The Philips BuckyVision is intended for use in general radiographic examinations and applications wherever conventional screen-film systems may be used (excluding fluoroscopy, angiography, and mammography).

Device Description

The Philips BuckyVision System uses the new x-ray imaging technology ( Solid State X-ray Imager, SSXI ), that converts x-rays directly into electrical signals which can, after appropriate processing, be displayed on a crt-monitor for medical diagnosis or printed out on laser-imager. The basis of the system is a standard Philips bucky Diagnost System with additional TRIXELL PIXIUM-4600 SSXI connected to a Philips Thoravision-like workstation for worklist-managment, image-processing, image-exporting, and printing. The complete system includes additional subsystems and components, like X-raytube(s), X-ray-generator, collimator, and optionally, a wall bucky with SSXI.

AI/ML Overview

Here's an analysis of the acceptance criteria and study detailed in the provided documents:

Acceptance Criteria and Device Performance

The provided document does not explicitly state quantitative acceptance criteria or a specific study proving the device meets those criteria. Instead, it focuses on demonstrating substantial equivalence to predicate devices. The implicit "acceptance criterion" for this 510(k) submission is that the Philips BuckyVision system is functionally and technologically similar enough to its predicate devices to be considered safe and effective for its intended use.

Table 1: Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implicit from Substantial Equivalence Claim)	Reported Device Performance (Implicit from Substantial Equivalence Claim)
Safe and effective for general radiographic examinations and applications.	"The Philips Bucky Vision system complies to the same or equivalent standards and has the same intended use as the predicate device."
Functionally comparable to conventional screen-film systems in general radiography (excluding fluoroscopy, angiography, and mammography).	"The Philips BuckyVision is intended for use in general radiographic examinations and applications wherever conventional screen-film systems may be used (excluding fluoroscopy, angiography, and mammography)."
Technologically equivalent to predicate digital radiography systems.	Based on "Substantial Equivalence Information" linking to K945287 (Philips Bucky Diagnost/Screen Film System), K973206 (Sterling Diagnostic Imaging Direct Radiography™ device), and K931071 (Philips Thoravision). The core technology is the Solid State X-ray Imager (SSXI) which converts x-rays directly into electrical signals for digital display/printing, which is compared to existing digital radiography systems.

Study Information (Based on the Provided Text)

Based on the provided text, there is no detailed description of a clinical study or performance study with specific data, sample sizes, or expert evaluations. The 510(k) submission primarily relies on demonstrating substantial equivalence to predicate devices, rather than presenting a de novo performance study with quantitative results.

Here's what can be inferred or confirmed as not present in the document:

Sample sizes used for the test set and the data provenance: Not provided.
The document does not describe a distinct "test set" in the context of a dedicated performance study with patient data. The basis of equivalence is technical and intended use comparison.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided.
There is no mention of a ground truth establishment process or expert involvement beyond the FDA's regulatory review process itself.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not provided.
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/Not done.
This device (Philips BuckyVision, cleared in 1998) is a direct digital radiography system, not an AI-powered diagnostic aid or an algorithm designed to assist human readers. Therefore, an MRMC study comparing human readers with and without AI assistance would not be relevant to this product.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable/Not done.
Similar to point 5, this is a hardware and software system for image acquisition and display, not a standalone diagnostic algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not provided.
As there's no described performance study, no ground truth method is mentioned.
The sample size for the training set: Not applicable/Not provided.
This is not an AI/machine learning device, so the concept of a "training set" for an algorithm is not relevant.
How the ground truth for the training set was established: Not applicable/Not provided.
As above, this is not an AI/machine learning device.

