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The VS800 system is an automated digital slide creation, management, and viewing system. It is intended for in vitro diagnostic use as an aid to the pathologist in the display, detection, counting and classification of tissues and cells of clinical interest based on particular color, intensity, size, pattern and shape.

The VS800HER2 Manual Read (MR) of digital slide application is intended for use as an aid to the pathologist in the detection and semi-quantitative measurement of HER2 by manual examination of the digital slide of formalin-fixed, paraffin-embedded and neoplastic tissue IHC stained for HER2 receptors on a computer monitor. HER2 results are indicated for use as an aid in the management, prognosis and prediction of therapy outcomes of breast cancer.

The VS800HER2 MR of digital slide application is intended for use as an accessory to the DakoHercepTest to aid the pathologist in the detection and semi-quantitative measurement of HER2 by manual examination of the digital slide of formalin-fixed, paraffin-embedded and neoplastic tissue immunohistochemically stained for HER2 receptors on a computer monitor. When used with the Dako Hercep Test, it is indicated for use as an aid in the assessment of breast cancer patients for whom HERCEPTIN® (Trastuzumab) treatment is being considered.

Note: The actual correlation of the Dako Hercep Test to the Herceptin® clinical outcome has not been established.

The VS800 System is an automated digital slide creation, management and viewing system. The VS800 System components consist of an automated digital microscope slide scanner (VS800-SS) which include a computer, keyboard and mouse, operating monitor (VS800-MTR) and VS Viewer software (VS2-ASW-IDB). The system capabilities include digitizing microscope slides at high resolution, storing and managing the resulting digital slide images, retrieving and displaying digital slides, including support for remote access over wide-area networks, providing facilities for annotating digital slides and editing metadata associated with digital slides, and facilities for image analysis of digital slides. The remote digital slide viewing capabilities of the system support reading digital slides on a computer monitor, enabling Pathologists to make clinically relevant decisions analogous to those they make using a conventional microscope. Specifically, the system supports the pathologist in the detection of HER2/neu by manual examination of the digital slide of formalin-fixed, paraffin-embedded normal and neoplastic tissue immunohistochemically stained for HER2 receptors on a computer monitor.

The VS800-SS (an automated digital microscope slide scanner) creates high resolution, color digital slide images of entire glass slides in a matter of minutes. High numeric aperture 20x objectives, specially designed for VS800-SS optical system and real time contrast auto focus system (AF) are used to produce high-quality images. VS800-SS employs a 2D CCD imager for fine image acquisition which is same technologies used in conventional microscope imaging system. VS800-SS captured image is as same as conventional microscope image.

The VS-ASW-IDB (VS Viewer software) is a full-featured digital pathology information management system. The software runs on a server computer, which stores digital slide images on disk storage such as a RAID array, and which hosts an SQL database that contains digital slide metadata. The VS-ASW-IDB includes a web application and services which encapsulate database and digital slide image access for other computers. The VS-ASW-IDB also includes support for locally or remotely connected Image Server, which run digital slide viewing software provided as part of VS-ASW-IDB.

The laboratory technician or operator of VS800-SS loads glass microscope slides into a specially designed slide carrier with a capacity up to 100 slides per carrier (300 total). The scanning process begins when the operator starts the VS800-SS scanner and finishes when the scanner has completed scanning of all loaded slides. As each glass slide is processed, the system automatically stores stitched images as a single digital slide image, which represents a histological reconstruction of the entire tissue section. When the slide scanning finished, then operator of scanner will confirms the image quality and records to the database. When the images are recorded, pathologists or authorized parsons can observe these images to access the VS-ASW-IDB.

Here's a summary of the acceptance criteria and study details for the Olympus VS800HER2 MR Application, based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

Note: The study describes percentages of agreement without predefined acceptance thresholds for substantial equivalence in the document. The statistical analysis is presented as Percent Agreement (PA) with a 95% Confidence Interval (CI) between manual microscopy reads and manual digital reads, and for precision studies.

