(257 days)
The ScanView System is an automated scanning microscope and image analysis system. It is intended for in vitro diagnostic use as an aiding tool to the pathologist or cytogeneticist in the detection, classification and enumeration of cells of interest based on color, intensity, size, pattern, and shape. The Scan View is indicated as an accessory to the following FDA cleared/approved devices to detect the following cell lypes:
- CEP® X Spectrum Orange™/CEP® Y Spectrum Green™ DNA Probe Kit 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.
- Human breast cancer containing the HER-2/neu gene labeled in Red and the centromere of chromosome 17 labeled in Green via fluorescence in situ hybridization (FISH) in interphase nuclei from formalin-fixed, paraffin embedded human breast cancer tissue specimens with Vysis® PathVysion™ HER-2 DNA Probe kit. Results from the PathVysion™ Kit are intended for use as an adjunct to existing clinical and pathologic information used as prognostic factors in stage II, node-positive breast cancer patients. The Path Vysion™ kit is further indicated as an aid to predict disease-free and overall survival in patients with stage II, node positive breast cancer, treated with adjuvant cyclophosphanide, doxorubicin, and 5fluorouracil (CAF) chemotherapy.
- Cells in urine specimens, stained by fluorescence in situ hybridization (FISH) using Vysis UroVysion™ Bladder Cancer Kit to detect aneuploidy for chromosomes 3, 7, 17, and loss of the 9p21 locus, from persons with hematuria suspected of having bladder cancer. The results are intended for use, in conjunction with and not in lieu of current standard diagnostic procedures, as an aid for initial diagnosis of bladder carcinoma in patients with hematuria and subsequent monitoring for tumor recurrence in patients previously diagnosed with bladder cancer.
The ScanView System is to be used as an adjunctive automated enumeration tool in conjunction with manual visualization.
The ScanView is an integrated digital imaging system constructed of an external microscope, motorized multi slide stage, camera, and a workstation. It is designed to acquire images of cells and enables identification and examination of cells of interest. Experts can view and sean cells and record the image, using both bright field and fluorescent illumination. The acquired images can be enhanced, retrieved and printed. The automated microscope enables Z motion of the slide and the motorized stage enables its X-Y motions. The microscope also includes motorized filter turret containing fluorescence filters.
The provided document, K110345, is a 510(k) summary for the ScanView device. While it states that "Performance test data demonstrate that the device meets the required specifications," it does not include detailed acceptance criteria or the study data proving these criteria were met. The document focuses on the regulatory submission, device description, and indications for use, rather than a comprehensive performance study report.
Therefore, many of the requested details cannot be extracted from this document.
Here's an attempt to answer based on the available information, with clear indications of what is not present:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not provided in the document. The document states, "Performance test data demonstrate that the device meets the required specifications," but does not list specific criteria or performance metrics. | Not provided in the document. No specific quantitative performance data (e.g., sensitivity, specificity, accuracy, concordance rates) are reported. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample size for test set: Not provided.
- Data provenance: Not provided.
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)
- Number of experts: Not provided.
- Qualifications of experts: Not provided. The device "is intended for in vitro diagnostic use as an aiding tool to the pathologist or cytogeneticist," implying these are the relevant expert roles.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Adjudication method: Not provided.
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
- MRMC study: The document states the ScanView System "is to be used as an adjunctive automated enumeration tool in conjunction with manual visualization." This implies human-in-the-loop operation, but it does not describe or provide results from a comparative effectiveness study (MRMC) to quantify improvement with AI assistance.
- Effect size of improvement: Not provided.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The document describes the device as an "aiding tool" and "adjunctive automated enumeration tool in conjunction with manual visualization." This suggests it is not intended for standalone use, and therefore, a standalone performance study is unlikely to have been presented or applicable for this submission. No standalone performance data are provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of ground truth: Not explicitly stated. Given the "pathologist or cytogeneticist" involvement and the specified FDA-cleared probe kits (CEP XY, PathVysion™ HER-2, UroVysion™ Bladder Cancer Kit), the ground truth for FISH often involves expert interpretation of the FISH signals (which can be considered a form of "expert consensus" or "pathology" within the context of cytogenetics). However, this is an inference, not directly stated.
8. The sample size for the training set
- Sample size for training set: Not provided.
9. How the ground truth for the training set was established
- Ground truth establishment for training set: Not provided.
§ 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.