Search Results

The AeroDR SYSTEM 2 is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen system in general-purpse diagnostic procedures.

The AeroDR SYSTEM 2 is not in mammography. fluoroscopy, tomography and angiography applications.

The AeroDR SYSTEM 2 including AeroDR P-51 and AeroDR P-52 is intended for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in general-purpose diagnostic procedures. The AeroDR SYSTEM 2 is not indicated for use in mammography, fluoroscopy, tomography and angiography applications.

The AeroDR P-51 and AeroDR P-52 (hereinafter AeroDR detector) are lightweight, mobile FPD those are that is compatible with the size of ISO standard.

The AeroDR SYSTEM 2 performs X-ray imaging of the human body using an X-ray planar detector (FPD) that outputs a digital signal, which is then input into an image processing device, and the acquired image is then transmitted to a filing system, printer, and image display device as diagnostic image data. The image processing device displays the image on the screen after applying image processing to the raw data of image provided by FPD. The AeroDR detector can communicate with the image processing device through the wired Ethernet and/or the Wireless LAN (IEEE802.11a/n and FCC compliant). The WPA2-PSK (AES) encryption is adopted for a security of wireless connection.

The operator console software, Console CS-7, is a software program for installation on a PC. It performs image processing of X-ray images received from an AeroDR FPDs. The modified post processing function named 'Intelligent Grid' (IG Processing) is introduced as a part of the Image post processing function of console CS-7 software. The IG processing are fundamentally the same as those functions of other post processing of the Image Processing module of Console CS-7. The IG Processing is NOT a function for substitution of Grid's effects. It's a post processing of image adjustment to reduce the effects of scatter radiation. The user can adjusts to improve contrast by reducing effects of scatter radiation, and then the user MUST confirm the effects of the processing prior to determining the final images as well.

The provided text does not contain detailed information regarding the acceptance criteria of device performance and the study that proves the device meets those criteria for the AeroDR System 2.

The document is a 510(k) premarket notification, which primarily focuses on demonstrating substantial equivalence to a predicate device rather than a comprehensive performance study with specific acceptance criteria.

Here's what can be extracted based on the request and the provided text:

• No detailed acceptance criteria or reported device performance for specific metrics are provided. The document states that the image performance specification of the proposed device (AeroDR P-52) is the same as the AeroDR P-12 (a component of the predicate AeroDR SYSTEM 2, K141271, and originally cleared as K102349).
• Non-clinical tests were conducted where "qualified persons have affirmed and have concluded that both nonclinical images of proposed AeroDR P-52 and predicate AeroDR P-12 are equivalent and have sufficient capabilities for the intended purpose of the device." However, no specific metrics or quantitative acceptance criteria for image quality are given.
• Risk analysis was performed for the modifications (addition of AeroDR P-52 and modification of 'Intelligent Grid' function), and the conclusion was that these changes "don't pose any significant risk to device safety or effectiveness." It also states that "All of the verification activities, as required by the risk analysis, for the modification to AeroDR SYSTEM 2 were performed and the results demonstrated that the predetermined acceptance criteria were met." However, these acceptance criteria are not detailed in the document.

Therefore, most of the specific information requested cannot be provided from this document.

Missing Information:

1. A table of acceptance criteria and the reported device performance.
2. Sample size used for the test set and the data provenance.
3. Number of experts used to establish the ground truth for the test set and qualifications.
4. Adjudication method for the test set.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, and its effect size.
6. If a standalone (algorithm only without human-in-the-loop performance) was done.
7. The type of ground truth used.
8. The sample size for the training set.
9. How the ground truth for the training set was established.

The document explicitly states: "The clinical studies as a performance testing are not required to support substantial equivalence for the proposed device." This further indicates that a comprehensive, independent study with detailed acceptance criteria and performance metrics (as typically looked for in an AI/ML context for diagnostic accuracy) was not conducted or reported in this 510(k) summary. The demonstration was largely based on the equivalence of technological characteristics and non-clinical image evaluations.

