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The AURA 10 PET/CT system is a cabinet diagnostic imaging device that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The AURA 10 PET/CT system images harvested specimens from various anatomical regions in order to provide rapid verfication that the correct tissue has been excised during the surgical procedure. Images can be obtained as CT only, or a combination of both by surgeon's discretion.

The AURA 10 cabinet PET/CT system provides an image of extent and degree of intensity radiopharmaceutical uptake in the specimen by PET and the anatomical information by CT, which will help the surgeon with further patient management.

The AURA 10 PET/CT system is not validated for margin detection.

The AURA 10 PET/CT is a mobile, vertical-bore PET/CT system with a Field of View (FOV) suitable for small pathology specimens. It is intended to be used in both the operating room (OR) as well as the pathology department to image pathology specimens from various anatomical regions in order to provide rapid pathology imaging. The AURA 10 PET/CT is intended to image pathology specimens for a wide range of patient types, sizes, and extent of diseases. It is designed as a mobile cart so that it is easily portable by one person and can be moved to different surgical suites or between departments as needed.

The provided text describes the regulatory clearance for the AURA 10 PET/CT system, which is a cabinet diagnostic imaging device for imaging harvested specimens. However, it explicitly states, "Not applicable. Clinical studies are not necessary to establish the substantial equivalence of this device." This means that the submission does not include information about clinical performance data or a study proving the device meets acceptance criteria derived from clinical studies.

The document focuses on demonstrating substantial equivalence to a predicate device (Vereos PET/CT) and a reference device (Faxitron VisionCT) through non-clinical performance data, primarily bench testing, electrical safety, EMC, and software verification/validation.

Therefore, it is not possible to provide the requested information regarding acceptance criteria and a study that proves the device meets those criteria from a clinical performance perspective. The clearance is based on technological characteristics and non-clinical testing demonstrating equivalency to existing cleared devices, not on a new clinical performance study.

Here's an explanation based on the provided text's limitations:

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

• Acceptance Criteria: No specific clinical acceptance criteria (e.g., sensitivity, specificity, accuracy against a clinical ground truth) are provided in the document. The acceptance for this device is based on meeting safety and performance standards through non-clinical testing and demonstrating technological equivalence to predicate devices.
• Reported Device Performance (Non-Clinical):
  • Electrical Safety & EMC: "The device passed all tests" for IEC 61010-1, IEC 61010-2-091, IEC 61010-2-101, and IEC 61326-2-6.
  • Software Verification & Validation: "Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance... The software for this device was considered as a moderate level of concern." "The AURA 10 PET/CT was tested in accordance with IEC 62304:2006 + A1:2015...".
  • Bench Testing:
    • Analytical performance testing: "The AURA 10 PET/CT was tested in accordance with NEMA NU 4-2008 - Performance measurements of small animal positron emission tomographs (PETs)." (Specific performance numbers from this test, like spatial resolution or peak NEC rate, are listed in the "Technological characteristics" table, but it's not explicitly stated that these are the "acceptance criteria" for clearance, rather they are characteristics measured against the predicate.)
    • Usability testing: "The AURA 10 PET/CT was tested in accordance with IEC 62366-1:2015... Usability testing was conducted and documentation provided as recommended by FDA's Guidance...".

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

• Since no clinical studies were performed, there is no "test set" in the context of clinical data. The non-clinical tests involved hardware and software evaluations.

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

• Not applicable, as no clinical ground truth was established by experts for a clinical test set.

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

• Not applicable, as no clinical test set requiring adjudication was used.

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 MRMC study was done, as explicitly stated, "Clinical studies are not necessary to establish the substantial equivalence of this device." This device is an imaging system, not an AI-assisted diagnostic tool for human readers in the traditional sense of improving reader performance. Its purpose is to provide images for verification.

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

• The device is a medical imaging system (PET/CT), not an algorithm that produces a diagnostic output on its own. Its "performance" is in image generation and quality, which was evaluated through bench testing.

7. The type of ground truth used:

• For the non-clinical bench testing, the "ground truth" would be the known physical properties and performance characteristics of phantoms and test setups used in accordance with standards like NEMA NU 4-2008.

8. The sample size for the training set:

• Not applicable, as this documentation does not describe an AI/ML model that would require a "training set" of data for its primary function. It's a hardware imaging system.

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

• Not applicable.

In summary: The provided FDA 510(k) clearance letter and summary for the AURA 10 PET/CT system indicate that its clearance was based on demonstrating "substantial equivalence" to existing, legally marketed predicate devices through non-clinical testing (electrical safety, EMC, software V&V, and bench testing against industry standards like NEMA NU 4-2008) and a comparison of technological characteristics. No clinical performance studies, human reader studies, or AI algorithm performance studies were deemed necessary for this clearance.

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The Micro C Medical Imaging System, M01 is a handheld and portable general purpose X-ray system that is indicated for use by qualified/trained clinicians on adult patients for taking diagnostic static and serial radiographic exposures of extremities. The device is not intended to replace a radiographic system that has both variable tube current and voltages (kVp) in the range that may be required for full optimization of image quality and radiation exposure for different exam types.

