(69 days)
The LUMISCAN 135 system is a laser phosphor plate digitizer designed for darkroom operation to read recorded patient radiation patterns in the plate and a plate eraser system to prepare the plate for re-use.
The LUMISCAN 135 system is a laser phosphor plate digitizer designed for darkroom operation to read recorded patient radiation patterns in the plate and a plate eraser system to prepare the plate for re-use. The system is based on a fixed size scanning spot and is characterized by high spatial resolution and a wide gray scale dynamic range. This is achieved with a high intensity spot of light derived from a solid-state laser that is scanned across the plate as the plate is moved perpendicular to the beam scan. As the laser scans the plate, the phosphor's stored x-ray attenuated equivalent energy is released as a different light wavelength. The emitted light is collected and digitized to provide an image that can be stored on disk, transmitted to other systems for processing and manipulation, archived or printed onto film. After the plate has been read, it is placed on a high intensity sealed lightbox for erasure. Erasing the plate brings all the phosphors down to a ground state from which the plate is now ready to be reused to record a patient's anatomy from x-rav.
The LUMISCAN 135 houses a plate transport system, optics module and reading electronics. Separate from the LUMISCAN 135 is the eraser unit, Lumisys 135E, which incorporates high intensity lamps with a light-tight lid for returning the phosphors to zero.
The LUMISCAN 135 uses a solid state laser diode as the beam source. The laser is conditioned by a lens for beam forming and coupled to a fiber. From the fiber, the energy is directed to a scanning galvanometer. The galvanometer has a mirror that is oscillating precisely across the width of the plate and irradiating the plate with laser light. As the light impinges the plate, stored energy from the plate is emitted and collected in an integrating cylinder. The collected light is detected by a photomultiplier, converted to an analog signal which is logarithmically amplified, corrected for spatial variations in the integrating cylinder, and then digitized by an A/D converter.
The provided document does not contain explicit acceptance criteria and a detailed study proving the device meets these criteria in the typical sense of a clinical trial or performance evaluation with specific metrics. Instead, it is a 510(k) summary for a medical device (Lumiscan 135 Phosphor Plate Digitizer), which aims to demonstrate substantial equivalence to previously marketed devices.
The document primarily focuses on:
- Device Description and Intended Use: Explaining what the device does and how it functions.
- Hazard Analysis and Safety Concerns: Addressing potential malfunctions and compliance with safety standards.
- Substantial Equivalence Comparison: Benchmarking key technical specifications of the Lumiscan 135 against predicate devices (Fuji FCR AC-3, Kodak System 400 Reader, Agfa ADC Digitizer).
Therefore, I cannot populate all the requested fields with specific values directly from the provided text, as this type of information is generally not included in a 510(k) summary focused on substantial equivalence. However, I can extract the comparative technical specifications which serve as a form of "performance comparison" for substantial equivalence.
Here's an attempt to answer based on the available information, noting where data is absent or implied by the nature of a 510(k) submission:
1. Table of Acceptance Criteria and Reported Device Performance
The "acceptance criteria" for a 510(k) submission are typically derived from demonstrating that the device is as safe and effective as a predicate device. This is often shown through comparable technical specifications. The table below uses the comparative technical specifications presented in the document as a proxy for "reported device performance" and implied "acceptance criteria" (i.e., being comparable to or better than predicate devices in these aspects).
| Performance Metric (Implied Acceptance Criteria) | Lumisys Lumiscan 135 Reported Performance | Predicate Devices (Fuji, Kodak, Agfa) |
|---|---|---|
| Scanning Area (max) | 35 x 43 cm | 35 x 43 cm (All listed) |
| Spot Size | 100 microns | 100 microns (Kodak), Not Known (Fuji), 120 microns (Agfa) |
| Dynamic Range | 5 Decades | Not Known (All listed) |
| Gray Scale | 12 Bit | 10 Bit (Fuji), 12 Bit (Kodak, Agfa) |
| Digitizing Rate | 60 per hour | 70 per hour (Fuji, Agfa), 50 per hour (Kodak) |
| Laser Type/Power | 30 mW Solid State | Not Known (Fuji), 30 mW HeNe (Kodak), 35 mW HeNe (Agfa) |
| Beam Scan Mechanism | Galvanometer | Polygonal Mirror (Fuji), Galvanometer (Kodak, Agfa) |
| Resolution X/Y | 2.85 - 5 LP/mm | Not Known (Fuji, Kodak), 3-4.5 LP/mm (Agfa) |
| Pixels per mm (35 x 43) | 5-10 | Not Known (Kodak), 5-10 (Fuji) |
Note on "Acceptance Criteria": In a 510(k) context, "acceptance criteria" are typically demonstrating substantial equivalence to a legally marketed predicate device. This means the new device must perform comparably in its intended use, typically through technical specifications and safety profile, rather than meeting a specific clinical accuracy threshold like an AUC or sensitivity/specificity.
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a specific "test set" or a formal study with patient data for performance evaluation in the way a clinical trial would. The 510(k) process for this type of device relies heavily on demonstrating substantial equivalence through technical specifications, engineering testing, and adherence to safety standards. Therefore, "sample size" and "data provenance" for a clinical test set are not applicable or mentioned.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not provided in the document as no specific test set or ground truth establishment process is described for clinical validation. The submission is focused on technical equivalence.
4. Adjudication Method for the Test Set
Since no clinical test set is described, an adjudication method is not applicable and not mentioned.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No MRMC comparative effectiveness study is mentioned in the provided 510(k) summary. The document focuses on the technical specifications of the digitizer itself, not its impact on human reader performance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) was done
This concept is not directly applicable to a phosphor plate digitizer. The device's primary function is to digitize analog X-ray information from a phosphor plate into a digital image for display and interpretation by a human. Its "performance" is inherent in the quality of the digitized image, measured by metrics like resolution, gray scale, dynamic range, and digitizing speed, as outlined in the comparison table above. There isn't an "algorithm-only" interpretation performance.
7. The Type of Ground Truth Used
As there's no clinical performance study involving diagnosis or interpretation described, the concept of "ground truth" (e.g., expert consensus, pathology, outcomes data) in that sense is not applicable to this 510(k) summary. The ground truth for the technical specifications would be engineering measurements and calibrations.
8. The Sample Size for the Training Set
The document does not describe a "training set" for an algorithm, as this is a hardware device (digitizer) and not an AI/ML algorithm that requires training data in the modern sense.
9. How the Ground Truth for the Training Set was Established
Since no training set for an algorithm is described, this question is not applicable.
§ 892.2030 Medical image digitizer.
(a)
Identification. A medical image digitizer is a device intended to convert an analog medical image into a digital format. Examples include Iystems employing video frame grabbers, and scanners which use lasers or charge-coupled devices.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std.). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.