(91 days)
The Core Vision 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 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 Core Vision 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 Core Vision 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 Core Vision Digital Specimen Radiography (DSR) System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly present a "table of acceptance criteria" in the format typically seen with quantitative metrics for accuracy, sensitivity, or specificity. Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (piXarray 100 Digital Specimen Radiography (DSR) System, K052433) by showing that it has the same indications for use and similar technological characteristics, with improvements or non-significant differences.
The primary "acceptance criteria" here appear to be:
- Compliance with regulatory standards: Adherence to 21 CFR 1020.40 for Cabinet X-ray systems, and meeting radiation emission limits.
- Performance as intended: The device performs its intended functions (rapid verification of excised tissue, high-resolution digital imaging, DICOM compliance, etc.).
- Equivalence to predicate device: The new device functions at least as well as the predicate device.
Given this, a table summarizing the "acceptance criteria" based on the provided text would look like this:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Conformance to 21 CFR 1020.40 (Cabinet X-ray systems) | The Core Vision Digital Specimen Radiography (DSR) System conforms to 21 CFR 1020.40. "Evidence of the compliance is provided throughout this submission." |
| Radiation Emission Limit (external surface) | "The radiation emitted from the Core Vision Digital Specimen Radiography (DSR) System cabinet x-ray system does not exceed an exposure of 0.5 milliroentgen in one hour at any point five centimeters outside the external surface." (Referenced: Radiographic Control Certificate, Document # 1240) |
| Functionality (image acquisition, display, analysis, etc.) | "The Bioptics Vision software handles the digital X-ray image acquisition, calibration, image display, image analysis and manipulation, patient database, image archiving, and transmittal." "The submitter believes and claims that the submitted device was developed, designed, tested and validated to perform in a manner that accurately portrays the submitted systems intended use, functionality, safety features, user interface, operation, and documentation." |
| Substantial Equivalence to Predicate Device | "The results of this testing substantiates that the Core Vision Digital Specimen Radiography (DSR) System performs as well as the predicate, the piXarray 100 Digital Specimen Radiography (DSR) System." |
| Software Quality and Safety (Moderate Level of Concern) | "Extremely controlled and detailed design inputs and outputs define all of Bioptics product development activities... An emphasis on controlled software activities include risk assessment and management, level of concern and configuration management." "The submitted device's software controls were subjected to significant verification and validation testing." |
| High resolution digital imaging with small area formats | "This device offers high resolution digital imaging with small area formats (26 X 75 mm)." (Resolution: 14 lp/mm) |
| Rapid image transfer via DICOM interface | "The Bioptics Vision software transfers images to Radiology and Pathology within seconds though the DICOM interface." |
Study Details:
It's important to note that this 510(k) submission primarily relies on non-clinical performance data testing and review to demonstrate substantial equivalence, rather than a traditional clinical study with defined acceptance criteria for diagnostic performance metrics.
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not specified in terms of number of images or patients. The testing appears to be focused on engineering verification and validation of system functionality and compliance, rather than a clinical dataset for diagnostic performance.
- Data Provenance: Not applicable in the context of a clinical test set. The data would be derived from internal engineering testing, hardware performance checks, and software validation.
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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):
- Not applicable as no clinical ground truth establishment is described for a diagnostic performance test set. The validation was against engineering specifications and regulatory compliance.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. There was no clinical ground truth established or adjudicated in this type of submission.
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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:
- No MRMC comparative effectiveness study was done. The device is a digital X-ray system, not an AI-assisted diagnostic tool for human readers.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The term "standalone" in this context refers to the device functioning independently (algorithm only without human-in-the-loop performance). The device itself (the Core Vision DSR System) is a standalone imaging system. The performance testing was of this system's ability to acquire, process, and display images according to its specifications and regulatory requirements. It's not an algorithm that outputs a diagnostic decision, but an imaging system for practitioners to use.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for this submission was primarily engineering specifications, regulatory standards (like 21 CFR 1020.40), and the performance characteristics of the predicate device. For example, the ground truth for radiation emission was the specified limit of 0.5 milliroentgen.
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The sample size for the training set:
- Not applicable. This device is an imaging system, not an AI model that requires a training set of data for learning. Its software handles image acquisition, processing, and display, which are functional tasks, not machine learning tasks.
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How the ground truth for the training set was established:
- Not applicable, as there was no training set for an AI model.
§ 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.