(79 days)
The EOS is intended for use in general radiographic examinations and applications, excluding the evaluation of lung nodules and examinations involving fluoroscopy, angiography and mammography. EOS allows the radiographic acquisition of either one or two orthogonal X-ray images for diagnostic purposes, in one single scan, of the whole body or a reduced area of investigation of a patient in the upright or seated position.
EOS is a digital radiography system in which two sets of xenon gas filled digital detectors and X-ray tubes are positioned orthogonally to generate frontal and lateral images simultaneously by scanning the patient over the area of interest. The diagnostic images are stored in a local database and are displayed on a high-resolution, medical-quality monitor, where the diagnosis is performed. The diagnostic image can be transmitted through a DICOM 3.0 compatible digital network for printing and archiving. The fundamental technological characteristics of the modified EOS are unchanged compared to the cleared EOS.
The provided 510(k) summary for EOS imaging's EOS (K123740) is a Special 510(k) notification, which means it addresses a modification to a previously cleared device (K120721; K071546). Due to this, the performance data section focuses on demonstrating equivalence to the predicate device rather than establishing new acceptance criteria or a comprehensive de novo validation study.
Here's an analysis based on the provided text, addressing your points where possible:
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided text, specific quantifiable acceptance criteria and directly "reported device performance" against those criteria are not explicitly stated in a systematic table format. The submission focuses on demonstrating that the modified EOS has "equivalent performance" to the predicate.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Conformance with IEC 60601-1 and collateral standards | CB (certification body) test certificate has been issued. |
| Appropriate dosing | Bench testing confirmed appropriate dosing. |
| Image quality | Bench testing confirmed appropriate image quality. |
| Software functionality and reliability | Software verification and validation testing was conducted. |
| No new questions of safety or effectiveness compared to predicate | Performance data demonstrates safety and effectiveness equivalent to predicate. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify a distinct "test set" with a particular sample size for clinical evaluation of diagnostic performance. The testing described (bench testing, software V&V) is primarily engineering and regulatory compliance focused.
- Data Provenance: Not applicable, as a clinical test set is not explicitly mentioned.
3. Number of Experts and Qualifications for Ground Truth
- Not applicable. The submission does not describe a study involving expert readers establishing ground truth for a clinical test set. The focus is on technical equivalence.
4. Adjudication Method
- Not applicable, as a clinical study with expert readers and ground truth establishment is not described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done according to the provided text. The submission aims to show technical equivalence to a predicate device, not an improvement in human reader performance with AI assistance.
6. Standalone Performance Study (Algorithm Only)
- No, a standalone performance study was not done. The EOS device itself is a digital radiography system, not an AI algorithm. The performance data refers to the overall system's technical operation and image output, not an AI component.
7. Type of Ground Truth Used
- The term "ground truth" as typically understood in AI/clinical performance studies (e.g., pathology, clinical outcomes) is not applicable here. The "truth" being established is that the modified device's technical characteristics (dosing, image quality, software) are equivalent to its predicate and meet relevant safety standards.
8. Sample Size for the Training Set
- Not applicable. As this is not an AI device, there is no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set was Established
- Not applicable, as there is no training set for an AI algorithm.
Summary of the Study that Proves Acceptance Criteria:
The study proving the device meets its (implied) acceptance criteria is a technical and regulatory compliance assessment rather than a clinical performance study. The key elements are:
- Bench Testing: To confirm appropriate dosing and image quality. This likely involved phantoms and standardized measurements.
- Software Verification and Validation: To ensure the software performs as intended and is free from defects.
- Conformance with Standards: Demonstrated by a CB (certification body) test certificate for IEC 60601-1 and collateral standards.
The essence of the K123740 submission is to show that the modifications to the EOS system (which are not detailed in this summary but are implicit given it's a Special 510(k)) do not alter the fundamental safety or effectiveness of the device compared to its already cleared predicate. It relies on the predicate's prior clearance and the demonstration that the modified device remains technically equivalent.
§ 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.