Ask a specific question about this device

The AeroDR SYSTEM 2 is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen system in general-purpse diagnostic procedures.

The AeroDR SYSTEM 2 is not in mammography. fluoroscopy, tomography and angiography applications.

The AeroDR SYSTEM 2 is a digital imaging system to be used with diagnostic x-ray systems. A new AeroDR Detector (flat panel digital detector: hereafter P-51) and AeroDR Generator Interface Unit2 has been just added to AeroDR SYSTEMS (The predicate devices:K102349, K113248, K120477, K130936) to function together such as with Console CS-7 (operator console), AeroDR Interface Unit, AeroDR Interface Unit2, AeroDR Generator Interface Unit, AeroDR Access Point and AeroDR Battery Charger, AeroDR Battery Charger2 and perform fundamentally same as Aero DR SYSTEMS do in physical and performance characteristics such as in device design, material safety and physical properties. Therefore, images captured with the flat panel digital detector in the AeroDR SYSTEM 2 can be communicated to the operator console via wired connection or wireless, depend on user's choice. The AeroDR SYSTEM 2 is just developed to meet user's compact layout needs without changing fundamental functions of the predicate devices.

AeroDR SYSTEM 2 is only connected with X-ray devices which are regally marketed in the United States of America and are compatible with XGIF, UEC, XIF Board along with certain electronic requirement, Specific signal controls for hardware and software and accessories described in Operation manual and Installation manual which is also fulfilled how to compatibility test at the time of installation also. In addition, for the use of pediatric, X-ray control system for pediatric are required.

The provided document, a 510(k) summary for the AeroDR SYSTEM 2, does not contain detailed information about acceptance criteria and a study proving the device meets those criteria in the format requested. The document focuses on demonstrating substantial equivalence to a predicate device, AeroDR SYSTEMS.

However, based on the information provided, here's what can be extracted and inferred:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly list specific quantitative acceptance criteria or a performance table. Instead, it states that the AeroDR SYSTEM 2 was evaluated for "equivalent evaluation outcome" to the predicate device. The performance characteristics mentioned are qualitative comparisons to the predicate device.

2. Sample Size Used for the Test Set and Data Provenance:

The document mentions "Non clinical and clinical testing" but does not specify the sample size for these tests or the data provenance (e.g., country of origin, retrospective/prospective).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

This information is not provided in the document.

4. Adjudication Method for the Test Set:

This information is not provided in the document.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study:

The document does not mention an MRMC comparative effectiveness study or any effect size of human readers improving with AI vs. without AI assistance. The AeroDR SYSTEM 2 is a digital radiography system, not an AI-assisted diagnostic tool.

6. Standalone Performance:

The document implies standalone performance testing ("Bench Testing," "Non clinical and clinical testing") was conducted to demonstrate equivalence to the predicate device. However, it does not explicitly state "algorithm only without human-in-the-loop performance" as would be relevant for an AI device. As it's a hardware/software system for image generation, its standalone performance refers to its ability to capture and process images equivalently to the predicate.

7. Type of Ground Truth Used:

The document does not explicitly state the type of ground truth used for the "clinical testing." Given the context of a diagnostic imaging system, it would typically involve images reviewed against a clinical standard, but the specific nature (e.g., expert consensus, pathology, outcomes data) is not detailed.

8. Sample Size for the Training Set:

The document does not mention a training set or its size. This is consistent with a device seeking substantial equivalence to a predicate, where the focus is on verification and validation against established standards and predicate performance rather than training a novel algorithm from scratch.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as no training set is mentioned for an AI model.

