(141 days)
Da Vinci SP Surgical System, Model SP1098:
The Intuitive Surgical Endoscopic Instrument Control System (da Vinci SP Surgical System, Model SP1098) is intended to assist in the accurate control of Intuitive Surgical EndoWrist SP Instruments during urologic surgical procedures that are appropriate for a single port approach and transoral otolaryngology surgical procedures in the oropharynx restricted to benign tumors and malignant tumors classified as T1 and T2. The system is indicated for adult use. It is intended for use by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.
EndoWrist SP Instruments:
Intuitive Surgical EndoWrist SP Instruments are controlled by the da Vinci SP Surgical System, Model SP1098, and include flexible endoscopes, blunt and sharp endoscopic dissectors, scissors, forceps/pick-ups. needle holders, endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, and suturing through a single port. The system is indicated for urologic surgical procedures that are appropriate for a single port approach and transoral otolaryngology surgical procedures in the oropharynx restricted to benign tumors and malignant tumors classified as T1 and T2. The system is indicated for adult use. It is intended for use by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.
The da Vinci SP Surgical System is designed to enable complex surgery using a minimally-invasive approach. The system consists of three major subsystems: a Surgeon Console, a Vision Cart, and a Patient Cart.
At the Surgeon Console, the surgeon controls all movements and endoscope by using two hand controls and a set of foot pedals. The surgeon views the live endoscope image on a three-dimensional (3D) viewer, which provides a view of patient anatomy and instrumentation, along with icons and other user interface features.
The Vision Cart includes supporting electronic equipment, such as the endoscope light source, video and image processing, and the networking hardware. The Vision Cart also has a touchscreen to view the endoscope image and adjust system settings.
The Patient Cart is the operative component of the da Vinci SP Surgical System. It supports the positioning of the surgical port and manipulation of the surgical instruments and endoscope.
This FDA 510(k) summary provides limited information regarding specific acceptance criteria and detailed study results for the da Vinci SP Surgical System. Most of the document focuses on regulatory approval based on "substantial equivalence" to a predicate device, rather than detailed performance studies against specific acceptance criteria.
However, based on the provided text, we can extract the following:
1. A table of acceptance criteria and the reported device performance
The document states: "The subject device met the same acceptance criteria as the predicate device." However, the specific acceptance criteria themselves are not listed in this document. The document primarily focuses on demonstrating that the new software feature (Custom Remote Center) did not negatively impact safety or effectiveness.
Therefore, we can only infer the type of performance evaluation rather than specific numerical criteria.
| Acceptance Criteria Category (Inferred) | Reported Device Performance |
|---|---|
| Safety and Effectiveness | Confirmed no issues of safety or effectiveness with changes. |
| Risks | Confirmed no additional unexpected risks were identified. |
| Software Verification and Validation | Met acceptance criteria (no specific details provided). |
| Human Factors Evaluation | Met acceptance criteria (no specific details provided). |
| Life Testing | Met acceptance criteria (no specific details provided). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not provide details on the sample size for any test set or the data provenance. It mentions "software verification and validation testing, human factors evaluation, and life testing," which are typically internal tests, but provides no specifics on the subjects, cases, or origin of data.
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 available in the provided document. The type of testing described (software V&V, human factors, life testing) typically does not directly involve establishing a "ground truth" by medical experts in the same way an AI diagnostic device would. For human factors, experts in usability or surgeons might be involved, but their number and qualifications are not specified.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not available in the provided document.
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
There is no indication that an MRMC comparative effectiveness study was done. This device is a surgical system with a new software feature, not an AI diagnostic tool designed to assist human readers. The document focuses on the device's safety and effectiveness in performing surgical procedures, not on improving human interpretation of images.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not fully applicable to the da Vinci SP Surgical System in the context of typical standalone AI performance. The device is an instrument control system, meaning a human surgeon is always "in the loop" controlling it. The "Custom Remote Center" feature is a software enhancement to this instrument control.
However, the "software verification and validation testing" mentioned would include standalone testing of the algorithm (the Custom Remote Center feature) to ensure it functions as intended without operator intervention, but this is a technical verification, not a clinical standalone performance evaluation in the diagnostic sense.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not explain the "ground truth" in clinical terms for the specific tests mentioned. For "software verification and validation," the ground truth would be the expected software output and system behavior according to design specifications. For "human factors evaluation," the ground truth relates to usability standards and user performance metrics. For "life testing," the ground truth is the device's durability and functional longevity. These are engineering and usability "ground truths," not clinical ones tied to patient pathology or outcomes.
8. The sample size for the training set
This information is not applicable and therefore not available. The da Vinci SP Surgical System is not an AI/ML device in the sense that it learns from a "training set" of data to perform a diagnostic or prognostic task. The new feature is a software adjustment to instrument control, not a learned algorithm.
9. How the ground truth for the training set was established
This information is not applicable as there is no mention or implication of a training set or a learned algorithm in the context of this device's approval.
§ 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.