The Core Vision Digital Specimen Radiography (DSR) System is a cabinet digital X-ray imaging system intended to generate and control X-rays for examination of various anatomical regions, and to provide rapid verification that the correct tissue has been excised during percutaneous biopsy.

Performing the verification directly in the same biopsy procedure room 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. This device is intended to be operated wherever the medical professionals deem appropriate, including a surgical suite or a room adjacent to a surgical suite.

Device Description

The Core Vision Digital Specimen Radiography (DSR) System is a stand-alone cabinet digital X-ray imaging system to provide rapid verification that the correct tissue has been excised during percutaneous biopsy.

The Core Vision Digital Specimen Radiography (DSR) System employs the use of Bioptics Vision image acquisition software. The Bioptics Vision software handles the digital X-ray image acquisition, calibration, image display, image analysis and manipulation, patient database, image archiving, and transmittal. Bioptics Vision software is the central part of this system. Bioptics Vision software is Digital Imaging and Communications in Medicine (DICOM) 3.0 compliant and comes with DICOM Print, Store and Modality Work List (MWL).

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for the Core Vision Digital Specimen Radiography (DSR) System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly present a "table of acceptance criteria" in the format typically seen with quantitative metrics for accuracy, sensitivity, or specificity. Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (piXarray 100 Digital Specimen Radiography (DSR) System, K052433) by showing that it has the same indications for use and similar technological characteristics, with improvements or non-significant differences.

The primary "acceptance criteria" here appear to be:

Compliance with regulatory standards: Adherence to 21 CFR 1020.40 for Cabinet X-ray systems, and meeting radiation emission limits.
Performance as intended: The device performs its intended functions (rapid verification of excised tissue, high-resolution digital imaging, DICOM compliance, etc.).
Equivalence to predicate device: The new device functions at least as well as the predicate device.

Given this, a table summarizing the "acceptance criteria" based on the provided text would look like this:

Acceptance Criteria (Implied)	Reported Device Performance
Conformance to 21 CFR 1020.40 (Cabinet X-ray systems)	The Core Vision Digital Specimen Radiography (DSR) System conforms to 21 CFR 1020.40. "Evidence of the compliance is provided throughout this submission."
Radiation Emission Limit (external surface)	"The radiation emitted from the Core Vision Digital Specimen Radiography (DSR) System cabinet x-ray system does not exceed an exposure of 0.5 milliroentgen in one hour at any point five centimeters outside the external surface." (Referenced: Radiographic Control Certificate, Document # 1240)
Functionality (image acquisition, display, analysis, etc.)	"The Bioptics Vision software handles the digital X-ray image acquisition, calibration, image display, image analysis and manipulation, patient database, image archiving, and transmittal." "The submitter believes and claims that the submitted device was developed, designed, tested and validated to perform in a manner that accurately portrays the submitted systems intended use, functionality, safety features, user interface, operation, and documentation."
Substantial Equivalence to Predicate Device	"The results of this testing substantiates that the Core Vision Digital Specimen Radiography (DSR) System performs as well as the predicate, the piXarray 100 Digital Specimen Radiography (DSR) System."
Software Quality and Safety (Moderate Level of Concern)	"Extremely controlled and detailed design inputs and outputs define all of Bioptics product development activities... An emphasis on controlled software activities include risk assessment and management, level of concern and configuration management." "The submitted device's software controls were subjected to significant verification and validation testing."
High resolution digital imaging with small area formats	"This device offers high resolution digital imaging with small area formats (26 X 75 mm)." (Resolution: 14 lp/mm)
Rapid image transfer via DICOM interface	"The Bioptics Vision software transfers images to Radiology and Pathology within seconds though the DICOM interface."

Study Details:

It's important to note that this 510(k) submission primarily relies on non-clinical performance data testing and review to demonstrate substantial equivalence, rather than a traditional clinical study with defined acceptance criteria for diagnostic performance metrics.

