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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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This instrument has been designed to be used with a video system center, light source, documentation equipment, monitor, hand instruments, electrosurgical unit, and other ancillary equipment for endoscopy and endoscopic surgery within the thoracic and abdominal cavities including the female reproductive organs.

The ENDOEYE HD II - High Definition Digital Video Laparoscope is a video endoscope used for endoscopy and endoscopic surgery within the abdominal cavities, which is basically identical to the predicate devices for the same application areas.

Here's a breakdown of the acceptance criteria and study information for the Olympus EndoEYE HD II, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not present a formal table of acceptance criteria with corresponding performance metrics for the Olympus EndoEYE HD II as one might expect from a detailed clinical or performance study report. Instead, it describes various non-clinical tests and validations performed to demonstrate substantial equivalence to predicate devices.

However, based on the information provided, we can infer the types of acceptance criteria and the confirmation that the device met these criteria through testing.

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

The document describes non-clinical testing for performance, safety, and reprocessing. It does not mention a "test set" in the context of clinical data or human evaluation (e.g., patient images). Therefore:

• Sample Size for Test Set: Not applicable as no clinical test set/data is described. The testing involved physical devices and their components.
• Data Provenance: Not applicable as no clinical data is described. The tests were likely conducted internally by the manufacturer (Olympus Winter & Ibe GmbH) in Germany.

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

This information is not provided in the document. Since the testing described is non-clinical/technical (e.g., resolution, sterilization, durability), the "ground truth" would be established by engineering and quality assurance standards and measurements, not by medical experts interpreting data like radiologists.

4. Adjudication Method for the Test Set

This information is not provided and is not applicable given the non-clinical nature of the described testing. Adjudication methods are typically used in studies involving human interpretation of data where consensus among experts is required.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study is not mentioned in the provided text. The submission focuses on demonstrating substantial equivalence through technical characteristics and non-clinical performance, not through a comparative clinical study with human readers assessing diagnostic performance.

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

No, a standalone algorithm study is not mentioned. The device is a video laparoscope, a physical instrument for visualization during surgery, not an AI algorithm.

7. Type of Ground Truth Used

The ground truth used for the described non-clinical testing would be based on objective technical specifications, engineering standards, and validated measurement techniques. For example:

• Resolution: Measured against established optical resolution charts/targets.
• Color Correctness: Measured against color calibration standards.
• Sterilization Effectiveness: Demonstrated through biological indicator kill rates and physical/chemical indicators conforming to sterilization standards (e.g., DIN EN ISO 17665-1).
• Durability: Assessed by subjecting devices to a specified number of sterilization cycles and then re-evaluating performance against initial specifications.
• Software Functionality: Verified against software requirements specifications.

8. Sample Size for the Training Set

This information is not applicable as the device is a physical instrument, not an AI/machine learning algorithm that requires a "training set" of data.

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

This information is not applicable as there is no training set for an AI/machine learning algorithm described.

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The Otympus CEA assay is a paramagnetic particle (Dynabeads"), chemiluminescent immunoassay for the quantitative determination of carcinoembryonic antigen levels in human serum and litthium heparin plasma using the Olympus AU3000i Immunoassay System. The Olympus CEA assay is indicated for serial measurement of CEA as an aid in the management (monitoning) of coloredal cancer patients. These CEA values must be interpreted in conjunction with all other clinical and laboratory data before a medical decision is made. For in vitro diagnostic use only.

The Olympus CEA Calibrator is for calibrating the quantitative Olympus CEA assay on the Olympus AU3000i Immunoassay System.

The Olympus CEA Control is used for quality control of the Olympus CEA assay on the Olympus AU3000i Immunoassay System.

Not Found

I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study that proves the device meets those criteria, specifically regarding device performance, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details. The document is primarily an FDA 510(k) clearance letter and an "Indications for Use" statement for the Olympus Carcinoembryonic antigen (CEA) Test System. It confirms the device's substantial equivalence to a predicate device and outlines its intended use but does not delve into the specifics of performance studies or acceptance criteria.

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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

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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.

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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

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System reagent for the quantitative determination of Uric Acid in human serum, heparinized plasma and urine on OLYMPUS analyzers

Measurements of Uric Acid are used in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation or other wasting conditions, and of patients receiving cytotoxic drugs.

Not Found

The provided text focuses on the FDA's 510(k) clearance of the Olympus Uric Acid Reagent, establishing its substantial equivalence to a predicate device. However, the document does not contain the detailed study information required to fully answer your request regarding acceptance criteria and performance studies.

Therefore, I cannot populate the table or provide specific answers to most of your questions based solely on the provided text. The document is a regulatory clearance letter, not a scientific study report.

