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510(k) Data Aggregation
(56 days)
RFA-1717DIG, RFA-1717DIC
The RFA-1717DI detector is indicated for digital imaging solution designed for general radiographic system for human anatomy. It is intended to replace film or screen based radiographic system in all general-purpose diagnostic procedures. It is not to be used for mammography.
The RFA-1717DI detector is a digital X-ray flat panel detector which has 43cm x 43cm imaging area and communicates with a wired communication feature. Giga-bit Ethernet communication method through connection of tether cable. The RFA-1717 detector is available in two types of scintillator: Csl: Tl type for RFA-1717DIC model and Gadox:Tb type for RFA-1717DIG model. The device accepts x-ray photons and the scintillator and emits visible spectrum photons that illuminate an array of photo (IGZO)-detector that creates electrical signals. After the electrical signals are generated, it is converted to digital values, and the images will be displayed on the monitor. This device should be integrated with an operating PC and an X-Ray generator. It can digitalize x-ray images and transfer them for radiography diagnostics. Advanced digital image processing allows considerably efficient diagnosis and imaging data management on network.
This document describes a 510(k) submission for the RFA-1717DI digital flat panel X-ray detector, seeking substantial equivalence to existing predicate devices. As such, the acceptance criteria and study described are for a non-clinical performance evaluation comparing the new device to established predicates, rather than a clinical study evaluating the impact of an AI algorithm on human reader performance.
Here's the breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by demonstrating comparability to the predicate devices. The "performance" here refers to the technical specifications and measurements of the device itself, rather than diagnostic accuracy.
| Characteristic | Acceptance Criteria (Predicate Device Performance) | Reported Device Performance (RFA-1717DI) | Remark |
|---|---|---|---|
| Intended Use | Same as predicate | For digital imaging solution designed for general radiographic system for human anatomy. Intended to replace film or screen based radiographic system in all general-purpose diagnostic procedures. Not to be used for mammography. | Same. This is a critical point for demonstrating substantial equivalence. |
| Detector Type | Amorphous Silicon, TFT | IGZO, TFT | Similar. The change in material (IGZO vs Amorphous Silicon) for the Thin Film Transistor array is noted, but deemed "similar" in the context of overall performance equivalence. |
| Scintillator | LTX240AA01: CsI; LLX240AB01: GdOS | RFA-1717DIC: Cesium Iodide: TI; RFA-1717DIG: Gadox : Tb | Same. While the specific chemical variations are slightly different (e.g., CsI vs CsI:Tl), the fundamental scintillator types used are the same as those present in the predicate devices. |
| Imaging Area | 17 x 17 inches | 17 x 17 inches | Same. |
| Pixel matrix | 3072 x 3072 (9.4 million) | 3072 x 3072 (9.4 million) | Same. |
| Pixel pitch | 143μm | 140μm | Similar. A slight difference, but within acceptable limits for a "similar" claim. |
| Resolution | 3.5 lp/mm | 3.4 lp/mm | Similar. A minor difference, still considered similar. |
| MTF (0.5 lp/mm) | GdOS: 76%; CsI: 81% | GdOS: 79%; CsI: 83% | Similar. The RFA-1717DI actually demonstrates slightly higher MTF (Modulation Transfer Function) values, which is generally a positive indicator of image quality. This supports the claim of equivalence. |
| DQE (1 lp/mm) | GdOS: 32%; CsI: 50% | GdOS: 34%; CsI: 60% | Similar. The RFA-1717DI demonstrates higher DQE (Detective Quantum Efficiency) values, which indicates better dose efficiency and image quality. This also supports the claim of equivalence. |
| A/D Conversion | 14 bit | 16 bit | Similar. The RFA-1717DI has a higher bit depth, allowing for more grayscale levels, which is an improvement but still within the scope of "similar" for its intended use. |
| Grayscale | 16384 (14bit) | 65350 (16bit) | Same. This reflects the higher A/D conversion, demonstrating improved grayscale capability while remaining within the expected performance of such devices. The document says "Same" despite the numerical difference, indicating it fulfills the "same" functional purpose. |
