(48 days)
The Accutech EndoLite Probe is intended for use in the treatment of ocular pathology.
The Accutech EndoLite Probe is indicated for use in ocular photocoagulation of the anterior and posterior segment for the indications for use cleared for the 532-659 nm laser system(s) with which it is compatible for use.
The Accutech EndoLite Probe is comprised of the following main components:
- A glass fiber optic protected by a medical grade stainless steel needle and handle at . the distal (patient contact) end and by a plastic jacket at the proximal (laser connection) end; and
- . A universal SMA laser connector.
The Accutech EndoLite Probe is provided as a sterile, single use 532-659 nm laser energy delivery system device (accessory). The universal SMA connector at the proximal end of the optical fiber delivery device is designed to be attached to the optical fiber Laser Port of the compatible 532-659 nm laser system with universal SMA compatibility that has been qualified by Accutech Medical Technologies, Inc. for use with the Accutech EndoLite Probe.
This document is a 510(k) summary for the Accutech EndoLite Probe. It does not contain information about specific acceptance criteria, a study proving device performance against those criteria, or details regarding ground truth establishment, sample sizes, or expert adjudication as it is a submission for substantial equivalence to predicates rather than a performance study report.
The document indicates that the device is "substantially equivalent" to predicate devices, meaning it has similar indications for use, device operation, and technical/functional capabilities. This type of submission relies on the safety and effectiveness profile of existing, legally marketed devices.
Therefore, I cannot provide the requested information based on the given text.
The document does not describe a study that proves the device meets specific acceptance criteria. Instead, it asserts substantial equivalence to predicate devices based on similarities in indications for use, design features, and functional features.
Here's a breakdown of why the requested information cannot be extracted:
- Acceptance Criteria and Reported Device Performance: This document does not specify any quantitative acceptance criteria or report specific performance metrics from a study. The basis for clearance is "substantial equivalence" rather than direct numerical performance outcomes.
- Sample Size and Data Provenance (Test Set): No specific test set or study data is presented. The submission relies on comparison to predicate devices, not an independent performance study.
- Number of Experts and Qualifications (Ground Truth): No ground truth establishment is described because there is no independent performance study.
- Adjudication Method: Not applicable, as there's no independent performance study requiring adjudication.
- MRMC Comparative Effectiveness Study: Not applicable. This is a claim of substantial equivalence for a medical device accessory, not a comparative effectiveness study involving AI or human readers.
- Standalone Performance Study: No standalone performance study (algorithm only) is described.
- Type of Ground Truth Used: Not applicable.
- Sample Size for Training Set: Not applicable, as this is not an AI/algorithm-based device requiring a training set in the conventional sense.
- How Ground Truth for Training Set Was Established: 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.