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MULTIX Impact E is a radiographic system used in hospitals, clinics, and medical practices. MULTIX Impact E enables radiographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and obese patients. Exposures may be taken with the patient sitting, standing, or in the prone position. MULTIX Impact E uses digital detectors for generating diagnostic images by converting X- rays into image signals. MULTIX Impact E is also designed to be used with conventional film/screen or Computed Radiography (CR) cassettes. MULTIX Impact E is not intended for mammography.

The MULTIX Impact E Radiography X-ray system is a modular system of X-ray components (floor-mounted x-ray tube, bucky wall stand, bucky table, x-ray generator, portable wireless detector) based on the predicate device, the MULTIX Impact E (VB10) (K220919). The following modifications have been made to the predicate device: 1) A new elevating table (option) 2) Upgraded software version to VB20 to support hardware modifications. The modified system will be branded as the MULTIX Impact E.

Please note, this document pertains to the MULTIX Impact E, which is a stationary X-ray system, and not an AI-powered diagnostic device. The submission focuses on demonstrating substantial equivalence to a predicate device, highlighting hardware modifications and software upgrades to support these changes. Therefore, the questions related to AI device performance, such as MRMC studies, ground truth establishment for AI, and training/test set sample sizes, are not applicable to this specific submission.

The acceptance criteria and performance are based on general safety and effectiveness of X-ray systems, primarily through compliance with recognized standards and non-clinical testing.

Here's a breakdown based on the provided document, addressing the applicable points:

Acceptance Criteria and Device Performance for MULTIX Impact E (X-Ray System)

1. A table of acceptance criteria and the reported device performance

The document does not present explicit "acceptance criteria" in a quantitative performance table for a diagnostic outcome (like sensitivity/specificity for a disease). Instead, the acceptance is based on demonstrating substantial equivalence to a predicate device through meeting regulatory standards, functional performance of components, and safety considerations. The performance is reported in terms of comparison to the predicate device for various attributes.

Here's an inferred "acceptance criteria" based on the document's structure, which is "Substantially Equivalent to Predicate Device (MULTIX Impact E VB10, K220919) and Reference Device (MULTIX Impact VA21, K213700) with no new safety risks":

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This document describes a premarket notification (510(k)) for a conventional X-ray system, not an AI/ML-driven device. The "test set" here refers to non-clinical verification and validation testing of the device hardware and software against engineering specifications and regulatory standards.

• Sample Size: Not applicable in the context of patient imaging data for an AI algorithm. The testing involves system-level and component-level verification, functional tests, and safety tests performed on representative units of the device. The document does not specify a "sample size" of devices tested, but rather indicates that such testing was "successfully completed."
• Data Provenance: Not applicable in the context of patient data. The "data" comes from engineering tests and measurements on the device itself, not from clinical images.

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 applicable. Ground truth as typically defined for medical image analysis (e.g., diagnosis of disease) is not established for this type of device submission. The "ground truth" for the performance of an X-ray system revolves around its physical characteristics, image quality parameters, and safety compliance, which are measured and evaluated by engineers and quality assurance personnel against established technical specifications and regulatory standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods are relevant for clinical studies where expert consensus is needed to establish ground truth for image interpretation. This submission is based on engineering and manufacturing verification and validation, not clinical image interpretation.

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

Not applicable. This is not an AI-powered device, and no MRMC study was performed or required for this type of submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an AI algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

The "ground truth" for this device's performance is established by engineering specifications, compliance with recognized industry standards (e.g., IEC, ISO, NEMA for X-ray systems), and adherence to manufacturing quality controls. This is demonstrated through physical measurements, electrical tests, safety circuit validation, software functionality tests, and image quality measurements, rather than clinical outcomes or diagnostic interpretations.

8. The sample size for the training set

Not applicable. This document does not describe an AI/ML device with a training set.

9. How the ground truth for the training set was established

Not applicable. This document does not describe an AI/ML device with a training set.

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MULTIX Impact E is a radiographic system used in hospitals, clinics, and medical practices. MULTIX Impact E enables radiographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and obese patients. Exposures may be taken with the patient sitting, standing, or in the prone position. MULTIX Impact E uses digital detectors for generating diagnostic images by converting X- rays into image signals. MULTIX Impact E is also designed to be used with conventional film/screen or Computed Radiography (CR) cassettes. MULTIX Impact E is not intended for mammography.

The MULTIX Impact E Radiography X-ray system is a modular system of x-ray components (floor-mounted x-ray tube, bucky wall stand, bucky table, x-ray generator, portable wireless detector) based on the predicate device, the MULTIX Impact (K203345). The following modifications have been made to the predicate device:

• A new X-ray Tube Assembly
• A new Collimator
• A new Generator
• Fixed patient table
• Tube-side control module (TCM)
• Upgraded software version to VB10 to support hardware modifications
  The modified system will be branded as the MULTIX Impact E.

This document describes modifications to an existing X-ray system, the MULTIX Impact E, and asserts its substantial equivalence to a predicate device, the MULTIX Impact (K203345).

Here's the breakdown of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria here are implicitly equivalence in safety and effectiveness to the predicate device, despite modifications. The performance is assessed through verification and validation testing of the modified components to ensure they do not negatively impact safety and effectiveness and perform as intended.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document extensively refers to "verification and validation testing" without specifying a distinct "test set" in terms of patient data or image data. The testing appears to be focused on hardware and software performance/functionality testing of the new components and the integrated system. There are no mentions of patient images or clinical data as a test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The provided document does not describe a clinical study involving experts establishing ground truth for a diagnostic test set. The testing described is technical verification and validation of the device's components and system functionality.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. There is no mention of a diagnostic test set requiring adjudication.

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

Not applicable. This device is an X-ray system, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a hardware system, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable in the context of a diagnostic test set. For the verification and validation described, the "ground truth" would be the engineering specifications, performance standards (e.g., IEC, ANSI, NEMA), and safety requirements that the new/modified components and the integrated system are assessed against.

8. The sample size for the training set

Not applicable. This is not a machine learning model requiring a training set. The software mentioned is system control software, validated through standard software development lifecycle processes.

9. How the ground truth for the training set was established

Not applicable.

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