of structures external to the parietal pleura, including nerves, blood vessels and other tissues of the chest wall.
The 7 mm Extended Length Endoscope consists of an elongated shaft that houses glass fibers for light delivery and an achromatic optical lens system (enclosed within the shaft and proximal hub) for image return. The distal shaft has a window for viewing and threads for attachment of the Dissection Tip. The proximal hub has a light guide post for attachment of light guides and an eyepiece with a clear viewing window for attachment of medical camera couplers. The Endoscope provides illumination and visualization of the working space during tissue dissection, vessel ligation, and vessel transection. With the Dissection Tip attached, the Endoscope is used to perform blunt dissection to separate tissue. The distal tip of the Endoscope has threads on the scope body for attachment of the Dissection Tip. The Dissection Tip may be removed once dissection is completed so that the Endoscope can continue to be used for visualization of a procedure.
The provided text is a 510(k) summary for a medical device (7 mm Extended Length Endoscope), which focuses on establishing substantial equivalence to previously cleared devices rather than presenting a performance study with acceptance criteria in the way a new, innovative device might.
Therefore, the document does not contain the specific information required to complete all sections of your request. It's a regulatory submission, not a research paper detailing a study designed to meet specific performance metrics.
Here's a breakdown of what can be extracted and what cannot, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
This information is not provided in the document. The 510(k) summary states, "All necessary testing was performed on the 7 mm Extended Length Endoscope with Dissection Tip to ensure that the product is substantially equivalent to the predicate devices and that the modifications do not affect safety and effectiveness." However, it does not detail specific performance criteria (e.g., resolution, field of view, illumination intensity, durability metrics) or the results of those tests. The focus is on demonstrating that the new device is "identical" or "substantially equivalent" in materials, design, and manufacturing to existing cleared devices, implying similar performance rather than establishing new, explicit performance targets.
Since no specific criteria or performance metrics are detailed, a table cannot be constructed.
2. Sample Size Used for the Test Set and Data Provenance:
This information is not provided. The document mentions "testing was performed" but does not specify any sample sizes for a test set or the types of data (e.g., patient data, bench test data) that were collected, nor its provenance (country, retrospective/prospective). This is typical for a 510(k) where the primary argument is substantial equivalence, relying on existing data and performance of predicate devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
This information is not provided. Since no specific performance study with a test set and associated ground truth is detailed, there's no mention of experts or their qualifications.
4. Adjudication Method for the Test Set:
This information is not provided. As no ground truth establishment process is described, no adjudication method is mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
This information is not provided. The 510(k) summary does not describe any MRMC study comparing human readers with and without AI assistance. The device is an endoscope, a visualization and dissection tool, not an AI-powered diagnostic device.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance:
This information is not provided. The device is a physical endoscope and does not appear to incorporate any standalone algorithms or AI for performance evaluation without a human user.
7. Type of Ground Truth Used:
This information is not provided. As explained, no specific performance study with a detailed ground truth methodology is presented in this 510(k) summary.
8. Sample Size for the Training Set:
This information is not provided. This device is a hardware instrument, not an AI/ML algorithm that would typically have a training set.
9. How the Ground Truth for the Training Set Was Established:
This information is not provided. As above, this concept doesn't apply to the type of device described.
In summary, the provided 510(k) document is a regulatory submission for premarket notification, not a detailed technical report of a performance study designed to meet explicit acceptance criteria with specific data sets and expert adjudications. The core argument for clearance is "substantial equivalence" to existing, legally marketed predicate devices, meaning that its design, materials, and intended use are similar enough that new, extensive performance studies demonstrating novel acceptance criteria are not required beyond ensuring the modifications don't negatively impact safety and effectiveness.
§ 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.