(133 days)
The ViKY System is a motorized device whose intended use is to allow a surgeon to hold and position a rigid endoscope during endoscopic surgical procedures. Its light architecture allows the ViKY System to be maintained above the patient by a dedicated arm attached to the table. The ViKY System movements are controlled by the surgeon either by a foot controller or a voice controller.
The ViKY System is indicated for thoracic and laparoscopic minimally invasive procedures for the purpose of holding and controlling the movement of standard rigid endoscopes within surgical cavities during endoscopic surgery.
ViKY is a motorized endoscope holder for thoracic, abdominal, and pelvic minimally invasive procedures. ViKY is maintained by a dedicated arm attached to the table. It is moved according to surgeon orders by means of either a foot controller or a voice controller, in caudal, cranial and lateral directions, as well as zoom in and zoom out of the field.
This is a 510(k) premarket notification for a medical device called ViKY, a motorized endoscope holder. The document focuses on establishing substantial equivalence to predicate devices, rather than presenting a study with specific acceptance criteria and detailed device performance metrics in the format requested.
Therefore, many of the requested sections regarding acceptance criteria, sample sizes, ground truth, and expert involvement are not applicable or cannot be extracted from the provided text.
Here is an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not detail specific acceptance criteria for performance metrics (e.g., accuracy of movement, speed, stability) for the ViKY device. Instead, it focuses on general safety and effectiveness through substantial equivalence and compliance with established electrical and EMC standards.
| Acceptance Criteria Category | Specific Criteria (from document) | Reported Device Performance (from document) |
|---|---|---|
| Electrical Safety | Compliance with EN 60601-1:1990 | Tested in accordance with EN 60601-1:1990 |
| Compliance with UL 60601-1:2003 | Tested in accordance with UL 60601-1:2003 | |
| Compliance with IEC 60601-1:1988 (with amendments) | Tested in accordance with IEC 60601-1:1988 (with amendments) | |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2 (Second Edition, 2001) | Tested in accordance with IEC 60601-1-2 (Second Edition, 2001) |
| Functionality | Ability to hold and position a rigid endoscope | "ViKY is a motorized endoscope holder for thoracic, abdominal, and pelvic minimally invasive procedures." "It is moved according to surgeon orders by means of either a foot controller or a voice controller, in caudal, cranial and lateral directions, as well as zoom in and zoom out of the field." |
| Material/Sterilization | Sterilization capability | "The main technological difference is that the ViKY System is sterilized" |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not specified. The document mentions "summaries of testing on animals and clinical experience with the system were provided," but does not give specific sample sizes for these tests.
- Data Provenance: Not specified.
- Animal testing: Country of origin and whether retrospective or prospective are not mentioned.
- Clinical experience: Country of origin and whether retrospective or prospective are not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided. The 510(k) submission focuses on regulatory compliance and substantial equivalence to existing devices, not on a detailed clinical study with ground truth established by experts in the context of AI or diagnostic performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. The document does not describe a study involving expert adjudication for a test set.
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 device is an endoscope holder, not an AI diagnostic tool that assists human readers/interpreters. Therefore, an MRMC study and AI assistance effect size are not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a robotic assistant, always used with a human surgeon in the loop. It does not operate as a standalone algorithm for diagnosis or interpretation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The concept of "ground truth" as typically applied to diagnostic AI studies (e.g., pathology as ground truth for cancer detection) is not applicable here. The "truth" for this device relates to its functional performance (e.g., does it hold the endoscope as intended, does it move accurately) and safety. The document refers to "testing on animals and clinical experience with the system," which likely serve as evidence of functional validation and safety, but specific "ground truth" definitions in this context are not provided.
8. The sample size for the training set:
Not applicable. This is a mechanical/robotic medical device, not an AI/machine learning algorithm that requires a "training set" in the conventional sense.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set for an AI algorithm.
§ 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.