(17 days)
The Nurse's Assistant® 1.7 O.R. Control System is a computerized control system that is intended to provide operating room (OR) staff with a simple, centralized user interface from which to activate, adjust and monitor certain settings of equipment located in the OR and to route video from multiple sources to multiple destinations.
The Nurse's Assistant® 1.7 O.R. Control System is indicated for use in an operating room for video assisted surgery. This includes minimally invasive procedures in all surgical specialties, as an adjunct display of interventional techniques and traditional open procedures.
The Nurse's Assistant 1.7 O.R. Control System indicated for use with ConMed Linvatec IM3300 Endoscopic Camera, ConMed Linvatec LS7500 Xenon Light Source, ConMed Linvatec GS1002 40L Insufflator, ConMed Electrosurgery System 5000 Electrosurgery Unit (ESU), ConMed Linvatec VP-1500 Digital Capture Device, Getinge ALM Surgical Lamp Energix WPS, Getinge ALM PrismaVision PRV3 Surgical Light Camera, Berchtold Chromophare D-Series Surgical Lamps, Berchtold ChromoVision HR24 Surgical Light Camera, National Display Systems 15" & 18" Vector III and 19" Radiance flat panel displays, Sony LMD-2140MD 21" flat panel display, Sony UP-51MD or Sony UP-51MDU video printers, Sony SVO-9500MD VCR, and ProVation™ procedure documentation device.
The Nurse's Assistant® 1.7 O.R. Control System is indicated for use in general, cardiovascular, ENT, gastroenterology, urology, plastic, obstetrics, gynecology, and orthopedic surgery, and general thoracoscopy, general cardiothoracic surgery, general laparoscopy, arthroscopy, laparoscopy, nasopharyngoscopy, ear endoscopy and sinusoscopy.
The Nurse's Assistant® 1.7 O.R. Control System is a computerized control system that is intended to provide operating room (OR) staff with a simple, centralized user interface from which to activate, adjust and monitor certain settings of equipment located in the OR and to route video from multiple sources to multiple destinations.
This 510(k) summary describes a modification to an existing device, the Nurse's Assistant® 1.7 O.R. Control System, and focuses on demonstrating substantial equivalence to predicate devices rather than independent performance testing against acceptance criteria. Therefore, many of the requested categories related to a de novo device study or AI-specific performance evaluation cannot be directly extracted from the provided text.
Here is an analysis based on the available information:
Description of the Device and Study Focus:
The Nurse's Assistant® 1.7 O.R. Control System is a computerized control system designed to provide OR staff with a centralized user interface for activating, adjusting, and monitoring certain equipment settings, and for routing video within the OR. The submission (K052740) describes a modification to an existing Nurse's Assistant® 1.7 O.R. Control System (predicate K050829) and also references the HERMES O.R. Control Center (predicate K030240). The primary goal of this submission is to demonstrate substantial equivalence to these predicate devices.
This means the "study" described is primarily a comparative effectiveness study against established predicate devices, focusing on demonstrating that the modified device has the same intended use, similar indications for use, and equivalent technological characteristics, safety, effectiveness, and performance. This is not a standalone performance study in the typical sense of establishing de novo performance metrics for a novel device. There is no indication of AI involvement in this device from the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
As this K052740 submission is for a modification to an already cleared device and relies on substantial equivalence, explicit "acceptance criteria" for a new device's performance are not detailed in the provided text. Instead, the "acceptance criteria" implicitly revolve around demonstrating equivalence to the predicate devices in terms of:
| Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance (as stated in submission) |
|---|---|
| Intended Use: Same as predicate devices. | The Modification to Nurse's Assistant® 1.7 O.R. Control System has the same intended use as the predicate device K050829 and K030240. |
| Indications for Use: Similar to predicate devices. | The Modification to Nurse's Assistant® 1.7 O.R. Control System has similar indications for use as the predicate device K050829 and K030240. (The full Indications for Use are detailed: computerized control system for OR staff, specified for video-assisted surgery, minimally invasive procedures, adjunct display for interventional techniques, traditional open procedures, and compatible with a list of specific OR equipment and surgical specialties). |
| Technological Characteristics: Equivalent to predicate devices. | The technological characteristics of the Modification to Nurse's Assistant® 1.7 O.R. Control System are equivalent to the predicate devices listed above. |
| Safety, Effectiveness, and Performance: Substantially equivalent to predicate devices. | Tests performed on the Modification to Nurse's Assistant® 1.7 O.R. Control System demonstrate substantial equivalence to the predicate devices listed above. The Modification to Nurse's Assistant® 1.7 O.R. Control System is substantially equivalent to the predicate devices in terms of safety, effectiveness, and performance. |
Note: The document explicitly states "Tests performed on the Modification to Nurse's Assistant® 1.7 O.R. Control System demonstrate substantial equivalence." However, the specific details or results of these "tests" are not provided in the submitted summary.
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the given text. As the submission is for a modification seeking substantial equivalence, it's likely the "tests" performed were focused on verifying the new components or software changes maintained compatibility and functionality consistent with the predicate, rather than an extensive new clinical trial with a large test set. The provenance of any data (e.g., country of origin, retrospective/prospective) is also not mentioned.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided and is generally not applicable to this type of 510(k) submission for a control system modification focusing on substantial equivalence. The "ground truth" here would be the established safe and effective operation of the predicate devices.
4. Adjudication Method for the Test Set
This information is not provided and is not typically relevant for a substantial equivalence submission for a modification to a control system.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance
- No Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done based on the provided document.
- AI is not mentioned in the context of this device or study. The device is described as a "computerized control system," which predates widespread clinical AI applications. Therefore, there is no discussion of human readers improving with or without AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This device is a "computerized control system" designed to provide a "user interface" for "OR staff." It inherently involves human interaction and is not an algorithm-only standalone device in the sense of an AI-powered diagnostic tool.
- The nature of the device (a control system for OR equipment) means its performance is inextricably linked to human operation and integration within the surgical environment.
7. The Type of Ground Truth Used
The "ground truth" for this substantial equivalence submission is implicitly the established safety, effectiveness, and performance of the legally marketed predicate devices (K050829 and K030240). The tests performed were to ensure the modified device maintained this established performance. There is no mention of pathology, outcomes data, or expert consensus being used to establish a new ground truth for this modification.
8. The Sample Size for the Training Set
This information is not provided and is irrelevant for this type of device and submission. This is not a machine learning or AI-driven device that requires a training set in that context.
9. How the Ground Truth for the Training Set Was Established
This information is not provided and is irrelevant for this type of device and submission.
§ 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.