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The C-Quest system is a dual head system designed to acquire data for cardiac multislice images. The system is intended for use as a diagnostic imaging device. When used with the appropriate radio pharmaceuticals, images are produced representing the internal distribution of radioactivity in the body. The system allows you to acquire data from high resolution three dimensional, static, gated or dynamic images of biochemical and metabolic processes using approved radionuclides within the energy range of 60 – 170 keV such as Tc-99m or TI-201.

A compact, dual-head dedicated cardiac camera system comprised of a gantry supporting a fixed 90 degree dual head detector and a patient table. The C-Quest system is operated through interaction with an acquisition and processing computer system (NuQuest) or dedicated handheld controller or touch screen.

Here's a breakdown of the acceptance criteria and study information for the C-Quest System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The acceptance criteria are inferred from the predicate device's performance, as the document states that the C-Quest system performs "as well as the predicate device" and provides a direct comparison table of technical characteristics. The C-Quest device generally shows performance that is either comparable to or slightly different from the predicate, but implicitly accepted as meeting the "as well as" criterion for 510(k) substantial equivalence. For spatial resolution (FWHM, FWTM), the C-Quest performs worse in the center FOV compared to the predicate, but better in the useful FOV. For spatial linearity and uniformity, the C-Quest's reported maximums are often higher than the predicate's reported values, indicating slightly worse performance in some technical aspects, yet still deemed substantially equivalent.

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

The provided 510(k) summary does not contain information about a test set involving patient data for clinical performance evaluation. The study presented focuses on a technical comparison of intrinsic device characteristics against a predicate device. Therefore, clinical sample size and data provenance are not applicable to the information given.

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

Not applicable. The study does not involve expert review of patient data to establish ground truth.

4. Adjudication method for the test set

Not applicable. No clinical test set or adjudication process is mentioned.

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. This document does not mention an MRMC comparative effectiveness study. This device is a cardiac gamma camera system, not an AI-assisted diagnostic tool for human readers.

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

Yes, in essence. The evaluation presented is a standalone technical performance study of the C-Quest system's physical characteristics (e.g., spatial resolution, linearity, uniformity) compared to its predicate. It is not evaluating an algorithm in isolation, but rather the intrinsic imaging capabilities of the hardware.

7. The type of ground truth used

The "ground truth" for this technical study is established by physical measurements and phantom studies for parameters like intrinsic spatial resolution, linearity, and uniformity, conforming to industry standards for gamma cameras. The 510(k) summary implicitly uses the established performance of the predicate device (Cardiocam) as a benchmark.

8. The sample size for the training set

Not applicable. This document describes a medical imaging device, not an AI model that requires a training set.

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

Not applicable. As this device is not an AI model, there is no training set mentioned or ground truth associated with it.

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The intended uses of the T-Quest™ System are the acquisition, processing, display and analysis of planar images of the thyroid gland and other small organs using approved pharmaceuticals.

The T-Quest System consists of a small mobile scintillation camera, accessories such as optional phantoms, and an optional patient bed. This product includes a notebook computer, an acquisition board, and IM512P Data and Image processor software marketed by MEDX, Inc. under the trade name of NuQuest™ Software. This system is primarily used for the acquisition, processing, and analysis of planar images of the thyroid gland and other small organs.

This appears to be a 510(k) premarket notification for a medical device, which focuses on demonstrating substantial equivalence to a predicate device rather than conducting a full clinical study with acceptance criteria in the typical sense of a de novo or PMA submission.

Therefore, many of the requested sections (2-9) about sample size, ground truth, expert adjudication, MRMC studies, and training sets are explicitly not applicable to this type of submission document as they are not typically required or included. The "study" mentioned here is primarily one of non-clinical device performance comparison and adherence to industry standards, not a clinical trial.

