fulAccess is a standalone software product that provides basic image processing and communication functionality for use in radiology, oncology, and other clinical specialties. With fulAccess the user can review images from different modalities including CT, MR, and PET, perform basic functions including zoom, pan, measure, sample pixel intensity, and make annotations. Users may also create and save a set of files that include a copy of the data being viewed, any annotations, and an instance of the viewer executable. These files can be stored locally or on portable media (e.g. CD and DVD).

fulAccess is a stand-alone software package that assists users in the display, analysis, comparison and communication of medical imaging data from various sources. It allows the display, analysis, annotation, and communication of medical images. The intended users of fulAccess are trained medical professionals including physicians, nurses, physicists and other medical technologists. fulAccess is not intended for use in mammography.

Device Description

fulAccess is a Windows application and will be used on recommended hardware that is provided by the company or the end user.

AI/ML Overview

The provided text describes the regulatory clearance of "fulAccess," a medical imaging software. However, it does not contain information about specific acceptance criteria, a detailed study proving device performance against those criteria, or the methodology (like sample sizes, expert qualifications, or ground truth establishment) typically associated with such studies.

The document focuses on:

Device Description: What fulAccess is and what it does (image processing, viewing, annotation, communication for CT, MR, PET data).
Intended Use: For trained medical professionals in various specialties, not for mammography.
Predicate Devices: Comparison to K071964 (MIM 4.1) and K081076 (Velocity AI) to establish substantial equivalence.
Verification and Validation: A general statement about internal testing.

Here's a breakdown of what is and is not in the provided text:

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

Acceptance Criteria: Not explicitly stated. The document mentions "functional specifications and performance requirements" but doesn't elaborate on specific metrics or thresholds.
Reported Device Performance: No quantitative performance metrics (e.g., accuracy, sensitivity, specificity, processing speed) are provided. The document generally states that "All verification tests were passed and no anomalies remained."

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

Sample Size (Test Set): Not specified. The validation testing used "a variety of data types and combinations" but no numbers are given.
Data Provenance: Not specified. It's unclear if the data was retrospective or prospective, or its country of origin.

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

Experts: "Validation testing was performed by a board certified clinician." Only one such clinician is mentioned for validation.
Qualifications: "board certified clinician." No specific specialty (e.g., radiologist, oncologist) or years of experience are detailed.

4. Adjudication method for the test set

Adjudication Method: Not applicable or not described, as only one clinician is mentioned for validation. There is no mention of consensus or multi-reader review for ground truth.

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

MRMC Study: No. This document describes a software for viewing and basic manipulation, not an AI-powered diagnostic aid that would typically undergo an MRMC study to compare reader performance with and without AI.
Effect Size: Not applicable.

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

Standalone Performance: The described "validation testing" by a single clinician could be considered a form of standalone testing in the sense that the software was evaluated on its own without comparing it to other tools or a specific human-in-the-loop scenario. However, it's not "algorithm only" in the sense of an AI model's performance on its own. The device is software for user interaction.

7. The type of ground truth used

Ground Truth Type: For validation, the "board certified clinician" judged the data types as "representative of the types of data the device will encounter in clinical use." This implies a clinical expert's judgment of the data's suitability and the device's functionality, rather than a specific "ground truth" derived from pathology, outcomes, or a detailed consensus on findings.

8. The sample size for the training set

Training Set Sample Size: Not applicable. This device is described as "Medical Imaging Software" for processing and communication, not an AI/ML device that requires a training set.

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

Training Set Ground Truth: Not applicable, as there's no mention of a training set for an AI/ML model.

In summary: The provided 510(k) summary for fulAccess focuses on establishing substantial equivalence to predicate devices based on intended use, features, and general claims of software verification and validation. It does not present the type of detailed performance study data, acceptance criteria, or ground truth methodology that would be expected for an AI-powered diagnostic device or a quantitative performance claim. The "study" mentioned is internal verification and validation testing, not a formal clinical efficacy study with specific endpoints and statistical measures.