Summary of what is present and absent regarding acceptance criteria and study details:

The document primarily acts as a 510(k) summary, aiming to prove substantial equivalence to existing predicate devices based on various safety, performance, and technical characteristics. It asserts that "equivalent evaluation outcome" was achieved in performance, non-clinical, and clinical testing, and that there were "no safety and effectiveness and performance issue or no differences were found" compared to the predicate. However, it lacks the detailed quantitative acceptance criteria, specific study designs, sample sizes, and expert qualification information that would be typically found for studies evaluating novel AI algorithms or clinical efficacy with precise endpoints.

Ask a specific question about this device

The AeroDR SYSTEM with P-31 is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in general-purpose diagnostic procedures. The AeroDR SYSTEM with P-31 is not indicated for use in mammography, fluoroscopy, tomography and angiography applications.

The AeroDR SYSTEM with P31(K130936) is a digital imaging system to be used with diagnostic x-ray systems. It consists of AeroDR Detector, Console CS-7 (operator console). Images captured with the flat panel digital detector can be communicated to the operator console via wired connection or wireless, depend on user's choice.

The following modifications were added to the AeroDR SYSTEM (K102349/ the predicate device) for the AeroDR SYSTEM with P-31(K130936/ the proposed device). The panel size of 10 x 12 inches (P-31) is added to 14 x 17 inches. The materials of the proposed panel also had been evaluated with the latest ISO 10993-1, and had been assured the safety as same as the predicate device. Two accessories were added: one is AeroDR Interface Unit2 designed to be able to replacement and function of both AeroDR Interface Unit and AeroDR Generator Interface Unit. The other is AeroDR Battery Charger2 designed for the 10X12 inches proposed panel (P-31) which can function as same as the AeroDR Battery Charger of predicate device. Irrespective of those minor modifications, the AeroDR SYSTEM (102349) and AeroDR SYSTEM with P-31(K130936) perform same, and also device design, material used and physical properties of both devices are substantially equivalent.

Here's an analysis of the provided text regarding the acceptance criteria and study for the AeroDR SYSTEM with P-31 (K130936).

Crucially, the provided document does not contain detailed acceptance criteria or the specifics of a comprehensive study proving the device meets said criteria in the way typically expected for an AI/ML medical device submission. This document is a 510(k) summary for a digital radiography system, likely focusing on demonstrating substantial equivalence to a predicate device rather than a de novo submission with extensive performance studies.

The document primarily focuses on demonstrating that the new model (AeroDR SYSTEM with P-31) is substantially equivalent to a previously cleared device (AeroDR SYSTEM, K102349) despite minor modifications (panel size, specific accessories).

Therefore, many of the requested data points (like sample size for test sets, number of experts for ground truth, MRMC studies, AI performance metrics) are not present in this type of submission. The "study" here is primarily a comparison to the predicate device and testing to ensure basic functionality and safety.

I will populate the table and answer the questions based on the information available and explicitly state when information is not provided.

Acceptance Criteria and Device Performance Study (K130936)

1. Table of Acceptance Criteria and Reported Device Performance

Interpretation: The acceptance criteria are implicitly met by demonstrating "substantial equivalence" to the predicate device. The primary "performance" reported is that the new device performs "the same" and has "no differences" in safety, effectiveness, or technological characteristics compared to the predicate.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not provided. The document refers to "Non clinical and clinical testing" but does not specify sample sizes for any test set or data provenance. This 510(k) summary focuses on equivalence, not a detailed performance study with specific test populations.

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)

• Not provided. Given that this is a digital radiography system aiming for equivalence and not an AI/CAD/image analysis device, the concept of "ground truth" and expert adjudication in this context is likely different or not explicitly detailed in this summary. The "clinical testing" mentioned likely refers to ensuring image quality is comparable, rather than disease detection/diagnosis.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not provided.

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. This is not an AI/CAD device. The AeroDR SYSTEM with P-31 is a digital X-ray imaging system. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and was not performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• No. This is not an AI/CAD device. Standalone algorithm performance is not relevant for a digital X-ray capture system itself.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not explicitly stated in terms of diagnostic ground truth. For a digital radiography system, "ground truth" regarding image quality might be based on established phantom testing, expert visual assessment of image fidelity, and comparison against images from the predicate device. Actual disease-specific ground truth (like pathology or outcomes) is not mentioned as this device is a general imaging system, not a diagnostic aid for specific conditions.

