FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The ConMed Linvatec 300W Xenon Light Source is a light generating device that when used in conjunction with an endoscope will illuminate the surgical site during minimally invasive surgical procedures. The ConMed Linvatec 300W Xenon Light Source is used with a fiber optic light guide cable during endoscopic surgical procedures. The Light Source emits light from the "LIGHT GUIDE" port which accepts the fiber optic cable. The cable is connected to the illumination portion of an endoscope. The endoscope is inserted into the surgical site to provide illumination for the surgeon's visualization.

AI/ML Overview

The provided text is a 510(k) summary for the ConMed Linvatec 300W Xenon Light Source. It does not contain any information about acceptance criteria, study data, or performance metrics for an AI/ML device or any device that would be subject to such detailed performance studies.

The document describes a conventional medical device (a light source for endoscopic procedures) and establishes its substantial equivalence to previously marketed devices (predicates). Therefore, I cannot fulfill the request to provide information about acceptance criteria, study details, and performance metrics as if it were an AI/ML device.

Here's why and what information is available in the document:

Why the requested information cannot be provided from this text:

Nature of the Device: The device is a "ConMed Linvatec 300W Xenon Light Source," which is a light-generating device used during endoscopic procedures. It is not an AI/ML diagnostic or prognostic tool.
Regulatory Pathway: The submission is a 510(k) for substantial equivalence to predicate devices, not a de novo or PMA submission that would typically require extensive clinical performance studies to establish safety and effectiveness for a novel AI/ML application.
Content: The document focuses on device description, intended use, and comparison to predicates based on design, technology, and intended use, rather than specific performance metrics against an established ground truth.

Information that is available (and relevant to the prompt, if it were an AI/ML device):

Acceptance Criteria and Reported Device Performance:
- NO INFORMATION PROVIDED. For a traditional medical device like a light source, acceptance criteria typically relate to functional performance (e.g., light intensity, color temperature, safety features, durability) based on internal testing and compliance with recognized standards, not clinical performance metrics like sensitivity or specificity. No such performance data or acceptance criteria are detailed in this 510(k) summary.
Sample sized used for the test set and the data provenance:
- NO INFORMATION PROVIDED. There's no test set described for evaluating performance in the context of AI/ML or even clinical performance. The focus is on substantial equivalence.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- NO INFORMATION PROVIDED. Ground truth establishment is not relevant for this type of device and regulatory submission.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- NO INFORMATION PROVIDED. Not applicable.
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:
- NO INFORMATION PROVIDED. Not applicable. This device does not involve human readers interpreting data with or without AI assistance.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- NO INFORMATION PROVIDED. Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- NO INFORMATION PROVIDED. Not applicable.
The sample size for the training set:
- NO INFORMATION PROVIDED. Not applicable. There's no AI/ML algorithm involved that would require a training set.
How the ground truth for the training set was established:
- NO INFORMATION PROVIDED. Not applicable.

Summary of Device in the Provided Text:

Device Name: ConMed Linvatec 300W Xenon Light Source
Intended Use: To be used with an endoscope to provide illumination during endoscopic procedures.
Regulatory Class: Class II
Predicate Devices:
- Linvatec Corporation Xenon 300W Light Source (K031994)
- Karl Storz Endoscopy Xenon 300W Light Source (K962595)
Substantial Equivalence: Claimed based on similar design, technology, and intended use to the predicate devices, with "minor differences" that "raise no new questions of safety and effectiveness."

In conclusion, the provided text describes a conventional medical device applying for 510(k) clearance via substantial equivalence, and therefore does not contain the detailed performance study information typically associated with AI/ML devices.

Summary

Regulation Number and Section

§ 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.