(39 days)
To provide illumination for examination, diagnostic, and therapeutic applications, particularly in endoscopy.
The PLS is a stand-alone, portable, detachable adaptation of the light source embedded into the ENTity NasoView Fiberscope. The PLS is an accessory to endoscopes and other devices that require an external light source.
The provided text describes a 510(k) premarket notification for a medical device called OPTIM's "PLS" Portable Light Source. This device is an LED light source intended to provide illumination for examination, diagnostic, and therapeutic applications, particularly in endoscopy.
Based on the information provided in the document, here's a breakdown of the requested criteria:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria or specific performance metrics in the way one might expect for a diagnostic or AI-driven device (e.g., sensitivity, specificity, accuracy thresholds). Instead, the performance assessment is based on demonstrating compliance with recognized medical electrical equipment standards and substantial equivalence to predicate devices.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Safety & Effectiveness | "Performance testing demonstrates that the PLS is as safe and as effective as the predicate device." |
| Electrical Safety | Declaration of conformity to IEC Medical Electrical Equipment standards: |
- 60601-1:1998
- 60601-2-18:1996
- 60601-1-2:2001 |
| Intended Use | Same intended use as the predicate devices. |
| Fundamental Scientific Technology | Same fundamental scientific technology as the light engine embedded into the ENTity NasoView Fiberscope (a predicate device). |
2. Sample size used for the test set and the data provenance
The document does not describe a "test set" in the context of collected data (e.g., images, patient records). The performance evaluation here is based on engineering testing and confirmation of compliance with standards for the device itself, rather than a study involving patient data. Therefore, there is no information about sample size or data provenance in this context.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is not a study requiring expert-established ground truth for a test set of data. The ground truth for device performance revolves around adherence to engineering specifications and regulatory standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As noted above, there is no "test set" in the context of data requiring expert adjudication.
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
No. This document pertains to a medical device (a portable light source), not an AI-driven system or a diagnostic tool that would involve human reader performance with or without AI assistance. Therefore, an MRMC study was not performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a hardware device (a light source), not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is established by its compliance with recognized industry standards for medical electrical equipment (IEC 60601 series) and demonstrating that its performance is equivalent to legally marketed predicate devices in terms of safety and effectiveness for its intended use. There is no biological or clinical ground truth like pathology or outcomes data mentioned for this specific device.
8. The sample size for the training set
Not applicable. This is a hardware device, not a machine learning model, so there is no training set mentioned.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this hardware 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.