8. The sample size for the training set

• Not applicable/Not provided. This device is a hardware imaging system, not a machine learning algorithm that requires a "training set" in the typical sense.

9. How the ground truth for the training set was established

• Not applicable/Not provided. As above, no training set for an AI/ML algorithm is mentioned or relevant to this device type.

Summary of what the document does communicate about the "study":

The "study" or evaluation of the AeroDR SYSTEM with P-31 was primarily focused on demonstrating substantial equivalence to its predicate device (AeroDR SYSTEM, K102349). This involved:

• Engineering and Performance Testing: "Bench testing" and "Non clinical and clinical testing" were performed. These likely involved technical measurements of image quality, dose efficiency, and physical properties, as well as comparison of images to those produced by the predicate device.
• Safety Testing: Evaluation of new materials (ISO 10993-1), electrical safety (IEC 60601-1), and electromagnetic compatibility (IEC 60601-1-2).
• Verification and Validation: For software and hardware.
• Risk Management: Based on ISO 14971.

The conclusion is that, despite minor modifications (a new panel size and updated accessories), the proposed device performs the same as the predicate and has no new safety or effectiveness issues.

Ask a specific question about this device

The AeroSync for AeroDR SYSTEM is a software device that is used in conjunction with AeroDR SYSTEM. This device is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in general-purpose diagnostic procedures.

This device is not indicated for use in mammography, fluoroscopy, tomography and angiography applications.

The AeroSync for AeroDR SYSTEM is a software device that is used in conjunction with our AeroDR SYSTEM, K102349. It adds minor change for our cleared AeroDR SYSTEM. It eliminates the need for an electrical connection between the AeroDR SYSTEM and X-ray generator. It can be detected X-ray irradiation without cables connected to X-ray generator.

The provided text describes the Konica Minolta AeroSync for AeroDR SYSTEM, a software device intended to eliminate the need for an electrical connection between the AeroDR SYSTEM and X-ray generator, thereby detecting X-ray irradiation without cables.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The submission primarily focuses on establishing substantial equivalence to a predicate device (AeroDR SYSTEM, K102349) rather than defining specific new acceptance criteria in terms of numeric thresholds for performance metrics. The core "acceptance criteria" here appear to be demonstrating equivalence to the predicate in key areas.

2. Sample Size Used for the Test Set and Data Provenance

The provided summary does not specify the sample size used for performance testing (e.g., number of images, patient cases). It also does not mention the data provenance (country of origin, retrospective/prospective).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not provide information on experts used to establish ground truth or their qualifications. Given the focus on "image quality equivalence," it is possible that image quality assessments were performed by qualified personnel, but this is not detailed.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method used for the test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

The document does not mention an MRMC comparative effectiveness study or any effect size for human reader improvement with/without AI assistance. This is a software device facilitating X-ray detection, not an AI diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The document describes "performance testing" leading to the conclusion that "the image quality of proposed device is equivalent to the predicate device." This suggests standalone testing of the system's ability to produce images. However, no specific details of this testing (e.g., what was measured, how it was performed) are provided in this summary. The device's primary function is X-ray detection and image generation, not an interpretation independent of a human.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, Etc.)

The document does not specify the type of ground truth used for performance testing. Given the context, ground truth for image quality equivalence would likely involve a comparison against images produced by the predicate device under controlled conditions, possibly evaluated by imaging experts.

8. The Sample Size for the Training Set

The document does not mention a training set sample size. This device is described as a "software device" for X-ray detection and image generation, not a machine learning or AI algorithm that typically requires a training set in the conventional sense for feature learning or classification. It adds a "minor change" to an existing system, suggesting an engineering modification rather than a complex algorithm requiring extensive algorithmic training data.

