(104 days)
The EOS is intended for use in general radiographic examinations and applications, excluding the evaluation of lung nodules and examinations involving fluoroscopy, angiography, and mammography. EOS allows the radiographic acquisition of either one or two orthogonal X-ray images for diagnostic purposes, in one single scan, of the whole body or a reduced area of investigation of a patient in the upright or seated position.
EOS is a digital radiography system in which two sets of xenon gas filled digital detectors and X-ray tubes are positioned orthogonally to generate frontal and lateral images simultaneously. The diagnostic images are stored in a database and are displayed on a high-resolution, medical-quality monitor, where the diagnosis is performed. The diagnostic image can be transmitted through a DICOM 3.0 compatible digital network for printing and archiving. This device employs the same technological characteristics as the predicate devices differing only in the specifics of subassembly component composition.
The provided text for Biospace Med's EOS (K071546) does not contain detailed information about specific acceptance criteria, a dedicated clinical study proving the device meets those criteria, or most of the requested performance data points. The submission relies primarily on a claim of substantial equivalence to predicate devices, stating that its "Performance data demonstrate that EOS is as safe and effective as common radiography systems."
Therefore, I cannot populate most of the requested fields definitively with information from the provided text. However, I can extract what is available and highlight what is missing.
Here's a breakdown based on the provided text, indicating where information is present and where it is lacking:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Not Explicitly Stated) | Reported Device Performance (Implied from the text) |
|---|---|
| Safe and Effective (Implied from predicate comparison) | "EOS is as safe and effective as conventional radiography systems." |
| Compliance with general radiographic examinations | "The EOS is intended for use in general radiographic examinations and applications..." |
| Ability to acquire one or two orthogonal X-ray images in a single scan | "EOS allows the radiographic acquisition of either one or two orthogonal X-ray images for diagnostic purposes, in one single scan..." |
| Non-inferiority to predicate devices in diagnostic accuracy (Implied) | "Additional testing confirmed the equivalent performance of the EOS as compared to the claimed predicate devices." |
| Compliance with IEC 60601-1 and collateral standards | "EOS is designed to comply with IEC 60601-1 and collateral standards." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- The text does not provide information on the sample size used for any test set or the data provenance. It generally refers to "performance data" and "additional testing" without specifics.
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)
- The text does not provide information on the number or qualifications of experts used for establishing ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- The text does not provide information on any adjudication method.
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
- The provided text does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. The device is described as a "Digital Radiography System," not an AI-assisted diagnostic tool in the sense of providing algorithmic interpretations for human readers to review.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The text describes the EOS as a "Digital Radiography System" that generates images for diagnostic purposes to be "displayed on a high-resolution, medical-quality monitor, where the diagnosis is performed." This implies human interpretation. The text does not indicate that any standalone algorithmic performance (without human-in-the-loop) was evaluated, nor does it present the device as having such a standalone diagnostic function.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The text does not specify the type of ground truth used for any performance evaluation. It broadly mentions "performance data" that demonstrated equivalence.
8. The sample size for the training set
- The text does not provide information on any training set sample size. The submission focuses on the system's design and equivalence to predicate devices, rather than a machine learning model's training.
9. How the ground truth for the training set was established
- The text does not provide information on how ground truth was established for any training set.
Summary of what's provided related to "study" and "acceptance":
The submission for K071546 does not detail a specific clinical study with explicit acceptance criteria and corresponding numerical performance metrics for the EOS device. Instead, it relies on a substantial equivalence claim. The core argument is that:
- The EOS has the "same intended use and similar indications, technological characteristics, and principles of operation as its predicate devices."
- "The minor technological differences between EOS and its predicate devices raise no new issues of safety or effectiveness."
- "Additional testing confirmed the equivalent performance of the EOS as compared to the claimed predicate devices."
- "Performance data demonstrate that EOS is as safe and effective as common radiography systems."
- "EOS is designed to comply with IEC 60601-1 and collateral standards."
