(61 days)
The "Brilliance Volume" is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.
The "Brilliance Volume" is a Whole Body Computed Tomography X-Ray System featuring a continuously rotating X-ray tube and detectors gantry and multi-slice capability. The acquired x-ray transmission data is reconstructed by computer into crosssectional images of the body taken at different angles and planes. This device also includes signal analysis and display equipment, patient and equipment supports, components and accessories.
This 510(k) summary for the "Brilliance Volume" CT scanner does not contain the detailed information required to describe acceptance criteria and a study that proves the device meets those criteria, as typically found in a clinical performance study report.
The document focuses on demonstrating substantial equivalence to a predicate device based on similar technological characteristics and adherence to general safety and quality standards. There is no mention of specific performance metrics, clinical studies, or an evaluation of an AI algorithm's performance.
Therefore, I cannot provide a table of acceptance criteria and reported device performance or answer most of your specific questions. However, I can extract information relevant to your inquiry based on the provided text, highlighting what is missing.
Here's an analysis of the provided text in relation to your questions:
1. A table of acceptance criteria and the reported device performance:
This information is not present in the provided document. The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (Philips Plus K033326) by stating that "Brilliance Volume" has "similar technological characteristics and sub-assemblies." There are no reported performance metrics (e.g., sensitivity, specificity, accuracy) or explicit acceptance criteria for a new device's performance.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
This information is not present. The document does not describe any specific test set or data used to evaluate the device's performance.
3. 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):
This information is not present. Since no test set or performance evaluation is described, there's no mention of experts or ground truth establishment.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not present.
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:
This information is not present. There is no mention of an MRMC study, human readers, or AI assistance. This device is a CT scanner, not explicitly an AI-driven image analysis tool in the context of this 2006 submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not present. The document describes a CT scanner, a hardware device, not an algorithm being evaluated in a standalone capacity for diagnostic performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
This information is not present.
8. The sample size for the training set:
This information is not present.
9. How the ground truth for the training set was established:
This information is not present.
Summary of available information related to your questions (mostly noting what is absent):
| Question | Information from K060937 (2006) for "Brilliance Volume" CT Scanner |
|---|---|
| 1. Acceptance Criteria & Reported Device Performance | Not Present. The submission |
| demonstrates substantial equivalence based on similar technological characteristics to a predicate device (Philips Plus, K033326), not specific performance metrics against acceptance criteria. | |
| 2. Test Set Sample Size & Data Provenance | Not Present. No specific test set data is described. |
| 3. Number & Qualifications of Experts for Ground Truth (Test Set) | Not Present. No mention of experts or ground truth establishment for performance evaluation. |
| 4. Adjudication Method (Test Set) | Not Present. |
| 5. MRMC Comparative Effectiveness Study (AI vs. without AI assistance) | Not Applicable/Not Present. This document pre-dates widespread AI clinical validation for diagnostic imaging in this context. The device is a CT scanner. |
| 6. Standalone Algorithm Performance Study | Not Applicable/Not Present. The device is a CT scanner, not an independent algorithm, in this submission. |
| 7. Type of Ground Truth Used | Not Present. |
| 8. Training Set Sample Size | Not Present. Not relevant for a hardware 510(k) submission primarily focused on substantial equivalence to a predicate device's design and technological characteristics. |
| 9. Ground Truth Establishment for Training Set | Not Present. |
In conclusion, the K060937 submission for the "Brilliance Volume" CT scanner is a typical 510(k) summary from 2006, demonstrating substantial equivalence through technological comparison and adherence to general safety and quality standards, rather than providing a detailed clinical performance study with defined acceptance criteria and proven device performance metrics. Such in-depth clinical studies and AI algorithm evaluations, as implied by your questions, became much more common and detailed in regulatory submissions in later years, especially with the rise of AI in medical devices.
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Ko60937
JUN - 5 2006
510(k) Summary Philips Medical Systems (Cleveland) Inc. "Brilliance Volume"
This summary of this 510(k) provides safety and effectiveness information submitted in accordance with the requirements of 21 CFR 807.92.
1. Submitter
Philips Medical Systems (Cleveland), Inc. 595 Miner Road Cleveland, OH 44143 (440) 483-3000
Contact:
| Robert L. Turocy | ||
|---|---|---|
| Telephone: | 440 483 3528 | |
| FAX: | 440 483 2989 | |
| Email: | Robert.Turocy@philips.com |
Date of Summary: April 1, 2006
2. Device Name and Classification
| Device Name: | Brilliance Volume |
|---|---|
| Classification Name: | Computed Tomography X-Ray System |
The FDA has classified the Computed Tomography X-Ray System and its accessories as Class II in 21 CFR 892.1750 (Product Code 90 JAK)
Predicate Device Information 3.
In the opinion of Philips Medical Systems Inc., the "Brilliance Volume" CT scanner is of comparable type and substantially equivalent to the legally marketed devices currently in commercial distribution, namely: the Philips Plus in K033326.
4. Device Description
The "Brilliance Volume" is a Whole Body Computed Tomography X-Ray System featuring a continuously rotating X-ray tube and detectors gantry and multi-slice capability. The acquired x-ray transmission data is reconstructed by computer into crosssectional images of the body taken at different angles and planes. This device also includes signal analysis and display equipment, patient and equipment supports, components and accessories.
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5. Intended Use of the device
The "Brilliance Volume" is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.
6. Comparison to Predicate Devices
In the opinion of Philips Medical Systems (Cleveland), Inc., the "Brilliance Volume" CT scanner is of comparable type and substantially equivalent to the legally marketed devices because it has the similar technological characteristics and sub-assemblies as the current commercial distribution of Philips Plus (K033326).
The safety and effectiveness of the "Brilliance Volume" is assured by adherence to Good Manufacturing Practices (GMP) 21 CFR 820 and to International Standards ISO 13485:2003. Potential hazards are identified in a hazard analysis and controlled in the following manner:
Software safety is assured by the company procedures that conform to accepted practices. Quality assurance procedures are adhered to, and meeting the specifications and functional requirements is demonstrated via testing.
Electrical and Mechanical safety is assured by adherence to IEC 60601-1 Standards,
Radiation safety is assured by compliance with 21 CFR, Subchapter J Performance Standards.
Based on the above considerations, it is Philips's opinion that the "Brilliance Volume" CT scanner is substantially equivalent in safety and effectiveness to the predicate device: Philips Plus with 510(k) Number K033326.
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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features an abstract image of an eagle with its wings spread, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The seal is black and white, providing a clear and recognizable emblem for the department.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
JUN - 5 2006
Mr. Robert L. Turocy Regulatory & Approbation Manager Philips Medical Systems (Cleveland), Inc. Business Unit Computed Tomography 595 Miner Road CLEVELAND OH 44143
Re: K060937
Trade/Device Name: "Brilliance Volume" Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: April 1, 2006 Received: April 5, 2006
Dear Mr. Turocy:
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 (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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Image /page/2/Picture/10 description: The image shows a logo for the FDA Centennial, which is celebrating 1906-2006. The logo is circular and contains the letters FDA in the center. Below the logo, the words "Protecting and Promoting Public Health" are written in a decorative font.
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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.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html
Sincerely vours.
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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"Brilliance Volume" Device Name:
The "Brilliance Volume" is a Computed Indications for Use: Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient, and equipment supports, components and accessories.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
OR
Over-The-Counter Use
(Per 21 CFR 801.109)
(Optional Format 1-2-96)
Daniel h. Larson
(Division Sign-Off ivision of Reproductive, Abdominal and Radiological Devic 510(k) Number
§ 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.