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510(k) Data Aggregation
(55 days)
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 is a new generation of Ceiling Suspension Radiographic System. This system is characterized by its simple and functional design. Thanks to its vertical and horizontal displacements, the suspension can cover almost all the room positions in which it is installed allowing all radiographic procedures. The system is modular and supports different configurations, such as radiographic system without radiographic table or without Wall Stand. The X-ray image receptors used in this system are digital detectors. X-ray film and Computed Radiography (CR) image receptors can be used but they rarely are these days. The device software used is the CANON CXDI which is supplied unmodified by CANON (Clearance numbers above). It has a moderate level of concern. The Radiographic System ChallengeX AP is provided with Auto-positioning, Auto-centering and Auto-tracking functions and it is composed of: Ceiling Suspension (OTC), Radiographic Table, Wall Stand, High Voltage X-ray Generator and acquisition image software. Auto-tracking allows the X-ray Tube to follow the Receptor when it changes position or the other way around while the SID remains constant. The "Auto" features were present and validated in the predicate system.
The document provided is a 510(k) premarket notification for a medical device called "Radiographic System Challenge X." This notification aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving that the device meets specific acceptance criteria in a clinical study with an AI component.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for AI-based analysis is not present in the provided text.
The document discusses non-clinical testing for compliance with international standards and FDA guidance for traditional medical device aspects such as safety, electrical compatibility, radiation protection, and software validation. It explicitly states that clinical testing was not required to establish substantial equivalence because the digital x-ray receptor panels already had previous FDA clearance.
Key takeaway from the document regarding studies:
- No AI component or AI-specific acceptance criteria are documented.
- The device is a traditional X-ray system, not an AI-powered diagnostic tool.
- Clinical testing was not performed for this submission. The substantial equivalence was established through non-clinical bench testing and compliance with existing standards and previously cleared components (like the detectors and software).
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(35 days)
ProRad Series Stationary Radiographic System is intended for use by a qualified, trained doctor or technician on both adult and paediatric 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.
The ProRad series Stationary Radiographic System is a diagnostic x-ray system intended for general purpose radiographic imaging of the human body. There are two types of configurations (2FC and 3NC) for ProRad; the difference is in the mounting of the X-ray tube. For X-ray tube mounting the configuration is either the floor mounted (2FC) or ceiling suspension (3NC) assembly.
The devices are a new combination of a previously cleared solid state digital x-ray acquisition panel and software with the diagnostic x-ray components (including Xray tube, high frequency X-ray generator, a tilting vertical bucky, X-ray table and collimator) required to make a complete system. The purchaser may select any of the digital panels and software based on the user's requirements. The other components are also available in different configurations to meet specific customer needs. The X-ray panel and imaging software have been previously cleared by the FDA, and most of the other components are used in previously cleared 510(k) devices.
Here's an analysis of the acceptance criteria and study information for the ProRad 2FC and ProRad 3NC Digital Stationary Radiographic Systems, based on the provided text:
Acceptance Criteria and Device Performance Table:
The document primarily focuses on demonstrating substantial equivalence to predicate devices rather than setting and reporting specific performance metrics with acceptance criteria in a comparative table for novel device features. The "Comparable Properties" table (pages 6-8) is used to show alignment with predicate devices.