Study Details for the Olympus VS800HER2 MR Application

1. Sample Size Used for the Test Set and Data Provenance:

   • Sample Size: 100 slides per clinical site, so a total of 200 slides were used for the comparison study (100 slides at Site 1, 100 slides at Site 2).
   • For the precision study, a subset of 30 slides from the comparison study was used.
   • Data Provenance: Retrospective. The slides were "selected from archive." The country of origin is not explicitly stated, but the study was conducted at "two clinical sites," implying local (likely within the US, given FDA submission context) data.

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

   • Number of Experts: Six pathologists in total for the comparison study (three at each of two clinical sites). One pathologist for the precision study (who repeated reads).
   • Qualifications of Experts: Described as "Pathologists." Specific years of experience or sub-specialty certifications are not provided in the summary.

3. Adjudication Method for the Test Set:

   • Adjudication Method: None for establishing a single "ground truth." The study compared each pathologist's "manual digital reads" against their own "manual microscopy reads." This is a paired comparison, where the conventional microscopy read by the same pathologist is considered the reference for that pathologist's digital read. The summary doesn't describe an external or consensus ground truth for the comparison study itself; rather, it assesses agreement between two reading methods by the same individual.
   • For the precision study, there was also no external adjudication; it assessed agreement of repeated reads by a single pathologist.

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:

   • This was a Multi-Reader Multi-Case (MRMC) comparative effectiveness study of digital pathology reads vs. conventional microscopy reads, but without AI assistance. The VS800HER2 MR Application is a "Manual Read" application, meaning the pathologist manually interprets the digital image.
   • Therefore, there is no AI component, and no effect size regarding human readers improving with AI assistance is reported or applicable to this specific application. The study focuses on the agreement between conventional microscopy and manual reading of digital slides.

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

   • No standalone algorithm-only performance study was done. The device (VS800HER2 MR Application) is explicitly described as for "Manual Read (MR) of digital slide application," intended "as an aid to the pathologist in the detection and semi-quantitative measurement of HER2 by manual examination of the digital slide." It is a display and management system for pathologists to manually review digital slides, not an automated AI-driven diagnostic algorithm.

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

   • For the comparison study: The "ground truth" or reference standard for each pathologist's digital read was their own prior manual microscopy read of the physical glass slide. This is a paired comparison, where the same pathologist acts as their own control.
   • For the precision study: The reference was the pathologist's own repeated manual digital reads from the same or different instruments.

7. The sample size for the training set:

   • The 510(k) summary does not mention a training set for an algorithm, as the VS800HER2 MR Application is a manual read application. The study described is entirely a clinical validation/test set.

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

   • Not applicable, as there is no mention of a training set or an algorithm being developed (which would typically require a training set with established ground truth). The device acts as a digital visualization and management system for manual pathologist interpretation.

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System reagent for the quantitative determination of IgM immunoglobulins in human serum and plasma on OLYMPUS analyzers. For in vitro diagnostic use.

In this Olympus procedure:

• When a sample is mixed with R1 buffer and R2 antiserum solution, human IgM reacts specifically with anti-human IgM antibodies to yield insoluble aggregates.
• Immune complexes formed in solution scatter light in proportion to their size, shape and concentration.
• Turbidimeters measure the reduction of incidence light due to reflection, absorption or scatter.
• In the Olympus procedure, the decrease in intensity of light transmitted (increase in absorbance) through particles suspended in solution is as a result of complexes formed during the antigen-antibody reaction.

The provided 510(k) summary describes a new Olympus IgM reagent (OSR6X173) and compares its performance to a predicate device. This document is a premarket notification for a diagnostic reagent, which falls under IVD (in vitro diagnostic) devices. For IVD devices, the "study" typically refers to analytical and clinical performance studies, not AI-specific studies like MRMC or standalone algorithm performance. Therefore, many of the requested items related to AI device performance (e.g., number of experts, adjudication methods, MRMC studies, standalone performance, training set details) are not directly applicable or reported in this type of submission.

