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Radiographic Film Reading

The SL800001 is a motorized radiographic film illuminator which enables electro-optical masking of the back illumination in such a way that those parts of the face plate which are covered by films are illuminated, and exposed parts of the face plate are masked (dark). The SL80000 is designed to minimize problems which are associated with glare induced degradation of visual perception capacity and fatigue of film readers. The SL800000 is is comprised of a motorized belt assembly, fluorescent backlight assembly, electro-optical shutter asembly, CCD based film detection assembly and PC-based control hardware and software.

The provided text describes the Smart Motorized Viewer SL8000DLX, a device designed to improve radiographic film reading by electro-optical masking of back illumination. However, the document does not contain information about specific acceptance criteria, a formal study design with performance metrics, sample sizes for test or training sets, details on expert readers, adjudication methods, or MRMC study results.

The 510(k) summary only states that the device is designed to minimize problems associated with glare-induced degradation of visual perception and fatigue. It also mentions compliance with MDD93/42/EEC standards for electrical and mechanical safety.

The summary concludes by stating, "Based on the above, it is SmartLight's opinion that the SL80000445 is substantially equivalent to the predicate devices." This implies that the device's acceptance criteria are implicitly met by demonstrating substantial equivalence to its predicate devices, which are AMS/Planilux Rotolux and Mammolux (K922079), S&S/RADX MV220/MV400, and SmartLight's Digital Film Viewer SL4000°LCS (K952188). The key difference highlighted is the method of restricting back illumination (electro-optical shutters vs. manual mechanical shutters).

Therefore, a table of acceptance criteria and a detailed study proving the device meets those criteria, as typically found in modern medical device submissions with quantitative performance claims, cannot be extracted from this document. The submission focuses on demonstrating substantial equivalence primarily through a qualitative comparison of design and intended use with predicate devices.

Summary of available information regarding acceptance criteria and study data:

• Acceptance Criteria/Performance Goal: Not explicitly stated as quantitative metrics. The implicit goal is to provide a radiographic film reading experience that minimizes glare-induced degradation of visual perception and fatigue, similar to or better than predicate devices, and to comply with electrical and mechanical safety standards.
• Reported Device Performance:
  • Functionality: Restricts back illumination to film areas by electro-optical shutters.
  • Benefit: Designed to minimize glare-induced degradation of visual perception capacity and fatigue of film readers.
  • Safety: Designed to comply with MDD93/42/EEC standards of electrical and mechanical safety.
  • Hazard Mitigation: Failure in electro-optical masking is immediately observed by the operator, who can reset the device.
• Study Details (Not explicitly present in the document):
  • Sample size for the test set and data provenance: No information.
  • Number of experts used to establish the ground truth for the test set and their qualifications: No information.
  • Adjudication method for the test set: No information.
  • MRMC comparative effectiveness study: No information on such a study or effect size.
  • Standalone (algorithm only without human-in-the-loop) performance: Not applicable, as this is an illuminator, not an AI algorithm. Its performance is inherent in its design and operation for human readers.
  • Type of ground truth used: Not applicable, as no diagnostic study with "ground truth" is described.
  • Sample size for the training set: Not applicable, as no AI model requiring a training set is described.
  • How the ground truth for the training set was established: Not applicable.

In essence, the 510(k) relies on a qualitative argument for substantial equivalence rather than a quantitative performance study with explicit acceptance criteria.

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