(29 days)
The da Vinci Xi Trocar has application in a variety of endoscopic procedures to provide a port of entry for endoscopic instruments.
The da Vinci Xi Bladeless Optical Obturators are used with the da Vinci Xi Cannulas and da Vinci Xi Cannula Seals to facilitate placement of the Cannula in the body wall. The Bladeless Optical Obturators consist of three components - a shaft, a handle, and two latches that allow the obturator to latch onto the Cannula Seal. The handle has an opening which allows the insertion of a size-compatible endoscope into the Bladeless Optical Obturator. The subject devices are single use devices and are offered in two sizes, 8 mm and 12 mm and in two lengths (standard and long) to match the Cannula lengths and to meet users' needs.
The provided document is a 510(k) summary for the "Bladeless Optical Obturators" by Intuitive Surgical, Inc. It describes the device, its intended use, and the testing performed to demonstrate substantial equivalence to a predicate device.
However, the document does not contain detailed acceptance criteria or numerical performance metrics typically found in a comprehensive study report. It states that design verification and validation testing were conducted, but only summarizes the types of tests performed.
Therefore, much of the requested information cannot be extracted from this document, particularly numerical data, sample sizes for specific tests, and expert involvement.
Here's a breakdown of what can be inferred and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance:
This information is not provided in the document in a clear, quantifiable table format. The document generally states that "design verification and design validation testing were conducted on the subject devices to confirm that the design outputs meet design input requirements and that the devices are safe and effective for its intended use."
The types of tests mentioned for verification are:
- Dimensional
- Mechanical
- Labeling requirements
- Drop test
- Axial load bearing capacity of the connection between the Obturator and Cannula Seal
- Maximum diametrical clearance when the Obturator is used with the Cannula
- Ability to differentiate between colors when used with a size-compatible endoscope
- Maximum length of the Obturator shaft past the distal end of the Cannula
- Adequacy of labeling to communicate compatibility
The types of tests mentioned for validation are:
- General, functional, and interaction (compatibility) requirements
- Latching mechanism assessment
- Verification that the obturator does not catch on tissue (tested in an animal model)
- Compatibility with cannulas, cannula seals, and size-compatible endoscopes to ensure they maintain insufflation
No specific acceptance criteria (e.g., "must withstand X N of force," "clearance must be less than Y mm," "color differentiation accuracy Z%") or reported performance values are given.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated for any of the individual tests. The document only generically mentions "the subject device" or "the subject devices."
- Data Provenance: The tests were conducted internally by Intuitive Surgical, Inc. No information about country of origin of data or whether it was retrospective/prospective is provided. The tests appear to be prospective design verification and validation tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not provided. This type of information is typically relevant for studies involving subjective assessments or interpretation (e.g., image analysis by radiologists). For a physical device's mechanical and functional performance tests, ground truth is established by engineering specifications and objective measurements. The document does not mention any expert panel or subjective assessment directly related to establishing "ground truth" for these engineering tests.
4. Adjudication method for the test set:
- Not applicable/Not provided. Adjudication methods (like 2+1, 3+1) are used to resolve discrepancies in subjective assessments, often by multiple human readers. Since the performance tests described are objective engineering and functional assessments, such adjudication is not relevant or mentioned.
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. This is a medical device for surgical access (trocar system), not an AI/imaging diagnostic device. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This device is a physical surgical instrument, not an algorithm or AI system. Standalone algorithm performance is not applicable.
7. The type of ground truth used:
- For Design Verification: The ground truth would be based on engineering specifications and measurable design inputs. For example, a specified axial load, a defined diametrical clearance, or a quantifiable measure of color differentiation (though the specific metrics are not provided).
- For Design Validation: The ground truth would likely be functional performance criteria (e.g., successful latching, no tissue catching, maintenance of insufflation) established during risk analysis and design input definition. The animal model study indicates an in vivo assessment of functionality.
8. The sample size for the training set:
- Not applicable/Not provided. This device does not involve machine learning or AI models that require a "training set."
9. How the ground truth for the training set was established:
- Not applicable/Not provided. As above, no training set for an AI model is involved.
In summary: The provided document is a 510(k) summary focused on demonstrating substantial equivalence through a general overview of design verification and validation. It lacks the granular detail about specific acceptance criteria, numerical results, and study methodology (like sample sizes and expert involvement) that would be present in a comprehensive study report for an AI or diagnostic device.
§ 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.