| Acceptance Criteria Category | Specific Criteria (Implicit from Equivalence) | Reported Device Performance (as stated in the document) |
|---|---|---|
| Intended Use | Equivalent to predicate devices (K150816, K153119) for diagnostic radiographic exposures of various body parts in adults and pediatrics, excluding mammography. | "Equivalent" to predicate devices. |
| Configuration of Digital Panels | Battery or AC operated wireless IEEE 802.11n or Wired Ethernet. | "Same" as predicate devices. |
| Digital Panel Models and their Clearance Numbers | Utilize previously cleared FDA digital flat panel detectors (specific K numbers listed in Note 1). | "Similar functionality" to predicate devices (Note 1 states the subject device uses different flat panel detectors that are previously FDA cleared, and testing demonstrates no increased safety concern or effect on effectiveness). |
| Image Acquisition Panel Specifications | Comparable pixel resolution and size range (e.g., 3,320 x 3,408 Pixels 125 µm, 3,072 x 3,072 Pixels 139 µm, etc.). | "Similar functionality" to predicate devices (Note 1). |
| DICOM Compliance | DICOM 3 compliant. | "Same" as predicate devices. |
| WiFi Wireless (if applicable) | Functionality similar to predicate wireless detectors. | "Similar functionality" to predicate devices (specific Canon, Varex, PerkinElmer, and DRTECH wireless detectors listed). |
| Image Acquisition Software | Utilize previously cleared FDA image processing software (specific K numbers listed in Note 2). | "Similar functionality" to predicate devices (Note 2 states Prognosys uses previously cleared FDA software and does not modify it). |
| Power Source | AC Line, various voltages available. | "Same" as predicate devices. |
| X-ray Generator | Range of power ratings (e.g., 32 kW to 80 kW, 125 kV/150 kV). | "Same or similar functionality" to predicate devices (Note 3 states the subject device uses similar X-ray generators with different power ratings and that these generators have been used in previously cleared 510(k) devices). |
| X-ray Tubes | Range of kV, focal spot sizes, and heat units (e.g., Toshiba E7239FX, Varex RAD14, etc.). | "Similar functionality" to predicate devices (Note 4 states both configurations provide similar imaging resolution and these tubes have been used in previously cleared 510(k) devices). |
| Collimator | Adequate inherent filtration. | "Similar functionality" to predicate devices (Note 5 states the inherent filtration is different but does not affect safety and effectiveness). |
| Performance Standard Compliance | Compliance with FDA 21 CFR 1020.30-31 (Performance Standards for Diagnostic X-Ray Systems and Their Major Components). | "Same" as predicate devices. |
| Electrical Safety | Compliance with IEC 60601-1. | "Same" as predicate devices. |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2. | Device complies with this standard. |
| Radiation Protection | Compliance with IEC 60601-1-3. | Device complies with this standard. |
| Specific Safety/Performance for X-ray Equipment | Compliance with IEC 60601-2-54. | Device complies with this standard. |
| Usability | Compliance with IEC 60601-1-6. | Device complies with this standard. |
| Risk Management | Compliance with ISO 14971. | Device complies with this standard. |
| Cybersecurity | Adherence to "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices, 2014" guidance for device labeling. | Cybersecurity concerns were addressed based on the US FDA Guidance document. |
1. Sample sized used for the test set and the data provenance:
- Sample Size: Not explicitly stated as a separate "test set" for a dedicated algorithm performance study. Instead, compliance is demonstrated through testing of the integrated system and reliance on previous FDA clearances for individual components.
- Data Provenance: Not applicable in the context of an algorithm performance test set. The clinical images reviewed by a radiologist were "acquired by the device," but the origin (e.g., country, prospective/retrospective status) is not specified.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: One radiologist.
- Qualifications of Experts: Only "a radiologist" is mentioned. Specific qualifications (e.g., years of experience, board certification) are not detailed.
3. Adjudication method for the test set:
- Adjudication method: Not applicable. The radiologist's review was a single assessment, not a consensus or adjudication process among multiple readers.
4. 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:
- MRMC Study: No. The document explicitly states: "Since the digital x-ray panels and software have previously received FDA clearance, a clinical study was not required as per the FDA guidance document." The clinical image review was supplementary.
- Effect size of human reader improvement with AI: Not applicable, as no MRMC study or AI assistance evaluation was conducted. The device is an imaging system, not an AI diagnostic tool.
5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Standalone Performance Study: No. This device is a diagnostic X-ray system, which intrinsically requires a human (a qualified doctor or technician) in the loop for operation and interpretation. The performance of individual cleared components (digital panels, software) was relied upon.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Type of Ground Truth: For the supplementary review, the "ground truth" was the radiologist's assessment that the images were "acceptable and allowed the radiologist to make an accurate diagnosis." This is a form of expert opinion on image quality and diagnostic utility, rather than an objective "truth" like pathology or outcomes.
7. The sample size for the training set:
- Sample Size for Training Set: Not applicable. This document does not describe a machine learning algorithm that requires a training set. The device is a conventional X-ray system composed of cleared components.
8. How the ground truth for the training set was established:
- Ground Truth for Training Set: Not applicable, as there is no machine learning algorithm described.
