(50 days)
The BioVision Digital Specimen Radiography (DSR) System is a cabinet digital X-ray imaging system intended to generate and control X-rays for examination of various anatomical regions, and to provide rapid verification that the correct tissue has been excised during excisional or percutaneous biopsy.
Performing the verification directly in the same biopsy procedure room enables cases to be completed faster, thus limiting the time the patient needs to be under examination. Specimen radiography can potentially limit the number of patient recalls. This device is intended to be operated wherever the medical professionals deem appropriate, including a surgical suite or a room adjacent to a surgical suite.
The BioVision Digital Specimen Radiography (DSR) System is a stand-alone cabinet digital X-ray imaging system to provide rapid verification that the correct tissue has been excised during percutaneous biopsy.
Performing the verification directly in the same biopsy procedure room enables cases to be completed faster, thus limiting the time the patient needs to be under examination. Specimen radiography can potentially limit the number of patient recalls.
The BioVision Digital Specimen Radiography (DSR) System employs the use of Bioptics Vision image acquisition software. The Bioptics Vision software handles the digital X-ray image acquisition, calibration, image display, image analysis and manipulation, patient database, image archiving, and transmittal. Bioptics Vision software is the central part of this system. Bioptics Vision software is Digital Imaging and Communications in Medicine (DICOM) 3.0 compliant and comes with DICOM Print, Store and Modality Work List (MWL).
Here's a breakdown of the acceptance criteria and the study information for the BioVision Digital Specimen Radiography (DSR) System, based on the provided 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document details the design specifications and testing performed to demonstrate substantial equivalence to a predicate device, rather than explicit acceptance criteria and performance against those criteria in a tabular format typical for AI/CADe devices. However, we can infer the acceptance criteria and reported performance from the provided specifications and claims. The primary acceptance criterion is substantial equivalence to the predicate device, the piXarray 100 Digital Specimen Radiography (DSR) System, focusing on technological characteristics and safety.
| Acceptance Criterion (Implied) | Reported Device Performance (BioVision DSR System) |
|---|---|
| Safety: | |
| Conformance to 21 CFR 1020.40 (Cabinet X-ray systems) | Conforms to 21 CFR 1020.40. |
| Radiation emission not exceeding 0.5 milliroentgen in one hour at 5cm outside external surface | Radiation emitted does not exceed 0.5 milliroentgen in one hour at 5cm outside the external surface. |
| Robust quality system for design and manufacturing | Developed in a device design and manufacturing environment with a robust quality system, including detailed design inputs/outputs, V&V, risk assessment/management for software. |
| Functionality/Performance (against predicate): | |
| Same Indications for Use | Same Indications for Use as the piXarray 100 DSR system. |
| Similar Technological Characteristics | Similar technological characteristics as the piXarray 100 DSR system (e.g., X-ray technology, power source, digital imaging, computer interface, hardware, OS). Differences identified (X-ray coverage, imaging area, energy range, resolution, footprint) are deemed not significant or evolutionary. |
| Software functionality, safety features, user interface, operation, and documentation accurately portray intended use | Developed, designed, tested, and validated to perform in this manner. Software controls subjected to significant verification and validation testing, including alpha validation of all functionality and hazard addressing. |
| Performs as well as the predicate device | Performance testing and validation studies substantiate that the BioVision DSR System performs as well as the predicate. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a test set in the context of clinical data, as the device is not an AI/CADe device that performs automated analysis on patient images. The testing conducted was primarily related to hardware and software validation, and safety compliance.
- Sample Size for Test Set: Not applicable in the context of clinical image analysis. The "test set" for hardware and software validation is not quantified in terms of number of cases or images.
- Data Provenance: Not applicable for clinical data. The validation activities mentioned are internal and related to device design and function. The document mentions "a few devices, labeled 'Research Use Only,' are being placed to further document the submitter's performance claims and attempt to identify any unknown hazards," which suggests some limited, prospective, real-world deployment for further internal evaluation, but not as a formal clinical test set for regulatory submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not provided as the submission does not detail a study involving expert-established ground truth on a clinical test set. The device is a digital X-ray imaging system, not an AI/CADe algorithm making diagnostic assessments.
4. Adjudication Method for the Test Set
This information is not provided as there is no mention of a formal clinical test set requiring adjudication in the context of image interpretation or diagnostic accuracy.
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
There was no MRMC comparative effectiveness study performed. Since this device is a digital specimen radiography system and not an AI/CADe or diagnostic aid intended to assist human readers, such a study is not relevant to its regulatory submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
A "standalone" performance study in the context of an algorithm's diagnostic accuracy was not performed. This device is a digital X-ray imaging system that produces images for human interpretation, not an algorithm that outputs a diagnostic result independently. The software in question (Bioptics Vision) handles image acquisition, display, analysis, and manipulation, not independent diagnostic assessment.
7. The Type of Ground Truth Used
The concept of "ground truth" as it applies to clinical diagnostic accuracy (e.g., pathology, outcomes data) is not relevant for this submission. The ground truth for the device's performance relates to its ability to accurately acquire and display X-ray images, adhere to safety standards (e.g., radiation leakage), and perform its stated functions in line with design specifications. The acceptance of the device's functionality is based on its ability to produce images that allow medical professionals to "rapidly verify that the correct tissue has been excised."
8. The Sample Size for the Training Set
This information is not applicable. The BioVision Digital Specimen Radiography (DSR) System is a hardware device with controlling software, not an AI/ML algorithm that is "trained" on a dataset. The software performs image acquisition and processing based on deterministic algorithms, not learned patterns from a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reasons stated in point 8.
§ 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.