(140 days)
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
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional Equivalence: Performs the same as the predicate device (AeroDR SYSTEM, K102349) in generating radiographic images. | "perform same" as the predicate device. |
| Safety: Meets relevant safety standards and is as safe as the predicate device. | Materials of the proposed panel evaluated with ISO 10993-1, assured safety as same as predicate device. Electrical safety (IEC 60601-1) and electromagnetic compatibility (IEC 60601-1-2) assured as the predicate device safety. |
| Effectiveness: No issues or differences in effectiveness compared to the predicate device. | Performance testing (Bench testing), including Non clinical and clinical testing referring to the FDA Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Device, conducted and showed equivalent evaluation outcome. "no impacts in technological characteristics such as design, material chemical composition energy source and other factors of the proposed device were recognized." "no safety and effectiveness and performance issue or no differences were found in further than the predicate device has." "no safety and effectiveness and performance issue or difference as the predicate devices has." |
| Material Compatibility: New panel materials are safe. | Materials of the proposed panel evaluated with ISO 10993-1, assured safety. |
| Software/Hardware V&V: Completed without problems. | Software and Hardware verification and validation completed without problem. |
| Risk Management: ISO 14971 based risk management completed. | Risk management based on ISO14971 completed without problem. |
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.
§ 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.