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(42 days)
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.
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(77 days)
These are stationary x-ray systems intended for obtaining radiographic images of various portions of the human body in a clinical environment. The devices are not intended for mammography
This is a complete stationary diagnostic x-ray system employing digital x-ray panels coupled with image acquisition software. The key features are: Ceiling Tube Suspension, Motorized Movements, Auto-Positioning, Tube Mounted 10" Touch Screen, Elevating 6 Way Table Patient Load: 5501bs, Single User Interface, High Frequency Generator. This ergonomic design incorporates automatic motorized positioning, creating an efficient workflow increasing the patient throughput. Precision offers automatic stitching enhancing the workflow further. Tube, vertical wall stand and table have extended range of motion for easy patient positioning. The acquisition software is installed on a Windows compatible workstation. The high frequency generator is available in different power ratings. All components are either 510(k) exempt or previously cleared. Generators are available in 50, 65, 80 kW (High Frequency) models.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Arcoma AB 0180 Intuition & 0072 Precision Stationary Digital X-Ray Systems (K140683):
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly list quantitative acceptance criteria for the device's performance. Instead, it focuses on demonstrating substantial equivalence to a predicate device (Arcoma Intuition, K073632) through functional comparisons, non-clinical tests, and a qualitative clinical evaluation.
The "acceptance criteria" can be inferred from the overall claim of substantial equivalence and the scope of the testing performed, primarily that the modified device is "as safe, as effective, and performs as well as or better than the legally marketed device."
| Acceptance Criteria (Inferred from Substantial Equivalence and Testing) | Reported Device Performance (Summary) |
|---|---|
| Non-Clinical Performance: |
- Individual and system performance.
- Electrical safety and electromagnetic compatibility.
- Software integration validation.
- Risk analysis.
- Compliance with IEC safety and EMC standards. | Met. "The modified unit has undergone individual and system performance tests, electrical safety and electromagnetic compatibility testing, as well as software integration validation and risk analysis. The unit meets IEC safety and EMC standards."
Functionally identical capabilities to predicate device despite panel, generator, and tube stand modifications. Specifically, new Canon digital panels (K103591, K102012) each have their own 510(k) clearances, implying their individual performance meets regulatory standards. |
| Clinical Performance:
- Diagnostic quality of images. | Met. "Clinical images were obtained in accordance with the FDA Guidance Document on Solid State Imaging Devices. They were evaluated by professional radiologist and found to be of good diagnostic quality." |
| Overall Equivalence: - As safe and effective as predicate.
- Performs as well as or better than predicate. | Met. "The nonclinical and clinical tests that the device is as safe, as effective, and performs as well as or better than the legally marketed device identified in paragraph 3."
Technological characteristics are "essentially the same" as the predicate, with modifications to digital panels, x-ray generator, and tube stands that retain "functionally identical capabilities." New panels offer higher resolution and wired/wireless options, suggesting potential improvements without detrimental impact. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not specify a numerical sample size for the clinical images used in the clinical study. It states only that "Clinical images were obtained."
- Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: The document states that clinical images "were evaluated by professional radiologist" (singular, though likely implying multiple, it does not specify the number).
- Qualifications of Experts: The experts are described only as "professional radiologist." No further details on their experience level (e.g., "10 years of experience") are provided.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the clinical image evaluation. It simply states that the images "were evaluated by professional radiologist and found to be of good diagnostic quality."
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study described is a qualitative evaluation of image quality by radiologists, comparing the modified device's performance to an implicit standard of "good diagnostic quality" rather than a direct comparison against the predicate by multiple readers on multiple cases. Therefore, no effect size of human readers improving with AI vs. without AI assistance is applicable or reported, as this device is a traditional x-ray system, not an AI-powered diagnostic tool.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No, a standalone (algorithm only) performance study was not done. This device is a digital X-ray system, and its primary output is human-interpretable images, not an automated diagnostic algorithm.
7. The Type of Ground Truth Used
The ground truth for the clinical images seems to be based on expert consensus (or individual expert opinion) regarding "good diagnostic quality." The text does not mention pathology, outcomes data, or other objective ground truth measures for evaluating the images.
