(49 days)
The MX-20 is a Cabinet x-ray system that is used to provide film and/or digital x-ray images of harvested specimens from various anatomical regions in order to provide rapid verification that the correct tissue has been excised during the biopsy procedure.
Doing the verification directly in the same room or nearby 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 Faxitron MX-20 Specimen Radiography System is a Cabinet X-ray System specifically designed to provide high detail radiographic imaging of surgically excised medical specimens. The exceptionally high magnification capability (up to 5X) from the 0.02 mm focal spot with optimized cabinet geometry and the superior contrast available from the low kV capability provides enhanced film and/or digital imaging performance. This device supports radiographic film sizes up to 30 x 35 cm and can be configured to acquire high resolution, DICOM compliant, digital x-ray images through the use of an integrated camera and Faxitron Specimen Radiography software.
The provided document is a 510(k) Premarket Notification for the Faxitron MX-20 Specimen Radiography System. It describes the device, its intended use, and its technical characteristics, comparing it to predicate devices. However, the document does not contain a study that proves the device meets specific acceptance criteria.
Instead, it states that the device has been designed and tested to comply with performance standards (specifically 21 CFR 1020.40 for Cabinet X-ray Systems) and has undergone electrical safety testing and compliance testing for European directives. This is a common approach for 510(k) submissions, where substantial equivalence to a legally marketed predicate device is established, rather than conducting a de novo clinical study to prove efficacy against novel acceptance criteria.
Therefore, many of the requested sections regarding a specific study and acceptance criteria cannot be filled from the provided text.
Here's a breakdown of what can and cannot be answered based on the input:
1. A table of acceptance criteria and the reported device performance
Not provided. The document states compliance with general standards (21 CFR 1020.40, electrical safety, European directives) but does not list specific quantitative acceptance criteria for device performance (e.g., image quality metrics, diagnostic accuracy) nor detailed reported performance against such criteria.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. No "test set" in the context of a clinical performance study is mentioned. The testing described focuses on regulatory compliance (e.g., X-ray emissions, electrical safety) rather than clinical performance with patient data.
3. 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. No ground truth establishment for a diagnostic test set is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No adjudication method for a diagnostic test set is described.
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
Not applicable. This device is an X-ray system, not an AI or diagnostic software intending to improve human reader performance. No MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is hardware; it's not an algorithm that performs standalone diagnostic tasks without human interaction.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. No diagnostic ground truth is established in the context of a performance study.
8. The sample size for the training set
Not applicable. No "training set" for an AI or machine learning model is mentioned.
9. How the ground truth for the training set was established
Not applicable. No "training set" for an AI or machine learning model is mentioned.
Summary of available information:
The Faxitron MX-20 Specimen Radiography System is a Cabinet X-ray System designed for high-detail radiographic imaging of surgically excised medical specimens. Its compliance with performance standards (21 CFR 1020.40), electrical safety, and European directives forms the basis of its acceptance. Substantial equivalence to predicate devices (Faxitron Micro 50, Faxitron DX-50, and piXarray Digital Specimen Radiography System) is claimed based on similar indications for use and comparable technological characteristics, with the MX-20 having advantages in focal spot size and magnification capability.
Essentially, the "acceptance criteria" here are regulatory compliance standards and demonstrating substantial equivalence to pre-existing, legally marketed devices, rather than meeting specific quantitative diagnostic performance metrics from a clinical study.
§ 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.