(61 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 TI and T2, and for benign base of tongue resection procedures, 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.
da Vinci S/ Si (IS2000/IS3000) EndoWrist Instruments have a unique articulating design at their distal tips that mimics the human wrist. While seated at the Surgeon Console of the Surgical System, the surgeon can precisely control movements of the end effectors/instrument tips to perform one or more specific surgical tasks e.g., grasping, suturing, cutting, cauterizing, or tissue manipulation.
The da Vinci X/Xi (IS4200/IS4000) EndoWrist Instruments have a unique articulating design at their distal tips that mimics the human wrist. While seated at the Surgeon Console of the Surgical System, the surgeon can precisely control movements of the end effectors/instrument tips to perform one or more specific surgical tasks e.g., grasping, suturing, cutting, cauterizing, or tissue manipulation.
The provided document is a 510(k) premarket notification for da Vinci surgical instruments, focusing on the changes to their reprocessing instructions to include an optional automated cleaning and disinfection process. It doesn't contain a detailed study proving the device's clinical performance, but rather validation of its reprocessing efficacy. The focus is on ensuring the instruments remain safe and effective after being cleaned and disinfected by an automated washer-disinfector, similar to their prior manual cleaning method.
Here's an analysis of the acceptance criteria and the studies that address them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Cleaning Validation | Efficacy of the automated cleaning process (using an automated washer-disinfector) for da Vinci S/Si and X/Xi Reusable Instruments, demonstrated in accordance with specific FDA guidance and AAMI standards. | The da Vinci S/Si and X/Xi Reusable Instruments successfully met the acceptance criteria for all markers (indicating cleanliness after automated reprocessing). This demonstrates the instruments can be cleaned effectively using an automated washer/disinfector. |
| Thermal Disinfection Validation | Efficacy of the thermal disinfection process for the subject devices within the automated washer/disinfector, per "Class II Special Controls Guidance Document: Medical Washers and Medical Washer-Disinfectors." | The subject devices met the acceptance criteria, validating the efficacy of the thermal disinfection cycle within the automated washer/disinfector. |
| Reliability/Life Testing | da Vinci instruments are not adversely affected (e.g., in terms of function, structural integrity) by the use of an automated washer-disinfector for reprocessing. | The subject devices within the scope of this submission met the acceptance criteria, indicating they maintain reliability and lifespan after automated reprocessing. |
| Human Factors Testing | The Reprocessing Instructions are usable, effective, and safe for end-users, based on preliminary evaluation, usability risk analysis, design team participation, formative testing, and validation testing with representative end-users. | The Reprocessing Instructions underwent a rigorous Human Factors Testing process, including a preliminary evaluation, Usability Risk Analysis (URA), design team participation, formative testing, and validation testing. This assessed usability, effectiveness, and use safety. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes (number of instruments, number of cycles) for the Cleaning Validation, Thermal Disinfection Validation, or Reliability/Life Testing.
- Cleaning Validation: "all markers" implies multiple types of soil/contaminants were tested.
- Thermal Disinfection Validation: "the subject devices" implies a representative set of instruments.
- Reliability/Life Testing: "the subject devices within the scope of this submission" implies a representative set of instruments was tested through multiple reprocessing cycles.
- Human Factors Testing: "representative end users" were used for validation testing.
Data Provenance: The studies were conducted by Intuitive Surgical, Inc. as part of their 510(k) submission to the FDA. The nature of these tests (validation of reprocessing) implies they were prospective studies performed specifically to support this regulatory submission. There is no information about the country of origin of the data, but given it's an FDA submission, the tests would conform to U.S. regulatory standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not explicitly state the number or qualifications of experts used to establish the "ground truth" for the test sets in the cleaning, disinfection, or reliability studies. These types of validation studies typically rely on established standards (e.g., AAMI, FDA guidance) for acceptance criteria rather than subjective expert consensus on "ground truth."
For Human Factors Testing:
- Experts involved: "Human Factors Engineers" participated in the design meetings.
- Ground Truth: For human factors, the "ground truth" is typically defined by the safe and effective execution of the reprocessing tasks by representative users, with risk analysis identifying potential use errors. The document states a "Usability Risk Analysis (URA)" was conducted and "validation test of representative Reprocessing Instructions was completed with representative end users," assessing "usability, effectiveness, and use safety." It does not specify how many experts defined the URA or evaluated the validation test outcomes.
4. Adjudication Method for the Test Set
The document does not describe a formal adjudication method (like 2+1 or 3+1) for the test results. For cleaning, disinfection, and reliability tests, performance is usually objectively measured against predefined quantitative limits set by standards. For Human Factors, the validation testing would likely involve observation of user performance, identification of errors (critical and non-critical), and assessment against pre-defined safety and usability objectives. The report implies direct measurement and comparison to acceptance criteria.
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 done. The device in question (da Vinci surgical instruments) and the submission's focus (reprocessing instructions) are not related to AI-assisted reading or診断 (diagnosis). This is a submission for medical devices that are physical surgical instruments and the validation of their cleaning and disinfection protocols.
6. If a Standalone (i.e. algorithm only, without human-in-the-loop performance) was done
Not Applicable. This is not an algorithmic or AI-based device, so the concept of standalone algorithm performance does not apply. The "device performance" here refers to the physical and functional integrity of the surgical instruments after undergoing a new reprocessing method (automated cleaning/disinfection) compared to how they performed after previous methods.
7. The Type of Ground Truth Used
- Cleaning Validation: Ground truth is established by quantitative measurement of residual soil/markers (e.g., protein, hemoglobin) against acceptance limits specified in recognized standards (AAMI TIR 30, AAMI TIR 12) and FDA guidance.
- Thermal Disinfection Validation: Ground truth is established by demonstrating the inactivation of microorganisms to a specified log reduction, as defined by FDA "Class II Special Controls Guidance Document."
- Reliability/Life Testing: Ground truth is established by verifying that the instruments maintain their functional and structural integrity after repeated reprocessing cycles, meeting specified performance criteria.
- Human Factors Testing: Ground truth is established by the successful, safe, and effective completion of reprocessing tasks by representative users, identifying and mitigating potential use errors through risk analysis and observed performance.
8. The Sample Size for the Training Set
Not Applicable. This submission is for physical surgical instruments and changes to their reprocessing instructions, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not Applicable. See point 8.
§ 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.