Here's the information extracted and interpreted based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not Applicable. This submission details non-clinical performance and substantial equivalence based on technical specifications and phantom studies, not a clinical test set with patient data in the typical sense.
• The "test set" for performance was likely phantom images, though the specific number of phantom images or type of phantoms is not detailed.
• The data provenance mentioned relates to adherence to international safety and performance standards (UL, CAN/CSA, NEMA) and comparison to a legally marketed predicate device (Inter Medical Gamma Camera System Model CX 250 C Plus, K052473).

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. No ground truth established by external experts is described for a clinical test set. The assessment of "excellence" for phantom images (linearity, resolution, uniformity) would have been determined internally by MEDX, Inc. engineers or quality assurance personnel against the NEMA standard.

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

• Not Applicable. No clinical test set or adjudication method is 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

• Not Applicable. No MRMC study or AI component is mentioned. This device is a traditional gamma camera system.

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

• Not Applicable. This is a physical device (gamma camera) with associated software (NuQuest™). Its performance is inherently linked to its operation, not a standalone algorithm in the AI sense. The "standalone" performance here refers to the device's technical specifications and adherence to NEMA standards.

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

• For Performance Testing: The ground truth for performance testing (linearity, resolution, uniformity) was based on physical phantom measurements and adherence to NEMA NU 1-2001 industry standards.
• For Substantial Equivalence: The "ground truth" for demonstrating substantial equivalence was the technical specifications and proven performance of the predicate device (Inter Medical Gamma Camera System Model CX 250 C Plus, K052473).

8. The sample size for the training set

• Not Applicable. This is not an AI/machine learning device requiring a training set in that context. The device and its software (NuQuest™ based on IM512P) have a history of prior FDA clearances (K945792, K961104), indicating established functionality rather than a recently trained algorithm.

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

• Not Applicable. See point 8.

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The intended uses of the MEDX NuQuest™- InteCam™ SPECT 37-75 System are the acquisition, processing, display and analysis of planar and SPECT nuclear images of all organ systems using approved pharmaceuticals.

The MEDX NuQuquest™ - InteCam™ SPECT 37-75 System is a Nuclear Medicine Gamma Camera System consisting of:

• A modified (remanufactured) Siemens Digitrac™ Orbiter™ . Gamma Camera and its associated Gantry which also was modified to operate with our computer (see bullet below) and software.
• NuQuest™ Nuclear Medicine Computer and related . software.
  The modification to the Siemens Orbiter Gamma Camera consisted of removal of certain low voltage circuit boards in the gamma camera and the gantry portions of the Siemens" device and installing proprietary low voltage circuit boards that allow the use of our NuQuest™Nuclear Medicine Computer to replace the Siemens computer and related imaging software.
  The Detector (Gamma Camera) portion of the system may have 37 or 75 photomultiplier tubes depending on whether the Siemens Digitrac 3700 or 7500 were converted to operate with the MEDX NuQuest Computer and its software.

This is a 510(k) summary for a gamma camera system, which means it evaluates the substantial equivalence to a predicate device rather than conducting a de novo study with acceptance criteria. Therefore, much of the requested information regarding specific acceptance criteria, detailed study design, and performance metrics in the context of a de novo study is not present in this document.

However, based on the provided text, here's what can be extracted and inferred:

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

The provided document describes a 510(k) submission, where the primary "acceptance criterion" is substantial equivalence to a predicate device. This is a regulatory pathway, not a performance study against predefined numerical targets.

• Acceptance Criteria (Implicit for 510(k)): The device, MEDX NuQuest™ - InteCam™ SPECT 37-75 System, must demonstrate that it is as safe and effective as the predicate device (Siemens Integrated ORBITER™ Gamma Camera System) and has the same intended use. This is achieved by showing that any differences do not raise new questions of safety or effectiveness.

