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The NanoZoomer S360MD Slide scanner system ("NanoZoomer System") is an automated digital slide creation, viewing, and management system. The NanoZoomer System is intended for in vitro diagnostic use as an aid to the pathologist to review and interpret digital images of surgical pathology slides prepared from formalin-fixed paraffin embedded ("FFPE") tissue. The NanoZoomer System is not intended for use with frozen section, cytology, or non-FFPE hematopathology specimens.

The NanoZoomer System comprises the NanoZoomer S360MD Slide scanner, the NZViewMD Software and a compatible display that has been 510(k) cleared for use with the NanoZoomer system or a 510(k)-cleared display that has been assessed in accordance with the Predetermined Change Control Plan (PCCP) for qualifying additional compatible displays. The NanoZoomer System is for creation and viewing of digital images of scanned glass slides that would otherwise be appropriate for manual visualization by conventional light microscopy. It is the responsibility of a qualified pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images obtained using NanoZoomer System.

The NanoZoomer S360MD Slide scanner system is an automated system for creating, viewing, and managing digital slides. The NanoZoomer S360MD Slide scanner system creates diagnosticquality digital images of glass slides containing formalin-fixed paraffin-embedded ("FFPE") tissue. Each digital image covers an entire slide and typically contains billions of image pixels. Slide images may be viewed, stored, retrieved, duplicated, and/or shared, permitting the pathologist to make a primary diagnosis without needing to view the original glass slides through a light microscope.

The NanoZoomer S360MD Slide scanner system is comprised of the NanoZoomer S360MD Slide scanner, NZViewMD image viewing software and compatible display.

The document describes the NanoZoomer S360MD Slide scanner system (K233027), which is an automated digital slide creation, viewing, and management system. This submission primarily focuses on adding compatibility with the BARCO MDPC-8127 Display to the existing NanoZoomer S360MD Slide scanner system (K213883) and establishing a Predetermined Change Control Plan (PCCP) for qualifying additional FDA-cleared displays. No new clinical studies were conducted as part of this submission, as substantial equivalence was demonstrated through non-clinical testing.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are derived from the special controls described under 21 C.F.R. § 864.3700 for Whole Slide Imaging Systems, and color reproducibility testing. The reported device performance indicates that the system met these criteria.

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

• Test Set Sample Size: The document specifies that color reproducibility testing "used three NanoZoomer Systems with BARCO MDPC-8127 displays and was conducted using a color calibration slide and a chroma meter." For the other non-clinical tests (spatial resolution, pixel defects, etc.), the document states "compatibility... was determined based on testing the below specified parameters," but it does not explicitly state the number of displays or specific test slides used for each parameter.
• Data Provenance: Not explicitly stated, but the submission is from Hamamatsu Photonics K.K. (Japan), implying the testing was likely conducted by the manufacturer. The tests are non-clinical, so "retrospective or prospective" is not directly applicable in the typical clinical study sense.

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

Not applicable. The tests conducted were non-clinical, related to display and system compatibility parameters. Ground truth for these tests would be established through objective measurement against technical standards and specifications (e.g., using a color calibration slide and chroma meter for color reproducibility), rather than expert assessment of pathological slides.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the tests were non-clinical technical evaluations and would not involve expert adjudication as typically understood in diagnostic accuracy studies.

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. The document explicitly states: "No clinical studies were required to demonstrate substantial equivalence of the modified NanoZoomer S360MD Slide scanner system." This submission focuses on adding a compatible display to an already cleared device and establishing a PCCP, not on evaluating AI assistance or human reader performance.

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

Not applicable. The NanoZoomer S360MD Slide scanner system is a whole slide imaging system intended as an aid to a pathologist, not a standalone AI algorithm for diagnosis. The non-clinical tests evaluated the system's technical performance with a new display component.

7. The Type of Ground Truth Used

For the color reproducibility testing, the ground truth was based on a color calibration slide and objective measurements obtained using a chroma meter. For the other non-clinical tests, the ground truth would be against general engineering and display performance specifications and standards relevant to 21 C.F.R. § 864.3700.

8. The Sample Size for the Training Set

Not applicable. This submission concerns compatibility of a new display with an existing cleared system and a PCCP. There is no mention of a machine learning algorithm being trained as part of this submission. The system is a slide scanner and viewer, not an AI diagnostic tool that requires a training set in the typical sense.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there was no training set for an AI algorithm in this submission.

