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Multiple Tubing Segment (MTS) Set with stay safe® PIN Connectors: The Multiple Tubing Segment (MTS) Set with stay safe PIN Connectors is indicated for use by patients with acute and chronic end-stage renal disease undergoing peritoneal dialysis (PD) in a healthcare facility or at home. The MTS Set is placed during set-up to make additional connections to the cycler set when an interruption in treatment is necessary. This device is compatible with stay safe Peritoneal Dialysis (PD) connectology system and is to be used only with Fresenius Medical Care (FMCNA) Cyclers and Cycler Sets.

stay·safe® Drain Set: The stay safe Drain Set is indicated for use by patients with acute and chronic end-stage renal disease undergoing peritoneal dialysis (PD) in a healthcare facility or at home. The staysafe Drain Set is used to connect directly to the stay safe catheter extension set to enable drainage and/or effluent sampling as needed. This device is compatible with Fresenius Medical Care (FMCNA) Peritoneal Dialysis (PD) stay safe catheter extension sets.

Multiple Tubing Segment (MTS) Set with stay safe® PIN Connectors: The MTS Set is a single-use device that provides additional connections/disconnections when used with a stay safe compatible cycler set during acute and chronic peritoneal dialysis (PD) treatment. The MTS Set is provided sterile and non-pyrogenic. The MTS Set is sterilized using ethylene oxide (EO). The MTS Set consists of two (2) stay safe PIN Connectors at the proximal end, tubing, and a Safe-Lock connector at the distal end.

stay·safe® Drain Set: The Drain Set is a single-use device that connects directly to the patient's stay safe catheter extension set to enable effluent drainage as needed. The Drain Set is provided sterile and non-pyrogenic. The Drain Set is sterilized using ethylene oxide (EO). The Drain Set consists of an empty three (3) L drain bag, a stay safe PIN connector, a sample port, tubing, and a low force clamp.

The provided text describes two medical devices: the Multiple Tubing Segment (MTS) Set with stay safe® PIN Connectors and the stay safe® Drain Set. Both are accessories for peritoneal dialysis.

Here's an analysis of the acceptance criteria and supporting studies for both devices, structured as requested. Please note that the document focuses on performance testing to demonstrate substantial equivalence to predicate devices, rather than a clinical effectiveness study in the typical sense of AI/reader studies.

Multiple Tubing Segment (MTS) Set with stay safe® PIN Connectors

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance (Test Set)

• The document does not explicitly state exact sample sizes for each test (e.g., number of MTS Sets tested for tubing verification, bond strength, etc.).
• It describes "test samples" for bond/tensile strength, "cases (corrugated cartons) of MTS Sets" for weight verification, and a general reference to methods for tubing, connector, and packaging verification.
• Data provenance is not specified (e.g., country of origin). The studies appear to be performed internally by the manufacturer or a contract lab.
• The studies are retrospective in the sense that they are conducted on manufactured devices as part of the market clearance process.

3. Number of Experts and Qualifications (Ground Truth for Test Set)

• Not applicable. These are engineering and biological performance tests, not AI-based diagnostic studies requiring expert review for ground truth.

4. Adjudication Method (Test Set)

• Not applicable. The tests involve objective measurements and visual inspections against predefined criteria, not expert adjudication.

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

• No. This is not an AI-based diagnostic device.

6. Standalone Performance Study (Algorithm Only)

• No. This is not an AI-based diagnostic device.

7. Type of Ground Truth Used

• The ground truth for these tests is based on established engineering standards (e.g., ASTM, ISO), internal design specifications (e.g., tubing dimensions, vent count, force resistance), and standardized biological evaluation methods.

8. Sample Size for Training Set

• Not applicable. This is not an AI-based device requiring a training set.

9. How Ground Truth for Training Set was Established

• Not applicable.

stay safe® Drain Set

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance (Test Set)

• The document does not explicitly state exact sample sizes for each test (e.g., number of Drain Sets tested for tubing verification, bond strength, etc.).
• It describes "test samples" for bond/tensile strength, "cases (corrugated cartons) of Drain Sets" for weight verification, and a general reference to methods for tubing, clamp, and packaging verification, and a single "Drain Set" for the drop test.
• Data provenance is not specified (e.g., country of origin). The studies appear to be performed internally by the manufacturer or a contract lab.
• The studies are retrospective as they are conducted on manufactured devices as part of the market clearance process.