Here's an analysis based on the provided text, focusing on the available information:

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

The document does not explicitly state "acceptance criteria" in a separate section. Instead, it presents performance characteristics of the new device and the predicate device side-by-side, implying that the new device's performance is acceptable if it is comparable to or better than the predicate. For the purpose of this analysis, I will treat the performance values of the predicate device and the new device as demonstrating acceptable performance through substantial equivalence.

Study Proving Device Meets Acceptance Criteria:

The study described is a comparative analysis against a legally marketed predicate device (Olympus (OSR6X46) IgM Reagent, K950900). The manufacturer carried out various analytical performance tests, including precision, assay range determination, prozone effect evaluation, method comparison (linear regression), and interference studies. The data presented demonstrates that the new device's analytical performance is substantially equivalent to the predicate device, or in some cases, improved (e.g., higher prozone limit).

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

• Test Set Sample Size:
  • Method Comparison: N = 107 (for linear regression). This represents 107 human serum/plasma samples analyzed.
  • Precision: The table lists 3 samples for each instrument type (AU400/400e, AU600/640/640e, AU2700/5400). It's implied that these samples were run multiple times to calculate the Total CV%.
  • Interfering Substances: The exact number of samples for each interference study is not specified, but the data indicates the upper limit of interferent concentration at which interference remained below a specified threshold.
• Data Provenance: The document states the intended use is for "human serum and plasma." The country of origin for the data is not specified in this summary. The studies appear to be prospective analytical performance evaluations performed by the manufacturer as part of the 510(k) submission.

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

This is not applicable for this type of IVD device. The ground truth for IgM measurement is established through quantitative laboratory methods, not by expert interpretation in an AI context. The predicate device's measurements serve as the reference for method comparison.

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

Not applicable. Adjudication methods are relevant for subjective interpretations (e.g., radiology reads) where discrepancies between experts need to be resolved. This device measures a quantitative analyte.

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 is an IVD reagent and not an AI-assisted diagnostic imaging or interpretation device.

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

This is not an AI algorithm. The device is a chemical reagent used in a laboratory analyzer. Its performance is inherently "standalone" in the sense that it directly measures IgM concentration, without human interpretive input for the measurement itself, but operated by laboratory personnel.

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

The "ground truth" a.k.a. reference method for the quantitative determination of IgM in the method comparison study is the predicate device (Olympus (OSR6X46) IgM Reagent, K950900), which is a legally marketed and presumably validated method for IgM quantification. The calibrator traceability is to the International Reference Preparation CRM470, which serves as a metrological standard.

8. The sample size for the training set:

Not applicable. This is not an AI device that requires a training set. The "training" for such a system would involve validating the chemical formulation and assay parameters through analytical studies.

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

Not applicable, as there is no training set in the context of an AI device. The development of the reagent involves chemical formulation and optimization, with performance verified against established analytical standards and reference methods.

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System reagent for the quantitative determination of IgA immunoglobulins in human serum and plasma on OLYMPUS analyzers.
For in vitro diagnostic use.

In this Olympus procedure:
When a sample is mixed with R1 buffer and R2 antiserum solution, human IgA reacts specifically with anti-human IgA antibodies to yield insoluble aggregates.
Immune complexes formed in solution scatter light in proportion to their size, shape and concentration.
Turbidimeters measure the reduction of incidence light due to reflection, absorption or scatter.
In the Olympus procedure, the decrease in intensity of light transmitted (increase in absorbance) through particles suspended in solution is as a result of complexes formed during the antigen-antibody reaction.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Olympus IgA Reagent (OSR6X171):

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

Note: Acceptance criteria are inferred based on the performance of the predicate device, as the document states "The following Tables compare the new Olympus IgA (OSR6X171) reagent with the predicate devices..." implying that comparable performance to the predicate is the acceptance standard for substantial equivalence.

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

• Precision: The sample sizes for the precision studies are not explicitly stated, but "Sample 1," "Sample 2," and "Sample 3" for each instrument suggest multiple measurements were taken for each of these samples. The number of replicates per sample and the total number of samples tested are not provided.
• Method Comparison (Linear Regression): N = 111 samples were used for the method comparison study.
• Interfering Substances: The sample sizes for interference studies are not provided.
• Prozone Capacity: The sample sizes for prozone capacity testing are not provided.
• Data Provenance: The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective. Given it's a 510(k) submission, it is typically based on prospective studies conducted in controlled laboratory settings for device validation.

