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The ImagePilot software is intended for installation on an off-the-shelf PC meeting or exceeding minimum specifications. The ImagePilot software primarily facilitates processing and presentation of medical images on display monitors suitable for the medical task being performed. The ImagePilot software can process and display medical images from the following modality types: Plain X-ray Radiography, X-ray Computed Tomography, Magnetic Resonance imaging, Ultrasound, Nuclear Medicine and other DICOM compliant modalities. The ImagePilot must not be used for primary image diagnosis in mammography.

The ImagePilot software is intended for installation on an off-the-shelf PC meeting or exceeding minimum specifications. The ImagePilot software primarily facilitates processing and presentation of medical images on display monitors suitable for the medical diagnostics task being performed. The ImagePilot software can process and display medical images from the following modality types: Plain X-ray Radiography, X-ray Computed Tomography, Magnetic Resonance imaging, Ultrasound, Nuclear Medicine and other DICOM compliant modalities including mammography. When used for mammography the ImagePilot should never be used as a diagnostic tool.

This document (K210066) is a 510(k) Summary for a medical image management and processing system called ImagePilot. It addresses the device's substantial equivalence to previously cleared predicate devices.

Crucially, this document states: "No clinical studies were required to support the substantial equivalence." This means the information requested regarding acceptance criteria, performance studies, sample sizes, expert ground truth, MRMC studies, and training data provenance is largely not applicable in the context of this 510(k) submission.

The acceptance criteria here are related to design verification activities and demonstrating that the device performs according to specifications and functions as intended based on internal testing. There is no large-scale clinical performance study described to prove the device meets specific performance criteria against a clinical ground truth.

However, I can extract information related to the device's technical characteristics and the basis for its clearance:

Summary of Acceptance Criteria and Study Information as Implied by the 510(k):

Given that "No clinical studies were required to support the substantial equivalence," the "acceptance criteria" and "study" are primarily focused on design verification and non-clinical performance testing to demonstrate that the updated software (ImagePilot v1.92) functions as intended and is equivalent to its predicates.

1. Table of Acceptance Criteria and Reported Device Performance:

Since no clinical study data is reported, the acceptance criteria are implicitly met by "design verification activities" and demonstration that the "ImagePilot performs according to specifications and functions as intended." No specific quantitative performance metrics against a clinical outcome are presented.

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: Not applicable. No clinical test set (i.e., patient data for clinical performance evaluation) was used for substantial equivalence. The "test set" would refer to internal software testing/design verification, for which details (like specific number of images or test cases) are not provided in this public summary.
• Data Provenance: Not applicable for a clinical test set. The document does not specify the origin of any images used for internal testing/verification, if applicable. These would likely be internally generated or representative test images.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

• Not applicable. Since no clinical studies were required, there was no need for expert-established ground truth in the context of clinical performance evaluation for this 510(k). The "ground truth" for the device's functionality would be established by its adherence to engineering specifications and software quality assurance.

4. Adjudication Method for the Test Set:

• Not applicable. No clinical test set requiring adjudication was used.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No. The document explicitly states, "No clinical studies were required to support the substantial equivalence."

6. Standalone (Algorithm Only) Performance:

• This device is software that processes and presents medical images. Its "performance" in this context is primarily functional – correctly processing and displaying images as specified. It is not an AI algorithm designed to make a diagnostic determination independently. Its function is to facilitate image review by a human.
• Therefore, performance is measured against its technical specifications, not typically as a standalone diagnostic algorithm.

7. Type of Ground Truth Used:

• Not applicable for clinical performance. The "ground truth" for this submission refers to the internal specifications and functional requirements of the software, and verifying that the software meets these requirements through design verification and non-clinical performance testing.

8. Sample Size for the Training Set:

• Not applicable. This device description does not indicate that it uses machine learning or an AI algorithm that requires a "training set" in the sense of a dataset for model development. Its function is image processing and presentation based on established algorithms, not learning from data.

9. How the Ground Truth for the Training Set was Established:

• Not applicable. As above, there's no mention or implication of a training set for an AI/ML model for this device.

In conclusion, this 510(k) submission for ImagePilot v1.92 focused on demonstrating substantial equivalence through non-clinical performance testing and design verification, primarily to show that software modifications (e.g., OS update, incorporation of a previously cleared function) did not negatively impact the device's safety or effectiveness compared to its predicates. It does not contain information about clinical studies or AI model development and validation as would be found for a device leveraging advanced AI for diagnostic assistance.

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The EUROIMMUN IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPattern test kit is intended for the qualitative and semiquantitative determination of human antibodies of immunoglobulin class IgG against anti-double stranded DNA (dsDNA) in human serum with the EUROPattern Microscope and Software automated instrument. It is a sensitive method, used as an aid in the diagnosis of systemic lupus erythematosus (SLE), in conjunction with other laboratory and clinical findings. All suggested results obtained with the EUROPattern system must be confirmed by trained personnel.

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This is an FDA 510(k) clearance letter for a medical device. It does not contain the detailed study information needed to answer the questions about acceptance criteria, device performance, and study design. The letter confirms that the device, "EUROIMMUN IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPattern," has been found substantially equivalent to a predicate device for aiding in the diagnosis of systemic lupus erythematosus (SLE).

To answer your questions, I would need access to the full 510(k) submission, which would include the performance studies and acceptance criteria agreed upon with the FDA. This information is typically not publicly available in the clearance letter itself.

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