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NanoZoomer S360MD Slide scanner system ("NanoZoomer System") is an automated digital slide creation, viewing, and management system. The NanoZoomer System is intended for in vitro diagnostic use as an aid to the pathologist to review and interpret digital images of surgical pathology slides prepared from formalin-fixed paraffin embedded ("FFPE") tissue. The NanoZoomer System is not intended for use with frozen section, cytology, or non-FFPE hematopathology specimens.

The NanoZoomer System comprises the NanoZoomer S360MD Slide scanner, the NZViewMD Software and the JVC Kenwood JD-C240BN01A display. The NanoZoomer System is for creation and viewing of digital images of scanned glass slides that would otherwise be appropriate for manual visualization by conventional light microscopy. It is the responsibility of a qualified pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images obtained using NanoZoomer System.

The NanoZoomer S360MD Slide scanner system is an automated system for creating, viewing, and managing digital slides. The NanoZoomer S360MD Slide scanner system creates diagnostic-quality digital images of glass slides containing formalin-fixed paraffin-embedded ("FFPE") tissue. Each digital image covers an entire slide and typically contains billions of image pixels. Slide images may be viewed, stored, retrieved, duplicated, annotated, and/or shared, permitting the pathologist to make a primary diagnosis without needing to view the original glass slides through a light microscope.

The NanoZoomer S360MD Slide scanner system is comprised of the NanoZoomer S360MD Slide scanner, the NZViewMD Software and the JVC Kenwood JD-C240BN01A display.

Here's a summary of the acceptance criteria and study details for the NanoZoomer S360MD Slide scanner system, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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The NIRO-200NX DP is intended for use as an adjunct trend monitor of regional hemoglobin oxygen saturation and relative level of oxygenated hemoglobin and deoxygenated hemoglobin of blood in brain or in other tissue beneath the probes in any individual. The clinical value of trend data has not been demonstrated in disease states. The NIRO-200NX DP should not be used as the sole basis for diagnosis or therapy.

The NIRO-200NX is a piece of equipment that uses near infrared light for non-invasive measurement of hemoglobin oxygen saturation and relative levels of oxygenated hemoglobin and deoxygenated hemoglobin of blood in brain or in other tissue beneath the probes. Patient probes are applied to the skin over the tissue of interest. The probes have a light source and 2 photodiodes, one closer to the light source and one further away from the light source. The 2 photodiodes detect the light transmitted through the patient's tissue. The detected light is analyzed with the known light absorption characteristics of oxyhemoglobin and deoxyhemoglobin. The amount of light detected by the photodiode closer to the light source is subtracted from the light detected by the farther photodiode. The result is then used to calculate the hemoglobin oxygen saturation. Also, by measuring the changes in light detected from one of the photodiodes, the relative levels of oxygenated hemoglobin and deoxygenated hemoglobin are calculated.

The predicate NIRO-200NX (K143219) utilized reusable patient probes. The purpose of this premarket notification is to obtain clearance for use of disposable probes and compatible connectors with the cleared display unit. Use of the disposable probes and compatible connectors with the cleared display unit is referred to as the NIRO-200NX DP.

The provided text describes the 510(k) summary for the Hamamatsu NIRO-200NX DP device. This document is a premarket notification to the FDA to demonstrate that the new device is substantially equivalent to a predicate device already on the market.

Based on the provided document, here's a breakdown of the acceptance criteria and the study that proves the device meets them:

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

The document does not present explicit acceptance criteria for performance in a quantitative table with corresponding numerical performance results. Instead, the performance testing focuses on demonstrating substantial equivalence to an existing predicate device (Hamamatsu NIRO-200NX, K143219).

The key "acceptance criteria" can be inferred from the areas where substantial equivalence was demonstrated:

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

The primary performance study mentioned is a phantom study.

• Sample Size: The document does not specify a quantitative sample size (e.g., number of phantom measurements, or number of different phantom conditions). It only states "a phantom study to compare performance."
• Data Provenance: The study was "performed a phantom study to compare performance of the proposed and predicate device side by side in a simulated model." This indicates a laboratory or in-vitro setting, not human data. The document also mentions the device has been sold and used clinically for more than two years in Japan and Europe without any reported adverse events, which is real-world observational data, but not a controlled clinical test set.

