(150 days)
The RSM 1824C is a detector indicated for use in screening and diagnostic mammography.
The RConsole1 is an integrated software solution indicated for use with the RSM Series detectors.
The RSM 1824C detector panel is an indirect conversion device in the form of a square plate in which the input x-ray photons are absorbed in an x-ray sensitive scintillator layer. The energy of the incoming photons generates light distribution in the scintillator laver. Light is converted to a modulated electrical signal through PIN diode within the pixel of the thin film transistor. The amplified signal is converted to a voltage signal and is then converted from an analog to digital signal which can be transmitted to a viewed image print out, transmitted to remote viewing or stored as an electronic data file for later viewing.
The RSM 1824C consists of main components such as SSU (System Synchronization Unit: RSM-SSU01, RSM-SSU02 (Code# B12160000)), LAN Cable (Code# C20050502) and POE Cable (Code# C16050700), Power Cord (Code# E00050023), Ethernet Adaptor and software CD.
The System Synchronization Units, RSM-SSU01 and RSM-SSU02, only differ in their sizes. Only one System Synchronization Unit will be provided to the customer based on their choice. Also, only one System Synchronization Unit can be connected to the one detector.
The RConsole1 is digital radiography operating console software specialized for the RSM series, a digital X-rav detector developed by DRECH Inc.
RConsloe1 provides an integrated solution for X-ray projection. It integrates with the X-ray generator and the digital detector and acquires and processes images. In addition, it complies with DICOM standards and is able to transmit and receive data with the PACS system, and print images through the DICOM printer.
The provided text describes a 510(k) summary for the DRTECH RSM 1824C with RConsole1, indicating its substantial equivalence to predicate devices. The information primarily focuses on the device's technical specifications and a clinical study conducted for the detector (RSM 1824C).
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Understanding the Acceptance Criteria and Device Performance from the Text:
The document states that substantial equivalence for the detector (RSM 1824C) was demonstrated through "non-clinical performance in compliance with the requirements specified in the international and FDA recognized consensus standards" and "a clinical test, which was conducted in compliance with the requirements specified in the 'CDRH's Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Full Field Digital Mammography System'". The "results of these tests demonstrate that the RSM 1824C meets the acceptance criteria".
However, the specific quantitative acceptance criteria are not explicitly listed in a table format with corresponding reported performance values in the provided document. Instead, the document compares technical characteristics of the subject device to the predicate devices, indirectly suggesting that meeting or being comparable to the predicate's performance serves as an acceptance criterion.
The document mentions several parameters and their values for the subject and predicate devices. While not explicitly termed "acceptance criteria," we can infer them from the comparison.
1. Table of Acceptance Criteria (Inferred from Predicate Comparison) and Reported Device Performance:
| Parameter | Inferred Acceptance Criterion (via Predicate) | Reported Device Performance (RSM 1824C) | Remark (from text) |
|---|---|---|---|
| For Detector (RSM 1824C) | |||
| Pixel Pitch | ~40 μm (Predicate: Lorad Digital Breast Imager) | 76 μm | Different |
| Image Size | 186 x 248 mm (Predicate: Lorad Digital Breast Imager) | 233.4 x 175.1 mm | Similar |
| Scintillator Material | CsI:Tl (Predicate: Lorad Digital Breast Imager) | CsI | Same |
| DQE @ 1 lp/mm | ~45% (Predicate: Lorad Digital Breast Imager) | 50% | Similar |
| DQE @ 2 lp/mm | ~35% (Predicate: Lorad Digital Breast Imager) | 43% | Similar |
| MTF @ 2 lp/mm | ~70% (Predicate: Lorad Digital Breast Imager) | 70% | Similar |
| MTF @ 5 lp/mm | ~30% (Predicate: Lorad Digital Breast Imager) | 20% | Similar |
| Resolution | 4,800 x 6,400 (Predicate: Lorad Digital Breast Imager) | 3,072 x 2,304 | Different |
| Detector Type | CCD CsI:Tl (Predicate: Lorad Digital Breast Imager) | TFT a-Si | Different |
| For Software (RConsole1) | |||
| Software Function | Image viewing, search, storage, annotation, measurement, processing, stitch (Predicate: Econsole1) | Image viewing, search, storage, annotation, measurement, processing, stitch | Same |
| DICOM 3.0 Compatibility | Yes (Predicate: Econsole1) | Yes | Same |
Note: The document explicitly states: "Even though the predicate device and the subject device differ in the pixel pitch, resolution and types of the detector, the differences are not critical in terms of the diagnostic purposes because the clinical image evaluation demonstrate that the subject devices are substantially equivalent to the predicate device." This indicates that the clinical study served to bridge the gap for these specific differences in technical parameters, demonstrating that despite the differences, the diagnostic capability is equivalent.
2. Sample size used for the test set and the data provenance:
- The document states "The single-blinded concurrence study conducted in compliance with CDRH's Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Full Field Digital Mammography System)".
- Sample Size: The exact sample size (number of images or cases) used in the clinical study is not specified in this document.
- Data Provenance: The document does not specify the country of origin of the data. It also does not explicitly state if the study was retrospective or prospective, though "concurrence study" often implies a retrospective comparison of images.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- The document mentions a "single-blinded concurrence study" but does not specify the number of experts used or their qualifications (e.g., "radiologist with 10 years of experience").
4. Adjudication method for the test set:
- The document mentions a "single-blinded concurrence study" but does not specify the adjudication method used (e.g., 2+1, 3+1, none).
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:
- The document describes a "single-blinded concurrence study" to confirm that the new x-ray detectors "provide images of equivalent diagnostic capability to the predicate device."
- It does not mention a multi-reader, multi-case (MRMC) comparative effectiveness study that involved AI assistance or human reader improvement with AI. The study appears to be focused on the equivalence of the detector's image quality for diagnostic capability, not on AI's impact on human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The document focuses on the performance of the detector (RSM 1824C) in terms of image quality and diagnostic capability for mammography, and the console software (RConsole1) as an integrated solution.
- There is no mention of a standalone algorithm or AI performance test in this document. The device primarily consists of a digital X-ray detector and its operating software, which facilitate imaging, not an AI for image analysis.
7. The type of ground truth used:
- The document states the study confirmed that the images "provide images of equivalent diagnostic capability to the predicate device." This implies that the ground truth was established by clinical assessment of the diagnostic content of the images, likely based on expert consensus or comparison to established diagnoses from the predicate device's images (given it's a "concurrence study").
- However, the specific nature of the ground truth (e.g., pathology, outcomes data) is not explicitly stated.
8. The sample size for the training set:
- The document describes a 510(k) submission for a digital X-ray detector and its console software. It primarily focuses on demonstrating substantial equivalence to predicate devices, which involves comparing technical characteristics and clinical image quality.
- There is no mention of a "training set" or "training data" as this device does not appear to be an AI/ML algorithm that requires a distinct training phase.
9. How the ground truth for the training set was established:
- As there's no mention of a training set for an AI/ML algorithm, this question is not applicable based on the provided text.
§ 892.1715 Full-field digital mammography system.
(a)
Identification. A full-field digital mammography system is a device intended to produce planar digital x-ray images of the entire breast. This generic type of device may include digital mammography acquisition software, full-field digital image receptor, acquisition workstation, automatic exposure control, image processing and reconstruction programs, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). The special control for the device is FDA's guidance document entitled “Class II Special Controls Guidance Document: Full-Field Digital Mammography System.”See § 892.1(e) for the availability of this guidance document.