(24 days)
The Intuitive Surgical Endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, ultrasonic shears, forceps/pick-ups, needle holders, endoscopic retractors, stabilizers, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, transoral otolaryngology surgical procedures restricted to benign and malignant tumors classified as T1 and T2, general thoracoscopic surgical procedures, and thoracoscopically assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use (except for transoral otolaryngology surgical procedures). It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.
The Intuitive Surgical da Vinci Si Surgical System is a computer-assisted device designed to facilitate complex surgery using a minimally invasive approach. The system consists of three main components: the Surgeon Console, the Patient Cart, and the Vision Cart. The Surgeon Console houses the hand (Master Tool Manipulators or MTMs) and foot controls for the system. These controls allow the surgeon to manipulate the endoscopic instruments and camera located on the Patient Cart. The Vision Cart houses the system's image processing unit as well as the Instrument Control Box and any electrosurgical generators used in conjunction with the endoscopic instruments. The proposed modification to the Intuitive Surgical da Vinci Si Surgical System user interface will result in a change from Functional Footpedal Mapping to Left/Right Associative Footpedal Mapping. Currently, under Functional Footpedal Mapping, instruments are assigned to footpedal banks according to their function (monopolar, bipolar, etc). The proposed change to Left/Right Associative Footpedal Mapping will provide a more intuitive user interface by associating each pedal bank with a hand controller or "master tool manipulator" (MTM). Therefore, instruments assigned to the left MTM will be controlled by the left pedal bank and the instruments assigned to the right MTM will be controlled by the right pedal bank.
The provided text describes a Special 510(k) Pre-market Notification for a device modification, focusing on a change in footpedal mapping for the da Vinci Si Surgical System. The purpose of the submission is to demonstrate substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Human Factors/Usability | Substantially equivalent in terms of error rate. | Human Factors testing was conducted to demonstrate that the subject device is substantially equivalent to the predicate device in terms of error rate. |
| Human Factors/Usability | Substantially equivalent in terms of risk profile. | Human Factors testing was conducted to demonstrate that the subject device is substantially equivalent to the predicate device in terms of... risk profile. |
| Software Verification | Design specifications meet design requirements. | Software verification testing was performed to confirm that the design specifications meet the design requirements. |
| Safety and Effectiveness | No new types of safety or effectiveness questions raised. | The results of the testing did not raise any new types of safety or effectiveness questions. |
| Technological Characteristics | Substantially equivalent in terms of intended use. | The subject device... is substantially equivalent in technological characteristics in terms of the intended use... as compared to the da Vinci Si System, with Functional Footpedal Mapping (the predicate device). |
| Technological Characteristics | Substantially equivalent in terms of indications for use. | The subject device... is substantially equivalent in technological characteristics in terms of the... indications for use... as compared to the da Vinci Si System, with Functional Footpedal Mapping (the predicate device). |
| Technological Characteristics | Substantially equivalent in terms of technological characteristics. | The subject device (da Vinci Si System, with Left/Right Associative Footpedal Mapping) is substantially equivalent in technological characteristics... as compared to the da Vinci Si System, with Functional Footpedal Mapping (the predicate device). |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions "Human Factors testing" and "Software verification testing," but does not specify the sample size used for the test set for either.
The data provenance is not explicitly mentioned, but given that Intuitive Surgical is a U.S.-based company and the submission is to the FDA, it is highly likely that testing was conducted in the United States. The text does not specify if the data was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
The document does not provide information on the number of experts used or their qualifications for establishing ground truth in the human factors testing. It only states that human factors testing was performed.
4. Adjudication Method for the Test Set:
The document does not specify any adjudication method used for the test set.
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 device is not an AI-based diagnostic tool for interpretation by human readers. It's a surgical system modification changing the input mechanism (footpedal mapping). Therefore, a MRMC comparative effectiveness study is not relevant or applicable in this context, nor is an "effect size of how much human readers improve with AI vs without AI assistance." The study focuses on usability and safety of a control interface change.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was done:
The document describes "Software verification testing" which confirms design specifications. This can be considered a standalone assessment of the software's functionality in fulfilling its requirements. However, the primary performance evaluation for the user interface change is the "Human Factors testing," which inherently involves humans (users of the system) in the loop to assess usability and error rates. So, while software verification might be considered standalone, the overall performance evaluation of the device modification is not.
7. The Type of Ground Truth Used:
For the "Human Factors testing," the ground truth implicitly refers to objective measures of errors and risk profiles in system operation, likely compared against a benchmark or expected safe performance, and against the predicate device's performance. For "Software verification testing," the ground truth is simply whether the software meets its predefined design requirements/specifications.
8. The Sample Size for the Training Set:
The concept of a "training set" is typically associated with machine learning or AI models. Since this device modification is a change in a user interface (footpedal mapping) for a surgical system, rather than an AI algorithm being trained, there is no mention or relevance of a training set in this document.
9. How the Ground Truth for the Training Set was Established:
As there is no training set for this type of device modification, this question is not applicable to the provided text.
§ 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.