(83 days)
"Provides light for examination, diagnostic and therapeutic applications, particularly in endoscopy"
The SOPRO 281 is a light source with one led lamp, electronic iris light intensity control, and connections for a fiber optic light cable. A switch on the top of the device enables light output and intensity control. A multi-color led indicates device status
The provided text describes a 510(k) summary for the SOPRO 281 LED LIGHT SOURCE, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than conducting a de novo study that would typically establish detailed acceptance criteria and a comprehensive study to prove the device meets them.
Therefore, the information required to fully answer the request regarding acceptance criteria and a study proving the device meets them, especially in the context of device performance metrics like sensitivity, specificity, and detailed study methodologies, is not present in the provided text.
However, I can extract the information that is available and explain why some parts of your request cannot be fulfilled based on this document.
Summary of Available Information from the Provided Text:
This document is a 510(k) premarket notification for the SOPRO 281 LED LIGHT SOURCE. The primary goal of a 510(k) submission is to demonstrate "substantial equivalence" to a legally marketed predicate device, not necessarily to independently prove specific numerical performance criteria through a dedicated clinical study with detailed statistical outcomes.
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: The acceptance criteria for a 510(k) submission for a light source like this are generally related to demonstrating substantial equivalence in terms of technical specifications, performance, and intended use compared to the predicate devices. The document implies that the device "has the same properties of safety and effectiveness as the predicates."
- Reported Device Performance: The document states: "The SOPRO 281 is similar to the LO-50 led light source (K102167) and to LLS-050 (K093792) predicate devices in terms of technical specifications, performances, and intended use." It does not provide specific numerical performance data (e.g., light output in lumens, color temperature, lifespan) for the SOPRO 281 itself or the predicates, nor does it present a comparison table of such metrics. The "performance" is generally demonstrated by meeting relevant standards for electrical safety, electromagnetic compatibility, and potentially light output, but these specific results are not detailed in this summary.
2. Sample size used for the test set and the data provenance
- Not Applicable / Not Provided: This is a light source, not a diagnostic or AI-driven device that would typically involve a "test set" of clinical cases or data. The "study" for a 510(k) for a light source usually involves engineering bench testing to ensure it meets general performance, safety, and electrical standards, and comparing its technical specifications to predicates. There is no mention of a human-interpretable dataset, sample size, or data provenance in the context of evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable / Not Provided: As this device is an LED light source, not a diagnostic imaging or AI system, the concept of "ground truth" established by experts for a test set of clinical data does not apply in this context. The "truth" here would refer to the physical properties of the light source, verified through engineering tests.
4. Adjudication method for the test set
- Not Applicable / Not Provided: No clinical test set requiring adjudication is described.
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 / Not Provided: This is a hardware device (an LED light source), not an AI-assisted diagnostic tool. Therefore, an MRMC study with human readers and AI assistance is not relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable / Not Provided: This is a hardware light source, not an algorithm.
7. The type of ground truth used
- Not Applicable / Not Provided: For a light source, "ground truth" would relate to its physical and electrical characteristics (e.g., light intensity, color rendering, operating temperature, safety features) verified through engineering specifications and testing, not clinical outcomes or expert consensus on medical findings. This document does not detail specific engineering tests or their outcomes.
8. The sample size for the training set
- Not Applicable / Not Provided: As this is a physical device and not an AI algorithm, there is no concept of a "training set."
9. How the ground truth for the training set was established
- Not Applicable / Not Provided: No training set is involved.
In summary: The provided document is a 510(k) notification for an LED light source. The "study" referenced in such a submission typically involves demonstrating that the device's technical specifications and safety profile are substantially equivalent to those of existing legally marketed predicate devices through engineering tests and comparison of specifications, rather than a clinical trial with performance metrics like accuracy, sensitivity, or specificity against established ground truth. Therefore, most of the detailed questions regarding study design, sample sizes, expert involvement, and AI performance are not applicable to the information contained in this specific document.
§ 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.