(367 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 subject da Vinci SP Surgical System, Model SP1098, uses advanced robotic technology to facilitate accurate movement of EndoWrist SP™ Instruments through a single surgical port. The System includes three major subsystems (Surgeon Console, Vision Cart, Patient Cart), which are used with instruments and accessories. The system is software controlled.
There are two types of changes that are the focus of this 510(k). The first change is a modification to the Surgeon Console's FootSwitch Panel. The second change is an update to the System Software.
The provided text is a 510(k) summary for the da Vinci SP Surgical System, Model SP1098. It details modifications made to the system and the performance data used to demonstrate substantial equivalence to a predicate device.
Here's an analysis of the provided information related to acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The document doesn't explicitly present a table of concrete, quantitative acceptance criteria for device performance in the typical sense of a diagnostic or algorithmic output (e.g., sensitivity, specificity thresholds). Instead, the acceptance criteria relate to the design and safety validation of a surgical robotic system after modifications. The reported performance is whether these criteria were met.
| Acceptance Criteria Type | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Design Verification | Device meets user interface and software specifications. | The device met all required specifications and functioned as intended. Software design verification testing confirmed the device meets user interface and software specifications. |
| Design Validation (Animal/Cadaver) | Device functions in accordance with its intended use. | Tests with animal and cadaver models confirmed that the subject device functions in accordance with its intended use. |
| Human Factors Validation - Safety | Participants are able to use the device in a safe and effective manner (minimize use errors and severity of hazards). Participants are able to safely complete critical tasks. No newly identified risks or use errors result in unacceptable residual risk. All residual risks remain acceptable. Validated design mitigations/risk control measures are effective. | Participants were able to perform Critical Tasks (Primary Operating Functions) and Essential Tasks safely and effectively. All residual risks remained acceptable. No newly identified risks or use errors resulted in unacceptable residual risk (post-mitigated). |
| Human Factors Validation - Usability | Participants are able to complete essential tasks. Participant subjective feedback indicates acceptable use safety. | Participants were able to complete essential tasks. Participant subjective feedback indicated that the use safety of the SP1098 Surgical System with P3 software is acceptable. |
| Substantial Equivalence | The modified device is substantially equivalent to the predicate device in terms of safety, effectiveness, and performance. | The device has been determined to be substantially equivalent to the predicate for its intended uses by intended users in the intended use environment. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Human Factors Validation: "representative end users (participants)" were used. The exact number of participants is not specified, but the study involved a "mix of RASD (Robotically Assisted Surgical Device) and non-RASD experienced surgeons."
- Design Validation (Animal/Cadaver): "Tests with animal model and cadaver models were performed." The number of animal/cadaver models is not specified.
- Data Provenance: Not explicitly stated, but given the company is based in Sunnyvale, CA, and it's an FDA submission, it's highly likely the studies were conducted in the US. The studies are prospective in nature, as they involve testing human performance with the device.
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 is not a diagnostic device where "ground truth" is established by experts for a specific diagnostic outcome. For the human factors validation, the "ground truth" is implicitly the objective evaluation of task completion and safety, as assessed by the study design and observers. The experts involved are the "representative end users (participants)," who are "RASD and non-RASD experienced surgeons." Their specific qualifications beyond experience type are not detailed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable in the typical sense of adjudicating diagnostic labels. The human factors study involved observing participants performing tasks, and evaluating their performance against predefined safety and effectiveness criteria. There is no mention of an adjudication panel for discordant observations.
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
Not applicable. This is not a diagnostic imaging device with an AI component assisting human readers. It is a surgical robotic system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to a surgical robotic system, which inherently involves human-in-the-loop operation (the surgeon). The "system software" modifications were evaluated (software design verification), but the device itself is not a standalone algorithm. Its performance is always in conjunction with a human operator.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
As mentioned in point 3, this is not a diagnostic device. For the human factors validation, the "ground truth" is based on:
* Objective task performance: Whether critical and essential tasks were correctly and safely completed.
* Observation of use errors: Identification and classification of any errors made by the participants.
* Assessment of residual risks: Evaluation of whether any identified risks (pre- or post-mitigation) are acceptable.
* Subjective feedback: Participant opinions on usability and safety.
8. The sample size for the training set
Not applicable. This is a surgical robotic system, not a machine learning algorithm that requires a "training set" in the conventional sense. The "system software" updates are based on design and engineering principles rather than statistical learning from a large dataset.
9. How the ground truth for the training set was established
Not applicable, as there is no "training set" in the context of machine learning. The "ground truth" for the device's development (its design inputs and specifications) would have been established through engineering requirements, risk analysis, clinical needs assessment, and regulatory standards.
§ 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.