The PathVision 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.

Device Description

The Faxitron PathVision 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 6X) 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 35 x 35 cm and can be configured to acquire high resolution, DICOM compliant, digital x-ray images up to 23 x 29 cm in size through the use an integrated camera and Faxitron Specimen Radiography software.

AI/ML Overview

The provided text is a 510(k) Pre-market Notification for the Faxitron PathVision Specimen Radiography System. It describes the device, its intended use, technical specifications, and declares substantial equivalence to predicate devices. However, this document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of AI/machine learning performance.

The document focuses on the hardware specifications, safety compliance, and equivalence to existing x-ray systems. It's a standard pre-market notification for a medical device that uses X-ray technology, not an AI or software algorithm.

Therefore, I cannot fulfill your request for the following information as it is not present in the provided text:

A table of acceptance criteria and the reported device performance: This document does not define performance metrics or acceptance criteria for an AI or software algorithm. It describes physical characteristics and compliance with X-ray system standards (e.g., 21 CFR 1020.40).
Sample sized used for the test set and the data provenance: Not applicable, as there is no mention of a test set for a software algorithm.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
Adjudication method: Not applicable.
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. The device is a specimen radiography system, not an AI-assisted diagnostic tool for human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used: Not applicable.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

The "software" mentioned in the document refers to system control software, image acquisition software, and DICOM compliance for image management, not a diagnostic AI algorithm.

In summary, the provided document does not support a description of acceptance criteria and a study proving an AI device meets those criteria because the device in question is a traditional X-ray specimen radiography system, not an AI/ML-based diagnostic system.

Summary

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K122428

SEP
2 5
2012

Image /page/0/Picture/2 description: The image shows the word "faxitron" in a bold, sans-serif font. The "x" in the word has a design element that looks like a burst of pixels or a stylized representation of data transmission. The overall appearance of the word is modern and technological.

Premarket Notification 510 (k) Summary As required by 21 CFR 807.92

Device name - as required by 807.92(a)(2):

Trade Name:.	PathVision Specimen Radiography System
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Common/Classification Name: Specimen x-ray System/Cabinet X-ray System

Classification Regulation: 21 CFR 892.1680

Device Class: Class II

Product Code (Procode): MWP

Panel: Radiologic Devices Panel

Company Name: Faxitron Bioptics. LLC

Company Address: 3440 East Britannia Drive, Suite 150 Tucson, Arizona 85706

Contact: Douglas C. Wiegman, VP Engineering

August 5, 2012 Preparation Date:

LEGALLY MARKETED PREDICATE DEVICES - as required by 21 CFR 807:92(a)(3)

The Faxitron PathVision Digital Specimen Radiography System is substantially equivalent to the following to the following predicate devices:

A. Hologic Trident Specimen Radiography System (K111508)
B. Faxitron Specimen Radiography System Model MX20 (K072557)
C. Bioptics BioVision Digital Specimen Radiography System (K091558)

Faxitron Bioptics LLC' PathVision 510(k) Submission Page 7 of 31

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DEVICE DESCRIPTION - as reguired by 21 CFR 807.92(a)(4)

DEVICE CLAIMS - as required by 807 92(a)

The Faxitron PathVision Specimen Radiography System is a fully shielded Cabinet Xray System that has been designed to comply with 21 CFR 1020.40. The system allows up to 6 times geometric magnification of excised specimens with minimal geometric distortion through the use of a focal spot size that is less than 20 microns. The x-rav coverage of the device allows the use of radiographic film sizes up to 35 x 35 cm. The device can also be configured to provide high resolution, DICOM compliant, digital images through the use an integrated digital camera that is up to 23 x 29 cm in size, and Faxitron Specimen Radiography software. The Faxitron Software supports the DICOM Store Print and Modality Worklist services .