The Micro C Medical Imaging System, M01 (subject device) is a handheld X-ray system designed to aid clinicians with point of care visualization through diagnostic X-rays of distal extremities. The device allows a clinician to select desired technique factors best suited for their patient anatomy. The Micro C Medical Imaging System, M01 consists of three major subsystems: The Emitter, Cassette, and Control Unit. The System is interface an external Monitor (touchscreen or non-touchscreen display), keyboard and a mouse, and can provide a remote operator interface over the network to a laptop. The Micro C Medical Imaging System, M01 utilizes a computer vision positioning system to allow the emitter to be positioned above the patient anatomy and aligned to the cassette by the operator. The device is used in a clinical environment.

This looks like a 510(k) summary for a medical device called "Micro C Medical Imaging System, M01". The summary primarily focuses on establishing substantial equivalence to a predicate device and discussing technical characteristics and compliance with various standards.

There is no information provided regarding acceptance criteria nor a typical clinical study with patient data that would involve the following:

• A table of acceptance criteria and the reported device performance: This document does not specify quantitative acceptance criteria for image quality or diagnostic performance, nor does it report device performance against such metrics.
• Sample size used for the test set and the data provenance: There is no mention of a test set with patient data.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: As there's no clinical test set, there's no mention of experts or ground truth establishment.
• Adjudication method for the test set: Not applicable as there's no patient test set.
• If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable as there's no patient test set or reader study mentioned.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The document describes an X-ray imaging system, not an AI algorithm. Therefore, this is not applicable.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable as there's no clinical test set.
• The sample size for the training set: Not applicable as there's no AI algorithm with a training set discussed.
• How the ground truth for the training set was established: Not applicable as there's no AI algorithm with a training set discussed.

What the document does provide:

The document focuses on demonstrating substantial equivalence to predicate devices based on:

1. Technological Characteristics Comparison (Table 5-2 and 5-3): This table compares the subject device (Micro C Medical Imaging System, M01) with a predicate mobile X-ray system (Nomad MD 75kV Handheld X-Ray System, K140723) and reference devices (KDR™ AU-DDR System, K193225 and Faxitron VisionCT, K173309). It details various technical specifications like product code, regulation, classification, indication for use, age of device use, principle of operation, image type, detector characteristics (for the detector incorporated), collimator, weight, dimensions, triggering mechanism, SSD, SID, light field, energy source, exposure time, mA, kVp, ingress protection, image processing, connectivity options, DICOM compliance, and device package contents.
2. Non-Clinical Performance Data: The document states that testing was performed successfully according to a list of international standards (e.g., ISO, IEC) and FDA regulations. These standards cover aspects like risk management, diagnostic X-ray system requirements, electrical safety, electromagnetic compatibility, usability, X-ray tube assemblies, software product lifecycle, biocompatibility, labeling, and laser safety.
3. Additional Non-Clinical Performance Testing: This includes Functional Testing, an Image Quality Study, Usability Testing, and a Cleaning Study. However, no specific details, criteria, or results from these studies are provided in this summary.

Conclusion from the document:
The summary concludes that the Micro C Medical Imaging System, M01 is similar to the legally marketed predicate device (Nomad MD 75kV Handheld X-Ray System) in intended use, similar technologies, and performance data, and therefore does not raise different questions of safety and effectiveness, thus supporting its substantial equivalence claim.

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The Volumetric Specimen Imager is a Cabinet x-ray system that is used to provide two and three dimensional digital x-ray images of harvested specimens from various anatomical regions in order to provide rapid verification that the correct tissue has been excised during the biopsy procedure. Doing the verification directly in the same room or nearby enables cases to be completed faster, thus limiting the time the patient needs to be under examination. Specimen radiography can potentially limit the number of patient recalls.

The Clarix Imaging Volumetric Specimen Imager (VSI) is a portable, fully shielded cabinet X-ray system that provides high resolution 2D and 3D radiographic images of surgically excised specimens. The VSI system consists of an image-acquisition device and software for image reconstruction, visualization, and archival. Enabled by optimized imaging geometry and iterative image reconstruction algorithm, VSI provides superior spatial and contrast resolution for visualizing specimens with soft tissues or boney structures. VSI is designed to comply with 21 CFR 1020.40 and DICOM standards.

The provided text is a 510(k) summary for the Clarix Imaging Volumetric Specimen Imager (VSI). It describes the device, its intended use, and a comparison with a predicate device. However, it explicitly states that clinical data was not required to demonstrate substantial equivalence to the predicate device. Therefore, the document does not contain the detailed information requested regarding acceptance criteria and a study proving the device meets those criteria through clinical performance.

The "Non-clinical Performance Data" section lists several tests performed, but these are primarily for electrical safety, electromagnetic compatibility, compliance with regulations and standards (IEC, CFR, DICOM), phantom imaging, and user testing. The "Tissue Verification" listed here would likely refer to non-clinical verification of image quality for tissue, not a clinical study involving human patients or complex diagnostic assessments.

Given the information provided in the 510(k) summary, I cannot fill out the requested table or describe a study that proves the device meets specific acceptance criteria based on clinical performance. The 510(k) pathway for this device relied on demonstrating substantial equivalence to a predicate, not on new clinical performance data to establish specific diagnostic accuracy or efficacy metrics.

Therefore, many of the requested fields about ground truth, expert readers, MRMC studies, and effect sizes cannot be answered from this document. If such a study were performed, its details would be found in a separate clinical study report, not typically summarized in this manner for a 510(k) submission where clinical data was explicitly not required for substantial equivalence.

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