Here's what I can extract and what is missing:

Information Present:

• Device Name: Olympus Uric Acid Reagent
• Intended Use: Quantitative determination of Uric Acid in human serum, heparinized plasma, and urine on OLYMPUS analyzers.
• Clinical Utility: Used in the diagnosis and treatment of numerous renal and metabolic disorders, including renal failure, gout, leukemia, psoriasis, starvation or other wasting conditions, and patients receiving cytotoxic drugs.
• Regulatory Clearance: 510(k) clearance (K062862) issued on April 6, 2007.

Information NOT Present (and why it's typically in a study report, not a clearance letter):

• Acceptance Criteria and Reported Device Performance Table: The document doesn't list specific performance metrics (like accuracy, precision, linearity, limits of detection) or the thresholds for acceptable performance. It only states the device is substantially equivalent, implying its performance is comparable to an existing device.
• Sample Size for Test Set and Data Provenance: This information would be detailed in a validation study report.
• Number of Experts and Qualifications: Not relevant for a chemistry reagent validation; typically for image-based diagnostics where human interpretation is involved.
• Adjudication Method: Not relevant for a chemistry reagent.
• MRMC Comparative Effectiveness Study: Not relevant for a chemistry reagent. This applies to diagnostic tools where human interpretation is augmented by AI.
• Standalone Performance: While the "device" (reagent) performs standalone, the document doesn't provide the specific performance data.
• Type of Ground Truth Used: For a chemistry assay, the ground truth would typically be established using a reference method or certified reference materials with known uric acid concentrations. The document doesn't specify this.
• Sample Size for Training Set: Not applicable in the context of a chemical reagent validation in the same way it would be for a machine learning model.
• How Ground Truth for Training Set was Established: Again, not applicable as there's no "training set" in the machine learning sense for this type of device.

Conclusion:

The provided document is a regulatory approval letter. While it confirms the device's market readiness and intended use, it does not contain the detailed technical specifications or study results required to answer your specific questions about acceptance criteria and performance study design. This information would typically be found in the 510(k) submission summary or a separate validation study report, which is not included here.

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System reagent for the quantitative determination of Triglyceride concentrations in human serum and plasma on OLYMPUS analyzers. Measurements of triglyceride are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various enocrine disorders, and in the assessment of risk factors for atherosclerosis and coronary artery disease.

This Olympus Triglyceride procedure is based on a series of coupled enzymatic reactions. The triglycerides in the sample are hydrolyzed by a combination of microbial lipases to give glycerol and fatty acids. The glycerol is phosphorylated by adenosine triphosphate (ATP) in the presence of glycerol kinase (GK) to produce glycerol-3-phosphate. The glycerol-3-phosphate is oxidized by molecular oxygen in the presence of GPO (glycerol phosphate oxidase) to produce hydrogen peroxide (H2O2) and dihydroxyacetone phosphate. The formed H2O2 reacts with 4-aminophenazone and N,N-bis(4-sulfobutyl)-3,5-dimethylaniline, disodium salt (MADB) in the presence of peroxidase (POD) to produce a chromophore, which is read at 660/800nm. The increase in absorbance at 660/800 nm is proportional to the triglyceride content of the sample.

Here's a summary of the acceptance criteria and study information for the Olympus Triglyceride Test System, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally implied by the comparison to a predicate device, showing "similarities" and specific performance characteristics. The specific thresholds for acceptable performance are not explicitly stated as strict "acceptance criteria" but rather as "Performance Characteristics" which are compared to the predicate device.

Study Details:

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

  • The document mentions "samples" for precision and method comparison studies but does not specify the exact number of samples (sample size) used for the test sets. For precision, multiple "samples" (likely control or pooled patient samples) were tested across different Olympus analyzer models. For method comparison, it implies a set of samples were run on both the new and predicate devices, yielding the Intercept, Slope, and R values.
  • Data Provenance: Not specified. The document does not indicate the country of origin of the data or whether the studies were retrospective or prospective.

• 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 is a diagnostic reagent for quantitative measurement of triglyceride concentrations, not an imaging device requiring expert interpretation. Therefore, the concept of "experts establishing ground truth" in the interpretive sense does not directly apply. The "ground truth" for such devices is established through reference methods or highly characterized control materials. The document states traceability to College of American Pathology (CAP) Serum Lipid (RM016) #2, which serves as the reference for accuracy.

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

  • Not applicable as this is a quantitative chemical assay, not an interpretive device 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 is a chemical diagnostic reagent device, not an AI or imaging device involving human readers.

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

  • Yes, the performance data presented (precision, assay range, method comparison, interfering substances) represents the standalone performance of the Olympus Triglyceride Reagent when run on Olympus analyzers. There is no human-in-the-loop component for the direct measurement of triglycerides by this device.