• Reported Device Performance: The document does not provide specific performance metrics (e.g., spatial resolution, sensitivity, processing speed) of the MEDX NuQuest™ system in comparison to the predicate. Instead, it focuses on the modifications made to a remanufactured Siemens device and the integration of previously cleared components (NuQuest™ Nuclear Medicine Computer and IM512P imaging software). The implication is that by using a modified version of a Siemens device and cleared components, the performance is at least equivalent.

  | Acceptance Criterion (Implicit for 510(k)) | Reported Device "Performance" (via Substantial Equivalence Claim) |
  | :------------------------------------------------------ | :--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
  | Substantially equivalent to predicate device | The MEDX NuQuest™ - InteCam™ SPECT 37-75 System is substantially equivalent to the Siemens Integrated ORBITER™ Gamma Camera System. |
  | Same Intended Use and Indications for Use | The intended uses of the MEDX NuQuest™- InteCam™ SPECT 37-75 System are the acquisition, processing, display and analysis of planar and SPECT nuclear images of all organ systems using approved pharmaceuticals, which is the same as commonly accepted uses for gamma cameras. |
  | Differences do not raise new questions of safety/effectiveness | The device consists of a modified (remanufactured) Siemens Digitrac™ Orbiter™ Gamma Camera (with its gantry) and a previously cleared NuQuest™ Nuclear Medicine Computer (K953255) with previously cleared imaging software (IM512P, K945792). The modification involved replacing low-voltage circuit boards in the Siemens device to operate with the new computer and software. This implies that the core imaging hardware (detector) is a known design, and the modifications are primarily in the control and processing electronics, which are covered by the cleared components. No new safety or effectiveness concerns are indicated. |

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

This information is not provided in the 510(k) summary. For a substantial equivalence claim based on modifications to an existing device and integration of pre-cleared components, extensive clinical test sets with patient data are often not required if the changes are deemed non-significant to safety and effectiveness. The focus would typically be on technical verification and validation, possibly using phantom studies, rather than a clinical dataset for performance evaluation against ground truth.

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)

This information is not provided as a formal clinical study with a ground truth assessment by experts for a test set is not described in this 510(k) summary.

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

This information is not provided as a formal clinical study with adjudication is not 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

An MRMC comparative effectiveness study is not mentioned and would not typically be performed for a 510(k) submission for a gamma camera system claiming substantial equivalence, especially one based on modifications and integration of pre-cleared components. This device is a primary imaging acquisition and processing system, not an AI-assisted diagnostic tool.

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

This device itself is the "standalone" imaging system. While it has algorithms for image processing and analysis (as indicated by the "processing, display and analysis" function and the cleared IM512P software), the 510(k) does not detail specific algorithm performance studies or metrics as it focuses on the substantial equivalence of the overall system.

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

Since a specific clinical performance study against ground truth is not described, this information is not provided. The ground truth for proving substantial equivalence usually revolves around technical specifications and engineering validation of the modified components and integrated system to ensure they perform equivalently to the predicate and comply with relevant standards.

8. The sample size for the training set

This information is not provided. The device is a gamma camera system, and while it uses software and processing, it's not described as a machine learning/AI classification algorithm that would require a "training set" in the common sense of AI development for diagnostic tasks. The software it uses (IM512P) was previously cleared, indicating its development and validation occurred prior to this submission.

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

This information is not provided as no training set (in the AI/ML context) is described for this specific 510(k) submission.

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The Giotto Image X-ray Mammographic System is intended to provide filmscreen X-ray imaging of the breast that can be imaged on a 18 x 24cm or 24 x 30cm film. With optional accessories the Giotto Image can also be used as the imaging device for stereotactic needle biopsy.

The Giotto Image is a conventional film-screen x-ray mammographic device. This device is designed to generate a high resolution image of the breast on film using an x-ray source designed specifically for mammography. It incorporates a state-of-the-art microprocessor controlled high frequency single phase x-ray generator and automatic exposure control, molybdenum rotating anode x-ray tube with 0.3 and 0.1 mm focal spots, gantry, compression device and film holder. The unique open design of the Giotto Image allows positioning of the patient with the operator facing the patient. This face-to-face positioning allows the operator to carefully center the breast and compress it quickly and efficiently. Optional accessories allow both prone and seated breast needle biopsy.