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

This document describes an in vitro diagnostic (IVD) reagent, not an AI/CADe device that uses expert-established ground truth from medical images. Therefore, this information is not applicable. For IVDs, the "ground truth" is typically established through reference methods or highly accurate comparative assays. In this case, the predicate device (Olympus IgA (OSR6X44) Reagent) served as the comparator for method comparison, and the "calibration traceability" to the International Reference Preparation CRM 470 (US designation RPPHS lot 91/0619) provides the ultimate "ground truth" for the quantitative measurements.

4. Adjudication Method for the Test Set

Not applicable, as this is an IVD reagent and not an AI/CADe device involving human expert 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 is an IVD reagent, not an AI/CADe device, and does not involve human readers interpreting results.

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

The device is an IVD reagent that performs quantitative measurements on Olympus analyzers. Its performance is inherently standalone in the sense that the measurement results are generated by the instrument and reagent system without human interpretation for the determination of the IgA level itself. The physician then interprets these quantitative results in a clinical context. The performance characteristics described (precision, assay range, method comparison, interference, prozone capacity) all reflect the standalone performance of the reagent on the specified analyzers.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the quantitative determination of IgA, the "ground truth" is implicitly established by:

• Traceability to an International Reference Preparation: The method is traceable to the International Reference Preparation CRM 470 (US designation RPPHS lot 91/0619). This serves as the primary reference standard for accurate IgA quantification.
• Comparison to a Legally Marketed Predicate Device: The performance is compared against the previously approved Olympus IgA (OSR6X44) Reagent (K951055), which itself would have been validated against accepted reference methods and standards.

8. The Sample Size for the Training Set

Not applicable. This is an IVD reagent, not a machine learning or AI device that uses a "training set" in the conventional sense. The development of such a reagent involves chemical formulation and analytical validation, not algorithm training.

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

Not applicable, as there is no "training set" for this type of device. The accuracy of the reagent is validated against established quantitative standards and predicate device performance.

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System reagent for the quantitative determination of IgG immunoglobulins in human serum, plasma and cerebrospinal fluid on OLYMPUS analyzers.
The measurement of IgG aids in the diagnosis of abnormal protein metabolism and the body's lack of ability to resist infectious agents.
For in vitro diagnostic use.

In this Olympus procedure:
When a sample is mixed with R1 buffer and R2 antiserum solution, human IgG reacts specifically with anti-human IgG antibodies to yield insoluble aggregates.
Immune complexes formed in solution scatter light in proportion to their size, shape and concentration.
Turbidimeters measure the reduction of incidence light due to reflection, absorption or scatter.
In the Olympus procedure, the decrease in intensity of light transmitted (increase in absorbance) through particles suspended in solution is as a result of complexes formed during the antigen-antibody reaction.

The provided document is a 510(k) summary for a medical device called "Olympus IgG Reagent (OSR6X172)". This is an in vitro diagnostic device, specifically a reagent used for quantitative determination of IgG immunoglobulins. The acceptance criteria and supporting studies are presented by comparing the new device's performance characteristics with those of predicate devices already on the market.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is an in vitro diagnostic reagent rather than an imaging or AI-driven diagnostic device, the "acceptance criteria" are not framed in terms of metrics like sensitivity, specificity, or AUC, but rather in terms of demonstrating substantial equivalence to predicate devices through various performance characteristics. The acceptance criterion is generally that the new device's performance characteristics (e.g., precision, assay range, method comparison) are comparable to or better than the predicate's, and suitable for its intended use.