3. Number of Experts and Qualifications (Ground Truth for Test Set)

• Not applicable. These are engineering and biological performance tests, not AI-based diagnostic studies requiring expert review for ground truth.

4. Adjudication Method (Test Set)

• Not applicable. The tests involve objective measurements and visual inspections against predefined criteria, not expert adjudication.

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

• No. This is not an AI-based diagnostic device.

6. Standalone Performance Study (Algorithm Only)

• No. This is not an AI-based diagnostic device.

7. Type of Ground Truth Used

• The ground truth for these tests is based on established engineering standards (e.g., ASTM, ISO), internal design specifications (e.g., tubing dimensions, vent count, force resistance, no-leak for drop test), and standardized biological evaluation methods.

8. Sample Size for Training Set

• Not applicable. This is not an AI-based device requiring a training set.

9. How Ground Truth for Training Set was Established

• Not applicable.

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A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. This glove has been tested for use with specific chemotherapy drugs listed below.

Powder Free Latex Patient Examination Glove, Blue, Tested for Use with Chemotherapy Drugs, with Protein Content Labeling Claim (Contains 50 Micrograms per dm2 of glove or Less of Water Extractable Protein) meets all the current specification for ASTM D3578-05 (2010). The gloves are non-sterile, ambidextrous and single-use disposable devices that come in five sizes (XS, S, M, L, XL).

This document describes the acceptance criteria and performance of the "Powder Free Latex Patient Examination Glove, Blue, Tested for Use with Chemotherapy Drugs, with Protein Content Labeling Claim".

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a distinct "test set" in the context of image or algorithmic data. Instead, it details various laboratory tests performed on the physical glove product. The sample sizes for each specific test (e.g., dimensions, physical properties, pinholes, protein content, biocompatibility, chemotherapy permeation) are not explicitly stated in the provided summary. However, it is implied that testing was conducted in accordance with the relevant ASTM and ISO standards, which typically prescribe minimum sample sizes for statistical validity.

Data Provenance: The data provenance is from laboratory testing performed by Top Calibre Sdn Bhd (Malaysia) or a contracted lab under their supervision, to demonstrate compliance with international standards (ASTM, ISO). This is retrospective data collected as part of the device's development and regulatory submission process.

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

N/A. This device is a physical product (medical glove), and the evaluation is based on laboratory performance against defined physical and chemical standards, not on expert interpretation of observational data or images. Therefore, clinical ground truth established by experts is not applicable.

4. Adjudication Method for the Test Set

N/A. As the evaluation is based on objective laboratory measurements against predefined standards, there is no need for an adjudication method as would be used in a clinical study with subjective interpretations.

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

N/A. This is a physical product (glove) and not an AI or imaging device, so MRMC studies are not relevant.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

N/A. This is a physical product and does not involve an algorithm.

7. Type of Ground Truth Used

The "ground truth" for this device's performance evaluation is established by:

• International Standards: Primarily ASTM (American Society for Testing and Materials) standards (D3578-05, D5151-11, D6124-11, D5712-10, D6978-05) and ISO (International Organization for Standardization) standards (10993-10:2010) for physical, chemical, and biocompatibility properties. These standards define the acceptable range or threshold for each characteristic.
• Direct Measurement/Testing: Laboratory measurements and assays were conducted to determine the actual performance values of the gloves (e.g., tensile strength, breakthrough time for chemotherapy drugs). These measurements are then compared directly to the specified acceptance criteria within the standards.

8. Sample Size for the Training Set

N/A. This is a physical product and does not involve AI or machine learning algorithms that would require a training set.

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

N/A. As there is no training set for an algorithm, this question is not applicable.

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A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

Powder Free Nitrile Patient Examination Gloves, Blue Colored and White (Non-Colored), Non-Sterile meet all the current specification for ASTM D6319.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Powder Free Nitrile Patient Examination Gloves:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided document (K123760) does not specify the sample size used for the test set for any of the performance characteristics. It only states that the device "Meets" the standards or passes the biocompatibility tests.

