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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.

• 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.

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