(691 days)
Transoral otolaryngology surgical procedures restricted to benign and malignant tumors, classified as T1 and T2, and for benign base of tongue resection procedures.
The safety and effectiveness of this device for use in the treatment of obstructive sleep apnea have not been established.
This 510(k) is being submitted for a revision to the Indications for Use to include Transoral Otolaryngology Robotic Surgery (TORS) procedures restricted to benign and malignant tumors, classified at T1 and T2, and for benign base of tongue resection procedures. There are no changes in the design, technology, materials, manufacturing, performance, specifications or method of use for the da Vinci Surgical Systems and EndoWrist Instruments and Accessories associated with this premarket notification. The da Vinci Surgical Systems (Models IS1200, IS3000) consist of two integrated sub-systems as follows:
Surgeon Console and a Patient Side Cart. While seated at the Surgeon Console, the surgeon controls critical aspects of the procedure, including movement of the endoscopic instruments and endoscope within the operative field. The endoscopic instruments and camera movements are controlled by the surgeon through use of the Master Tool Manipulators (MTM); two hand-operated mechanisms residing with the Surgeon Console. The endoscopic Instruments are held in a fixed position with respect to the patient by either two (or optionally three) unique arms known as Patient Side Manipulators (PSM), which are located on the Patient Side Cart (PSC). The endoscope is also held in a fixed position (with respect to the patient) by another arm, similar to the PSM, known as the Endoscope Camera Manipulator (ECM), which is also located on the PSC. Commands from the surgeon console are relayed to the PSC, which is located immediately adjacent to the patient, via cables. Instrument and endoscopic changes are performed by another individual positioned adjacent to the PSC.
Intuitive Surgical Stereo View Endoscopic System. The Endoscopic vision system used with the da Vinci Surgical Systems, also known as the Intuitive Surgical Insite Vision system, consists of a stereo endoscope, endoscopic camera and various accessories, including a light source and light guides. The Insite Vision system provides two independent images that are relayed to the surgeon located at the Surgeon Console, where they are fused to form a 3-D (or alternatively a 2-D) image of the surgical field.
This document is a 510(k) premarket notification from the FDA regarding the Intuitive Surgical da Vinci Surgical Systems. It primarily discusses the expansion of the device's indications for use to include specific transoral otolaryngology surgical procedures and imposes a limitation regarding its use for obstructive sleep apnea.
Unfortunately, the provided text does not contain a traditional acceptance criteria table or a report of device performance against specific metrics of accuracy, sensitivity, specificity, etc. This document is a regulatory clearance letter, not a detailed study report. The FDA's review for this device, which is an Endoscopic Instrument Control System, focuses on demonstrating substantial equivalence to a predicate device and ensuring safety and effectiveness for its intended use, rather than presenting a statistical performance study against defined acceptance criteria.
However, I can extract information related to the clinical data used to support the expanded indication for use for "benign base of tongue resection procedures," and details about how the ground truth was established for this assessment.
Here's a breakdown of the information requested, based on the provided text, with acknowledgments of what is not present:
1. Table of Acceptance Criteria and Reported Device Performance:
As noted above, a formal table of acceptance criteria with corresponding performance metrics (e.g., accuracy, sensitivity, specificity for a diagnostic device) is not present in this regulatory document. The focus for this surgical system's expanded indication is on safety and effectiveness for a surgical procedure, primarily supported by clinical outcomes reported in existing literature and retrospective data, rather than specific numerical performance against a pre-defined threshold.
The document states: "The safety and effectiveness of this device for use in the treatment of obstructive sleep apnea have not been established." This indicates a negative finding regarding certain acceptance for a specific use case.
For the accepted use (benign base of tongue resection), the "reported device performance" is inferred from the clinical outcomes described in the literature, which generally supported the safety and effectiveness for this type of procedure, leading to the clearance. However, specific quantitative performance metrics are not given.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The premarket submission included:
- Unpublished retrospective data on 293 subjects.
- Information from 32 published literature articles. For the specific indication of "benign base of tongue resection," 9 of these articles were cited, providing data from a total of approximately 206 patients (by summing the "No. of Patients" column from the table on page 6, though some entries are "N/a" or combine multiple procedures). It's important to note that the total subject count from the published articles is likely higher than 206 if all 32 articles were considered, but only 9 were specifically highlighted for the benign base of tongue resection.
- Data Provenance:
- Unpublished Retrospective Data: Retrospective. No specific country of origin is mentioned, but "3 institutions" are noted, suggesting data from multiple sites.
- Published Literature Articles: These are published studies and case reports, likely from various institutions and potentially countries, although specific origins are not detailed in this summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
This document does not specify the number or qualifications of experts used by Intuitive Surgical Inc. to establish the ground truth for their internal test sets or the retrospective data provided.
For the published literature, the "ground truth" would have been established by the authors/clinicians of those studies based on their clinical diagnoses and surgical outcomes, often by surgeons and pathologists. The FDA's review team consists of experts (e.g., William H. Maisel, MD, MPH, Director, Office of Device Evaluation) who assess the submitted evidence.
4. Adjudication Method for the Test Set:
The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) used for establishing ground truth within Intuitive Surgical's submitted data. For published medical literature, individual study methodologies would vary, and adjudication is often inherent in clinical diagnosis and outcome assessment processes.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size of how much Human Readers Improve with AI vs. Without AI Assistance:
This document is for an endoscopic instrument control system, a surgical device, not a diagnostic AI or imaging interpretation device. Therefore, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study, which is typically used for assessing AI's impact on human diagnostic performance, is not applicable and was not conducted or mentioned in this context. The device is a tool used by a surgeon, not an AI that assists in interpreting images for diagnostic purposes.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This device is inherently a "human-in-the-loop" system, where the surgeon controls the instruments. It is not a standalone algorithm. The entire premise of the da Vinci Surgical System is to enhance a surgeon's dexterity and vision during surgery.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for the expanded indication of "benign base of tongue resection procedures" was primarily established through clinical outcomes data reported from the submitted unpublished retrospective data and the published literature. This includes:
- Clinical diagnoses: Classification of tumors as T1 and T2, and benign base of tongue conditions.
- Surgical outcomes: Success of the resection, adverse events (e.g., bleeding, dehydration, dysphagia, pneumonia, hypoxemia), and patient follow-up.
- Pathology: While not explicitly stated as the sole ground truth, it is an implicit and critical component of diagnosing and confirming the nature of "benign and malignant tumors, classified as T1 and T2."
8. The Sample Size for the Training Set:
The document does not specify a "training set" size. This is because the da Vinci Surgical System is a medical device, not an AI/ML algorithm that undergoes a distinct training phase on a dataset in the same way. The development and refinement of such a system would involve engineering, bench testing, pre-clinical studies, and then human clinical experience (from which the submitted literature and retrospective data are derived) which informs its safety and efficacy.
9. How the Ground Truth for the Training Set was Established:
As there is no "training set" in the context of an AI/ML algorithm described in this document, the method for establishing its ground truth is not applicable here. The "ground truth" for the device's functionality and safety and effectiveness, as demonstrated to the FDA, stems from the body of clinical evidence (retrospective data and published literature) gathered from its use by surgeons in actual patient care.
§ 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.