8. The Sample Size for the Training Set
This information is not applicable and not provided in the document. This device is a traditional digital X-ray system, not an AI or machine learning algorithm that requires a training set. The "software integration validation" mentioned refers to the system's operational software, not an AI model.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no training set for an AI/ML algorithm described.
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(99 days)
Sedecal "NOVA FA DR 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.
"NOVA FA DR System" refers to a full Digital Radiography system consisting of: NOVA: Automatic Ceiling Suspension NBS: Tilting Vertical Wall Stand system with CXDI Canon Detectors 401C / 401C Compact / 55C / 501C (Option 1) NET: Elevating Table with CXDI Canon Detector (same detectors as Wall Stand) (Option 2) Flexi DT: Mobile Elevating Table SEDECAL SHF Generator Series, output powers: 50 kW / 65 kW / 80 kW Toshiba Tube: maximum heat dissipation: 300 kHU / 400 kHU Ralco Collimator: Manual / Motorized
Here's a breakdown of the acceptance criteria and study information for the Sedecal "NOVA FA DR System" based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes a modification to an existing X-ray system (K090279). The acceptance criterion for this modification is implicitly to demonstrate that the modified device is as safe and effective as the predicate device, with images of at least comparable quality.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| I. Non-Clinical Performance: | |
| - Electrical Safety (IEC 60601-1) | Demonstrated compliance with electrical safety standards. |
| - Electromagnetic Compatibility (IEC 60601-1-2) | Demonstrated compliance with electromagnetic compatibility standards. |
| - Software Integration Functionality | Unmodified software packages integrated and worked properly. |
| - Risk Analysis for Modifications/Integration | Performed for modifications, system integration, elevating table, generators, mobile table, overhead tube stand, and wall stand. |
| II. Clinical Performance (Image Quality): | |
| - Image quality comparable to predicate device | Images found to be of good quality, high resolution, and clinically acceptable. |
| - Image quality for various body structures | Demonstrated good quality for images of chest, skull, abdomen, and extremities. (Implicitly comparable to predicate given "clinically acceptable") |
| - Techniques comparable to predicate device | Techniques employed were comparable to those employed by the predicate panel. |
| III. Substantial Equivalence: | |
| - As safe as predicate | Demonstrated (via non-clinical and clinical tests) as safe as the predicate. |
| - As effective as predicate | Demonstrated (via non-clinical and clinical tests) as effective as the predicate. |
| - Performs as well as or better than predicate | Demonstrated (via non-clinical and clinical tests) performs as well as or better than the predicate. |
| - Materials and construction nearly identical to predicate | Stated that materials and construction methods are nearly identical to the predicate. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: Not explicitly stated. The document mentions "various human body structures (chest, skull, abdomen, extremities)" were acquired, but no number of cases or patients is provided.
- Data Provenance: Not explicitly stated (e.g., country of origin). The study used "clinical images," implying prospective acquisition for the purpose of the study, but this is not explicitly confirmed. Given Sedecal is based in Spain, it's plausible the images were acquired there, but this is speculation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- Number of Experts: One.
- Qualifications of Experts: "Board Certified Radiologist." No specific years of experience are mentioned.
4. Adjudication Method for the Test Set:
- Adjudication Method: None explicitly mentioned. With only one radiologist, there was no need for adjudication for consensus.
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:
- No MRMC or AI comparative effectiveness study was performed or mentioned. This submission is for a modification to a digital X-ray system, not an AI-powered diagnostic tool. The focus is on the imaging system itself, not on reader performance improvement with or without AI.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This is not applicable as the device is a digital X-ray system, not an algorithm, and its performance inherently involves human operation and interpretation.
7. The Type of Ground Truth Used:
- Ground Truth Type: Expert opinion/evaluation by a Board Certified Radiologist. The "good quality, high resolution, and clinically acceptable" assessment served as the ground truth for image quality.
8. The Sample Size for the Training Set:
- Not applicable/Not mentioned. This document describes a 510(k) for a hardware modification and new detectors, not an AI/machine learning algorithm that requires a training set. The "testing" refers to verification and validation of the hardware performance, software integration, and image quality.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable/Not mentioned. As above, there is no training set for an AI algorithm.
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