DEVICE TECHNICAL SPECIFICATIONS - as required by 807.92(a)(4) Cabinet Specifications:

· Energy Range: 10-100 kV Constant Potential
Tube Current: 0.3 mA from 10 kV to 40 kV, iso-watt limited to 12 o watts from 40 to 100 KV
o Focal Spot Size: < 20 microns
o X-ray beam divergence: 44 deg. Min.
Target material: Tungsten o
· Bervillium Window Filtration: 0.010"
o X-ray Coverage: 35 x 35 cm
o Power: 100 240 VAC, ±10%, 50/60 Hz, 200 VA
o Dimensions:
- External: 23" W x 21" D x 36" H
- Internal: 15.4" W x 15.4" D x 22.2" H
o Weight: 413 lbs.

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DEVICE TECHNICAL SPECIFICATION cont.

Digital System Specifications:

· Active image Area: 23 x 29 cm Options: 18 x 20 cm
· Typical Spatial resolution: 7-10 lp/mm
O DICOM 3.0 compliant software includes Store, Print and Modality Worklist
· Network ready workstation and monitor included

INTENDED USE - as required by 807.92(a)(5)

Indications for Use: The PathVision 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.

LEVEL OF CONCERN - as required by recent FDA quidance

Faxitron has determined that the submitted device has a "moderate" software Level of Concern and has provided that documented record as part of this submission.

TECHNOLOGICAL CHARACTERISTICS SUMMARY- as required by 807.92(a)(6)

The PathVision Specimen Radiography System has the same indications for use, general configuration, and principles of operation as the predicate devices listed above. The technological characteristics of the PathVision Specimen Radiography System have been compared to the predicate devices sited and is covered in detail in the Substantial Equivalence section of this submission.

NONCLINICAL PERFORMANCE DATA TESTING AND REVIEW - as required by 807.92(b)(1-)

The PathVision Specimen Radiography System is a Cabinet X-ray System and has been designed and tested to comply with the performance standards set forth in 21. CFR 1020.40 Cabinet X-ray Systems. Testing and performance data pertaining to this standard has been included as part of the submission. This device has also been successfully tested to the European EMC Directive and will undergo Safety testing to IEC 61010 prior to being placed on the market.

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Substantial Equivalence Summary

The PathVision Specimen Radiography System has the same indications for use as the predicate devices sited. The technical characteristics of the PathVision are very similar to the predicate devices. One major difference that we believe allows the PathVision Radiography System to perform better than the predicate devices sited is the size of the focal spot (<20 microns), greater sixe of the digital detector and the optimized cabinet geometry which allows greater x-ray coverage and higher geometric magnification of excised specimens with minimal geometric distortion.

CONCLUSIONS - as required 807.92(b)(3)

We conclude that the documentation and testing included in this submission indicates that the PathVision Specimen Radiography System is safe and effective and substantially equivalent to the predicate devices sited.

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Image /page/4/Picture/0 description: The image contains a logo for the Department of Health & Human Services - USA. The logo features a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem consisting of three curved, overlapping shapes, resembling a stylized caduceus or a symbol representing health and human services.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

SEP 2 5 2012

Mr. Douglas C. Wiegman VP Engineering Faxitron Bioptics LLC 3440 E. Britannia Drive, Suite 150 TUCSON AZ 85706

Re: K122428

Trade/Device Name: PathVision Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MWP Dated: August 7, 2012 Received: August 9, 2012

Dear Mr. Wiegman:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into class II (Special Controls), it may be subject to such 11 your device to trassified for ajor regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean r that FDA has made a determination that your device complies with other requirements of the Act that I Dr Has intatutes and regulations administered by other Federal agencies. You must or any I ederal statutes and regainments, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice medical device-related adverse events) (2) regulation (21 CFR Part 820). This letter requirements as set form in are qu your device as described in your Section 510(k) premarket witi anow you to begin marketing your intil equivalence of your device to a legally marketed nontreation. The I Drivination of sussion for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 11 you desire specific days to: your itro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket 5 150. Thise, promote 100.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Tou may obtain other generers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours,

Janine M. Morris

Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Statement of Indications for Use

510(k) Number (if known): K122428

Device Name: PathVision

Indications for Use:

Prescription Use ___ Y _______________________________________________________________________________________________________________________________________________________

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

Division Sign-Off

Office of In Vitro Diagnostic Device Evaluation and Safety

510(k) K122428

Page 1 of

Regulation Number and Section

§ 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.