(86 days)
The General Scanning model LD2800 laser film digitizer is intended to create copies of medical images stored on film when connected to a laser imager. It is intended for use in making copies of conventional x-ray films as well as films produced by imagers that fall in the ranges specified for size and optical density range detailed in the specifications.
The General Scanning model LD2800 laser film digitizer is intended to create copies of medical images stored on film when connected to a laser imager. It is intended for use in making copies of conventional x-ray films as well as films produced by imagers that fall in the ranges specified for size and optical density range detailed in the specifications.
The digitizer utilizes laser light to scan the film, extracts the image data by measuring the transmitted light, converts it into digital form, and transmits the data over a digital link. A laser imager may then be used to print a copy of the original image.
The LD2800 contains the scanning laser and detection module, a film transport, and electronics to convert and transmit the image data and provide control and calibration.
The provided document is a 510(k) summary for the LD2800 Film Digitizer. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain any information regarding acceptance criteria or a study that proves the device meets specific acceptance criteria.
The 510(k) summary focuses on establishing substantial equivalence, which primarily involves demonstrating that the new device is as safe and effective as a legally marketed predicate device. This process typically relies on comparing technical specifications, intended use, and performance claims to those of existing devices rather than presenting a novel study against predefined acceptance criteria for the new device as would be seen for a new technology or clinical claim.
Therefore, I cannot provide the requested information from the given text.
To elaborate on why the requested information is not present:
- Acceptance Criteria Table: There is no mention of specific performance metrics (e.g., accuracy, sensitivity, specificity, resolution, optical density range, signal-to-noise ratio) defined as acceptance criteria.
- Study Proof: No experimental or clinical study is described that tests the LD2800 against pre-defined performance thresholds.
- Sample Size and Data Provenance: Since no study is described, there's no information on sample size, test sets, or data provenance.
- Number of Experts/Qualifications: There's no mention of experts establishing ground truth, as no study is detailed.
- Adjudication Method: Not applicable as no study is described.
- MRMC Study: This type of study would compare human performance with and without AI. The LD2800 is a film digitizer, not an AI-powered diagnostic tool, so such a study would not be relevant.
- Standalone Performance: While the device has inherent performance characteristics (like resolution, optical density range), a formal "standalone study" with defined acceptance criteria for these is not provided in this document.
- Type of Ground Truth: Not applicable, as no study is described.
- Training Set Sample Size/Ground Truth: Not applicable, as this is a hardware device (film digitizer), not an algorithm that requires a training set.
§ 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.