(51 days)
The intended use of the P111, TeleRADPRO, and VXR-12 plus is to produce digital copies of medical x-ray films.
The VIDAR P111, TeleRADPRO, and VXR-12 plus x-ray film digitizers are intended for producing digital copies of medical x-ray films.
The VIDAR P 111, TeleRADPRO, and VXR-12 plus film digitizers are intended for making digital copies of medical x-ray films.
The x-ray film digitizer is an electronic device used to convert analog x-ray films to digital images.
This 510(k) summary (K993597) for the VIDAR P111, TeleRADPRO, and VXR-12 plus x-ray film digitizers does not include detailed information about specific acceptance criteria, device performance studies, or clinical trials with human readers. The submission primarily focuses on establishing substantial equivalence to a predicate device (MedScan 12, K933632).
Therefore, I cannot fulfill all parts of your request as the information is not present in the provided document.
Here's what can be extracted based on the provided text, and where information is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
This information is not provided in the 510(k) summary. The document states that "Technical differences between the devices and the predicate raise [sic] of safety and effectiveness," implying a comparison, but it doesn't detail specific performance metrics or acceptance criteria for the new devices or the predicate.
2. Sample Size Used for the Test Set and Data Provenance:
This information is not provided. The document makes no mention of a test set, study design, or data provenance (country of origin, retrospective/prospective).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
This information is not provided. Since there's no mention of a test set or ground truth establishment, this detail is absent.
4. Adjudication Method for the Test Set:
This information is not provided.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
This information is not provided. The document does not mention any studies involving human readers or comparative effectiveness with or without AI assistance.
6. Standalone (Algorithm Only) Performance Study:
Since the device is an "x-ray film digitizer" which converts analog films to digital images, its "performance" would likely relate to image quality parameters (resolution, density accuracy, signal-to-noise ratio, etc.) rather than an "algorithm only" performance in the sense of a diagnostic AI. The document does not detail any standalone performance studies using specific metrics.
7. Type of Ground Truth Used:
This information is not provided.
8. Sample Size for the Training Set:
This information is not provided. The document does not describe a training set for an AI algorithm. The devices are digitizers, not AI diagnostic tools.
9. How the Ground Truth for the Training Set Was Established:
This information is not provided.
Summary of Device and its Purpose (from the provided text):
- Device Trade Name: P111, TeleRADPRO, and VXR-12 plus x-ray film digitizers.
- Common Name: X-ray film digitizer.
- Intended Use: To produce digital copies of medical x-ray films.
- Classification: Class II (per 21 CFR 892.2030, but the initial 510(k) summary states "Class 11 per CFR 892.2040 (proposed)"). The FDA response clarifies it as Class II, 21 CFR 892.2030.
- Predicate Device: MedScan 12 (K933632).
- Substantial Equivalence: Claimed based on similarities to the MedScan 12, with acknowledgement of "Technical differences... [that] raise [of] safety and effectiveness." (The wording "raise of safety and effectiveness" seems like a grammatical error and likely implies "raise issues of safety and effectiveness" that need to be addressed, which the submission presumably does, or "do not raise concerns of safety and effectiveness.")
Conclusion based on the provided document:
This 510(k) summary is very high-level and characteristic of submissions for devices seeking substantial equivalence rather than approval based on extensive clinical performance data or AI model validation. It focuses on the device's function as a digitizer and its comparison to an existing predicate. Detailed performance metrics, study designs, or AI-specific validation details are not included in this particular summary.
§ 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.