Here's an analysis of the acceptance criteria and the study information based on the provided text:

Key Takeaways:

• This 510(k) summary is for a conventional film-screen X-ray mammographic device, not an AI-powered system.
• The primary method for demonstrating equivalence is by showing the device meets or exceeds existing regulatory and accreditation standards for mammography equipment and that its performance is substantially equivalent to a predicate device (Giotto HT).
• The text does not describe a study involving an AI algorithm or human readers interpreting images with or without AI assistance. Therefore, most of the requested AI-related information (MRMC study, standalone AI performance, training set details) is not applicable or cannot be extracted from this document.

Acceptance Criteria and Reported Device Performance

Study Information (Based on provided text)

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

   • The document does not describe a specific "test set" in the context of an algorithm or human reader study. It refers to meeting ACR accreditation standards for mammography equipment. These standards generally involve phantom imaging and calibration tests, not a clinical study with a patient dataset.
   • No data provenance (country of origin, retrospective/prospective) is mentioned, as a clinical study with a patient test set isn't detailed.

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

   • Not applicable. No ground truth for an image-reading test set is described. The "ground truth" here is adherence to engineering and performance specifications defined by the ACR.

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

   • Not applicable. No test set requiring expert adjudication is described.

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. This is a conventional X-ray mammography device, not an AI-powered system designed to assist human readers. Therefore, an MRMC study comparing human readers with and without AI assistance was not performed (and is not mentioned).

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

   • No. This is a hardware device for image acquisition, not an AI algorithm.

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

   • The ground truth in this context is the adherence of the device's physical and performance characteristics (image resolution, contrast, dose, kV accuracy, etc.) to established industry and regulatory standards (ACR requirements adopted by MQSA) for mammography equipment. This is assessed through physical measurements and phantom tests, not clinical outcomes or expert consensus on patient images.

7. The sample size for the training set:

   • Not applicable. This document describes a physical imaging device, not an AI algorithm that requires a training set.

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

   • Not applicable. No training set is described.

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The intended uses of the MEDX InteCam™ Interface accessory together with the NuQuest™ Nuclear Medicine Computer are the acquisition, processing, display and analysis of planar and SPECT nuclear images of all organ systems using approved pharmaceuticals.

The NuQuest™ Nuclear Medicine Computer together with the MEDX InteCam™ Interface is used to acquire data from nuclear medicine gamma cameras. The data consists of a representation of the x coordinate and y coordinate of the position and optionally a signal representing the energy of a gamma ray emitted from the decay of radioisotopes injected into a patient. The position of the decay is calculated (a ray from the event to the detector) by the gamma camera. The positions of a large number of decay events are used to form an image of the location of the radioactive material. This image acquired can be displayed on a computer monitor or transferred to photographic film for review. The collection of data at multiple detector positions allows three dimensional information to be obtained by tomographic means. The computer is then used to reconstruct slices, or two dimensional views, of the data viewed from any angle or orientation. The computer can also be used to obtain quantitative information such as the number of counts in a particular area of the image, or the rate of change of counts in an area of the image with respect to time.

The provided K993893 document (510(k) summary) does not contain the type of detailed study information required to fill out the requested table regarding acceptance criteria and device performance.

Specifically, the document states: "The characteristics of the MEDX InteCam™ Interface when used with the NuQuest™ Nuclear Medicine Computer compare substantially with the predicate device, in both materials used, technology applied, and functional methodology. Differences of note do not affect safety and effectiveness of the device, intended use, or application methods. The device operates in a manner substantially equivalent to other cleared devices in this category, and performs as well as the predicate device."

This indicates that the submission relies on demonstrating substantial equivalence to a predicate device (G.E. Starcam 4000, K904174), rather than providing detailed performance studies with acceptance criteria, sample sizes, expert ground truth establishment, or comparative effectiveness studies. The FDA's decision letter confirms that they reviewed the 510(k) notification of intent to market and found the device "substantially equivalent."

Therefore, I cannot provide the requested table and study details from the given text. The document focuses on device description, intended use, and technological characteristics, asserting substantial equivalence but not presenting specific study results or performance metrics against defined acceptance criteria.

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