Search Results

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

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).

Ask a specific question about this device

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.

Ask a specific question about this device

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.

Ask a specific question about this device

OLYMPUS System reagent for the quantitative determination of calcium concentrations in human serum, plasma and urine on OLYMPUS analyzers.

Measurement of calcium is used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).

Olympus Calcium Arsenazo Reagent

This is a 510(k) clearance letter for the Olympus Calcium Arsenazo Reagent, a calcium test system. This document grants market clearance based on substantial equivalence to a predicate device, not on specific performance data and acceptance criteria detailed in the letter itself. Therefore, the requested information regarding acceptance criteria and the study proving the device meets them, including sample sizes, expert details, adjudication methods, and MRMC/standalone studies, cannot be found in the provided text.

The document only states the device's indications for use: "OLYMPUS System reagent for the quantitative determination of calcium concentrations in human serum, plasma and urine on OLYMPUS analyzers. Measurement of calcium is used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms)."

To obtain the detailed study information, one would typically need access to the full 510(k) submission, which is not provided here.

Ask a specific question about this device

Olympus RF Latex System Reagent for the quantitative determination of Rheumatoid Factor (RF) in human serum and plasma on OLYMPUS Analyzers. Measurement of rheumatoid factor may aid in the diagnosis of rheumatoid arthritis.

The Olympus RF Latex Calibrator is a liquid human serum based matrix calibrator intended to be used with the Olympus RF Latex reagent OSR61105 for the quantitative determination of Rheumatoid Factor (RF) on Olympus analyzers.

Not Found

The provided text describes a 510(k) premarket notification for the "Olympus RF Latex Reagent" and "Olympus RF Latex Calibrator". However, the document is a clearance letter from the FDA and the "Indications for Use" statements.

Crucially, the provided document does not contain any information about acceptance criteria or specific studies proving the device meets those criteria.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the given text. The text only confirms the FDA's "substantially equivalent" determination to legally marketed predicate devices, which is part of the 510(k) process but does not detail the specific performance studies conducted by the manufacturer.

Ask a specific question about this device

Olympus System Reagent and calibrators for the quantitative determination of C-Reactive Protein in human serum and plasma 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 of future cardiovascular disease. High sensitivity CRP (hsCRP) measurements, when used in conjunction with traditional clinical laboratory evaluation of acute coronary syndromes, maybe useful as an independent marker of prognosis for recurrent events, in patients with stable coronary disease or acute coronary syndromes.

Not Found

The provided document is a 510(k) clearance letter from the FDA for an in vitro diagnostic device (IVD) called "Olympus CRP Latex Immunoturbidimetric Reagent and Calibrators." This type of device is a reagent system used in laboratory settings to measure C-Reactive Protein (CRP) in human serum and plasma.

The request asks for information about acceptance criteria, device performance, and study details typically associated with AI/ML-driven medical devices, especially those interpreting images or signals. However, this document describes a chemical reagent and not an AI/ML or image analysis device. Therefore, most of the requested information (like sample size for test set, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) is not applicable to this type of IVD and will not be found in the provided text.

The document discusses the regulatory clearance process for a common laboratory test kit, where "performance" relates to its analytical accuracy and precision in measuring a biomarker, not interpretive accuracy of AI.

I will address the applicable parts of your request based on the provided text, and explicitly state when information is not available or not relevant for this type of device.

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

The provided document (an FDA clearance letter) does not explicitly state the specific acceptance criteria or detailed performance data (like sensitivity, specificity, accuracy, precision, linearity ranges) for the Olympus CRP Latex Immunoturbidimetric Reagent and Calibrators. Such data would typically be found in the 510(k) submission itself, which is not provided here, or in the device's labeling/instructions for use.

The letter merely states that the FDA has "reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent... to legally marketed predicate devices." This substantial equivalence determination is based on the data presented in the 510(k) submission, confirming the device performs as intended and is as safe and effective as a predicate device.

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 document is an FDA clearance letter for a chemical reagent. It does not contain information about sample sizes for test sets, data provenance, or study design (retrospective/prospective) for performance evaluation. These details would be in the full 510(k) submission.

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. This information is relevant for devices that require human interpretation or expert labeling (e.g., imaging devices). For a CRP reagent, the "ground truth" would be established by reference methods or validated laboratory measurements of CRP, not by expert consensus in the typical sense for image or signal interpretation.

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

• Not applicable / Not provided. Adjudication methods are typically used for establishing ground truth in expert-based assessments (e.g., image interpretation). This is not relevant for a chemical reagent's performance evaluation.

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. MRMC studies are used for evaluating diagnostic devices, especially those involving human interpretation (e.g., radiologists reading images), often with AI assistance. This device is a chemical reagent, not an AI-driven image analysis or diagnostic interpretation tool.

