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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. The system design features an x-ray source that produces a high resolution, 5 -45 micron focal spot. The control system, coupled with a touch panel screen for operator interface. The XPERT system features a DICOM 3.0 compliant DIGICOM computer and software application. The DIGICOM enables the display and analysis of x-ray images, either live (real time) or previously captured, and the storage and transmission of these imagines to the PACS.

The provided text does not contain detailed information regarding acceptance criteria, specific device performance metrics, or a robust study design with sample sizes, expert qualifications, adjudication methods, or comparative effectiveness. The submission primarily focuses on establishing substantial equivalence to a predicate device based on physical and performance characteristics, and compliance with general safety and software validation.

Here's an analysis based on the limited information available:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, no specific quantitative acceptance criteria or numerical performance metrics are outlined for the device itself. The "Performance Data" section states: "The subject device complies electrical and radiation safety requirements and utilizes software that has been validated." This suggests the "acceptance criteria" are related to established electrical and radiation safety standards and successful software validation, rather than clinical performance for tissue verification.

2. Sample Size Used for the Test Set and Data Provenance

No information is provided regarding a specific "test set" in the context of clinical performance data used to demonstrate statistical equivalence or superiority. The submission focuses on substantial equivalence to the predicate device.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. There is no mention of experts being used to establish ground truth for a test set, as no such test set for clinical performance is described.

4. Adjudication Method

Not applicable. No adjudication method is mentioned as there is no described study involving expert review of device outputs against a ground truth.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No multi-reader multi-case (MRMC) comparative effectiveness study is mentioned. The submission does not discuss human readers or AI assistance.

6. Standalone (Algorithm Only) Performance

Not applicable. The device is an X-ray system, not an AI algorithm. Its performance is tied to its ability to generate images, not to interpret them autonomously.

7. Type of Ground Truth Used

Based on the available information, the "ground truth" implicitly refers to the expected functioning of an X-ray system for imaging tissue specimens. This would be assessed through technical validation against engineering and safety standards, and potentially comparison of image quality against the predicate device. There is no mention of clinical outcomes data, pathology, or expert consensus being used as ground truth for a performance study.

8. Sample Size for the Training Set

Not applicable. The device is a hardware X-ray system that produces images; it does not explicitly describe an AI component that would require a "training set" in the machine learning sense. The software is validated, which implies testing, but not a "training set" for an AI model.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for an AI component.

Summary of what is present:

The submission for the KUB Technologies, Inc. XPERT Specimen Radiography System (K083510) is a 510(k) premarket notification. The primary argument for clearance is substantial equivalence to a predicate device (XPERT 40, K071233).

• Acceptance Criteria (Implied):
  • Compliance with electrical and radiation safety requirements.
  • Validated software.
  • Similar physical and performance characteristics to the predicate device.
  • Ability to provide digital X-ray images of harvested tissue specimens for rapid verification.
• Study That Proves Device Meets Criteria:
  • The document states that the "subject device complies electrical and radiation safety requirements and utilizes software that has been validated."
  • It also states, "The subject device represents a minor modification to the predicate device."
  • The "performance data" section in {1} is very brief and does not detail a specific clinical or technical study beyond stating compliance with safety requirements and software validation. The conclusion explicitly states: "We believe the changes are minor and conclude that the subject devices are as safe and effective as the predicate device."

In essence, the "study" demonstrating the device meets its (implied) acceptance criteria is the documentation of its technical specifications, compliance with relevant standards, successful software validation, and the argument that as a minor modification to a previously cleared predicate, its safety and effectiveness are maintained. No detailed clinical performance study with defined criteria, test sets, experts, or ground truth is described in the provided text.

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