(191 days)
The EndoWrist® One Suction/Irrigator, when attached to an external suction/irrigation source(s), is intended for use with the da Vinci Si Surgical System as a general purpose suction and/or irrigation device used during surgical procedures.
The EndoWrist® One Suction/Irrigator is a single-use, disposable instrument developed for use with the da Vinci Surgical System. The instrument provides the surgeon with the ability to activate suction and irrigation directly from the surgeon console. Activation will be controlled through the foot pedal at the surgeon side console. An additional feature allows manual activation by the patient side assistant. The suction and irrigation sources are supplied by conventional devices (suction - canister, hospital line, etc; and irrigation - closet, compressed air, gravity flow, etc) that are normally available in an operating room setting.
Here's an analysis of the provided text regarding acceptance criteria and supporting studies:
It appears that the provided document is a 510(k) summary for the Intuitive Surgical EndoWrist® One Suction/Irrigator, a device for use with the da Vinci Surgical System. This document does not describe acceptance criteria in the typical sense of numerical thresholds for performance metrics (like sensitivity, specificity, accuracy) that are met by a particular study.
Instead, this 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (Surgiflex® WAVE™ Suction-Irrigation System, K992126). This regulatory pathway means the manufacturer needs to show that their new device is as safe and effective as a legally marketed device, not necessarily that it meets specific, predefined performance benchmarks in the same way a novel algorithm might.
Therefore, many of the requested items (like a table of acceptance criteria, sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance, etc.) are not applicable or not provided in this type of regulatory submission.
Let's break down what is available and what is not:
Acceptance Criteria and Device Performance
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly defined as numerical acceptance criteria. The overarching "acceptance criterion" is demonstrating substantial equivalence to the predicate device in terms of safety, effectiveness, and performance. | Performance tests (bench and animal lab tests) were conducted to demonstrate that the subject device is substantially equivalent to the predicate device and that the design output meets the design input requirements. The results of the testing did not raise any new issues of safety or effectiveness as compared to the predicate device for the same indications for use. |
Explanation: In a 510(k) for a device like this, the "acceptance criteria" are implied by the substantial equivalence pathway. The device must perform comparably to its predicate without raising new safety or effectiveness concerns across its intended use and technological characteristics. Specific numerical performance metrics (e.g., suction flow rates, irrigation volume, articulation range, durability) would be part of the internal design input requirements and verification testing, but these are summarized rather than detailed in the public 510(k) summary.
Study Details (where applicable for a 510(k) substantial equivalence)
2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Sizes: Not specified. The document mentions "bench and animal lab tests" but does not give specific numbers for devices tested, animals used, or the nature of "test sets."
- Data Provenance: Not specified. Testing would likely have been conducted by Intuitive Surgical, Inc., a U.S. company, but the specific location of the labs or animal facilities is not mentioned.
- Retrospective or Prospective: Not applicable in the context of device function testing for a mechanical surgical instrument. These would be controlled laboratory and animal studies.
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)
- Not applicable / Not specified. Establishing "ground truth" with experts isn't relevant in the same way for a mechanical surgical instrument's performance testing. "Ground truth" for this device would relate to its physical functionality (e.g., does it suction, does it irrigate, does it articulate correctly) verified by engineering specifications and direct observation. If animal studies involved surgical outcomes, the assessment would be by veterinary surgeons or pathologists, but details are not provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable / Not specified. Adjudication methods are typically used in clinical studies or image-based diagnostic evaluations where human interpretation or consensus is required. For bench and animal lab tests of a surgical instrument, results are usually based on objective measurements or observations by trained personnel following established protocols.
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. This is entirely not applicable. The device is a surgical instrument (suction/irrigator), not an AI diagnostic or assistance system. MRMC studies are used for evaluating diagnostic performance, often for AI in imaging.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. The device is a human-controlled surgical instrument. There is no "algorithm only" performance to evaluate. Its function requires human operation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Inferred based on "bench and animal lab tests": For bench tests, ground truth would be based on engineering specifications, direct measurements, and functional verification (e.g., confirmed flow rates, pressures, sealing integrity, articulation range). For animal lab tests, it would involve direct observation of surgical performance and potentially assessment of physiological effects or outcomes by veterinary professionals. The document doesn't provide specifics.
8. The sample size for the training set
- Not applicable. This device is not an AI/ML algorithm that requires a "training set."
9. How the ground truth for the training set was established
- Not applicable. As above, no training set for an AI/ML algorithm.
Summary of what the document does convey:
- Regulatory Pathway: 510(k) premarket notification, demonstrating substantial equivalence.
- Predicate Device: Surgiflex® WAVE™ Suction-Irrigation System (K992126).
- Performance Validation: Bench tests and animal lab tests were conducted.
- Conclusion: The tests demonstrated substantial equivalence, meeting design input requirements, and raised no new safety or effectiveness issues compared to the predicate device. The device is considered equivalent in terms of safety, effectiveness, and performance.
§ 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.