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A cabinet X-ray system used to provide digital X-ray images of surgical and core biopsy specimens from various anatomical regions in order to allow rapid verification that the correct tissue has been excised during the procedure.

Doing the verification in the same room as the procedure or nearby improves workflow, thus reducing the overall operative time.

The TrueView 200 Pro-US is a Cabinet X-ray System intended to provide the detailed radiographic imaging of small surgical excised or biopsy specimens and to further provide rapid verification that correct tissue has been excised. The TrueView 200 Pro-US includes the following major components: system monitor, touch-screen control display, and an imaging cabinet.

This all-in-one system includes shielding that is incorporated within the cabinet chamber system design, eliminating the need for separate shielding. The unit is mounted on casters for easy transportation.

The provided document is a 510(k) premarket notification for the TrueView 200 Pro-US Specimen Radiography System. It primarily focuses on demonstrating substantial equivalence to a predicate device (TrueView 100 Pro) rather than describing a study proving the device meets specific acceptance criteria for AI performance.

Therefore, many of the requested details, particularly those related to AI algorithm performance (e.g., sample sizes for test/training sets, expert ground truth, MRMC studies, specific acceptance criteria for AI metrics), are not present in this document. This device is a cabinet X-ray system, suggesting it's hardware for imaging, not an AI-powered diagnostic tool. The document doesn't mention any AI components or algorithms that would require such specific performance testing.

Here's what can be extracted from the document, and where information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the context of AI performance metrics (e.g., sensitivity, specificity, AUC). Instead, it focuses on demonstrating compliance with recognized standards and functional performance of the radiography system.

• IEC 61010-2-091:2019
• IEC 61010-2-101:2018
• IEC 61326-1 Edition 3.0 2020-10
• IEC 61326-2-6 Edition 3.0 2020-10
• ISTA 3B-2017
• 21 CFR 1020.40 | Complies with applicable IEC-61010 standards (general electrical safety including mechanical hazards plus particular standards for cabinet x-ray systems) and international EMC standards. Compliance demonstrated by Intertek (third-party test house). |
  | Functional Performance (Bench Testing) | - Functional testing
• Usability testing | Successfully performed design control verification tests and validation tests. Results support substantial equivalence. |
  | Imaging Performance Parameters | - Limiting Spatial Resolution
• Output Image
• Display Monitor
• Time to Preview
• Cycle Time | - 10 lp/mm
• 14-bit image data
• 2.3 MP High luminescence diagnostic monitor

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A cabinet X-ray system used to provide digital X-ray images of surgical and core biopsy specimens from various anatomical regions in order to allow rapid verification that the correct tissue has been excised during the procedure. Doing the verification in the same room as the procedure or nearby improves workflow, thus reducing the overall operative time.

The TrueView Core 100Pro-US Core Specimen Radiography System (CSRS) is a Cabinet X-ray System intended to provide the detailed radiographic imaging of small surgical excised or biopsy specimens and to further provide rapid verification that correct tissue has been excised. The TrueView Core 100Pro-US includes the following major components: touch-screen control display, and an imaging cabinet. This all-in-one system includes shielding that is incorporated within the cabinet chamber system design, eliminating the need for separate shielding.

The provided FDA submission for the TrueView Core 100Pro-US Core Specimen Radiography System is not an AI/ML device. It is a cabinet X-ray system used for digital X-ray imaging of surgical and core biopsy specimens. Therefore, the specific criteria requested for AI/ML devices regarding acceptance criteria, study details, human reader improvement, and ground truth establishment (for training/test sets) are not applicable to this submission.

The document discusses performance data related to the device's electrical safety, mechanical hazards, and electromagnetic compatibility, as shown by compliance with IEC 61010 standards and various functional and usability tests.

Here is a summary of the information that is applicable and found in the document:

1. A table of acceptance criteria and the reported device performance:

The document primarily focuses on compliance with standards rather than specific acceptance criteria in the context of diagnostic accuracy for AI/ML.

Ask a specific question about this device