Summary of the FDA 510(k) process for this device:

The provided text is a 510(k) summary and the FDA's clearance letter. For devices like the Philips BuckyVision, which were cleared in the late 1990s as substantial equivalence to predicate devices, it was common for the submission to focus on technical specifications, intended use, and comparison to existing legally marketed devices rather than extensive clinical efficacy trials or sophisticated performance studies like those required for novel AI-powered devices today. The "proof" of meeting acceptance criteria (i.e., being safe and effective) for such a submission was largely based on the demonstration that it was fundamentally similar to previously cleared devices.

Summary

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NOV 24 1998

Image /page/0/Picture/1 description: The image shows the Philips logo and brand name. The logo is a shield-like shape with a circle inside, containing wavy lines and stars. Next to the logo, the word "PHILIPS" is written in bold, sans-serif font. Below the brand name, there is a handwritten alphanumeric code "K982795".

Philips Medical Systems

510(k) Summary of Safety and Effectiveness

Company Name:	Philips Medical Systems North America Company
Address:	710 Bridegeport AvenueShelton, CT 06484
Contact Person:	Peter Altman
Telephone Number:	203-926-7031
Prepared (date):	June 15, 1998
Device Name:	Philips BuckyVision
Classification Name:	Stationary Diagnostic X-ray System using Digital SolidState X-ray Imaging Detector
Common/Usual Name:	General Purpose X-ray System
Predicate Device:	Philips bucky Diagnost / Screen Film System

Philips Medical Systems
710 Bridgestics Archives of Company
Pro Bridges Bronners Arcompany
Pro Box Bell Bromers Court 06484-0917
Fax: (203) 929-6099

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System Description:

The basis of the system is a standard Philips bucky Diagnost System with additional TRIXELL PIXIUM-4600 SSXI connected to a Philips Thoravision-like workstation for worklist-managment, image-processing, image-exporting, and printing. The complete system includes additional subsystems and components, like X-raytube(s), X-ray-generator, collimator, and optionally, a wall bucky with SSXI.

Intended Use:

Substantial Equivalence Information:

The Philips Bucky Vision is of comparable type and substantially equivalent to:

the Philips bucky Diagnost Systemwith Radiographic Screen Film Systems,	510(k) Number :	K945287.
the Sterling Diagnostic Imaging Direct Radiography™ device:	510(k) Number :	K973206
and the Philips Thoravision	510(k) Number :	K931071.

Therefore the Philips Bucky Vision system complies to the same or equivalent standards and has the same intended use as the predicate device.

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Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure, with three overlapping profiles suggesting a sense of community and support. The profiles are rendered in a simple, flowing line style. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" is arranged in a circular pattern around the central figure, indicating the department's name and national affiliation.

NOV 2 4 1998

Peter Altman Director of Regulatory Affairs Philips Medical Systems 710 Bridgeport Avenue P. O. Box 860 Shelton, Connecticut 06484-0917 Re:

Food and Drug Administration 9200 Corporate Boulevard K982795 K982795
Philips Bucky Vision Family Comprising: bucky Diagnost TH (+SSXI) with bucky Diagnost CS2: bucky Diagnost TH (+SSXI) with bucky Diagnost CS4: bucky Diagnost VT (+SSXI) with bucky Diagnost CS2: and bucky Diagnost VT (+SSXI) with bucky Diagnost CS4. Dated: November 12, 1998 Received: November 13, 1998 Regulatory class: II 21 CFR 892.1680/Procode: 90 MOB 21 CFR 892,1680/Prodode: 90 KPR

Dear Mr. Altman:

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 to devices marketed in interstate commerce prior to May 28, 1976, the enacument 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). You may, therefore, market the device, subject to the general controls provisions of 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 (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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory 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) 594-4591 for Radiology devices, or 594-4613 for Ear. Nose and Throat devices. 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 at (301) 443-6597.

Sincerely yours.

William Yin
Lillian Yin, Ph.D.

Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ Unknown

Philips BuckyVision Device Name :

Indications For Use :

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K982795/51

Prescription Use
( Per 21 CFR 801.109
OR
Over-The-Counter Use __

(Optional Format 1-1

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.