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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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