(115 days)
OnSite for da Vinci Surgical Systems is an accessory indicated for use by trained Intuitive Surgical Field Service personnel to: (1) obtain system information for the purpose of diagnosing faults, (2) remotely enable/disable features including configuration updates through either a wired or wireless Ethernet connection between the da Vinci Surgical System and the hospital's Internet Protocol (IP) infrastructure.
OnSite is a software accessory compatible with da Vinci Surgical Systems and allows Intuitive Surgical, Inc. (ISI) personnel to remotely, through either a wired or wireless Ethernet connection between the da Vinci Surgical System and the hospital's Internet Protocol (IP) infrastructure:
• Obtain system information for the purpose of diagnosing faults
• Enable/disable features including configuration updates
The provided text describes a 510(k) summary for the "Intuitive Surgical® OnSite™ for da Vinci® Surgical Systems," which is a software accessory. However, it does not include information typically found in a study demonstrating device performance against specific acceptance criteria for diagnostic accuracy or clinical effectiveness in the way an AI/ML device would.
Instead, the document focuses on demonstrating substantial equivalence to predicate devices based on its intended use, design, technological characteristics, and software verification/validation.
Here's an analysis based on the provided text for each requested item, noting where information is absent:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria for diagnostic accuracy (e.g., sensitivity, specificity, AUC) or clinical outcomes. The "Performance Data" section states:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| New OnSite device performs as intended. | All test cases successfully passed. |
| Proposed software changes have no adverse impact on functionality. | All test cases successfully passed. |
| Substantially equivalent to predicate devices (K081207, K101581). | Demonstrating that the subject device is substantially equivalent to the predicate devices. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "Software Verification Testing and In Vitro Validation Testing." It states "All test cases successfully passed." However, it does not specify the sample size for the test set (number of devices, scenarios, or test cases), nor does it provide information on data provenance (country of origin, retrospective/prospective). Given the nature of the device (software accessory for system troubleshooting and servicing), the "test set" likely refers to a set of software test cases rather than clinical data.
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 information is not provided in the document. For a software accessory focused on system functionality, ground truth establishment would typically involve engineering specifications and expected system behavior rather than expert clinical judgment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. Given the type of testing (software verification and in vitro validation), adjudication methods like 2+1 or 3+1 (common in image analysis for clinical ground truth) are not applicable or mentioned.
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
There is no indication that an MRMC comparative effectiveness study was conducted. The device is a software accessory for remote servicing and troubleshooting, not an AI/ML diagnostic interpretation tool that would typically involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The "Performance Data" section refers to software and in vitro validation testing. This inherently describes a standalone evaluation of the software's functionality against its specifications. The entire premise of the device is for trained Intuitive Surgical Field Service personnel to use it, implying human interaction, but the "performance data" focuses on the software's ability to execute its functions correctly. So, while it's not a "standalone performance" in the sense of a clinical diagnostic algorithm, the verification and validation tests evaluate the software itself. There is no separate human-in-the-loop performance study described in the document.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For "Software Verification Testing and In Vitro Validation Testing," the ground truth would most likely be defined by engineering specifications and expected functional behavior of the da Vinci Surgical System and the OnSite software. It would not typically involve expert clinical consensus, pathology, or outcomes data.
8. The sample size for the training set
The document does not mention a training set. This device is described as a software accessory with expanded capabilities, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
Since there is no mention of a training set, this information is not applicable/provided.
§ 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.