(227 days)
The Intuitive Surgical Endoscopic Instrument Control System is intended for accurate control of selected endoscopic instruments including, rigid endoscopes, blunt endoscopic dissectors and endoscopic retractors during thoracoscopic and laparoscopic surgical procedures. It is intended to be used by professionals in operating room environments.
The Intuitive Surgical Endoscopic Instrument Control System is an electro-mechanical device consisting of a Surgical Console including "Master Manipulators", articulated Instrument Control Arms or "Slave Manipulators" and Limited Reuse Tools or end effectors.
The provided text describes the 510(k) summary for the Intuitive Surgical Endoscopic Instrument Control System (K965001). However, it does not contain the specific details required to complete all sections of your request, particularly regarding detailed acceptance criteria, specific reported device performance metrics against those criteria, and granular information about the study design (e.g., sample sizes for test and training sets, expert qualifications, ground truth establishment methods for training data).
Here's an analysis based on the available information and what is missing:
Acceptance Criteria and Study for Intuitive Surgical Endoscopic Instrument Control System (K965001)
The submission focuses on establishing substantial equivalence to predicate devices rather than demonstrating performance against predefined, quantitative acceptance criteria via a comprehensive clinical study as might be seen for novel devices.
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided text, specific quantitative acceptance criteria and corresponding reported device performance metrics are NOT explicitly stated. The document refers to "internal specification requirements" and "external standard requirements and predicate performance expectations" but does not detail what these are.
| Acceptance Criteria (Quantitative/Qualitative) | Reported Device Performance |
|---|---|
| Reproducibility | "All data fell within... internal specification requirements as well as external standard requirements and predicate performance expectations." |
| Hysteresis | "All data fell within... internal specification requirements as well as external standard requirements and predicate performance expectations." |
| Functional Adequacy | "All data fell within... internal specification requirements as well as external standard requirements and predicate performance expectations." |
| Substantial Equivalence to Predicates | Confirmed through "Design analysis and in vitro data" and comparison of intended use, basic functionality, and tissue effects. |
| Capability of precisely moving and controlling endoscopic tools | "The Intuitive system is substantially equivalent to both the Computer Motion and Andronic devices in terms of the capability of precisely moving and controlling endoscopic tools." |
| Tissue Effects | "The Intuitive system is substantially equivalent to the cited predicates in terms of the tissue effects." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Test Set): Not specified. The document mentions "in vitro test data" and "design analysis" but does not give a number of tests or samples.
- Data Provenance: The tests are described as "in vitro data," suggesting laboratory or bench testing. No information on country of origin or whether it was retrospective or prospective human clinical data is provided, as it appears to be primarily bench/pre-clinical testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. It's likely that internal engineers or subject matter experts evaluated the in vitro test results against specifications, but this is not detailed.
4. Adjudication Method for the Test Set
- Adjudication Method: Not specified. Given the nature of "in vitro test data," it's more likely that direct measurements were taken and compared against pre-defined specifications rather than requiring expert adjudication in the traditional sense of clinical imaging studies.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No. The provided information does not describe any MRMC study comparing human readers with and without AI assistance. This device is an electromechanical control system for surgical instruments, not an AI-powered diagnostic or assistive tool in the context of interpretation.
6. Standalone (Algorithm Only) Performance Study
- Standalone Performance Study: Yes, in a sense. The "in vitro test data" and "design analysis" would represent the "standalone" performance of the device's functional characteristics (reproducibility, hysteresis, functional adequacy) in a controlled environment. However, it's not an "algorithm only" study in the typical AI sense, but rather a performance study of the electromechanical system.
7. Type of Ground Truth Used
- Type of Ground Truth: The "ground truth" for the in vitro tests would be the pre-defined engineering specifications and performance expectations for reproducibility, hysteresis, and functional adequacy. These would likely be based on established engineering principles, predicate device performance, and clinical needs for precise instrument control.
8. Sample Size for the Training Set
- Sample Size (Training Set): Not applicable in the context of machine learning. This device is an electromechanical system, not an AI/ML algorithm that requires a training set. Its design and validation rely on engineering principles, material science, and control systems, not data-driven machine learning models.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth (Training Set): Not applicable, as there is no training set for this type of device.
§ 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.