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not specified in terms of number of images or patients. The testing appears to be focused on engineering verification and validation of system functionality and compliance, rather than a clinical dataset for diagnostic performance.
- Data Provenance: Not applicable in the context of a clinical test set. The data would be derived from internal engineering testing, hardware performance checks, and software validation.
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 as no clinical ground truth establishment is described for a diagnostic performance test set. The validation was against engineering specifications and regulatory compliance.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. There was no clinical ground truth established or adjudicated in this type of submission.
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:
- No MRMC comparative effectiveness study was done. The device is a digital X-ray 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:
- The term "standalone" in this context refers to the device functioning independently (algorithm only without human-in-the-loop performance). The device itself (the Core Vision DSR System) is a standalone imaging system. The performance testing was of this system's ability to acquire, process, and display images according to its specifications and regulatory requirements. It's not an algorithm that outputs a diagnostic decision, but an imaging system for practitioners to use.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for this submission was primarily engineering specifications, regulatory standards (like 21 CFR 1020.40), and the performance characteristics of the predicate device. For example, the ground truth for radiation emission was the specified limit of 0.5 milliroentgen.
The sample size for the training set:
- Not applicable. This device is an imaging system, not an AI model that requires a training set of data for learning. Its software handles image acquisition, processing, and display, which are functional tasks, not machine learning tasks.
How the ground truth for the training set was established:
- Not applicable, as there was no training set for an AI model.

Summary

{0}------------------------------------------------

K082432

NOV 21 2008 PREMARKET NOTIFICATION 510(k) SUMMARY As required by §807.92

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

Trade Name:	Core Vision Digital Specimen Radiography (DSR)System
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
Premarket Notification submitter:Company Name:	Bioptics, Inc.
Company Address:	4605 S. Palo Verde Rd, Suite 605Tucson, AZ 85714
Contact:	Thom Kerr, General Manager
Preparation Date:	June 30, 2008

A. LEGALLY MARKETED PREDICATE DEVICE - as required by 807,92(a)(3)

The Core Vision Digital Specimen Radiography (DSR) System is substantially equivalent to the piXarray 100 Digital Specimen Radiography System. manufactured by Bioptics, Inc. as a cabinet X-ray system, K052433.

B. DEVICE DESCRIPTION - as required by 807.92(a)(4)

{1}------------------------------------------------

and Communications in Medicine (DICOM) 3.0 compliant and comes with DICOM Print, Store and Modality Work List (MWL).

C. DEVICE CLAIMS - as required by 807.92(a)(4)

The Core Vision Digital Specimen Radiography (DSR) System is of compact and portable design plugs into any A/C outlet and requires no external X-ray shielding. The Core Vision DSR System offers one-button operation utilizing automatic exposure control for optimal X-ray exposure. This device offers high resolution digital imaging with small area formats.

The Bioptics Vision software transfers images to Radiology and Pathology within seconds though DICOM interface.

PRODUCT AND TECHNICAL SPECIFICATIONS - as required by 807.92(a)(4) D.

The Core Vision Digital Specimen Radiography (DSR) System is of compact and portable design, plugs into any A/C outlet, and requires no external X-ray shielding. The Core Vision DSR System offers one-button operation utilizing automatic exposure control for optimal X-ray exposure. This device offers high resolution digital imaging with small area formats (26 X 75 mm).

The Bioptics Vision software handles the digital X-ray image acquisition, calibration, image display, image analysis and manipulation, patient database, image archiving, and transmittal. Bioptics Vision software is the central part of this system. Bioptics Vision software is Digital Imaging and Communications in Medicine (DICOM) 3.0 compliant and comes with DICOM Print, Store and Modality Work List (MWL). The Bioptics Vision software transfers images to Radiology and Pathology within seconds though the DICOM interface.

Below is a specifications chart of the Predicate Device with the Core Vision DSR System.

