(450 days)
The NovaProbe Inc. LED Light is used to illuminate the site of the surgery during minimally invasive surgical procedures in Arthroscopy (orthopedic surgery), Laparoscopy (general and gynecological surgery) and Endoscopy (general, gastroenterological and ENT surgery). The light is transmitted from the source through an optical cable and a scope.
The NOVAPROBE LED LEUKOS 175 is specifically designed to provide the cold light intensity required for modern day Endoscopic procedures. The LED light provides the color temp of 6500 deg K also known as white light. The white light offers unmatched quality for the single chip, three chip and HD cameras. The LED light intensity is controlled digitally. Using LED nullifies any skin burning problems that may occur due to the use of arc lamps. The NovaProbe LED Light source assures that the light passing through the fiber optic cable is a cold light.
The provided text is a 510(k) summary for the NovaProbe LED Light Source (LEUKOS 175). This document focuses on demonstrating substantial equivalence to pre-existing predicate devices rather than providing unique performance data or clinical study results for the new device. Therefore, it does not contain the specific information requested in your prompt regarding acceptance criteria, detailed study design, or specific performance metrics in the way a clinical trial report would.
Here's the breakdown of what can be extracted based on the provided text, and what cannot:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present a table of acceptance criteria with corresponding performance results. Instead, it states that "Design verification testing demonstrates that the devices function as intended, and the Performance did not raise any new issues of safety and effectiveness, and that formal user training is not required." It also mentions that the device "performs to its specifications, operates as intended, is safe and effective, and is substantially equivalent to legally marketed devices."
The "performance" information provided is primarily comparative to predicate devices, focusing on technological characteristics like:
| Characteristic | NovaProbe LED Light Source (LEUKOS 175) | Predicate Devices (Stryker L9000, SOPRO 281, Richard Wolf 5160, Sunoptic LLS-050) |
|---|---|---|
| Lamp Type | LED | LED |
| Color Temperature | 6500K | 6500K (Stryker L9000), 6000K (SOPRO 281, Richard Wolf 5160, Sunoptic LLS-050) |
| Intended Use | Cold Light Sources for endoscopic and diagnostic procedures | Cold Light Sources for endoscopic and diagnostic procedures |
| Safety | Light Source output identical to K121724 and K082813 | Safety demonstrated in 510k submission |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document explicitly states: "No clinical data was required to confirm safety and effectiveness." Therefore, there is no test set, sample size, or data provenance as would be found in a clinical study report. The evaluation was based on non-clinical design verification testing and comparison to predicate devices.
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, as no clinical data or test set involving expert review was utilized for this 510(k) submission.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable, as no clinical data or test set requiring adjudication was performed.
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. The device is an LED light source, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. The device is a physical light source, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The concept of "ground truth" as typically defined in diagnostic algorithm studies is not applicable here. The evaluation of this device relies on non-clinical design verification testing to ensure it functions as intended and meets safety standards, and on its substantial equivalence to predicate devices which have already established their safety and effectiveness through their own approval processes.
8. The sample size for the training set
Not applicable. This device is a physical medical device (LED light source), not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this device.
§ 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.