(147 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 and general thoracoscopic 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 and general thoracoscopic 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, Model SP1098 is a software-controlled, electro-mechanical system designed for surgeons to perform minimally invasive surgery. The Model SP1098 Surgical System consists of a Surgeon Console, a Patient Cart, and a Vision Cart, and is used with a Camera Instruments, and Accessories. The surgeon seated at the Surgeon Console controls all movement of the EndoWrist SP Instrument by using two Master Controls and a set of foot pealals. The surgeon views the three-dimensional endoscopic image on a High-Resolution Stereo Viewer (3D Viewer), which provides him/her a view of patient anatomy and instrumentation, along with icons and other user interface features.
The Vision Cart includes the supporting electronic and video processing equipment for the system.
The Patient Cart is positioned at the operating room table and has four instrument drives on a single arm that is positioned over the target patient anatomy. A Camera Instrument attaches onto one instrument drive and provides the surgeon a high resolution, threedimensional view of the patient anatomy. A suite of da Vinci SP Instruments can be attached from the other three instrument drives, enabling the surgeon to perform various surgical tasks. The Camera Instruments can be used simultaneously, entering the patient through a single port. Accessories including a cannula, an ontry guide, SP Access Port and disposable tips for selected instruments, instrument sheaths, and a drape are needed to perform procedures with the system.
The EndoWrist SP Instruments come in various configurations such as graspers, scissors, and needle drivers. The da Vinci SP instruments have a unique articulating design at the distal tip that mimics the human wrist, shoulder, and elbow to enable triangulation and X-Y movement of the instrument in the body. Each instrument is used to perform specific surgical tasks such as grasping, suturing, tissue manipulation, and electrocautery. The da Vinci SP Instruments can be used only with the SP1098 Surgical System. The instruments are reusable. They are programmed with a maximum number of surgical procedures based upon life testing.
The provided document describes the FDA's 510(k) premarket notification acceptance for new da Vinci SP Instruments, a robotic surgical system. It focuses on the substantial equivalence of the new instruments (subject devices) to previously cleared predicate devices. The acceptance criteria and supporting studies are detailed, primarily through comparisons to existing devices and performance testing.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of quantitative acceptance criteria with corresponding performance metrics like sensitivity, specificity, or AUC, as would be typical for an AI/CADe device. Instead, the acceptance is based on demonstrating substantial equivalence to predicate devices through various performance tests and comparisons.
The general acceptance criteria are implied to be that the new instruments do not raise new questions of safety and effectiveness compared to the predicate devices and meet established performance benchmarks.
The reported device performance is described qualitatively as:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| No new questions of safety or effectiveness | Performance test data (bench, animal, and cadaver tests) demonstrate that the subject device is substantially equivalent to the predicate device and does not raise different questions of safety and effectiveness than the predicate device. |
| Meets physical, mechanical, user interface, and equipment interface requirements | Bench verification testing confirmed that the design meets physical specifications (dimensions, weight, materials), mechanical requirements (force, range of motion, accuracy), and equipment interfaces (mechanical, electrical, software). User interface and patient safety (re-use, reliability, environmental, cleaning, disinfection, sterilization, shipping, storage, package, labeling) were also verified. |
| Clinical performance (anatomical access and reach) | Cadaver models were used to demonstrate clinical performance for anatomical access and reach for SP Instruments. |
| Safety and performance in live tissue | Live animal models were used to assess safety and performance for SP Instruments in cases where a live tissue model was required, replicating factors experience during clinical use (perfused organs, bleeding, hemostasis). |
| No significant user-facing changes (human factors) | No significant user-facing changes were identified for the SP Force Bipolar Instruments, SP Extended Range Instruments, or Enhanced Wrist Instruments compared to their respective predicates. Therefore, human factors testing performed on predicate devices was leveraged. |
| Grip characteristics (for SP Force Bipolar) | The Strong Grip Mode provides grip characteristics that are 50% greater than the Force Bipolar default mode. The default grip is the same as the predicate SP Fenestrated Bipolar Forceps. |
| Wrist ROM updates (for Extended Range and Enhanced Wrist) | The wrist range of motion is increased from 72 degrees (predicate physical limit) to 86 degrees (subject device software limit). |
| Life and Reprocessing Cycles (Increased for some instruments) | Number of Lives and Reprocessing Cycles increased for several new instruments (e.g., SP Maryland Bipolar Forceps, Extended Range: 25 lives, 38 reprocessing cycles; Predicate: 20 lives, 30 reprocessing cycles). |
| No change in Principle of Operation | There are no changes to the Principle of Operation between the subject and predicate devices for all categories of new instruments. |
2. Sample sizes used for the test set and the data provenance
The document does not specify a distinct "test set" in the context of an AI/algorithm evaluation with a fixed sample size of data points. The assessment involves a combination of engineering tests and biological models:
- Bench Verifications: The sample size for each specific physical, mechanical, electrical, or software test is not detailed.
- Cadaver Models: The number of cadaver models used is not specified. Data provenance is implied to be laboratory-based (experimental).
- Animal Models: The number of animal models used is not specified. Data provenance is implied to be laboratory-based (experimental).
There is no mention of retrospective or prospective data in the sense of clinical patient data for algorithm testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable in the traditional sense for this type of device submission. There is no mention of experts establishing a "ground truth" for a test set of medical images or diagnostic data. Instead, the evaluation relies on:
- Engineering specifications and measurements: For bench testing.
- Surgical observation and performance assessment by trained personnel (likely surgeons and researchers): For cadaver and animal studies. While these individuals are experts in surgery, their role is not described as establishing ground truth for an AI algorithm's output.
4. Adjudication method for the test set
This information is not applicable as there is no mention of a "test set" of diagnostic cases requiring expert adjudication for ground truth.
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, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or reported for this submission. The device is a surgical instrument system, not an AI-assisted diagnostic or interpretative tool for "human readers" in the context of medical image analysis. Human factors evaluation focused on user-device interaction and leveraging prior human factors testing for predicate devices.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a robotic surgical instrument system, which by its nature operates with a human surgeon in the loop. There is a software algorithm, "GripSelect," mentioned for the SP Force Bipolar Instruments, but its performance is integrated into the instrument's function and assessed through overall device performance rather than standalone algorithmic accuracy.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The concept of "ground truth" as typically applied to AI/diagnostic device evaluation (e.g., pathology for disease detection) is not directly present in this submission. For this medical device, the "ground truth" and evidence of safety and effectiveness are established by:
- Engineering specifications and test results: Verifying that the instruments meet design requirements (e.g., force, range of motion, durability).
- Physiological and anatomical performance in biological models: Demonstrating effective manipulation, dissection, grasping, and coagulation in cadaver and animal models, ensuring the instruments function as intended in a surgical environment.
- Historical safety and effectiveness of predicate devices: The primary argument for substantial equivalence relies heavily on the similarity and demonstrated safety/effectiveness of previously cleared devices.
8. The sample size for the training set
Not applicable. The document describes a medical device (surgical instruments) that underwent engineering verification and validation studies. It does not refer to an AI algorithm that would require a "training set" of data in the machine learning sense. The "GripSelect" software algorithm mentioned is likely a deterministic control algorithm rather than a learned AI model.
9. How the ground truth for the training set was established
Not applicable. As there is no training set mentioned for an AI algorithm, the method for establishing its ground truth is not relevant to this submission.
§ 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.