Here's a table summarizing the reported device performance and comparison to predicate devices, acting as de-facto acceptance criteria for substantial equivalence:

Serum/Plasma Applications

CSF Application

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

• Serum/Plasma Method Comparison:
  • Sample Size (n): 120 samples for the new device study. The predicate had n=98.
  • Data Provenance: Not explicitly stated (e.g., country of origin). However, given the context of a 510(k) submission for the US market, it's typically assumed to be relevant clinical samples, likely from a US-based or similar regulated environment unless specified otherwise. No indication of retrospective or prospective.
• CSF Method Comparison:
  • Sample Size (n): Not explicitly stated numbers for the new device in the table for CSF, but linear regression data is provided. The predicate's study data (R2=1.000) shows a range of 1.07-18.6 mg/dL indicative of using patient samples, but the 'n' is not mentioned.
  • Data Provenance: Not explicitly stated (e.g., country of origin, retrospective or prospective).
• Precision: 3 samples (levels) were tested for each instrument platform (AU400/400e, AU600/640/640e, AU2700/5400) for both serum/plasma and CSF applications. These would typically be control materials or pooled patient samples.
• Interfering Substances: Testing was conducted at specific concentrations of bilirubin, hemolysate, lipemia, and RF (for serum/plasma) or bilirubin and hemolysis (for CSF). The number of individual samples tested at these concentrations is not specified.

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

This document describes the performance of an in vitro diagnostic reagent measuring a biochemical analyte (IgG). "Ground truth" in this context refers to the true concentration of IgG in the samples, which would usually be established by a reference method or a highly accurate, often predicate, measurement system. Expert consensus or interpretation (e.g., radiologists) is not applicable here. The "ground truth" for the method comparison studies is the result obtained from the predicate device or a recognized reference method.

4. Adjudication Method for the Test Set

Not applicable. As described above, this is for an in vitro diagnostic reagent, not a diagnostic imaging or AI-driven device requiring human adjudication of results. The performance is assessed by comparing quantitative results to a predicate device's results.

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 is an in vitro diagnostic reagent, not an AI-assisted diagnostic device, and therefore does not involve human readers or MRMC studies.

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

This device is a standalone diagnostic test in the sense that it performs a quantitative measurement on a biochemical analyzer without direct human interpretation of a complex output. The tables provided illustrate the performance of the reagent on various Olympus AU analyzers. This data directly represents the "algorithm only" performance (i.e., the reagent's performance on the specified instruments).

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The "ground truth" for the test set (method comparison) was obtained by running the same patient samples on the predicate device(s).

• For Serum/Plasma, the predicate was "Olympus (OSR6145) IgG Reagent".
• For CSF, the predicate was "Roche Tina-Quant IgG GEN.2".
  The precision and interference studies use contrived samples (e.g., spiked samples, control materials) where the "true" value or concentration is known or independently verified.

8. The Sample Size for the Training Set

Not applicable in the conventional sense of machine learning. This is a biochemical reagent, not a machine learning model. The "development" or "optimization" of the reagent would involve chemical formulation and analytical testing, not a "training set" in the AI context.

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

Not applicable for a biochemical reagent. The formulation and performance characteristics of the reagent are established through standard chemical and biological assay development and validation practices.

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System reagent for the quantitative determination of C-Reactive Protein in human serum on OLYMPUS Analyzers. Measurement of CRP is useful for the detection and evaluation of infection, tissue injury, inflammatory disorders and associated diseases. Measurements may also be used as an aid in the identification of individuals at risk for future cardiovascular disease. High sensitivity CRP (hsCRP) measurements, when used in conjunction with traditional clinical laboratory evaluation of acute coronary syndromes, may be useful as an independent marker of prognosis for recurrent events, in patients with stable coronary disease or acute coronary syndromes.

Not Found

This document is a 510(k) clearance letter for a medical device called "Olympus CRP Latex Immunoturbidimetric Reagent." It does not contain a study that describes acceptance criteria and device performance in the way requested by the prompt for an AI/ML device.

This document is primarily concerned with the regulatory clearance process for a diagnostic reagent, affirming its "substantial equivalence" to legally marketed predicate devices. It does not provide details of specific performance studies or acceptance criteria tables relevant to AI/ML device evaluation.

Therefore, I cannot extract the requested information from the provided text. The prompt asks for information pertaining to studies and acceptance criteria for an AI/ML device, which is not what this document describes.

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