(48 days)
Provide digital x-ray images of harvested tissue specimens from various anatomical regions in order to provide rapid verification that the correct tissue has been excised during the biopsy procedure.
The XPERT Specimen Radiography System is a self contained, shielded cabinet x-ray system designed to meet imaging requirements for surgically excised and needle core biopsies. This device does not expose the patient to radiation, it is used for biopsy tissue samples only. This equipment provides high resolution, high contrast, X-ray images, using either radiographic file up to 10x12" or digitally with the DICOM compliant DIGIVIEW digital detectors up to 8x10" in size.
With its small focal spot x-ray source and adjustable sample positioning capability, the XPERT 40 provides variable magnification for increased visibility and sharpness of detail for lesions and abnormalities in biopsies.
The device is provided with a PC including the DICOM compliant software and an LCD monitor for high resolution imaging.
The provided text does not contain detailed acceptance criteria or a comprehensive study proving the device meets specific performance metrics. Instead, it describes a 510(k) submission for the XPERT Specimen Radiography System to demonstrate substantial equivalence to predicate devices, rather than establishing specific performance criteria through a detailed study.
Here's an analysis based on the provided text, addressing your points where possible:
1. Table of Acceptance Criteria and Reported Device Performance
No specific quantitative acceptance criteria (e.g., sensitivity, specificity, resolution targets) are stated in the document. The document focuses on demonstrating substantial equivalence to predicate devices based on "physical and performance characteristics."
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Electrical Safety | Passed |
| Radiation Safety | Passed |
| Software Validation | Passed |
| Imaging Function | "Provides high resolution, high contrast, X-ray images, using either radiographic file up to 10x12" or digitally with the DICOM compliant DIGIVIEW digital detectors up to 8x10" in size." (General description, not a specific performance metric) |
| Magnification | "Provides variable magnification for increased visibility and sharpness of detail for lesions and abnormalities in biopsies." (General description, not a specific performance metric) |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "software validation testing" and "electrical and radiation safety requirements." These generally involve technical tests rather than a clinical "test set" of patient data. There is no information about a test set, its sample size, or data provenance (country of origin, retrospective/prospective).
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not provided. The "performance data" described refers to technical validation, not clinical evaluation requiring expert ground truth.
4. Adjudication Method for the Test Set
Not applicable, as no clinical test set requiring adjudication is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study is mentioned. The document focuses on the device's technical performance and substantial equivalence, not its impact on human reader performance.
6. Standalone (Algorithm Only) Performance Study
While the device is a standalone X-ray system, the document doesn't describe an "algorithm only" performance study in the context of AI or automated analysis. The performance data refers to the system's ability to produce images and meet safety standards.
7. Type of Ground Truth Used
The "performance data" mentioned (electrical safety, radiation safety, software validation) would typically be evaluated against technical specifications and regulatory standards, not clinical ground truth like pathology or outcomes data.
8. Sample Size for the Training Set
No information about a training set is provided. This type of device (a specimen radiography system) typically doesn't involve machine learning models that require a "training set" in the conventional sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set is mentioned.
Summary of the Study and Acceptance Criteria (Based on Provided Text):
The document describes a 510(k) submission for the KUBTEC XPERT 40, a specimen radiography system. The "study" referenced is primarily a technical validation to demonstrate that the device is substantially equivalent to legally marketed predicate devices.
The acceptance criteria, though not explicitly quantified in a table, revolve around the device successfully passing:
- Electrical safety requirements.
- Radiation safety requirements.
- Software validation testing.
The "proof" that the device meets these criteria is simply stated: "The subject device has been subjected to and passed electrical and radiation safety requirements, as well software validation testing."
This submission strategy relies on comparing the new device's technological characteristics and intended use to existing, legally marketed devices (the predicates: piXarray by Biotics K052433, Dx-50 by Faxitron K061361, MX 20 by Faxitron K953404) rather than conducting extensive new clinical performance studies with specific statistical endpoints and ground truth. The FDA's letter confirms their review and determination of substantial equivalence, allowing the device to be marketed.
§ 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.