(112 days)
The Applied Imaging CytoVision™ system is an automated scanning microscope and image analysis system. It is intended for in vitro diagnostic use as an aid in chromosomal analysis. Cyto Vision assists in the location of interphase and metaphase nuclei on standard microscope slides using both brightfield and fluorescent microscopy.
This particular CytoVision software application is an accessory to the CEP® X Spectrum Orange™/CEP® Y Spectrum Green™ DNA Probe kit (Vysis, Inc. Downer's Grove, IL) and is limited to the analysis of CEP XY probes via high magnification capture and analysis of interphase nuclei. CEP XY is indicated for use to assess the effectiveness of bone marrow transplantation in opposite-sex transplants.
The Applied Imaging CytoVision™ system is an automated scanning microscope and image analysis system. It is intended for in vitro diagnostic use as an aid in chromosomal analysis. Cyto Vision assists in the location of interphase and metaphase nuclei on standard microscope slides using both brightfield and fluorescent microscopy.
This letter does not provide the detailed study results needed to complete all sections of your request. It's a 510(k) clearance letter, which confirms substantial equivalence to a predicate device, not a full summary of performance studies.
However, based on the provided text, here's what can be extracted:
1. A table of acceptance criteria and the reported device performance
This information is not provided in the given document. The letter states "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent," implying that performance data was submitted, but the specific acceptance criteria and reported device performance are not detailed here.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the given document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the given document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the given document.
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
This information is not provided in the given document. The device is described as an "automated scanning microscope and image analysis system" that "assists in the location of interphase and metaphase nuclei," suggesting it operates as an aid, but no MRMC study details or effect sizes are mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is described as an "automated scanning microscope and image analysis system" that "assists in the location of interphase and metaphase nuclei." The "Indications For Use" state it is an "aid in chromosomal analysis" and "assists in the location of interphase and metaphase nuclei." This implies it's not a fully standalone diagnostic device but rather a tool to support human analysis. However, a standalone performance study of the algorithm within its assisting role is not explicitly described or quantified in this document.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not provided in the given document. The device is used with the "CEP® X Spectrum Orange™/CEP® Y Spectrum Green™ DNA Probe kit" for "analysis of CEP XY probes" to "assess the effectiveness of bone marrow transplantation." This suggests the ground truth would likely be related to the actual chromosomal status or transplant success, but how that ground truth was established for a study is not detailed.
8. The sample size for the training set
This information is not provided in the given document.
9. How the ground truth for the training set was established
This information is not provided in the given document.
§ 866.4700 Automated fluorescence
in situ hybridization (FISH) enumeration systems.(a)
Identification. An automated FISH enumeration system is a device that consists of an automated scanning microscope, image analysis system, and customized software applications for FISH assays. This device is intended for in vitro diagnostic use with FISH assays as an aid in the detection, counting and classification of cells based on recognition of cellular color, size, and shape, and in the detection and enumeration of FISH signals in interphase nuclei of formalin-fixed, paraffin-embedded human tissue specimens.(b)
Classification. Class II (special controls). The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Automated Fluorescencein situ Hybridization (FISH) Enumeration Systems.” See § 866.1(e) for the availability of this guidance document.