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

  • The ground truth for accuracy and calibration is based on traceability to College of American Pathology (CAP) Serum Lipid (RM016) #2. This implies that the device's measurements are referenced against established standards or values obtained from a highly reliable and recognized reference material.

• 8. The sample size for the training set

  • Not applicable. This is a chemical reagent, not a machine learning or AI device that typically requires a "training set." The development would involve chemical optimization and formulation, followed by validation 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/ML algorithm for this type of device. The development and validation relied on established chemical principles and reference materials (like CAP standards).

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OSferion is indicated to be gently packed or placed into bony voids or gaps of the skeletal system (i.e. the extremities, spine and pelvis,) that are not intrinsic to the stability of the bony structure. Following placement in the bony void or gap, the calcium phosphate scaffold resorbs and is replaced with bone during the healing process.

OSferion is a white porous material composed of β-tricalcium phosphate. It is intended to fill bony voids or gaps caused by trauma or surgery that are not intrinsic to the stablity of the bony structure. OSferion is used as a bone replacement material and has properties that allow it to be replaced by autogenous bone after implantation. The OSferion range consists of two product types with porosities of 75% and 60%. Osferion (porosity:75%) tends to have less compression strength than Osferion (porosity:60%.) Products are supplied in blocks, cylinders, granules and wedges.

The provided text is a 510(k) summary for a medical device called OSferion, a bone void filler. It describes the device, its intended use, and compares it to predicate devices to demonstrate substantial equivalence.

However, the document does not contain information related to a study that establishes acceptance criteria for performance, device performance metrics, sample sizes for test or training sets, ground truth establishment, expert involvement, or any multi-reader multi-case (MRMC) comparative effectiveness studies.

The document concludes that "When compared to the predicate device, this particular device "OSferion" does not incorporate changes in intended use, method of operation, material, or design that could affect the safety or effectiveness of the device." This implies that the acceptance criteria are met by demonstrating substantial equivalence to a legally marketed predicate device, rather than through a direct performance study with predefined metrics.

Therefore, I cannot populate the table or answer most of the questions as the information is not present in the provided text.

Here's what can be inferred or explicitly stated based on the text for the questions that can be answered:

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

   • Not applicable / Not provided. The document establishes substantial equivalence to predicate devices (chronOS and Vitoss) rather than reporting specific performance metrics against pre-defined acceptance criteria for OSferion itself. The "performance" is considered equivalent if the device shares the same intended use, materials (with some variation in porosity), and operates safely and effectively, as confirmed by regulatory review.

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

   • Not applicable / Not provided. The submission focuses on demonstrating substantial equivalence to predicate devices through a comparison of specifications and clinical literature, not on a new clinical trial with a "test set" in the context of device performance metrics.

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 / Not provided. Ground truth establishment, in this context, is not mentioned as part of the 510(k) submission process described. The "ground truth" for regulatory clearance is the accepted safety and effectiveness of the predicate devices.

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

   • Not applicable / Not provided.

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 / Not provided. This device is a bone void filler, not an AI-assisted diagnostic or imaging device, so an MRMC study is not relevant here.

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

   • Not applicable / Not provided. This is not an algorithm-based device.

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

   • Not applicable / Not provided in the context of performance testing for this specific device. The "ground truth" for the 510(k) process is the established safety and effectiveness of the legally marketed predicate devices. The submission relied on "clinical literature provided in this submission supports the safety and efficacy of OSferion," which would presumably draw upon outcomes data or clinical observations related to similar materials.

8. The sample size for the training set

   • Not applicable / Not provided. There is no mention of a "training set" as this is not an AI/machine learning device.

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

   • Not applicable / Not provided.

Summary of what the document implies about meeting acceptance criteria:

The acceptance criteria for OSferion, as presented in this 510(k) summary, are met by demonstrating substantial equivalence to existing predicate devices (chronOS and Vitoss). This means the device is deemed safe and effective if it shares the same:

• Intended Use: Filling bony voids or gaps of the skeletal system that are not intrinsic to stability.
• Patient Population: Individuals with bone voids or gaps caused by surgery or trauma.
• Anatomical Location: Extremities, spine, and pelvis.
• Labeling: Similar intended use, contraindications, warnings, precautions, and adverse events.
• Basic Material Composition: β-Tricalcium phosphate.
• Biocompatibility: Established.
• Mechanical Strength Characteristics: Does not impart mechanical strength to the surgical site.
• Sterility: Sterile, single use.

The document highlights that OSferion is "basically identical to the predicate devices in the indication for use, and is similar in specifications except for the porosity of the material." The "clinical literature provided in this submission supports the safety and efficacy of OSferion" as a basis for meeting these criteria.

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The Olympus thyroid stimulating hormone (TSH) assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of TSH levels in human serum and plasma using the Olympus AU3000i™ Immunoassay System.

Measurements of TSH produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.