| Data output | RAW, convertible to DICOM 3.0 | RAW, convertible to DICOM 3.0 | Same. |
| Dimensions | 500 x 496.6 x 45 mm | 460 x 460 x 15 mm | Similar. Differences in physical dimensions are noted but do not impact the core functional equivalence for intended use. |
| Application | General Radiology system, various stands | General Radiology system, various stands | Same. |
| Electrical Safety | Conformance to IEC 60601-1 | Conformance to IEC 60601-1: 2005 + CORR. 1 (2006) + CORR. 2 (2007) + AM1 (2012) | Demonstrated compliance with updated standards. |
| EMC Compliance | Conformance to IEC 60601-1-2 | Conformance to IEC 60601-1-2: 2014, CISPR 11: 2015 Group 1, Class A, IEC61000-3-2: 2014, IEC 61000-3-3: 2013, EN 55011: 2009 +A1: 2010, EN 60601-1-2:2015. EN 61000-3-2:2014. EN 61000-3-3:2013. | Demonstrated compliance with updated standards. |
| Software Validation | Yes, predicate was validated | Software validation and verification testing performed. | Demonstrated compliance. |
| Risk Management | ISO 14971 compliance | ISO 14971: Risk management file A | Demonstrated compliance. |
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 "test sets" in the traditional sense of a clinical trial with patient cases. The evaluation is primarily based on bench testing and technical performance measurements of the device itself (e.g., MTF, DQE, NPS).
- Data Provenance: The testing was conducted by ASTEL Inc. (the manufacturer) and a 3rd party testing lab A (for electrical safety and EMC). The country of origin for the data (and manufacturing) is explicitly stated as Korea (26-79, Gajeongbuk-ro, Yuseong-gu, Daejeon, 34113, Korea). This was a prospective evaluation of the new device's performance against established standards, not a retrospective analysis of patient data.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Number of Experts: Not applicable. For this type of device (a digital X-ray detector, not an AI diagnostic algorithm), "ground truth" is established via physical measurements and adherence to engineering standards, not clinical expert consensus on image interpretation.
- Qualifications of Experts: The experts would be qualified engineers and physicists specializing in medical imaging device testing and regulatory compliance. The document mentions "3rd party testing lab A," implying accredited professionals conducted the safety and performance tests.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. There is no human interpretation or diagnostic "ground truth" adjudicated for this type of device submission. The device's performance is objectively measured against physical and engineering standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was it done? No. This type of study (MRMC) is typically performed for AI-powered diagnostic aids, where the impact of the AI on human reader performance is being evaluated. This submission is for a basic imaging acquisition device, not an AI diagnostic tool.
- Effect Size: Not applicable.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Was it done? Yes, in essence. The "non-clinical tests" and "performance testing/data" section describe the standalone performance of the RFA-1717DI detector. This includes measurements of MTF, DQE, and NPS, which are intrinsic performance metrics of the device itself, independent of human interpretation or any AI algorithm. The device's ability to produce images comparable to the predicate devices is the core of this "standalone" assessment.
7. Type of Ground Truth Used
- Type of Ground Truth: The ground truth for this device is based on objective physical and engineering standards and measurements. This includes:
- International Standards: IEC 62220-1 (for DQE, MTF, NPS performance), IEC 60601-1 (electrical safety), IEC 60601-1-2 (electromagnetic compatibility).
- Predicate Device Specifications: The performance values of the legally marketed predicate devices (LLX240AB01 and LTX240AA01) serve as the benchmark for "substantial equivalence."
- Risk Management Standards: ISO 14971.
8. Sample Size for the Training Set
- Sample Size: Not applicable. This is a 510(k) for a hardware device (X-ray detector). It does not involve AI algorithms that require a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
- How Established: Not applicable, as there is no training set for this type of device.
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