The Legs Option uses a series of images of the skeletal leg anatomy generated with a digital fluoroscopic X-ray system and reconstructs these images as a single composite image of the complete skeletal anatomy of the lower limbs.

AI/ML Overview

Here's an analysis of the provided text regarding the Philips Easy Vision Family Workstation Legs Option, focusing on the acceptance criteria and study details.

Important Note: The provided text is a 510(k) summary and FDA clearance letter from 1999. These documents typically focus on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance studies with acceptance criteria in the way a modern AI/ML device submission would. Therefore, much of the requested information, particularly regarding specific performance metrics, sample sizes for training/test sets, ground truth establishment, and MRMC studies, is not explicitly present in this type of submission from that era.

Acceptance Criteria and Device Performance

The provided document does not explicitly state quantitative acceptance criteria or detailed device performance metrics in a tabular format as would be expected for a modern AI/ML device. The "performance" described is largely functional and qualitative, focusing on the features and capabilities of the device in relation to its intended use and comparison to a predicate device.

Table 1: Acceptance Criteria and Reported Device Performance (Inferred)

Feature/Criterion (Inferred)	Acceptance Criteria (Not Explicitly Stated)	Reported Device Performance (From Document)
Functionality	Device enables visualization, registration, and measurement of lower-limb skeletal geometry.	"enables visualization, (digital) registration, and measurement of the lower limb skeletal geometry."
Lower Limb Discrepancy	Supports diagnosis of leg length discrepancies when both legs are acquired in the same image.	"Diagnosis of leg length discrepancies (when both legs are acquired in the same image)... are supported through the measurement tools provided."
Length & Angle Info	Supports length and angle information on anatomical and mechanical axis.	"...as well as length and angle information on anatomical and mechanical axis are supported..."
Safety	No new hazards introduced compared to the predicate device.	"No new hazards are introduced by the addition of the Legs Option to the Easy Vision Workstation."
Substantial Equivalence	Device is substantially equivalent to predicate device.	"We have determined the device is substantially equivalent... to legally marketed predicate devices."

Additional Study Details

Given the nature of a 1999 510(k) for a workstation option, the depth of study information for AI/ML performance is not available.

Sample Size used for the test set and the data provenance:
- Not explicitly stated. The document is a 510(k) summary, not a detailed clinical study report. It implies functional testing and comparison to predicate device capabilities but does not specify a "test set" of images or patients for performance evaluation in the way a modern AI/ML submission would. Data provenance is not mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not stated. This submission pre-dates the common methodologies for establishing ground truth for AI/ML performance. The "truth" would have likely been clinical observations by radiologists using the system or comparison of measurements against established methods.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not stated. Adjudication methods for ground truth in AI/ML performance studies were not common practice for this type of device submission in 1999.
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. An MRMC study is not mentioned or implied. This device is an "option" for a workstation, providing tools for visualization and measurement, not an AI-assisted diagnostic algorithm in the modern sense. The focus is on the availability of these tools, not on how they improve human reader performance through AI integration.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No, not in the AI/ML sense. The device is a "Workstation Legs Option," implying human interaction and control. It supports visualization, registration, and measurement, which are functionalities the user performs or guides, not fully automated, standalone algorithmic decisions.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not explicitly stated for a "test set." For evaluating the functionality of a measurement tool, the ground truth would typically be derived from established clinical measurement techniques or phantoms, with human expertise (e.g., orthopedic surgeons or radiologists) making the measurements or assessments. It's unlikely that pathology or outcomes data would be directly used for validating the measurement accuracy of this type of image processing tool.
The sample size for the training set:
- Not applicable/Not stated. This is not an AI/ML algorithm that undergoes a "training" phase with a large dataset. The "development" would have involved programming and engineering to implement the image reconstruction, registration, and measurement functionalities.
How the ground truth for the training set was established:
- Not applicable/Not stated. As it's not an AI/ML device in the modern context, there wouldn't be a "training set" with ground truth in that specific manner. The "ground truth" for development would be the accurate mathematical and anatomical principles underlying the image processing and measurement algorithms.

Summary

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MAY 1 2 1999

Image /page/0/Picture/1 description: The image shows a logo for Philips. The logo is a shield shape with the word "PHILIPS" at the top. Below the word is a circle with two stars and three horizontal wavy lines inside. The logo is black and white.

510 (k) Summary

Philips Medical Systems

K990455

Company Name:	Philips Medical Systems North America Company
Address:	710 Bridgeport AvenueShelton, CT 06484
Contact Person	Peter Altman
Telephone Number:	203-926-7031
Prepared (date):	February 11, 1999
Device Name:	Philips Easy Vision Family Workstation Legs Option
Classification Name:	Image Processing System (90 LLZ)
Common/Usual Name	Workstation
Predicate Device	Philips Easyvision Workstation, Spine Option

System Description:

Intended Use:

The Easy Vision Legs option enables visualization, (digital) registration, and measurement of the lower limb skeletal geometry. Diagnosis of leg length discrepancies (when both legs are acquired in the same image), as well as length and angle information on anatomical and mechanical axis are supported through the measurement tools provided.

Safety Information:

No new hazards are introduced by the addition of the Legs Option to the Easy Vision Workstation.

Philips Medical Systems North America Company 710 Bridgeport Avenue P.O. Box 860 Shelton, Connecticut 06484-0917 Tel: (203) 926-7674 Fax: (203) 929-6099

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 1 2 1999

Frank Gianelli Senior Regulatory Affairs Specialist Philips Medical Systems North America Company 710 Bridgeport Avenue P.O. Box 860 Shelton, Connecticut 06484-0917

Re:

K990455 Philips Easy Vision Family Workstation Option: Legs Option Dated: February 11, 1999 Received: February 12, 1999 Regulatory Class: II 21 CFR 892.2050/Procode: 90 LLZ

Dear Mr. Gianelli:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 III (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

CAPT David C. Scholl, M.D.

CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

Image /page/1/Picture/15 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's seal, which includes an abstract caduceus symbol with three lines representing the branches of government. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the seal.

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K99045 510(K) Number (if known): ___________________________________________________________________________________________________________________________________________________

Device Name:

Philips EasyVision Legs Option

Indications for Use:

The Easy Vision Legs option is intended for visualization, registration, and measurement of the lower-limb skeletal geometry.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

David A. Segerson
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT and Radiological D 510(k) Number

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

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).