(268 days)
The Virtuoso system provides automated digital slide creation, management, analysis, and viewing. It is intended for in vitro disgnostic use as an aid to the pathologist in the display, detection, counting, review and classification of tissues and cells of clinical interest based on particular morphology, color, intensity, size, pattern and shape.
The Virtuoso™ System for IHC ER (SPI) is for digital read and image analysis spplications. This particular Virtures system is intended for use as an aid to the pathologist in the detection and semi-quantitative measurement of estrogen receptor (ER) protein in formalin-fixed, paraffin-embedded neoplastic tissue. This device is sn accessory to Ventana Medical Systems, Inc. CONFIRM™ anti-Estrogan Receptor (ER) (SPI) Rabbit Monoclonal Primary Antibody assay. The CONFIRM™ anti- ER (SPI) Rabbit Monoclonal Primary Antibody assay is indicated for use as an aid in the assessment of breast cancer patients for whom endocrine treatment is being considered (but is not the sole basis for treatment).
Note: The IHC ER (SPI) Digital Read and Image Analysis applications are adjunctive computer-assisted methodologies for the qualified pathologist in the acquisition and measurement of images from microscope glass slides of breast cancer specified for the presence of ER protein. The pathologist should verify agreement with the Image Analysis software application score. The accuracy of the test results depends on the immunobistochemical staining. It is the responsibility of a qualified pathologist to employ appropriate morphological studies and controls as specified in the CONFIRM™ ani-Estrogen Receptor (RR) (SPI) Rabit Monoclonal Primary Antibody used to assure the validity of the Virtusso System for IBC ER Digital Read and Invage Analysis scores. The actual correlation of CONFIRM anti-Estrogen Receptor (ER)(SPI) Rabbit Monocload Antibody to clinical outcome has not been established.
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This detailed response is based on the provided text, but it's important to note that the document is a 510(k) clearance letter and not the 510(k) summary itself. Therefore, specific details about the study design, sample sizes for training, and ground truth establishment in the scientific study are not explicitly present in this document. The information provided heavily relies on the content within the "Indications for Use" section.
Here's the breakdown based on the input document:
Acceptance Criteria and Device Performance Study for Virtuoso System for IHC ER(SP1)
The Virtuoso System for IHC ER (SP1) is intended as an aid to the pathologist for digital read and image analysis applications in the detection and semi-quantitative measurement of estrogen receptor (ER) protein in formalin-fixed, paraffin-embedded neoplastic tissue, specifically in breast cancer.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state quantitative acceptance criteria (e.g., minimum sensitivity, specificity, or agreement rates) or detailed reported device performance metrics from a specific study. Instead, the "Indications for Use" section describes the intended functionality and adjunctive nature of the device.
The qualitative "acceptance criteria" can be inferred from the device's stated purpose: "an aid to the pathologist in the detection and semi-quantitative measurement of estrogen receptor (ER) protein in formalin-fixed, paraffin-embedded neoplastic tissue." The "reported device performance" is that the system fulfills this role as an adjunctive, computer-assisted methodology, requiring pathologist verification.
| Acceptance Criteria Category | Specific Criteria (Inferred from "Indications for Use") | Reported Device Performance (Inferred/Stated) |
|---|---|---|
| Functionality | Aid in detection of ER protein | Provides computer-assisted detection of ER protein |
| Quantification | Aid in semi-quantitative measurement of ER protein | Provides computer-assisted semi-quantitative measurement of ER protein |
| User Role | Adjunctive tool for qualified pathologist | Designed to be used by qualified pathologists as an aid; pathologist verification required |
| Tissue Type | Formalin-fixed, paraffin-embedded neoplastic tissue | Designed for this specific tissue type (breast cancer) |
| Clinical Context | Assessment of breast cancer patients for endocrine treatment consideration | Intended for this clinical application (not sole basis for treatment) |
| Immunohistochemistry | Accuracy dependent on IHC staining quality | Acknowledges dependency on upstream IHC staining validity |
| Correlation | Not the sole basis for treatment | Reaffirms that the device is an aid, not a definitive basis for treatment decisions |
| Validation | Pathologist verification of Image Analysis software score agreement | Pathologist is responsible for verifying agreement with software scores |
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) clearance letter and "Indications for Use" statement do not contain information regarding the specific sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective nature). These details would typically be found in the 510(k) summary document or the underlying study report.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The provided document does not specify the number of experts used to establish the ground truth for the test set or their qualifications. However, it does emphasize that the device is an "aid to the pathologist" and that "It is the responsibility of a qualified pathologist to employ appropriate morphological studies and controls as specified...to assure the validity of the Virtusso System for IBC ER Digital Read and Invage Analysis scores." This implies that qualified pathologists are central to the interpretation and validation process.