9. How the Ground Truth for the Training Set Was Established

Since no training set is mentioned in the context of machine learning, there is no information on how its ground truth was established.

Ask a specific question about this device

The AeroDR SYSTEM with P-21 is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in general-purpose diagnostic procedures. The AeroDR SYSTEM with P-21 is not indicated for use in mammography, fluoroscopy, tomography and angiography applications.

The AeroDR SYSTEM, K102349 is a digital imaging system to be used with diagnostic x-ray systems. It consists of AeroDR Defector (flat panel digital detector), Console CS-7 (operator console), AeroDR Interface Unit, AeroDR Generator Interface Unit, AeroDR Access Point and AeroDR Battery Charger. Images captured with the flat panel digital detector can be communicated to the operator console via wired connection or wireless, depend on user's choice. The modification was made to the AeroDR SYSTEM with P-21 to add the different panel size. The panel size of 17 x 17 inches (P-21) is added to 17 x 14 inches. The materials of the panel remain unchanged and no other changes were made other than the panel size from 17 x 14 inches to 17 x 17 inches.

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study proving the device meets those criteria. The document describes a 510(k) submission for a medical device (AeroDR SYSTEM with P-21), but it primarily focuses on its substantial equivalence to a predicate device, its indications for use, and regulatory compliance.

Specifically, the "Performance Testing" section states: "Performance data from non-clinical testing of the AeroDR SYSTEM with P-21 is compared with data from the predicate device, AeroDR SYSTEM (P-11). This comparison showed that the AeroDR SYSTEM with P-21 performed as well as the predicate device."

This statement indicates a comparison was made, but it does not provide details on:

• Specific acceptance criteria.
• The results of the performance data in terms of specific metrics.
• The type of study conducted (e.g., sample size, data provenance, ground truth, expert involvement, MRMC, standalone performance).

Therefore, I cannot populate the table or answer the specific questions about the study from the given text.

Ask a specific question about this device

The AeroDR SYSTEM is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in general-purpose diagnostic procedures. The AeroDR SYSTEM is not indicated for use in mammography, fluoroscopy, tomography and angiography applications.

The AeroDR SYSTEM is a digital imaging system to be used with diagnostic x-ray systems. It consists of AeroDR Detector (flat panel digital detector), Console CS-7 (operator console), AeroDR Interface Unit, AeroDR Generator Interface Unit, AeroDR Access Point and AeroDR Battery Charger. Images captured with the flat panel digital detector can be communicated to the operator console via wired connection or wireless, depend on user's choice.

The provided text describes a 510(k) summary for the Konica Minolta AeroDR SYSTEM. However, it does not contain information about acceptance criteria for device performance or any studies conducted to prove it meets such criteria.

The document mainly focuses on:

• Company and Device Identification: Basic information about the manufacturer and the device.
• Device Description: General overview of the AeroDR SYSTEM components and its function as a digital imaging system.
• Indications for Use: Specifies what the device is intended for and what it is not for (general radiography, not mammography, fluoroscopy, etc.).
• Substantial Equivalence: Claims that the device is substantially equivalent to predicate devices (Carestream DRX-1 System, K090318 and KONICAMINOLTA, FlexDR C30, K082347) based on similar indications for use, detector type (FPD with CsI scintillator), principles of operation, and technological characteristics.
• Safety Information: Mentions compliance with IEC 60601-1 and IEC 60601-1-2 standards and risk analysis conducted per ISO 14971.
• Conclusion: Reaffirms substantial equivalence to predicate devices.
• FDA Correspondence: An FDA letter confirming the 510(k) clearance and reiterating general regulatory requirements.

Therefore, I cannot provide the requested information regarding acceptance criteria and performance studies based on the provided text. The document describes a substantial equivalence submission, which typically focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device, rather than providing detailed performance study data against specific acceptance criteria.

Ask a specific question about this device