This regulatory strategy indicates that the acceptance criteria are implicitly tied to demonstrating that the EOS performs equivalently to already legally marketed and established radiography systems, thereby being "as safe and effective." The "study" in this context is likely a series of technical and comparative evaluations (referred to as "additional testing" and "performance data") rather than a formal, prospective clinical trial designed to prove specific numerical efficacy metrics against a pre-defined ground truth in a clinical population. The absence of details on patient numbers, expert reads, ground truth, or statistical methods suggests a non-clinical performance evaluation focused on demonstrating technological equivalence to predicates.
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510(k) SUMMARY
Biospace Med's EOS
SEP 1 8 2007
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
Biospace Med 10 rue Mercoeur Paris F-75011 France
Phone: +33 1 55 25 60 60 Facsimile: +33 1 55 25 60 61
Contact Person:Karine Chevrie
Date Prepared: June 5, 2007
Trade Name: EOS
Common or Usual Name: Digital Radiography System
Classification Name: Radiology
Predicate Devices
- The Lodox Digital Radiography System (K013999) .
- . Toshiba's Auklet CT scanner TSX-003-A (K973908)
- GE Televix 1600 (K790692) with AGFA Cornex 5 film .
- Philips Bucky Diagnost System (K945278) with AGFA Curix-Ortho HT-G film .
- CGR Prestilix (K843926) + Kodak DirectView CR 900 System (K020635) .
- Siemens DR Thorax/Multix FD (K983732) ◆
Intended Use / Indications for Use
The EOS is intended for use in general radiographic examinations and applications, excluding the evaluation of lung nodules and examinations involving fluoroscopy, angiography, and mammography. EOS allows the radiographic acquisition of either one or two orthogonal X-ray images for diagnostic purposes, in one single scan, of the whole body or a reduced area of investigation of a patient in the upright or seated position.
Technological Characteristics
EOS is a digital radiography system in which two sets of xenon gas filled digital detectors and X-ray tubes are positioned orthogonally to generate frontal and lateral images simultaneously. The diagnostic images are stored in a database and are displayed on a high-resolution, medical-quality monitor, where the diagnosis is performed. The diagnostic image can be transmitted through a DICOM 3.0 compatible digital network for printing and archiving. This device employs the same technological characteristics as the predicate devices differing only in the specifics of subassembly component composition.
Performance Data
EOS is designed to comply with IEC 60601-1 and collateral standards.
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Additional testing confirmed the equivalent performance of the EOS as compared to the claimed predicate devices.
Substantial Equivalence
EOS is as safe and effective as conventional radiography systems. EOS has the same intended use and similar indications, technological characteristics, and principles of operation as its predicate devices. The minor technological differences between EOS and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that EOS is as safe and effective as common radiography systems. Thus, EOS is substantially equivalent.
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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
Biospace Med % Mr. John J. Smith Regulatory Counsel Hogan & Hartson L.L.P. 555 Thirteenth Street, NW WASHINGTON DC 20004
AUG 2 0 2013
Re: K071546
Trade/Device Name: EOS Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR and MOB Dated: August 9, 2007 Received: August 10, 2007
Dear Mr. Smith:
This letter corrects our substantially equivalent letter of September 18, 2007.
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 nredicate 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,
Janine M. Morris
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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Indications for Use Statement
KO71546 510(k) Number (if known):_
Device Name: EOS
The EOS is intended for use in general radiographic examinations and applications, excluding the evaluation of lung nodules and examinations involving fluoroscopy, angiography, and mammography, EOS allows the radiographic acquisition of either one or two orthogonal X-ray images for diagnostic purposes, in one single scan, of the whole body or a reduced area of investigation of a patient in the upright or seated position.
Prescription Use __ X AND/OR (Part 21 C.F.R. 801 Subpart D)
Over-The-Counter Use (21 C.F.R. 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
CDRH, Office of Device Evaluation (ODE)
Concurrence of
Hubert Leinen
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
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§ 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.