(8 days)
The Hill-Rom PrimaView Mouitor System is indicated for use in providing the clinician with a color video display of images that are generated from endoscopic, laproscopic or similar equipment (not supplied by Hill-Rom) during surgical procedures. This system may also be used to display radiographic images for reference only.
The Hill-Rom PrimaView Monitor System is considered and accessory item to an endoscopic or laproscopic system (not supplied by Hill-Rom) in that it provides a means to view images generated by an endoscopic or laparoscopic camera and their associated components. The PrimaView flat screen display is mounted in the operating room or other area of a medical facility where endoscopic or similar procedures are done. Output video signals from the camera and processing unit are fed into the appropriate input connector of the PrimaView System. The signal is then routed to the display for presentation to the clinician. The system can also be used to display reference quality (not for diagnosis) radiographic images
This document describes the Hill-Rom PrimaView Monitoring System, which is a video display system intended for use during surgical procedures with endoscopic or laparoscopic equipment. It also mentions its use for displaying radiographic images for reference.
Based on the provided text, a conventional acceptance criteria table and detailed study information as typically seen in AI/ML device submissions cannot be fully extracted for the following reasons:
- This document is a 510(k) summary for a medical device (a monitor), NOT an AI/ML algorithm. The criteria and study types requested (e.g., MRMC studies, ground truth establishment, training/test set sizes for algorithms, AI improvement effect size) are specifically relevant to AI/ML device performance evaluation, which this device is not.
- The document predates the widespread regulatory framework for AI/ML in medical devices. The K013709 clearance is from 2001, at which point AI/ML in medical imaging was not a primary focus of regulatory submissions in the same way it is today.
- The "performance data" section refers to compliance with electrical and safety standards, not diagnostic or interpretive accuracy.
However, I can interpret the document to provide information relevant to its own type of "acceptance criteria" and "study" as presented in the 510(k) summary.
Here's an attempt to structure the available information per your request, with significant caveats that it does not align with AI/ML specific criteria:
Acceptance Criteria and Device Performance (Interpreted for a Monitor Device)
| Acceptance Criterion (Interpreted) | Reported Device Performance / Compliance |
|---|---|
| Intended Use: Provide color video display of images from endoscopic, laparoscopic, or similar equipment during surgical procedures. Display radiographic images for reference. | The Hill-Rom PrimaView Monitor System is designed to fulfill this intended use. It accepts various types of signals (analog and digital) from endoscopic, laparoscopic, or similar sources for display. |
| Substantial Equivalence: Equivalent to a predicate device in intended use. | Substantially equivalent to the Sony Trinitron Color Video Monitor PVM-1343MD (K885042) in its intended use of displaying video images. |
| Safety and Electrical Standards Compliance: Meet applicable parts of recognized national and international safety, EMC, and electrical standards. | Compliance to all or applicable parts of IEC, EN, CISPR, UL, and CSA standards (IEC 601-1-2, EN 60601-1 and -2, EN 61000-4-3,4,5, CISPR 11, UL 2601-1 and CSA C22.2 601.1-M90) will be confirmed through design testing and documented. Documentation retained in the Design History File (DHF). |
| Overall Safety and Effectiveness: The device is safe and effective for its intended use. | Conclusion: The Hill-Rom PrimaView Monitor System is designed to be safe and effective for its intended use. Verification and Validation Testing will be completed prior to commercial distribution. |
Detailed Study Information (Applying AI/ML Questions to a Non-AI/ML Context where possible):
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- This question is not applicable in the context of a video monitor without any AI/ML components performing diagnostic or analytical tasks. The "testing" referred to is for electrical safety, electromagnetic compatibility, and functional performance (e.g., displaying a video signal), not image interpretation accuracy. The document does not specify a "test set" of medical images or patient data.
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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. There is no diagnostic "ground truth" to be established for a monitor displaying images. The "ground truth" for this device would be its ability to correctly power on, display a clean video signal, and meet electrical safety specifications. These are verified by engineering tests, not expert clinical consensus on images.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable for the reasons stated above.
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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 a display monitor, not an AI assistance tool. There is no AI component to measure improvement for human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. There is no algorithm. The device's standalone performance refers to its ability to function as a monitor without human interaction in its core function of display, but this is a very different concept than "standalone algorithm performance."
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- As mentioned, "ground truth" in the AI/ML context is not relevant here. The 'ground truth' for monitor performance would be electrical engineering standards, functional specifications (e.g., color accuracy, refresh rate, resolution), and safety requirements as defined by the IEC, EN, CISPR, UL, and CSA standards listed.
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The sample size for the training set:
- Not applicable. There is no AI/ML algorithm requiring a training set.
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How the ground truth for the training set was established:
- Not applicable. There is no AI/ML algorithm.
In summary, the provided document is a regulatory submission for a basic medical display monitor from 2001. The regulatory requirements and evaluation metrics described are entirely different from those applicable to modern AI/ML medical devices. Therefore, most of your specific questions cannot be answered from the provided text, as they pertain to a different type of medical technology.
§ 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.