(58 days)
The SKR 4000 is indicated for use in generating radiographic images of human anatomy. It is intended to replace a radiographic film/screen system in general-purpose diagnostic procedures.
The SKR 4000 is not indicated for use in mammography, fluoroscopy and angiography applications.
The SKR 4000 consists of the DR Detector (P-41), Battery, Battery Charger, AC Adapter, AC Power Cable and DC Power Cable It is intended for use replacing a radiographic film/screen system in general-purpose diagnostic procedures of human anatomy.
The SKR 4000 performs radiography imaging of the human body using an X-ray FPD that outputs a digital signal, which is then input into an image processing device.
The SKR 4000 can communicate with the image processing device through the Wireless LAN (IEEE802.11a/b/g/n/ac and FCC compliant). The WPA2-PSK (AES) encryption is adopted for a security of wireless connection.
The provided document is a 510(k) summary for the Konica Minolta SKR 4000, a stationary x-ray system. This document is primarily focused on demonstrating substantial equivalence to predicate devices, rather than presenting a detailed clinical study with acceptance criteria and performance data for a new AI algorithm or standalone device.
Therefore, much of the requested information regarding acceptance criteria, study design, ground truth establishment, expert adjudication, MRMC studies, or training/test set sample sizes for an AI-driven device is NOT available in this document. The SKR 4000 is a digital radiography hardware system, not an AI-powered diagnostic tool.
The document states: "The performance tests according to the 'Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices' and the other verification and validation including the items required by the risk analysis for the SKR 4000 were performed and the results demonstrated that the predetermined acceptance criteria were met. The concurrence study is not necessary because the proposed modifications are categorized as the type of unnecessary to provide additional clinical data in accordance with the SSXI guidance. Besides, the results of risk management did not require clinical studies to demonstrate the substantial equivalency of the proposed device."
This means that the "acceptance criteria" referred to are likely technical performance specifications for the imaging hardware itself, and the "study" was primarily engineering verification and validation against those technical specifications, rather than a clinical study evaluating diagnostic accuracy with a human-in-the-loop or standalone AI.
However, based on the provided text, I can extract and infer some limited information:
1. A table of acceptance criteria and the reported device performance:
The document provides a "Comparison Table" which lists specifications for the subject device (SKR 4000) and its predicate devices. These effectively act as the "acceptance criteria" in terms of mirroring or improving upon the predicate's performance for a hardware device.
| Characteristic | Acceptance Criteria (based on Predicate 1 or 2) | Reported Device Performance (SKR 4000) |
|---|---|---|
| Detection method | Indirect conversion method (PD1, PD2) | Same as PDs (Indirect conversion method) |
| Scintillator | Csl (Cesium Iodide) (PD1, PD2) | Same as PDs (Csl) |
| Image area size | PD1: 343.2mm x 420mm; PD2: 348.95x425.25mm | 345.6 x 420.0 mm |
| Pixel size | PD1: 150 µm; PD2: 100/200/400 µm | Same as PD1 (150 µm) |
| A/D conversion | PD1: 14 bit; PD2: 16 bit | Same as PD2 (16 bit) |
| MTF (1.0 cycle/mm) | PD1: 0.83 @ 0.5 (1/mm) (Better); PD2: >0.53 | More than 0.60 |
| DQE (1.0 cycle/mm) | PD1: 0.55 @ 0.5 (1/mm) (Better); PD2: >49%@1mR, >39%@0.1mR | More than 30%@0.3mR |
| Electrical Power Source | AC Line and/or Removable Battery (PD1) | Same as PD1 |
| Battery type | Lithium Ion Battery (PD1) | Same as PD1 |
| External dimensions | PD1: 384(W)x460(D)x15.2(H)mm; PD2: 384(W)x460(D)x15(H)mm | 384(W)x460(D)x15(H)mm |
| Weight | PD1: 3.82 kg (with battery); PD2: 2.6 kg | 3.6kg (with battery) |
| IPX | PD1: IPX0; PD2: IPX6 | IPX1 |
| Communication | Wireless/Wired (PD1, PD2) | Wireless |
Note: The "acceptance criteria" columns above are derived from the specifications of the predicate devices. The SKR 4000's reported performance is compared against these to demonstrate substantial equivalence.
2. Sample size used for the test set and the data provenance:
- Not applicable / Not specified for a clinical test set. The performance evaluation was based on technical specifications and engineering verification, not a clinical study on a patient sample set involving diagnostic outcomes.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth in the context of diagnostic interpretation by experts is not relevant for this type of hardware performance evaluation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable.
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 device is a digital radiography system, not an AI assistance tool. The document explicitly states: "The concurrence study is not necessary because the proposed modifications are categorized as the type of unnecessary to provide additional clinical data in accordance with the SSXI guidance."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable for a clinical ground truth. The "ground truth" for this device would be established by validated measurement equipment and scientific standards for assessing the physical performance characteristics (e.g., MTF, DQE, pixel size, etc.) of an x-ray detector.
8. The sample size for the training set:
- Not applicable. This relates to machine learning models, which are not part of this device.
9. How the ground truth for the training set was established:
- Not applicable.
In summary: The provided document is for a medical device (a digital radiography system) that is hardware-based. The "acceptance criteria" and "study" refer to engineering and technical performance validations against established standards and predicate device specifications, not to clinical studies involving human diagnostic performance or AI algorithms.
§ 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.