The VIDA Pulmonary Workstation 2 (PW2) software provides reproducible CT values for pulmonary tissue, which is essential for providing quantitative support for diagnosis and follow up examinations. The PW2 can be used to support the physician in the diagnosis and documentation of pulmonary tissue images (e.g., abnormalities) from CT thoracic datasets. Three-D segmentation and isolation of sub-compartments, volumetric analysis, density evaluations, low density cluster analysis and reporting tools are combined with a dedicated workflow. The VIDA Pulmonary Workstation 2 (PW2) software package is also intended to be a real-time interactive evaluation in space and time for CT volume data sets that provides the reconstruction of two-dimensional images into a three-dimensional image format.

Device Description

VIDA Pulmonary Workstation 2 (PW2) is a self-contained image analysis software package. This real-time interactive evaluation in space and time for CT volume data sets provides the reconstruction of two-dimensional images into a three-dimensional image format. VIDA Pulmonary Workstation 2 (PW2) can be used to support the physician in the diagnosis and documentation of chest diseases, e.g. when examining the pulmonary tissue (i.e. lung parenchyma) in CT thoracic datasets. Evaluation tools (3D seamentation & isolation of sub-compartments. volumetric analysis, density evaluations, and low density cluster analysis) and reporting tools are combined with a dedicated workflow.

The PW2 is designed to analyze pulmonary CT slice data and display analysis results. Each voxel of the scan is measured by Hounsfield units (HU), a measurement of x-ray attenuation that is applied to each volume element in threedimensional space ("voxel"). The HU are utilized to distinguish between air, water, tissue and bone, such distinction is common in the industry. Figure 1 shows the basic Input/ Output of the CT volume converting to a digitized, colorized picture.

PW2 provides computed tomography (CT) viewing, airway analysis, and parenchymal density analysis in one application. PW2 provides imaging of bronchial airways that can be used to assess therapy effectiveness based on CT scan data. PW2 reconstructs multiple cross-section images from CT data into a computer model displaying complex bronchial branches.

PW2 does not interface directly with any CT or data collection equipment; instead PW2 imports data files previously generated by such equipment.

PW2 provides quantitative measurements and tabulates quantitative properties. PW2 focuses on what is visible to the eye and applies volumetric methods that might otherwise be too tedious to use. The software does not perform any function which cannot be accomplished by a trained user utilizing manual tracing methods; the intent of the software is to save time and automate potential errorprone manual tasks.

The software has functions for loading, analyzing, saving datasets and will generate screen displays, computations and aggregate statistics.

AI/ML Overview

Despite the extensive documentation provided, the 510(k) summary for the VIDA Pulmonary Workstation 2 (PW2) does not contain the specific details required to fully address all aspects of your request.

Here's a breakdown of what can be extracted and what is missing:

The 510(k) submission primarily focuses on establishing substantial equivalence to a predicate device (Siemens InSpace 4D, K071513) based on intended use, technology, and safety considerations, rather than providing detailed performance studies with acceptance criteria, sample sizes, and ground truth methodologies for the PW2's quantitative measurements.

Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state specific acceptance criteria for quantitative measurements (e.g., accuracy, precision for volumetric analysis or density evaluations) nor does it present a table of reported device performance against such criteria. The document states that the software provides "reproducible CT values for pulmonary tissue" and that its intent is to "save time and automate potential error-prone manual tasks," implying that its performance should be comparable to or better than manual methods in terms of consistency and efficiency, but without specific metrics.

Study Details (Missing from the Provided Document)

The document does not describe a standalone study with acceptance criteria, sample sizes, or ground truth establishment that would definitively "prove" the device meets specific performance metrics. The 510(k) process for this device focused on substantial equivalence to a predicate, and the provided text does not contain independent performance study results.

Therefore, for aspects 2-9, the information is largely not present in the provided 510(k) summary. I can only report what is not there:

2. Sample size used for the test set and the data provenance:

Not provided. The document does not describe a test set or its sample size.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not provided. The document does not describe the establishment of a ground truth for a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not provided. No test set or adjudication method 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 provided. The document does not mention an MRMC study or any assessment of human reader improvement with AI assistance. The focus is on the software's ability to automate tasks that could otherwise be done manually, rather than an AI-assisted workflow improvement for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not explicitly described as a formal validation study with metrics. The document states, "The software does not perform any function which cannot be accomplished by a trained user utilizing manual tracing methods; the intent of the software is to save time and automate potential error-prone manual tasks." While this implies the algorithm performs these tasks, it doesn't detail a standalone quantitative performance study with specific outcomes.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not provided. The document does not describe the use of any specific ground truth for validating the quantitative measurements. The comparison is implicitly against manual methods performed by a "trained user."