4. Adjudication Method for the Test Set
The document does not specify the adjudication method used for the test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size.
The provided document does not indicate whether a MRMC comparative effectiveness study was done, nor does it provide any effect size of how much human readers improve with AI vs. without AI assistance. The language ("adjunctive computer-assisted methodologies") suggests the device is intended to assist, but no performance metrics for this assistance are given in this document.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was done.
The provided document does not explicitly state if a standalone performance study was conducted. However, the consistent phrasing "aid to the pathologist" and "pathologist should verify agreement with the Image Analysis software application score" strongly implies that the device is not intended for standalone interpretation and its performance is always considered in conjunction with a human expert.
7. The Type of Ground Truth Used
The document implies that the ground truth for evaluation would be established by expert consensus/pathologist assessment, particularly given the statement: "The pathologist should verify agreement with the Image Analysis software application score. The accuracy of the test results depends on the immunohistochemical staining. It is the responsibility of a qualified pathologist to employ appropriate morphological studies and controls..." This suggests that expert pathological review, potentially supported by appropriate controls and validated IHC staining, forms the basis of ground truth. There is no mention of pathology reports as the sole ground truth, or outcomes data.
8. The Sample Size for the Training Set
The provided document does not contain information regarding the sample size used for the training set.
9. How the Ground Truth for the Training Set Was Established
The provided document does not contain information on how the ground truth for the training set was established. Given the nature of the device, it is highly probable that expert pathologists would have been involved in establishing the ground truth for training data, similar to the inference for the test set ground truth.
§ 864.1860 Immunohistochemistry reagents and kits.
(a)
Identification. Immunohistochemistry test systems (IHC's) are in vitro diagnostic devices consisting of polyclonal or monoclonal antibodies labeled with directions for use and performance claims, which may be packaged with ancillary reagents in kits. Their intended use is to identify, by immunological techniques, antigens in tissues or cytologic specimens. Similar devices intended for use with flow cytometry devices are not considered IHC's.(b)
Classification of immunohistochemistry devices. (1) Class I (general controls). Except as described in paragraphs (b)(2) and (b)(3) of this section, these devices are exempt from the premarket notification requirements in part 807, subpart E of this chapter. This exemption applies to IHC's that provide the pathologist with adjunctive diagnostic information that may be incorporated into the pathologist's report, but that is not ordinarily reported to the clinician as an independent finding. These IHC's are used after the primary diagnosis of tumor (neoplasm) has been made by conventional histopathology using nonimmunologic histochemical stains, such as hematoxylin and eosin. Examples of class I IHC's are differentiation markers that are used as adjunctive tests to subclassify tumors, such as keratin.(2) Class II (special control, guidance document: “FDA Guidance for Submission of Immunohistochemistry Applications to the FDA,” Center for Devices and Radiologic Health, 1998). These IHC's are intended for the detection and/or measurement of certain target analytes in order to provide prognostic or predictive data that are not directly confirmed by routine histopathologic internal and external control specimens. These IHC's provide the pathologist with information that is ordinarily reported as independent diagnostic information to the ordering clinician, and the claims associated with these data are widely accepted and supported by valid scientific evidence. Examples of class II IHC's are those intended for semiquantitative measurement of an analyte, such as hormone receptors in breast cancer.
(3) Class III (premarket approval). IHC's intended for any use not described in paragraphs (b)(1) or (b)(2) of this section.
(c)
Date of PMA or notice of completion of a PDP is required. As of May 28, 1976, an approval under section 515 of the Federal Food, Drug, and Cosmetic Act is required for any device described in paragraph (b)(3) of this section before this device may be commercially distributed. See § 864.3.