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

Not applicable. The reported performance data comes from a phantom study comparing the new device against a predicate device in a simulated model, and from engineering tests (electrical safety, EMC, laser safety). There is no mention of human expert involvement for establishing ground truth in these types of tests, as these are objective physical measurements.

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

Not applicable. This concept applies to studies involving human interpretation or subjective assessments, often in imaging. The described studies are objective phantom measurements and engineering tests.

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. The NIRO-200NX DP is an oximeter, a measurement device, not an AI-assisted diagnostic imaging system that would involve human readers interpreting cases.

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

Yes, in a sense. The phantom study evaluates the device's measurement capability independently. The device itself performs the measurement of hemoglobin oxygen saturation and relative levels of oxygenated and deoxygenated hemoglobin based on light absorption, which is an algorithmic process. The study evaluates the device's performance in isolation from a human operator's interpretation of the raw signals, though the operator would monitor the calculated values.

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

For the phantom study, the "ground truth" is implied to be the known or established properties of the simulated tissue phantom model and the performance of the predicate device which is already cleared and accepted. The goal was to prove substantial equivalence, meaning the new device performs measurements consistent with the predicate device in the same conditions. For the electrical, EMC, and laser safety tests, the "ground truth" is established by the standards (IEC 60601-1, IEC 60601-1-2, IEC 60825-1) themselves, which define acceptable parameters.

8. The sample size for the training set

Not explicitly stated. The device is not a "learning" algorithm in the sense of modern deep learning AI that requires a labeled training set. It's a measurement device based on established physical principles (near-infrared light absorption characteristics of oxyhemoglobin and deoxyhemoglobin). If there's any internal calibration or parameter tuning, the "training set" would likely be laboratory measurements or physical models used during design and development, but this is not detailed in the 510(k) summary.

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

Not applicable or not detailed, as elucidated in point 8. The device operates on fixed physical principles rather than being a trained AI model.

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The NIRO-200NX is intended for use as an adjunct trend monitor of regional hemoglobin oxygen saturation and relative level of oxygenated hemoglobin and deoxygenated hemoglobin of blood in brain or in other tissue beneath the probes in any individual. The clinical value of trend data has not been demonstrated in disease states. The NR0-200NX should not be used as the sole basis for diagnosis or therapy.

The NIRO-200NX is a reusable piece of equipment that uses near infrared light for non-invasive measurement of hemoglobin oxygen saturation and relative levels of oxygenated hemoglobin and deoxygenated hemoglobin of blood in brain or in other tissue beneath the probes. The patient probes are applied to the skin over the tissue of interest. The probes have a light source and 2 photodiodes, one closer to the light source and one further away from the light source. The 2 photodiodes detect the light transmitted through the patient's tissue. The detected light is analyzed with the known light absorption characteristics of oxyhemoglobin and deoxyhemoglobin. The amount of light detected by the photodiode closer to the light source is subtracted from the light detected by the farther photodiode. The result is then used to calculate the hemoglobin oxygen saturation. Also, by measuring the changes in light detected from one of the photodiodes, the relative levels of oxygenated hemoglobin and deoxygenated hemoglobin are calculated.

The provided document describes the Hamamatsu NIRO-200NX device, a near-infrared oximeter, and its clearance process. Here's a breakdown of the acceptance criteria and the studies that support it:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally framed as the device performing "equivalently" to predicate devices, rather than specific quantitative thresholds.

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

Phantom Study:

• Sample Size: Not explicitly stated as a number of "samples" but implied to be a comparative study using multiple phantom configurations.
• Data Provenance: Retrospective, conducted internally by Hamamatsu (manufacturer of NIRO-200NX).

Published Clinical Literature (Bickler et al.):

• Sample Size: 23 individuals for the comparison between NIRO-200NX and INVOS.
  • 181 individual measurements for INVOS.
  • 179 individual measurements for NIRO-200NX.
• Data Provenance: Prospective clinical study. The country of origin for the study is not specified in the provided text.

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

The document does not specify the number or qualifications of experts used to establish ground truth for the phantom study.