The data provenance is not explicitly stated as "country of origin" for the specific test data, but the submitter is based in Malaysia. The testing refers to international and US-based standards (ASTM, ISO, CFR), implying these tests were conducted according to those guidelines, potentially by an accredited lab. The study is retrospective in the sense that the test data was collected prior to this submission, but it's not a clinical study involving patients over time.

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

This information is not applicable to this submission. The device is a patient examination glove, and its performance is evaluated against established physical, chemical, and biocompatibility standards, not through clinical expert review or diagnosis of medical images/conditions. The "ground truth" for this type of device is defined by the technical specifications outlined in the ASTM, ISO, and CFR standards.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods (like 2+1, 3+1) are used in studies involving subjective assessments, often by human readers (e.g., radiologists interpreting images). The performance of these gloves is assessed objectively against quantifiable standards.

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

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices where human readers interpret results, often with and without AI assistance. This document describes a physical medical device (gloves) and its conformity to technical standards.

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

This information is not applicable. This device is a physical product, not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance relies on established industry standards and regulatory criteria. These involve:

• Physical Specifications: ASTM D6319-10 for dimensions and physical properties.
• Freedom from Defects: ASTM D5151-11 and D6319-10 for pin-holes.
• Chemical Properties: ASTM D6124-11 and D6319-10 for powder-free residue.
• Biocompatibility: ISO 10993-10:2010 for dermal sensitization and 16 CFR Part 1500 for primary skin irritation.

These standards define the acceptable range or limits for each characteristic.

8. The Sample Size for the Training Set

This information is not applicable. This submission concerns a physical medical device and its conformity to standards. There is no AI or machine learning "training set" involved in its evaluation.

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

This information is not applicable as there is no training set for this type of device. The "ground truth" for the performance evaluation, as described in point 7, is established by industry and regulatory bodies through the development and publication of the relevant standards.

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To be used by trained medical professionals for the stable support and positioning of patients undergoing external beam radiation therapy treatment in a clinic or hospital setting.

In particular, these items provide the stable positioning of patients in various positions, chosen to facilitate accurate treatment of tumors.

Patients are those that have been diagnosed and are undergoing treatment for cancerous tumors. Treatment is supervised and administered by licensed doctors and therapists trained in the application of radiation therapy treatments.

Not Found

The provided document is a 510(k) clearance letter from the FDA for several medical devices, primarily baseplates and support systems used in radiation therapy. It does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The document is a regulatory approval notice, not a scientific study report.

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The Multiple Biopsy System is intended to be used with a suction source to collect biopsy samples from the upper and lower gastrointestinal tract for microscopic examination.

Not Found

This is a letter for a 510(k) premarket notification for a "Multiple Biopsy System". This document does not contain information about acceptance criteria or a study proving device performance, as it is a regulatory clearance letter rather than a scientific study or performance report.

Therefore, I cannot extract the requested information from the provided text.

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A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

Powder Free Nitrile Examination Gloves, White (non-colored) or Blue (colored), Non Sterile will meet all the current specification for ASTM D6319.

The provided document describes the acceptance criteria and a study that proves a medical device, specifically "Powder Free Nitrile Examination Gloves," meets those criteria. Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the exact sample size used for each test. However, it indicates that the tests conform to ASTM standards (D6319, D5151, D6124, F720) and 16CFR Part 1500, which inherently define the sample sizes and methodologies for these tests.

• Data Provenance: The tests are conducted by the manufacturer, IDEAL QUALITY SDN. BHD., located in Malaysia. The type of study (retrospective or prospective) is not explicitly stated, but given the nature of product testing for regulatory clearance, it would be prospective testing conducted by the manufacturer.

