(63 days)
The SolarTec™ Source 270 System is intended for use:
- To provide visible light for with various rigid or flexible endoscopes, other lighted tools, and surgical headlamps that contain fiber bundles or single fibers for illumination
- In providing illumination for the purposes of allowing observation and manipulation of body cavities and tissues, hollow organs, and canals.
- With applications that include, but are not limited to, headlights and/or externally illuminated endoscopes used in arthroscopy, bronchoscopy, gynecology, laparoscopy, obstetrics, oto-rhyno-laryngoscopy, urology, and vascular endoscopy as well as surgical headlights used in various open surgical procedures.
The Subject Device is designed with a safety interlock on the lamp replacement door. If the cover is opened, the power to the device will be interrupted. The Subject Device is cooled with a forced air fan to prevent the temperature of the unit from exceeding a safe level. If in the event that the fan malfunctions and/or fails to operate properly and the internal temperature of the device exceeds the engineered specifications, the device is designed with an internal thermal protection mechanism that automatically shuts off the power to the lamp. The Subject Device contains a user replaceable lamp fixture. The Subject Device has incorporated several safety features into the product design. These safety features include: a) The lamp is never operated beyond its specified power range, b) The lamp life is limited to approximately 1000 hours by analog circuitry. This limit is significantly below the safe rated life expectancy of the lamp (approximately 4000 hours) as stated by the lamp manufacturer, c) The enclosure has interlor structures (baffles), which will dampen the sound level and confine any debris which might result from the non-passive lamp failure. The Subject Device used with a Cogent Light single fiberoptic cable typically produces a uniform output image.
The provided document is a 510(k) Premarket Notification for the SolarTec™ Source 270. It primarily focuses on the safety and effectiveness of the device, rather than diagnostic performance metrics typically associated with AI/ML devices. Therefore, much of the requested information regarding sample sizes, expert evaluations, ground truth, and comparative effectiveness studies is not applicable to this type of device and submission.
Here's an breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
This device is a light source, not a diagnostic tool with performance metrics like sensitivity or specificity. The "acceptance criteria" presented are primarily safety standards and effectiveness claims related to light production and delivery.
| Acceptance Criteria (Safety) | Reported Device Performance (Safety Features) |
|---|---|
| Safety Interlock | Device designed with a safety interlock on the lamp replacement door; power to the device is interrupted if the cover is opened. |
| Overheating Prevention | Cooled with a forced air fan to prevent temperature exceeding safe levels. Internal thermal protection mechanism automatically shuts off power to the lamp if fan malfunctions or internal temperature exceeds engineered specifications. |
| Lamp Failure (Non-passive) | Incorporated safety features to minimize non-passive lamp failures: |
| a) Lamp never operated beyond specified power range. | |
| b) Lamp life limited to ~1000 hours by analog circuitry (significantly below safe rated life expectancy of ~4000 hours). | |
| c) Enclosure has interior structures (baffles) to dampen sound and confine debris from non-passive lamp failure. | |
| Product Safety Standards | Subject Device will meet: |
| a) IEC601-1-2.1993 (Class B) Medical electrical equipment Part 1: General requirements for safety | |
| b) IEC601-2-18:1996 Medical electrical equipment Part 2: Particular requirements for the safety of endoscopic equipment | |
| c) UL2601-1 2nd ed. Standard for Safety Part 1: General Requirements for safety. | |
| Acceptance Criteria (Effectiveness Claims) | Reported Device Performance (Effectiveness Claims) |
| Light Quality | Metal halide arc lamps produce light spectrally similar to sunlight. Color of light delivered determined by optical coatings and light delivery system. |
| Output Imagery Uniformity | Subject Device used with a Cogent Light single fiberoptic cable typically produces a uniform output image, independent of light source intensity. This contrasts with other commercial fiber bundles and illuminators producing non-uniform images. Uniform illumination is beneficial for direct illumination applications (e.g., surgical headlamp). |
| White Light Transmission | Cogent Light single fiberoptic cables, used as part of the Subject Device, transmit white light uniformly throughout the visible spectrum, unlike traditional fiber bundles that attenuate more in the blue region leading to yellower light. |
2. Sample size used for the test set and the data provenance
This information is not applicable as this is a medical device for illumination, not a diagnostic AI/ML system requiring a test set of data. The submission focuses on engineering specifications and compliance with safety standards rather than performance on a clinical dataset.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable. The "ground truth" for this device would be its adherence to safety standards and its ability to produce light as described, not clinical diagnoses by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. No test set requiring adjudication of findings is described for this device.
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
This information is not applicable. This device is a light source, not an AI/ML diagnostic tool, and therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This is a physical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for this device's safety is its compliance with specified international and national safety standards (IEC601-1-2.1993, IEC601-2-18:1996, UL2601-1). For its effectiveness claims, the "ground truth" would be physical measurements of light output, spectral characteristics, and image uniformity, as demonstrated through engineering testing and design specifications. No clinical "ground truth" in the diagnostic sense (e.g., pathology) is relevant.
8. The sample size for the training set
This information is not applicable. This is a physical light source, not a machine learning model.
9. How the ground truth for the training set was established
This information is not applicable.
§ 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.