For the clinical study (Bickler et al.), the ground truth for regional hemoglobin oxygen saturation was established through blood draw results, which is a direct, objective measurement, not based on expert interpretation.

4. Adjudication Method for the Test Set

Not applicable. The ground truth for the clinical study was based on direct blood draw measurements, which does not require adjudication. For the phantom study, the ground truth was based on the controlled properties of the phantom, also not requiring adjudication.

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. This device is an oximeter, which provides quantitative measurements, not images requiring human interpretation or AI assistance in reading. There are no "human readers" involved in interpreting the device's direct output in the context of an MRMC study.

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

Yes, the NIRO-200NX is a standalone device that provides measurements directly. Its performance as an algorithm-only device was evaluated both through the phantom study and the comparison to blood draws in the clinical study.

7. The Type of Ground Truth Used

• Phantom Study: Controlled and known properties of tissue phantoms (simulated models).
• Clinical Study (Bickler et al.): Direct blood draw results (for regional hemoglobin oxygen saturation).

8. The Sample Size for the Training Set

The document does not specify a training set sample size. This is typical for devices using established biophysical principles and comparative equivalence to predicates, rather than machine learning models that require explicit training datasets. The device's underlying principles are based on known light absorption characteristics of oxyhemoglobin and deoxyhemoglobin.

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

Not applicable, as no explicit machine learning training set is mentioned or implied. The device's operation is based on established optical spectroscopy principles rather than data-driven machine learning training.

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The Pde-neo is an imaging system used in capturing fluorescent images for the visual assessment of blood flow, as an adjunctive method for the evaluation of tissue perfusion, and related tissue-transfer circulation in tissue and free flaps used during plastic, micro-, reconstructive, and organ transplant surgeries.

The pde-neo is an imaging system used in capturing and viewing fluorescent images for the visual assessment of blood flow, as an adjunctive method for the evaluation of tissue perfusion, and related tissue-transfer circulation in tissue and free flaps used during plastic, micro-, reconstructive, and organ transplant surgeries. The pde-neo is intended for intraoperative visual assessment of blood vessels and related tissue perfusion by enabling surgeons to observe fluorescent images of blood vessels and related tissue perfusion. Indocyanine green (ICG) is injected intravenously into patients. Infrared light-emitting diodes (LEDs) are used to excite the fluorescence of ICG and illuminate the regions of a patient's anatomy to be observed. A charge coupled device (CCD) camera captures the fluorescent image that is used to assess the blood vessels and related tissue perfusion.

The pde-neo consists of the following components: Camera Unit, Controller, and Remote Controller. The Camera Unit contains a CCD camera and LED light sources and is used either by hand or attaching it to a mechanical arm. The Controller receives the video signal of the fluorescent image from the Camera Unit and outputs the processed fluorescent image to the external video monitor and recorder. Adjustments of the fluorescent image are possible either by the Camera Unit or the Remote Controller.

This document describes the 510(k) summary for the pde-neo, a fluorescent angiographic system.

1. Table of acceptance criteria and the reported device performance:

The document does not explicitly state quantitative acceptance criteria in terms of performance metrics (like sensitivity, specificity, accuracy). Instead, the performance evaluations focus on functional aspects, safety, and image quality comparison to a predicate device.

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

• Test set sample size: Not explicitly stated for image quality or functional testing. The "study of image quality" is mentioned but without the number of images or cases.
• Data provenance: Not specified. Given that Hamamatsu Photonics K.K. is the submitter in Japan, the data likely originates from Japan, but it's not confirmed whether it was retrospective or prospective.

3. 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 image quality study is mentioned but lacks details on human expert involvement or ground truth establishment.

4. Adjudication method for the test set:

This information is not provided in the document.

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:

A multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not conducted or reported. This device is not an AI-assisted diagnostic tool in the sense of providing automated interpretations or predictions that would require such a study. It's an imaging system providing visual information to the surgeon.

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

A standalone algorithm-only performance study was not explicitly reported or necessary for this device type. The device provides visual information for human interpretation, not automated diagnostic outputs. The "software verification" indicated that the software operates as intended but doesn't describe an algorithm's standalone performance in a medical context.

