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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

2. Sample Size for the Test Set and Data Provenance

The document does not explicitly state the total sample size for the test set across all studies, nor the country of origin. It indicates that the primary diagnosis study involved multiple organs with varying numbers of cases:

• Breast: 1198 (Observed) cases for WSI Major Discordance, 1200 (Observed) for Glass Major Discordance
• Prostate: 1200 (Observed) cases for WSI Major Discordance, 1200 (Observed) for Glass Major Discordance
• Respiratory: 400 cases
• Colorectal: 600 cases
• GE Junction: 400 cases
• Stomach: 400 cases
• Skin: 700 cases
• Lymph Node: 400 cases
• Bladder: 400 cases
• Gynecological: 600 cases
• Liver/Bile Duct: 200 cases each
• Endocrine: 400 cases
• Brain/Neuro: 240 cases
• Kidney: 200 cases
• Salivary Gland: 200 cases
• Hernial/Peritoneal, Gallbladder, Appendix, Soft Tissue Tumors, Anus/Perianal, Other Miscellaneous: Smaller numbers, some as low as 40 or 79.

The data provenance is not specified as retrospective or prospective, but the description of the "Primary Diagnosis Study" suggests a prospective comparison between WSI and glass slide diagnoses.

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

The document does not specify the exact number of experts (pathologists) involved in establishing the ground truth, nor their specific qualifications (e.g., years of experience). It only states that the system is intended "as an aid to the pathologist to review and interpret digital images" and that "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."

4. Adjudication Method for the Test Set

The document does not describe a specific adjudication method (e.g., 2+1, 3+1, none) for the test set. It mentions "major discordance rates" between WSI diagnoses and Glass diagnoses, implying a comparison against an existing diagnosis, but the process of resolving disagreements or establishing a definitive ground truth in cases of discordance is not detailed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance

The study described is a comparative effectiveness study comparing WSI diagnoses to glass slide diagnoses. It is not an "AI vs. without AI assistance" study. The NanoZoomer System is described as an "automated digital slide creation, viewing, and management system" and not specifically an AI-driven diagnostic aid. Therefore, the effect size of human readers improving with AI vs without AI assistance is not applicable or provided.

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

No, a standalone (algorithm only) performance study was not done. The NanoZoomer System is described as a tool for a pathologist to review and interpret images – a human-in-the-loop system.

7. The Type of Ground Truth Used

For the primary diagnosis study, the ground truth appears to be established through the comparison of diagnoses made using the NanoZoomer System (WSI diagnoses) versus diagnoses made using conventional light microscopy of glass slides (Glass diagnoses). The document specifically details "major discordance rates" between these two methods rather than against an independent gold standard like pathology or outcomes data. For the feature detection study, the ground truth is inferred by the agreement rates of feature detection across different scans/scanners/sites, essentially defining agreement as the ground truth.

8. The Sample Size for the Training Set

The document does not mention a training set. The NanoZoomer System is primarily a slide scanning, viewing, and management system, not described as an AI algorithm that requires a separate training set for diagnostic purposes.

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

As no training set is mentioned for an AI algorithm, this information is not applicable.

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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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