8. The sample size for the training set:

Not provided. The document does not discuss a training set, as it predates the widespread regulatory requirement for detailed AI/ML model training information.

9. How the ground truth for the training set was established:

Not provided. As no training set is mentioned, the method for establishing its ground truth is also not.

Summary of available information related to performance/validation:

Intended Use Statement: The device "provides reproducible CT values for pulmonary tissue" and can "support the physician in the diagnosis and documentation of pulmonary tissue images (e.g., abnormalities)."
Device Description: The device measures Hounsfield units (HU) to distinguish between air, water, tissue, and bone. It performs 3D segmentation, volumetric analysis, density evaluations, and low-density cluster analysis.
Functionality: "The software does not perform any function which cannot be accomplished by a trained user utilizing manual tracing methods; the intent of the software is to save time and automate potential error-prone manual tasks."
Validation Context: The 510(k) mainly focuses on demonstrating substantial equivalence to a predicate device (Siemens InSpace 4D K071513) in terms of intended use and technological characteristics, not a detailed performance study with quantitative acceptance criteria for the new device itself.

In conclusion, the provided text from the 510(k) summary, while detailing the device's intended use and functionality, does not contain the specific quantitative performance metrics, acceptance criteria, study methodologies (including sample sizes, ground truth establishment, or expert involvement), or comparative effectiveness study results that you have requested. The submission strategy relied on demonstrating substantial equivalence rather than a detailed, independent performance validation study against predefined acceptance criteria for the PW2's measurements.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for VIDA Diagnostics. The logo is in black and features the word "VIDA" in large, bold letters. Below the word "VIDA" is the word "Diagnostics" in a smaller font. There is a curved line that extends from the bottom of the "V" to the right of the "A".

NOV 1 8 2008

VIDA Pulmonary Workstation 2 (PW2)

5 510(k) Summary 510(k) Summary of Safety and Effectiveness [As required by 21 CFR 807.92(c)]

General information regarding the VIDA Diagnostics, Inc., Inc., VIDA Pulmonary Workstation 2 (PW2) is contained in the following table 1.

Table 1: General Information

Manufacturer	VIDA Diagnostics100 Oakdale Campus, Suite 225 TIClowa City, IA 52242USAFDA Establishment Registration No. Pending
Submitter's Name, Titleand Phone Contact	Jack Slovick, RA/QA, 763-639-0238 (phone)RA/QA AffairsFax: 763-434-0966VIDA Diagnostics100 Oakdale Campus,Suite 225 Technology Innovation Centerlowa City, IA 52242
Trade Name	VIDA Pulmonary Workstation 2 (PW2)
Common Name	Computed tomography x-ray system
Classification	This device has been classified by the Reproductive,Abdominal and Radiological Panel into Class II (21 CFR892.1750), Product Code 90 JAK Class 11
Date Prepared	October 13, 2008
Intended Use	The VIDA Pulmonary Workstation 2 (PW2) softwareprovides reproducible CT values for pulmonary tissue,which is essential for providing quantitative support fordiagnosis and follow up examinations. The PW2 can beused to support the physiclan in the diagnosis anddocumentation of pulmonary tissue images (e.g.,abnormalities) from CT thoracic datasets. Three-Dsegmentation and isolation of sub-compartments,volumetric analysis, density evaluations, low densitycluster analysis and reporting tools are combined with adedicated workflow. The VIDA Pulmonary Workstation 2(PW2) software package is also intended to be a real-timeinteractive evaluation in space and time for CT volume

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Image /page/1/Picture/0 description: The image shows the logo for VIDA Diagnostics. The logo is in black and white and features the word "VIDA" in large, bold letters. Below the word "VIDA" is the word "Diagnostics" in a smaller font. There is a curved line that extends from the bottom of the "V" to the right of the "A", with a dot at the end.