The Olympus TSH Calibrator is used for calibrating the quantitative Olympus TSH Assay on the Olympus AU3000i Immunoassay System.

The Olympus TSH Control is used for quality control of the Olympus TSH test system on the Olympus AU3000i Immunoassay System.

The Olympus AU3000i Immunoassay System is a chemiluminescent discrete photometric chemistry analyzer for the quantitative determination of analytes in human serum and plasma.

The Olympus TSH assay is a two-step paramagnetic particle enzyme immunoassay. It is based on the sandwich principle and used to quantitate TSH in serum/plasma.

The Olympus TSH assay reagent and sample are added to the assay cuvette in the following sequence:

1. Samples are incubated first with a monoclonal anti-TSH antibody bound to paramagnetic particles.
2. After a washing step, a second monoclonal anti-TSH antibody conjugated with alkaline phosphatase is added. The TSH reacts with the paramagnetic particles and the conjugated antibody to form a sandwich complex. Washing steps remove the unbound material.
3. The chemiluminescent substrate is added to the assay cuvette and reacts with the bound alkaline phosphatase (ALP). Light generated by the reaction is measured by the luminometer. The light emission is proportional to the quantity of TSH in the sample.
4. Results are calculated from a pre-defined calibration curve. The Olympus AU3000i system automatically calculates the TSH concentration of each sample in mIU/L or µIU/mL.

The provided 510(k) summary focuses on demonstrating substantial equivalence of the Olympus TSH Test System to predicate devices rather than establishing novel acceptance criteria and proving the device meets them with a dedicated study. Instead, the performance characteristics of the Olympus TSH Test System are compared directly to those of the predicate Roche Elecsys® TSH Test System.

Therefore, the response below will present the performance characteristics as a comparison to the predicate device, rather than explicit "acceptance criteria" and "reported device performance."

Here's the breakdown of the information requested, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission demonstrating substantial equivalence, explicit "acceptance criteria" are not stated in the typical sense of a performance goal. Instead, the performance of the Olympus TSH Test System is compared directly to the predicate device, the Roche Elecsys® TSH Test System. The implicit acceptance criterion is that the performance of the new device is comparable to the predicate.

2. Sample Size for the Test Set and Data Provenance

The document does not explicitly state the sample sizes used for the performance characteristic studies (e.g., precision, method comparison, interference). The data provenance (e.g., country of origin, retrospective/prospective) is also not specified.

3. Number of Experts and Qualifications for Ground Truth

For in vitro diagnostic (IVD) devices like the Olympus TSH Test System, "ground truth" is typically established through reference methods, certified calibrators, or established analytical techniques, rather than expert human interpretation (like radiologists). The document indicates traceability to "WHO" (World Health Organization) for both the predicate and proposed device, implying the use of international reference standards. No human experts are mentioned for establishing ground truth.

4. Adjudication Method for the Test Set

Not applicable for an IVD device where ground truth is typically assessed through quantitative analytical methods and reference standards, not human adjudication of subjective interpretations.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This is an in vitro diagnostic device for quantitative determination of TSH levels, not an imaging or diagnostic aid for human readers.

6. Standalone Performance Study

Yes, the performance characteristics listed in the table above (Precision, Functional Sensitivity, Analytical Sensitivity, Measurable Range, Method Comparison, Interference, Specificity) represent the standalone (algorithm/device only) performance of the Olympus TSH Test System. These are intrinsic analytical performance metrics of the device itself.

7. Type of Ground Truth Used

The ground truth for this type of IVD device is based on reference materials, certified calibrators, and/or comparison to a well-established and accepted reference method. The document states "Traceability: WHO" for both the Olympus TSH Test System (WHO 3rd IS 81/565) and the predicate (WHO 2nd IRP 80/558), indicating that the results are standardized against internationally recognized standards for TSH measurement.

8. Sample Size for the Training Set

The document does not specify a separate "training set" sample size. For IVD devices, method development and optimization studies are conducted, but usually, a distinct "training set" and "test set" in the context of machine learning (where this terminology is common) are not explicitly detailed in 510(k) summaries for traditional immunoassay systems. The performance characteristics described are typically derived from verification and validation studies.

9. How Ground Truth for the Training Set Was Established

Not explicitly detailed as a "training set" in the machine learning sense. However, for the development and calibration of such an assay, ground truth would be established through a combination of:

• Using calibrators with known TSH concentrations (e.g., Olympus TSH Calibrator, referenced to WHO standards).
• Testing against reference samples or patient samples analyzed by established, validated reference methods, often traceable to international standards.
• The "Olympus TSH Calibrator is used for calibrating the quantitative Olympus TSH Assay," and its matrix is "Bovine serum human pituitary TSH," implying that the calibrators themselves embody the "ground truth" for the device's measurement scale.

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