(227 days)
The Flared Cannuiae are intended to be used with the da Vinci Surgical System (da Vinci S (Model IS2000) or da Vinci Si (Model IS3000)) to serve as a port of entry during da Vinci procedures that do not require maintenance of insufflation.
The Intuitive Surgical Flared Cannula consists of a tapered hollow tubular shaft with a flared distal tip and a bowl with an Integral receptacle. The hollow shaft serves as the port of entry, the bowl is used to attach the cannula to the da Vinci Surgical System and the receptacle allows for attachment of commercially available dispersive electrode grounding pad via a 2-Pin grounding connector
The provided text describes the 510(k) summary for the Intuitive Surgical 5 mm and 8 mm Flared Cannulas (K101743). This document is for a medical device that serves as a port of entry during surgical procedures, not an AI/ML-driven device for diagnostic or predictive purposes. Therefore, most of the requested information regarding acceptance criteria for AI models, sample sizes for test/training sets, expert consensus, adjudication methods, and MRMC studies are not applicable.
However, I can extract information related to the device's performance claims and how they were substantiated for this specific medical device submission.
Here's the relevant information based on the provided text, acknowledging that most questions about AI model validation don't apply:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Functional Equivalence | The device must demonstrate substantial equivalence to the predicate device (Intuitive Surgical, Inc. da Vinci Endoscopic Instrument Control System (Model IS1000) and Endoscopic Instruments K990144) in intended use, design, and technology. | The subject device is equivalent in Intended use, design, and technology as compared to the predicate device. |
| Safety and Efficacy | Performance testing must demonstrate that the device is substantially equivalent to the predicate device in terms of safety and efficacy and that the design output meets the design input requirements without raising any new issues of safety or efficacy. | "Performance tests (bench and animal lab tests) were conducted to demonstrate that the device Is substantially equivalent to the predicate device and that the design output meets the design input requirements. The results of the testing did not raise any new Issues of safety or efficacy." |
| "Based on the technical characteristics, Intended use and performance test data, the Intuitive Surgical 5mm and 8mm Flared Cannula have been determined to be equivalent in in safety, efficacy, and performance to the predicate device." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not explicitly stated. The document mentions "bench and animal lab tests," but details on the number of tests performed or animals used are not provided.
- Data Provenance: Not explicitly stated. Assuming tests were conducted by Intuitive Surgical, Inc., based in Sunnyvale, California, USA, the data likely originates from internal testing. It would be prospective testing as it relates to the development and validation of the new device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This question is not applicable as the device is a physical surgical instrument, not an AI/ML model requiring expert-established ground truth for diagnostic accuracy. The validation is physical and functional, not clinical interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This question is not applicable as the device is a physical surgical instrument and does not involve clinical interpretation requiring adjudication.
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
- This question is not applicable as the device is a physical surgical instrument, not an AI/ML system, and therefore does not involve human readers interpreting images with or without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This question is not applicable as the device is a physical surgical instrument, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For this type of physical device, the "ground truth" would be established by engineering specifications, material standards, and surgical functional requirements. The tests ("bench and animal lab tests") would verify that the device performs according to these pre-defined physical and functional standards, ensuring it is safe and effective for its intended use (acting as a port of entry without maintaining insufflation). There is no "pathology" or "outcomes data" in the sense of diagnostic accuracy for this device.
8. The sample size for the training set
- This question is not applicable as the device is a physical surgical instrument and does not involve AI/ML training.
9. How the ground truth for the training set was established
- This question is not applicable as the device is a physical surgical instrument and does not involve AI/ML training.
§ 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.