Summary

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K101707

Section 5 510(k) Summary or 510(k) Statement

Premarket Notification [510(k)] Summary OCT 2 9 2010

(Provided in conformance with 21 CFR 807.92)

Submitter: 1.

Company Name and Address: Fulcrum Medical, Inc 17209 Chesterfield Airport Rd. Chesterfield, MO 63005

Ryan S. Brame, Ph.D. Contact Person: President Contact Title: 800-515-9132 Contact Phone: 888-788-5946 Contact Fax:

Date of Summary:

May 28, 2010

Device Name and Classification: 2.

Trade Name:	fulAccess
Common and Usual Name:	Medical Imaging Software
Classification Name:	Image Processing System, Radiology(21 CFR 892.2050)
Regulatory Class:	Class II
Product Code:	LLZ

Predicate Device(s): 3.

K071964	MIM 4.1	MIMVista Corporation
K081076	Velocity AI	Velocity Medical Solutions, LLC

Description of Device: 4.

fulAccess is a standalone software product that provides basic image runcessor is a communication functionality for use in radiology, oncology, processing and solecialties. With fulAccess the user can review images and other entired on only ing CT, MR, and PET, perform basic functions including zoom, pan, measure, sample pixel intensity, and make annotations. meraamig 200m, passe and save a set of files that include a copy of the data being viewed, any annotations, and an instance of the viewer executable. being viewed, any annellatorally or on portable media (e.g. CD and DVD).

fulAccess is a Windows application and will be used on recommended hardware that is provided by the company or the end user.

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fulcrummedical

5. Indication for Use:

Comparison with Predicate Devices: 6.

fulAccess is substantially equivalent to the identified predicate devices. The fulAccess product is similar in characteristics, materials, and features, and has similar technological features, intended use and indications for use as the predicates, and does not pose any new issues of safety and effectiveness.

A detailed comparison can be found in Section 12 of this submittal.

Non-Clinical Performance Summary 7.

Fulcrum Medical has verified and validated that the fulAccess software meets its functional specifications and performance requirements. Verification testing was accomplished using a combination of unit, system and integration tests. Verification testing was organized with reference to discrete units of software functionality (e.g., DICOM import, image control, structure control, data export/saving, etc.) and the results of hazard analyses. All verification tests were passed and no anomalies remained at the conclusion of testing. Validation testing was performed by a board certified clinician who organized the testing according to the intended clinical use (i.e. importing data, viewing data, manipulating data, saving data, etc.). Validation testing was performed in a simulated clinical environment using a variety of data types and combinations that were judged by the clinician to be representative of the types of data the device will encounter in clinical use. All validation tests were passed and no anomalies remained at the conclusion of testing.

8. Conclusions

In summary, Fulcrum Medical, Inc. is of the opinion that fulAccess does not introduce any new potential safety risks, is as effective, and performs as well mat devices currently on the market, and thus concludes that the fulAccess software is substantially equivalent to the predicate devices.

K101767 7. 2 of 2

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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

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

Mr. Scott Brame President Fulcrum Medical, Inc 17209 Chesterfield Airport Rd. CHESTERFIELD MO 63005

UCI 2 9 20:0

Re: K101707

Trade Name: fulAccess Regulation Number: 21 CFR § 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: September 21, 2010 Received: October 1, 2010

Dear Mr. Brame:

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 additional controls. Existing major 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 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 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 requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). 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 Division of Small Manufacturers, 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,

David G. Brown, Ph.D. Acting 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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Section 4

Indications for Use Statement

510(k) Number (if known) K101707

Device Name: fulAccess

fulAccess is a Windows application and will be used on recommended hardware that is provided by the company or the end user.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use	X
(Per 21 CFR 801.109)

Over-The-Counter Use
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(Division Sign-Off)

Division of Radiological Devices

Office of In Vitro Diagnostic Device Evaluation and Safety

§10K	K101707
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K101707

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OCT 2 9 2010

KI 01707

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).