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

The document does not explicitly define the type of ground truth used. For the "image quality study," the implication is that images from the new device were compared against those from the predicate device to establish "substantial equivalence" in quality, likely based on visual assessment.

8. The sample size for the training set:

There is no mention of a "training set" as this device does not appear to employ machine learning or AI that would require one for its primary function.

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

Not applicable, as no training set for machine learning/AI is described.

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The PDE is an imaging system used in capturing and viewing fluorescent images for the visual assessment of blood flow as an adjunctive method for the evaluation of tissue perfusion, and related tissue-transfer circulation in tissue and free flaps used during plastic, micro-, reconstructive and organ transplant surgeries.

The PDE is an imaging system used in capturing and viewing fluorescent images for the visual assessment of blood flow as an adjunctive method for the evaluation of tissue perfusion, and related tissue-transfer circulation in tissue and free flaps used during plastic, micro-, reconstructive and organ transplant surgeries. The PDE is intended for intraoperative visual assessment of blood vessels and related tissue perfusion, by enabling surgeons to observe fluorescent images of blood vessels and related tissue perfusion. Indocyanine green (ICG) is injected intravenously into patients. Infrared light-emitting diodes (LEDs) are used to excite the fluorescence of ICG and illuminate the regions of a patient's body to be observed. A charge coupled device (CCD) camera captures the fluorescent image that is used to assess the blood vessels and related tissue perfusion. The PDE consists of the following components: Camera Unit, Controller, and Remote Controller. The Camera Unit contains a CCD camera and LED light sources and is used either by hand or attaching it to a mechanical arm. The Controller receives the video signal of the fluorescent image from the Camera Unit and outputs the processed fluorescent image to the external video monitor and recorder. Adjustments of the fluorescent image are possible either by the Camera Unit or the Remote Controller.

The provided document describes a 510(k) submission (K110480) for the Hamamatsu Photonics K.K. PDE device, a fluorescent angiographic system. This device is an imaging system used for the visual assessment of blood flow as an adjunctive method for evaluating tissue perfusion and related circulation in certain surgical contexts.

However, the document does not contain the detailed information typically found in a clinical study report that would allow for a comprehensive description of acceptance criteria and a study proving the device meets those criteria, especially in the context of an AI/human-in-the-loop system.

Instead, the submission primarily focuses on establishing substantial equivalence to predicate devices (Novadaq Technologies Inc.'s SPY Imaging System SP2000 and SPY Fluorescent Imaging System SP2001) based on:

• Identical intended use, indications for use, and principles of operation.
• Similar technological characteristics.
• Safety and efficacy confirmation through Hamamatsu's testing and validation activities.

The "Performance data" section lists the following as having been conducted:

1. Electrical per IEC 60601-1.
2. Electromagnetic Compatibility per IEC 60601-1-2.
3. Light Emitting LED Product per IEC 60825-1 (Class1 LED product).
4. Clinical use in Japan for 5 years without adverse events and a review of published literature.

This submission is for a medical imaging device, not an AI algorithm, and therefore the types of studies and acceptance criteria (e.g., MRMC, standalone algorithm performance, ground truth establishment by experts, adjudication methods) relevant to AI-based medical devices are not detailed.

Therefore, based only on the provided text, I cannot complete a table of acceptance criteria and reported device performance, nor can I describe study specifics like sample size for test sets, number of experts, adjudication methods, MRMC studies, or specific ground truth methodologies in the way you've outlined for an AI-centric study.

The document does mention "clinical tests" and states that "All tests demonstrate that the device functions as intended," and refers to "a review of the published literature" and 5 years of clinical use in Japan. However, these are high-level statements and do not provide the granular detail required for your request.

Summary of what can be extracted from the document regarding "proof" the device meets criteria (though not in the requested format):

• Acceptance Criteria (Implied):
  • Compliance with electrical safety (IEC 60601-1).
  • Compliance with electromagnetic compatibility (IEC 60601-1-2).
  • Compliance with LED product safety (IEC 60825-1, Class 1).
  • Functioning as intended for visual assessment of blood flow for tissue perfusion (based on substantial equivalence and lack of adverse events in 5 years of clinical use in Japan).
  • Being at least as safe and effective as predicate devices.
• Reported Device Performance (Implied from the text):
  • "All tests demonstrate that the device functions as intended."
  • "The PDE has been sold and used clinically for 5 years in Japan without any adverse events."
  • "A review of the published literature concludes that the device worked as intended by safely assessing the blood flow and related tissue perfusion during surgeries."
  • The FDA's determination of "substantial equivalence."

