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IMIX PanoRad and PanoRad SL X-Ray Systems are indicated for use in generating radiographic images of human anatomy. They have Solid State X-ray Imaging systems intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures. (Not for mammography.)

The modified device can produce digital x-ray images in various configurations.

The provided text is a 510(k) summary for the IMIX ADR Finland OY PanoRad and PanoRad SL Systems. This document aims to demonstrate substantial equivalence to previously cleared devices, rather than establishing acceptance criteria for a new, distinct device's performance.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria, device performance studies, and ground truth establishment because it is focused on demonstrating that the revised device is substantially equivalent to existing, legally marketed devices.

Here's why each of your requested points is not present in the provided text:

1. A table of acceptance criteria and the reported device performance: This document doesn't define new performance criteria or report performance against them. Instead, it compares the characteristics of the modified device to a predicate device to show they are essentially the same.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No specific test sets or clinical studies for performance evaluation are described. The filing relies on the established safety and effectiveness of the existing predicate devices and the individual components.
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): Since no new performance studies are detailed, there's no mention of experts establishing ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as there's no new test set described.
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: This is not an AI/CAD device. It's an X-ray imaging system, so MRMC studies, especially with AI assistance, are not relevant to this filing.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable, as this is a hardware device (X-ray system), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable, as there's no new performance study requiring ground truth.
8. The sample size for the training set: Not applicable, as this is not an AI/Machine Learning device that requires a training set.
9. How the ground truth for the training set was established: Not applicable for the same reason as point 8.

In summary, the provided document focuses on demonstrating substantial equivalence of a modified X-ray system to a predicate device by comparing technical specifications and intended use, rather than presenting a de novo performance study with specific acceptance criteria and ground truth validation.

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IMIX PanoRad and SomaRad X-Ray Systems are indicated for use in generating radiographic images of human anatomy. It has a Solid State X-ray Imaging system intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures. (Not for mammography.)

The PanoRad consists of: A high resolution CCD detector with 14" x 17" or 17" x 17" image area. An X-Ray Tube & Collimator. A fully motorized positioned. A 65 kW high frequency generator. A 4 way floating table. An Image Acquisition workstation with DICOM 3 compliance.

The SomaRad consists of: A high resolution CCD detector with 14" x 17" or 17" x 17" image area. An X-Ray Tube & Collimator. A fully motorized positioned. A 50 kW high frequency generator. A table. An Image Acquisition workstation with DICOM 3 compliance.

The provided text describes a 510(k) summary for the IMIX PanoRad and SomaRad X-Ray Systems (K101435). This document focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific performance acceptance criteria through a clinical study.

Therefore, many of the requested elements for a study proving acceptance criteria (like sample size for test set, number of experts for ground truth, adjudication method, MRMC study, sample size for training set, how training set ground truth was established, and specific quantifiable acceptance criteria) are not applicable in this context. The document's purpose is to show that the new device is as safe and effective as previously cleared devices by comparing technical specifications and intended use.

Here's a breakdown of the available information:

Acceptance Criteria and Reported Device Performance

The concept of "acceptance criteria" in this 510(k) is primarily based on substantial equivalence to predicate devices. The device "meets acceptance criteria" if it is determined to be as safe and effective as the predicate devices, with no new indications for use or significant technological differences that would raise new questions of safety or effectiveness.

Study Information (Based on the provided text)

1. Sample size used for the test set and the data provenance:

   • The document mentions "user (clinical image pairs)" as part of the testing data. However, it does not specify the sample size (number of images or patients) used for this "user" testing.
   • The data provenance (country of origin, retrospective/prospective) is not explicitly stated.

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

   • This information is not provided in the document. The "user (clinical image pairs)" testing implies some form of review, but the details of who performed this review, their number, or qualifications are absent. Given it's a 510(k) for an X-ray system rather than an AI diagnostic device, formal ground truth establishment by multiple experts is less common.

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

   • This information is not provided.

4. 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 MRMC study was done or mentioned. This document is for an X-ray imaging system, not an AI-assisted diagnostic tool. Its purpose is to demonstrate the safety and effectiveness of the hardware and software for image acquisition, primarily through comparison with predicate devices' technical specifications.