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

• Not applicable / Not provided. This relates to AI algorithms. The Olympus CRP device is a reagent system, not an algorithm. Its performance is inherent to the chemical reactions and measurement principles.

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

• Not applicable / Not provided in detail. For a chemical reagent like this, the "ground truth" for evaluating its performance (e.g., accuracy, precision) would typically be reference methods or highly validated laboratory measurements of CRP in clinical samples. The document does not specify the exact methods used for establishing this ground truth.

8. The sample size for the training set

• Not applicable / Not provided. The concept of a "training set" doesn't apply to a chemical reagent device in the way it does for AI/ML algorithms.

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

• Not applicable / Not provided. See explanation for #8.

Ask a specific question about this device

The Olympus GF-UE160-AL5 Ultrasonic Endoscope is intended to be used for endoscopic ultrasonic inaging of the gastrointestinal wall, bile and pancreatic ducts and surrounding organs. It is to be used with the Aloka SSD-5000 (K033311) Diagnostic Ultrasound system and various other video and light source accessories.

The Olympus GF-UE160-AL5 is an ultrasonic gastro video endoscope to be used with an Aloka diagnostic ultrasound system, video system center, light source, video monitor, endo-therapy accessories for endoscopic ultrasound imaging of the gastrointestinal wall, bile and pancreatic ducts and surrounding organs.

The Olympus GF-UC140P-A15 is an electronic radial scan ultrasound endoscope providing a 360° view angle.

The provided document is a 510(k) summary for the Olympus GF-UE160-AL5 Endoscope used with the Aloka SSD-5000 Diagnostic Ultrasound System. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific performance acceptance criteria through a clinical study. As such, it does not contain the detailed information necessary to fully address all aspects of your request regarding acceptance criteria and a study proving their fulfillment.

Here's a breakdown of what can be extracted and what is missing:

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

The document does not explicitly state "acceptance criteria" in terms of clinical performance metrics. Instead, it compares the technological characteristics of the subject device to its predicate devices to demonstrate substantial equivalence. The implication is that if the new device has similar characteristics, it will perform equivalently.

The "acceptance criteria" here are implicitly that the new device's specifications are comparable to, or within acceptable variations of, the predicate devices, thereby ensuring equivalent safety and effectiveness.

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

The document describes a submission for substantial equivalence based on technological characteristics and intended use comparison. It does not refer to a clinical "test set" in the context of performance evaluation with patient data. Therefore, there is no information on:

• Sample size used for a test set.
• Data provenance (e.g., country of origin, retrospective or prospective).

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

Since no clinical test set for performance evaluation is described, there is no information on:

• Number of experts used to establish ground truth.
• Qualifications of those experts.

4. Adjudication method for the test set

Similarly, as there is no clinical test set for performance evaluation, there is no information on an adjudication method.

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

The device is an endoscope and ultrasound system, not an AI-powered diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and not mentioned in the document.

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

This point is not applicable as the device is not an algorithm for standalone performance. It is a medical imaging device used by a human operator.

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

The document does not describe a study involving "ground truth" as typically understood in performance validation of diagnostic accuracy (e.g., against pathology). The "ground truth" for this 510(k) submission is effectively the established safety and effectiveness of the predicate devices.

8. The sample size for the training set

The document describes a comparison to predicate devices, not a machine learning model. Therefore, there is no information on a "training set" sample size.

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

As there is no training set for a machine learning model, this question is not applicable.

Summary of the Study (as described in the 510(k) submission):

The "study" presented here is a comparison to predicate devices to demonstrate substantial equivalence, as required for a 510(k) submission to the FDA. It is not a clinical study designed to test novel performance claims against specific acceptance criteria.

• Purpose: To demonstrate that the Olympus GF-UE160-AL5 Endoscope used with the Aloka SSD-5000 Diagnostic Ultrasound System is substantially equivalent to legally marketed predicate devices, specifically the Olympus GF-UC140P-AL5 Endoscope (K011314) and the GF-UM130 Endoscope (K971660).
• Methodology: Direct comparison of technological characteristics (physical specifications, optical characteristics, angulations, etc.) and intended use between the subject device and the predicate devices.
• Conclusion: The submission concludes that "When the GF-UE 160-AL5 is compared to its predicates, the device does not incorporate any significant changes in intended use, method of operation, material or design that could affect the safety and effectiveness." The FDA concurred with this finding of substantial equivalence.
• Key Finding for Equivalence: The key "performance" demonstrated is that the device's technical specifications and intended use are similar enough to existing, cleared devices that it can be considered equally safe and effective without requiring new clinical performance data.

Ask a specific question about this device