In conclusion, the provided 510(k) summary focuses on demonstrating substantial equivalence and compliance with general safety and performance standards for a traditional medical device, not on specific AI algorithm performance metrics or study designs typically employed for AI/ML-based medical devices.

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The Hamamatsu PET Scanner Model SHR-22000 is indicated for the imaging of the distribution in the body of physiological tracer molecules labeled with positron-emitting isotopes. Such images are particularly useful in the assessment of brain function.

The Hamamatsu PET Scanner Model SHR-22000 is similar to previous PET scanners marketed by other companies, but it represents an increase in performance over other PET Scanners through improved resolution. The system was developed in a joint venture with Hitachi Medical Corporation (HMC). HMC provided the imaging workstation, patient table, and user interface, adapted from its nuclear medicine imaging workstation.

The SHR-22000 PET Scanner system consists of five main subsystems: the main gantry with the detector arrays, the signal processing unit, the data acquisition unit, the patient table and positioning sub-system, and the imaging workstation and user interface.

Model SHR-22000 has almost 22000 scintillator segments in its detector arrays, providing very fine resolution. The gantry also has a 6Ge-6Ga source mounted in a stainless steel rod for calibration.

The provided document describes a 510(k) premarket notification for the Hamamatsu PET Scanner Model SHR-22000. This is a medical imaging device, and the submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria for an AI/CADe device.

Therefore, many of the requested elements (acceptance criteria, specific performance metrics, sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, standalone performance, etc.) are not applicable or not explicitly detailed in this type of regulatory submission for a hardware device like a PET scanner.

Here's an breakdown based on the information available:

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

• Acceptance Criteria: Not explicitly stated as quantifiable metrics for a specific diagnostic task like an AI/CADe device. The primary "acceptance criteria" for a 510(k) submission for a traditional medical device are demonstrating substantial equivalence to a legally marketed predicate device. This typically involves demonstrating similar technological characteristics and performance (e.g., image quality, resolution, safety) to the predicate.
• Reported Device Performance: The document states:
  • "Model SHR-22000 has almost 22000 scintillator segments in its detector arrays, providing very fine resolution." (This is a design characteristic, implying improved resolution).
  • "The system was developed in a joint venture with Hitachi Medical Corporation (HMC). HMC provided the imaging workstation, patient table, and user interface, adapted from its nuclear medicine imaging workstation."
  • "Imaging performance tests were carried out to assure equivalence of image characteristics with the predicate device." However, specific numerical performance metrics (e.g., spatial resolution in mm, sensitivity in cps/kBq) are not provided in this summary.

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 / Not explicitly detailed. This document is for a hardware PET scanner. The "testing" mentioned refers to compliance with electrical safety and general imaging performance characteristic equivalence, not a clinical study on a patient test set for a diagnostic algorithm.

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 such clinical test set or ground truth establishment is described in this 510(k) summary for a PET scanner.

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

• Not applicable. See point 3.

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 is a hardware device (PET scanner), not an AI/CADe algorithm. MRMC studies are typically performed for AI or CADe devices to assess improved reader performance.

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

• Not applicable. This describes a hardware device, not an algorithm.

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

• Not applicable. No clinical ground truth is mentioned for performance evaluation in this 510(k) summary. The "testing" focused on device characteristics and safety.

8. The sample size for the training set:

• Not applicable. This is a hardware device; there isn't a "training set" in the context of an AI algorithm.

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

• Not applicable. See point 8.

Summary for the Hamamatsu PET Scanner Model SHR-22000:

This 510(k) summary demonstrates that the Hamamatsu PET Scanner Model SHR-22000 is substantially equivalent to the Siemens ECAT Exact HR PET scanner (K962797). The equivalence is based on similar indications for use, technological characteristics (coincidence detection, scintillator segments, image reconstruction), and the results of imaging performance tests to ensure similar image characteristics. The details provided are typical for a hardware device submission, focusing on safety and equivalence to established technology rather than rigorous clinical performance metrics for a diagnostic algorithm.

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