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

   • Not applicable. This is an X-ray system, not a standalone algorithm for diagnosis. The "standalone" performance here refers to the system's ability to produce diagnostic quality images, which is addressed by a combination of bench testing, user testing, and adherence to standards.

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

   • The term "ground truth" in the context of an X-ray system's performance is typically less about definitive diagnostic labels (like pathology) and more about the diagnostic quality of the images produced and their ability to aid in general diagnostic procedures. The "user (clinical image pairs)" testing likely involved qualitative assessment of image quality for diagnostic purposes, relative to the predicate devices. However, the specific type of ground truth (e.g., clinical interpretation, comparison to established standards for image quality) is not detailed.

7. The sample size for the training set:

   • Not applicable. This is not an AI algorithm trained on a dataset in the way a diagnostic AI would be. The device's software is "identical to K070618" (a DICOM Pacs device), indicating it's a pre-existing software component rather than one developed through machine learning.

8. How the ground truth for the training set was established:

   • Not applicable for the same reasons as above.

Summary of the Study and Conclusion:

The "study" or evaluation performed for the IMIX PanoRad and SomaRad X-Ray Systems was a substantial equivalence comparison. This involved:

• Bench testing: Evaluating the technical specifications and performance of the components.
• User testing (clinical image pairs): Likely qualitative assessment of image quality in a clinical setting by users. The details of this testing (sample size, expert involvement, ground truth, adjudication) are not provided.
• Standards testing: Ensuring compliance with relevant industry and safety standards (e.g., UL listed).

The conclusion was that the device is "as safe and effective as the predicate devices, have few technological differences, and have no new indications for use," thereby establishing substantial equivalence. This is a regulatory pathway, not a clinical trial designed to quantify performance against a specific clinical acceptance criterion.

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IMIX Insight X-Ray Systems are indicated for use in generating radiographic images of human anatomy. It has a Solid State X-ray Imaging system intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures. IMIX Insight X-Ray Systems are not indicated for diagnostic X-ray mammography.

System Features

• URS Radiographic Stand .
• Fully motorized movements with intelligent anti-collision system .
• Automatic settings for 40 and 72 inch SID, auto-position for table exposures .
• Patient Table capacity of 440 lbs .
• Collimator with light field and laser positioning .
• X-Ray Subsystem 65 kW High Frequency Compact Generator .
• Full Anatomical Programming .
• Automatic Exposure Control .
• High Capacity (300kHU) X-ray tube with 0.6/1.2mm focus (27/75kW) .
• Microprocessor System Monitor .
• IMIX Insight Detector: High Resolution 9 megapixel or 16 megapixel CCD detector .
• 40cm x 40cm Image Format (16 x 16 inch) .
• Spatial Resolution: >3.1 1p/mm (4Mp) or >4.3 1p/mm (16Mp) .
• Image Acquisition: 16 bit .
• 3 Field Ionization Chamber .

The provided text (K073114) describes an X-ray system called the IMIX Insight X-Ray System. However, it does not contain information about acceptance criteria or a study proving that the device meets those criteria.

The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed performance studies against specific acceptance criteria.

Therefore, I cannot provide the requested information from the given text. The text does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for test sets or data provenance.
3. Number of experts or their qualifications for establishing ground truth.
4. Adjudication methods.
5. Information about MRMC comparative effectiveness studies or effect sizes.
6. Information about standalone algorithm performance studies.
7. The type of ground truth used.
8. The sample size for the training set.
9. How ground truth for the training set was established.

The document primarily states:

• Device Name: IMIX Insight X-Ray Systems
• Intended Use: Generating radiographic images of human anatomy, replacing radiographic film/screen systems in general-purpose diagnostic procedures. Not indicated for diagnostic X-ray mammography.
• Substantial Equivalence: The device is a modified combination of a cleared device (IMIX Digital Thorax K974863) with exempt devices, and is functionally identical to the SEDECAL URS LP X-Ray Units with Digital Detector (K042876) and similar to Vidar Vision 3000 and 4000 (K071193).
• Device Description: Provides details about system features like the URS Radiographic Stand, X-Ray Subsystem, and IMIX Insight Detector specifications (e.g., 9 or 16 megapixel CCD detector, 40cm x 40cm image format, spatial resolution >3.1 lp/mm or >4.3 lp/mm, 16-bit image acquisition).

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