VIDA Pulmonary Workstation 2 (PW2)

	data sets that provides the reconstruction of two- dimensional images into a three-dimensional image format.
Identification of EquivalentDevices	Manufacturer:	Siemens Medical Solutions
	Trade name:	InSpace 4D - Software Package withExtended Functionality
	510(k) Number:	K071513
	Date Cleared:	June 26, 2007
Compliance with SpecialControls or PerformanceStandards	Special Controls: No special controls or mandatoryperformance standards for this device have beenestablished. Voluntary standards were used throughoutthe development; testing and manufacturing processes(see section 9.0 for detailed list of voluntary standards thatwere used)
Product Code	90 JAK, Class II
Regulation Number	21 CFR 892.1750
Reason for PremarketNotification	VIDA Diagnostics, Inc. intends to introduce the VIDAPulmonary Workstation 2 (PW2) into interstate commercefor commercial distribution.

1 General Safety and Effectiveness Concerns

The device labeling contains instructions for use and any necessary cautions and warnings, to provide for safe and effective use of the device. Risk management is ensured via a hazard analysis, which is used to identify potential hazards. These potential hazards are controlled via software development, verification and validation testing. To minimize electrical, mechanical, and radiation hazards, VIDA Diagnostics adheres to recognized and established industry practice and standards.

2 Substantial Equivalence

The VIDA Pulmonary Workstation 2 (PW2), addressed in this pre-market notification, is substantially equivalent to the following commercially available software package.

3 Manufacturer Product 510(k) Clearance date

Siemens InSpace 4D K071513 June 26, 2007

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Image /page/2/Picture/0 description: The image shows the logo for VIDA Diagnostics. The logo consists of the word "VIDA" in large, bold, sans-serif font, with a swoosh-like line extending from the bottom of the "A" to the right, ending in a solid circle. Below the word "VIDA" is the word "Diagnostics" in a smaller, serif font.

VIDA Pulmonary Workstation 2 (PW2)

In summary, VIDA Diagnostics is of the opinion that VIDA Pulmonary Workstation 2 (PW2) does not introduce any new potential safety risks and is substantially equivalent to and performs as well as the predicate software components and the predicate device.

3. Intended Use

4. Device Description

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Image /page/3/Picture/0 description: The image shows the logo for VIDA Diagnostics. The logo is in black and features the word "VIDA" in large, bold letters. A curved line extends from the bottom of the "V" to the right of the "A", with a dot at the end. Below the word "VIDA" is the word "Diagnostics" in a smaller font.

VIDA Pulmonary Workstation 2 (PW2)

Image /page/3/Figure/2 description: The image shows a diagram of an airway tree extraction process. On the left side of the image, the input is a CT volume with dimensions 512x512x550 voxels, a voxel size of 0.65x0.65x0.6 mm^3, a 16-bit gray-scale, and a size of 250-300 MByte. On the right side of the image, the output is a binary image of the airway tree.

Figure 1: Input/ Output

PW2 does not interface directly with any CT or data collection equipment; instead PW2 imports data files previously generated by such equipment.

The software has functions for loading, analyzing, saving datasets and will generate screen displays, computations and aggregate statistics.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a bird or a person with outstretched arms. The symbol is composed of three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 8 2008

VIDA Diagnostics, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313

Re: K083227

Trade/Device Name: VIDA Pulmonary Workstation 2 (PW2) Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: October 31, 2008 Received: November 3, 2008

Dear Mr. Job:

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.

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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" (21CFR 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/odrh/industry/support/index.html.

Sincerely yours.

forque M. 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

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Image /page/6/Picture/1 description: The image shows the logo for VIDA Diagnostics. The logo is in black and white and features the word "VIDA" in large, bold letters. Below the word "VIDA" is the word "Diagnostics" in a smaller font. There is a curved line that extends from the bottom of the "D" in VIDA to the right, ending in a small circle.

VIDA Pulmonary Workstation 2 (PW2)

4 Indications for Use Statement

The VIDA Pulmonary Workstation 2 (PW2) software provides reproducible CT values for pulmonary tissue, which is essential for providing quantitative support for diagnosis and follow up examinations. The PW2 can be used to support the physician in the diagnosis and documentation of pulmonary tissue images (e.g., abnormalities) from CT thoracic datasets. Three-D segmentation and isolation of sub-compartments, volumetric analysis, density evaluations, low density cluster analysis, and reporting tools are combined with a dedicated workflow. The VIDA Pulmonary Workstation 2 (PW2) software package is also intended to be a real-time interactive evaluation in space and time for CT volume data sets that provides the reconstruction of two-dimensional images into a three-dimensional image format.

Hills Penn

(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Device 510(k) Number

Prescription Use __ (per 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (Part 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)

Regulation Number and Section

§ 892.1750 Computed tomography x-ray system.

(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.