(351 days)
The Bioptics 10 X 10 VISION is a digital specimen radiography add-on upgrade to previously released cabinet x-ray systems. The 10 X 10 Vision is used for digital specimen radiography to provide rapid verification that the correct tissue has been excised during excisional or percutaneous biopsy. The 10 X 10 Vision is excluded from any use in in-vivo diagnostic or screening mammography applications.
The 10 X 10 VISION will be marketed as a digital specimen radiography add-on upgrade for standard film-based cabinet x-ray systems. using high-performance, flat panel CMOS detector, and high-resolution Gd202S:Tb (Gadolinium Oxysulfide) scintillator technologies. Bioptics digital x-ray imagers are packaged in a thin (
The submission describes a digital specimen radiography add-on upgrade called "10 X 10 VISION" intended for use with existing film-based cabinet x-ray systems. The device provides digital x-ray imaging for rapid verification of excised tissue during biopsy procedures.
Here's an analysis of the provided information regarding acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Explicitly Stated or Implied) | Reported Device Performance |
|---|---|
| Compliance with 21 CFR 1020.30 & 1020.40 | Validated that use of 10 X 10 VISION will not affect compliance with 21 CFR 1020.31 upon installation. Tests performed to assure radiation emissions and leakage current are in compliance. |
| High sensitivity, high resolution, dynamic range | Gd2O2S(Tb) scintillator and 50 micron pixels provide high sensitivity with high resolution and dynamic range. Resolution (contact mode): 10 lp/mm (50 microns). |
| Easy to use, intuitive software controls | Device is easy to use, has "easy to learn (intuitive) software controls." |
| Repeatable results with automatic exposure | Allows the user to select automatic exposure techniques, providing for repeatable results. |
| DICOM 3.0 Compliance | Bioptics Vision software is compliant with Digital Imaging and Communications in Medicine (DICOM) 3.0, and comes with DICOM Print, Store and Modality Work List (MWL). DICOM V3.0 standards and protocol structure. Provides DICOM networking interface. |
| Rapid image transfer to Radiology/Pathology | Bioptics Vision software transfers images to Radiology and Pathology within seconds through DICOM interface. |
| Adherence to design specifications and requirements | "The output of these two performance data records [software validation and operational environment tests] documents that 10 X 10 VISION met its required requirements and design specifications as intended." |
| Safety Features | "Confirmation that all identified hazards have been adequately addressed by software functionality, the user interface, documentation or user SOP." |
| Functionality (image acquisition, display, analysis, storage, etc.) | Software controls complete image acquisition and processing. Handles digital x-ray image acquisition, calibration, image display, image analysis and manipulation, patient database, image archiving. |
| Minimum Image Display Time | 4 seconds. |
| Substantial Equivalence to predicate device | Performance testing and validation studies document that 10 X 10 VISION is substantially equivalent to the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not specify a sample size for a test set in the context of clinical or image-based performance evaluation. The testing described primarily focuses on engineering verification and validation of the device's technical specifications and software functionality.
The data provenance is for engineering verification and validation data, not patient data. It is internal company data generated during device development ("Extremely controlled and detailed design inputs and outputs define Bioptics product development activities").
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document does not mention the use of experts or the establishment of ground truth by experts for a test set. This type of evaluation is typically associated with clinical performance studies, which were explicitly stated as not being conducted or required. The testing performed was technical (software validation, compliance with radiation standards).
4. Adjudication Method for the Test Set
As there is no mention of a test set involving human interpretation of images or clinical outcomes, there is no adjudication method described. The "review" of performance data was done by "appropriate management" within Bioptics, Inc.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submitter explicitly states: "To the submitters knowledge, the predicate device...did not provide or reference any clinical tests submitted in compliance with 807.92(b)(2), therefore the submitter believes such clinical testing is not appropriate or required by FDA and has not made or provided any summary of such testing."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was Done
The primary studies described are related to the standalone performance of the device's technical attributes and software functionality, but not in the context of an "algorithm only" with clinical outcomes without human interaction. This device is an imaging system, not an AI diagnostic algorithm. The "standalone" testing refers to the system meeting its design specifications and processing images as intended.
7. The Type of Ground Truth Used
For the technical and software validation, the "ground truth" was essentially the device's own design specifications and requirements, along with compliance standards (e.g., DICOM, 21 CFR 1020.30/1020.40). The testing confirmed that the device operated according to these pre-defined technical benchmarks. There was no "expert consensus," "pathology," or "outcomes data" ground truth established for the purpose of proving diagnostic accuracy.
8. The Sample Size for the Training Set
The document does not specify a sample size for a training set. This is expected as the device is a digital imaging system, not an AI model that typically requires a large training dataset for learning. The software "handles digital x-ray image acquisition, calibration, image display," etc., implying standard image processing and display functionalities, not machine learning model training based on a dataset.
9. How the Ground Truth for the Training Set Was Established
Since there is no mention of a training set in the context of an AI/ML model, the concept of establishing ground truth for a training set is not applicable to this submission. The validation focused on the system's engineering and software adherence to specifications.
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.