(35 days)
The SOPRO 225 Dual halogen light source is intended to be used by qualified physicians in general and plastic surgery to provide light for examination, diagnostic and therapeutic applications, particularly in endoscopy".
The SOPRO 225 is a light source with two 250W Halogen reflector lamps, mechanical iris light intensity control, and connections for fiber optic light cable. A switch on the front panel provides for lamp selection.
The provided text is a 510(k) Summary for the SOPRO 225 Dual Halogen Light Source, which is a medical device. This type of document is used to demonstrate substantial equivalence to a legally marketed predicate device, rather than to establish new safety and effectiveness through clinical trials with defined acceptance criteria and performance metrics typically associated with AI/software devices.
Therefore, many of the requested sections (e.g., sample size for test set, number of experts, MRMC studies, standalone performance, training set details) are not applicable to this type of device and submission.
Here's a breakdown based on the information provided, and where information is not applicable:
1. Table of Acceptance Criteria and Reported Device Performance
| Criteria Category / Performance Metric | Acceptance Criteria (Implicit by Predicate Equivalence) | Reported Device Performance |
|---|---|---|
| Intended Use | To be used by qualified physicians in general and plastic surgery to provide light for examination, diagnostic and therapeutic applications, particularly in endoscopy. | The SOPRO 225 has the same intended use as the predicate device. |
| Technology / Design | Dual Halogen light source. | The SOPRO 225 is a dual halogen light source with two 250W Halogen reflector lamps, mechanical iris light intensity control, and connections for fiber optic light cable. A switch on the front panel provides for lamp selection. |
| Safety & Effectiveness | Substantially equivalent to predicate in safety and effectiveness. | The device is deemed substantially equivalent to the WOLF LP 4251 (K010033). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. This is a traditional medical device (light source) submission, not an AI/software device that typically uses test sets for performance evaluation. Substantial equivalence is demonstrated through comparison of technical characteristics and intended use to a predicate device, not through a test set.
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. See point 2.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. See point 2.
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. This is not an AI-assisted device. The submission focuses on the technical characteristics and intended use of a physical light source.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. Substantial equivalence for this device is based on technical comparison to a predicate, not clinical performance against a "ground truth" as would be defined for diagnostic or AI/software devices. The "ground truth" in this context is the established safety and effectiveness of the existing predicate device.
8. The sample size for the training set
- Not Applicable. This is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
- Not Applicable. See point 8.
Study that proves the device meets the acceptance criteria:
The study proving the device meets the acceptance criteria is the 510(k) premarket notification process itself, specifically the comparison to a legally marketed predicate device.
The text explicitly states:
- "The SOPRO 225 is substantially equivalent to the predicate device by the Richard Wolf Instruments Corporation, the WOLF LP 4251 (K010033) previously cleared by the FDA and currently marketed."
- "The SOPRO 225 dual halogen light source and the predicate device WOLF LP 4251 dual halogen light source are both in Class II Endoscope and Accessories intended for use by qualified physicians."
- "The SOPRO 225 and the predicate are both dual halogen light sources intended to be used by qualified physicians in general and plastic surgery to provide light for examination, diagnostic and therapeutic applications, particularly in endoscopy."
The "study" here is a comparative analysis of device characteristics and intended use against the predicate WOLF LP 4251 (K010033). The FDA's review of this comparison led to the determination of "substantial equivalence," meaning that the SOPRO 225 is as safe and effective as the predicate device. This is the mechanism by which the device "meets acceptance criteria" in the context of a 510(k) submission for this type of medical 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.