Specifications

Automatic KV Option Automatic Exposure Time Option Manual Exposure Time Selection Geometric Magnification One-Button Calibration Energy Range Tube Current X-ray Coverage External X-ray shielding Imaging Area (mm) Resolution (contact mode) Focal Spot DICOM Interface (store, print, work list) Manual kV Selection Window Filtration Footprint (Overall Dimensions)*

Included Included Included Included Included 5-25 kV 0.5 mA 11.2 cm Not required 26 X 75 mm 14 lo/mm 50 um nominal Included Included 0.2 mm Beryllium 31cm w x 38cm d x 46.6cm h

{2}------------------------------------------------

E. INTENDED USE - as required by 807,92(a)(5)

Bioptics defines intended use as the objective intent of the manufacturer or person(s) legally responsible for the labeling of devices and includes labeling claims, advertising matter, and approved oral or written statements by such firms or their representatives. As such, Bioptics intends its advertising matter, specifications, user manual and other written or authorized oral statements to identify the objective intent of Bioptics.

Bioptics intends that the submitted device's intended uses include, but are not limited to, the following:

Uses typical of those for "cabinet x-ray" or "specimen x-ray" devices. .
. A device intended to generate and control x-rays for examination of various anatomical regions.
. A device intended to provide rapid verification, through x-ray examination, that the correct tissue has been excised during percutaneous biopsy.
. A device intended to create an x-ray image of biopsy material, including in the biopsy procedure room or wherever medical professionals deem appropriate, to enable the rapid x-ray examination of the biopsy specimen and the rapid verification that the correct specimen was excised.

F. INDICATIONS FOR USE

LEVEL OF CONCERN ~ as requested by recent FDA guidance G.

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

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

The Core Vision Digital Specimen Radiography (DSR) System has the same indications for use as the piXarray 100 Digital Specimen Radiography (DSR) System, K052433. The Core Vision Digital Specimen Radiography (DSR) System has the same technological characteristics as the piXarray 100 Digital Specimen Radiography (DSR) System. Section III Substantial Equivalence of this submission provides a detailed COMPARISON MATRIX of the predicate piXarray 100 Digital Specimen Radiography (DSR) System to the Core Vision Digital Specimen Radiography (DSR) System.

The submitter claims that the Core Vision Digital Specimen Radiography (DSR) System is substantially equivalent to the predicate device, the piXarray 100 Digital Specimen Radiography (DSR) System.

{3}------------------------------------------------

The technological characteristics of the piXarray 100 Digital Specimen Radiography (DSR) System are very similar to those of the Core Vision Digital Specimen Radiography (DSR) System. The differences include:

TABLE OF DIFFERENCES BETWEEN THE piXarray 100 DIGITAL SPECIMEN RADIOGRAPHY (DSR) SYSTEM AND THE CORE VISION CABINET X-RAY SYSTEM

Characteristic	Core Vision	piXarray 100 DSR
X-ray coverage	11.2 cm	19.0 cm
Imaging area (mm)	26 X 75	50 x 50, 50 x 100,100 x 100
Film or Digital Imaging	Digital Only	Yes
Energy Range	5-25 kV	5-45 kV
Resolution (contact mode)	14 lp/mm (35 microns)	10 lp/mm (50 microns)
Footprint(Overall Dimensions)	36cm w x 34cm d x 39cm h	38cm w x 41cm d x 66cm h
Used for excised andpercutaneous biopsy samples	Yes	Percutaneous Only

The submitter concludes that the piXarray 100 Digital Specimen Radiography (DSR) System employs the same type of technological characteristics including X-ray technology, power source, digital imaging, computer interface for user functionality, computer hardware, operating system, and similar functionality to the Core Vision Digita, Specimen Radiography System. The majority of differences are either not significant or relate to evolutionary changes in technology that has occurred since the release of the piXarray 100 Digital Specimen Radiography (DSR) System.

I. NON-CLINICAL PERFORMANCE DATA TESTING AND REVIEW - as required by 807.92(b)(1)

As a cabinet or specimen X-ray device, the submitted device is required to comply with Part 1020, FDA's performance standards for ionizing radiation emitting products and specifically to 21 CFR 1020.40 Cabinet X-ray systems. The Core Vision Digital Specimen Radiography (DSR) System conforms to 21 CFR 1020.40. Evidence of the compliance is provided throughout this submission and is referenced in the appropriate exhibits.

