Search Results
Found 1 results
510(k) Data Aggregation
(42 days)
Jumong Series
The Jumong Series Stationary Radiographic System is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest. abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Not for mammography.
This device represents a new combination of an already cleared solid state digital x-ray acquisition panel with software and diagnostic x-ray compnents required to make a complete system. Film cassettes may be employed in place of the digital panel. The purchaser can select from one of four configurations. The x-ray generator is a CPI CMP 200DR. The x-ray tubes are supplied by Varian (RAD-14), and the collimator is the Ralco R225 ACS DHHS. The system complies with the CDRH Radiological Health performance standard in the Code of Federal Regulations, as well as the voluntary IEC standards IEC 60601-1 and IEC 60601-1-2. All major components are either UL or CSA listed.
The provided text is a 510(k) summary for the "Jumong Series Stationary Radiographic System." It primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing specific acceptance criteria and performance data from a standalone study. Therefore, much of the requested information cannot be extracted directly from this document.
Here's what can be gathered:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state quantitative acceptance criteria for image quality or clinical performance that the device was tested against. Instead, it relies on demonstrating that the device meets general safety and performance standards, and that its components (like digital panels) are previously cleared. The "performance" assessment is framed as "bench, safety test, and software validation documentation indicates that the new device is as safe and effective as the predicate device" and that the device "conforms to US Performance Standards" and various IEC/NEMA voluntary standards.
| Characteristic | Acceptance Criteria (Not explicitly stated as quantitative targets) | Reported Device Performance |
|---|---|---|
| Overall Performance | Safe and effective as the predicate device. Conforms to US Performance Standards and listed voluntary international standards. | "Results of a review of bench, safety test, and software validation documentation indicates that the new device is as safe and effective as the predicate device. The device conforms to US Performance Standards..." and lists compliance with standards like IEC 60601-1 (Safety of Electrical Medical Equipment), IEC 60601-1-2 (Electromagnetic Compatibility), IEC 60601-1-3 (Radiation protection), IEC 60601-1-6 (Usability), IEC 60601-2-28 (X-ray tube assemblies), IEC 60601-2-54 (X-ray equipment for radiography), IEC 62366 (Usability engineering), and NEMA PS 3.1 - 3.18 (DICOM). |
| Image Quality | Not explicitly defined with quantitative metrics, but inferred to be comparable to cleared digital panels. | Clinical images were provided; these images were not necessary to establish substantial equivalence but "provide further evidence in addition to the laboratory performance data to show that the complete system works as intended." The digital panels used are previously 510(k) cleared. |
| Intended Use | Identical to the predicate device. | The Jumong Series has "identical indications for use" as the predicate device. |
2. Sample Size Used for the Test Set and the Data Provenance:
The document mentions that "Clinical images were provided," but does not specify the sample size, data provenance (e.g., country of origin), or whether they were retrospective or prospective. It explicitly states these images "were not necessary to establish substantial equivalence."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
This information is not provided in the document. The phrase "clinical images were provided" suggests some form of evaluation but no details on expert involvement or ground truth establishment for a test set.
4. Adjudication Method:
This information is not provided in the document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study is mentioned in the document. The submission focuses on substantial equivalence based on technical characteristics and safety/performance standards, rather than a clinical trial comparing human reader performance.
6. Standalone Performance Study:
The document implies that images were used to show the "complete system works as intended," suggesting some form of standalone evaluation. However, it does not describe a formal standalone performance study with specific metrics, acceptance criteria, or a detailed methodology. The "non-clinical testing" section primarily covers integration, bench, safety, and software validation.
7. Type of Ground Truth Used:
The document does not explicitly state the type of ground truth used for any clinical image evaluation, given that the clinical images were "not necessary to establish substantial equivalence."
8. Sample Size for the Training Set:
This information is not applicable as the document describes a device (X-ray system), not an AI algorithm that would typically require a training set.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable as the document describes a device (X-ray system), not an AI algorithm.
Ask a specific question about this device
Page 1 of 1