The radiation emitted from the Core Vision Digital Specimen Radiography (DSR) System cabinet x-ray system does not exceed an exposure of 0.5 milliroentgen in one hour at any point five centimeters outside the external surface. See Radiographic Control Certificate, Document # 1240 is included in this exhibit.

Additionally, the submitted device has been designed in a device design and manufacturing environment with a robust quality system.

Extremely controlled and detailed design inputs and outputs define all of Bioptics product development activities. Some of these activities include, but are not limited to, detailed design specifications, verification and validation activities, and revision history and revision documentation. An emphasis on controlled software activities include risk assessment and management, level of concern and configuration management. These activities are thoroughly documented and reviewed and approved by appropriate authorized authorities.

{4}------------------------------------------------

The submitter believes and claims that the submitted device was developed, designed, tested and validated to perform in a manner that accurately portrays the submitted systems intended use, functionality, safety features, user interface, operation, and documentation. The results of these activities were reviewed by appropriate management and that review resulted in the documented determination that the submitted device met its design plan, is safe and effective, and, subsequent to FDA review of this submission, is ready for commercial distribution as a medical device.

The submitted device's software controls were subjected to significant verification and validation testing. Verification testing was performed during software coding and results were recorded as "comments" in the software code. Alpha validation testing included testing of all functionality and confirmation that all identified hazards have been adequately addressed by software functionality, the user interface or documentation.

Alpha validation activities included specified system software and operating software performance and environmental testing within the specified environment. Refer to "Software Revision History", Document # 1239, included in Exhibit 9.

Additionally, a few devices, labeled "Research Use Only," are being placed to further document the submitter's performance claims and attempt to identify any unknown hazards. Any significant findings will be investigated and resolved appropriately. If a significant finding rises to an appropriate level, the submitter will take appropriate FDA notification action.

The predicate device, pixarray 100 Digital Specimen Radiography (DSR) System did not provide or reference any clinical tests submitted in compliance with 807.92(b)(2), therefore the submitter believes such clinical testing is not appropriate or required by FDA and has not made or provided any summary of such testing.

J. SUBSTANTIAL EQUIVALENCE SUMMARY

The piXarrav 100 Digital Specimen Radiography (DSR) System has the same indications for use as the Core Vision Digital Specimen Radiography (DSR) System. The Core Vision Digital Specimen Radiography (DSR) System has the same technological characteristics as the piXarray 100 Digital Specimen Radiography (DSR) System. However, while the submitter believes the characteristics are sufficiently precise to assure equivalence, the submitter has carried out validation and performance testing to further document equivalence. The results of this testing substantiates that the Core Vision Digital Specimen Radiography (DSR) System performs as well as the predicate, the piXarray 100 Digital Specimen Radiography (DSR) System.

K. CONCLUSIONS

The performance testing and validation studies document that the Core Vision Digital Specimen Radiography (DSR) System is substantially equivalent to the piXarray 100 Digital Specimen Radiography (DSR) System.

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle, with three lines representing the eagle's body and wings.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 21 2008

Bioptics, Inc. % Ms. Patricia Wade Consultant 15546 W Gelding Dr. SURPRISE AZ 85379

Re: K082432

Trade/Device Name: Core Vision Digital Specimen Radiography (DSR) System Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MWP Dated: July 26, 2008 Received: August 22, 2008

Dear Ms. Wade:

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 either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

{6}------------------------------------------------

Page 2

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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 Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

21 CFR 876.xxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 894.xxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Arque Mr. Whang

Joyce M. Whang, Ph.D. Acting Director. Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{7}------------------------------------------------

Indications for Use

510(k) Number (if known):___ K082432

Device Name: __ Core Vision Digital Specimen Radiography (DSR) System

Indications For Use:

Performing the verification directly in the same biopsy procedure room enables cases to be completed faster, thus limiting the time the patient noom chanisation. Specimen radiography can potentially limit the patient recalls. This device is intended to be operated wherever the medical professionals deem appropriate, including a surgical suite or a room adjacent to a surgical suite

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence/of(CDRH, Office of Device Evaluation (ODE)

Helu Keun

(Division Stan-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number LGG2432

Page 1 of 1

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.