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

This document describes the testing of a medical glove, which relies on objective, standardized physical, chemical, and biological tests rather than subjective human interpretation of images or symptoms. Therefore, the concept of "experts establishing ground truth" in the way it applies to diagnostic AI is not applicable here. The "ground truth" is established by the defined test methods themselves and the laboratories performing these tests.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the tests are objective and based on established industry standards and regulations. There is no mention of an adjudication process among human readers or experts for the results of these physical and biological tests.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices (e.g., AI in radiology) where human readers interpret cases, and the AI's impact on their performance is measured. For a physical device like an examination glove, this is not applicable.

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

This question is not applicable to the device described. The device is a physical product (gloves), not an algorithm or AI system.

7. The Type of Ground Truth Used

The ground truth used is based on objective, standardized test methods and criteria defined by:

• ASTM International standards (e.g., D6319, D5151, D6124, F720)
• U.S. Code of Federal Regulations (e.g., 16CFR Part 1500 for skin irritation).

These standards dictate the acceptable limits for various physical properties, freedom from defects, and biocompatibility, which constitute the "ground truth" for the device's performance.

8. The Sample Size for the Training Set

This question is not applicable. The device is a manufacturing product (gloves) and does not involve AI or machine learning models that require a "training set."

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

Not applicable, as there is no training set for this type of device.

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A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's for the expected contamination between patient and examiner. This device is for over-the counter use.
A patient examination gloves is a disposable device intended for medical purpose that is worn on the examiner's hand or fingers to prevent contamination between patient and examiner. This device is for over-the counter use.

Non Sterile Powder Free Nitrile Examination Gloves meets all the current specifications listed under the ASTM Specification D6319-05, Standard Specification for Nitrile Examination Gloves for Medical Application.

Here's an analysis of the provided text regarding the acceptance criteria and study for the "Non-Sterile, Blue Color Powder Free Nitrile Examination Glove":

This document describes a 510(k) summary for a medical device, which is a premarket notification demonstrating substantial equivalence to a legally marketed predicate device. For such devices, the "acceptance criteria" are generally compliance with recognized standards and performance specifications, and the "study" is the testing conducted to show this compliance.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the specific sample sizes for each test within the "Summary of Performance Data." However, for gloves, industry standards like ASTM D6319-05 typically specify sampling plans (e.g., AQL levels for attributes like watertightness). The "Multiple Normal G1" indicated for the Watertight test likely refers to a sampling plan for inspection level G1.

The data provenance is from Malaysia (BIOGREEN YIELDS SDN. BHD. is located in Sitiawan, Perak, Malaysia). The nature of the tests (physical and chemical properties, bio-compatibility) indicates this data is prospective in the sense that the manufacturer conducted these tests specifically to demonstrate compliance for this submission.

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

This type of device (patient examination gloves) does not typically involve human expert interpretation for establishing "ground truth" in the way an AI diagnostic algorithm would. The "ground truth" is established by direct measurement of physical and chemical properties and biological reactions according to standardized protocols (ASTM D6319-05, FDA watertight test, bio-compatibility tests). Therefore, there were no human experts establishing ground truth in the context of interpretation; rather, qualified laboratory personnel would have conducted the tests according to established scientific methods.

4. Adjudication method for the test set

Not applicable for this type of device testing. Adjudication is relevant for subjective interpretations, often in diagnostic imaging, where multiple experts may disagree. Here, the tests are objective measurements.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, an MRMC comparative effectiveness study was not done. This type of study is specifically designed for AI-assisted diagnostic tools where human readers (e.g., radiologists) interpret cases with and without AI assistance. This device is a physical product (gloves) and does not involve AI or human "readers" in its performance evaluation.

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

No, a standalone study (in the context of AI algorithms) was not done. This device is a physical product and its performance is measured directly against established physical and chemical standards, not through an AI algorithm.

7. The type of ground truth used

The ground truth used is based on:

• Performance Standards/Specifications: Established by recognized standards organizations (ASTM D6319-05) and regulatory bodies (FDA 1000ml watertight test).
• Objective Measurements: Direct quantitative and qualitative measurements of physical properties (length, width, thickness, tensile strength, elongation), chemical properties (powder content, moisture content), and biological reactions (bio-compatibility tests).

8. The sample size for the training set

Not applicable. This device is a physical product, not an AI algorithm, and therefore does not have a "training set" in the machine learning sense. The manufacturing process itself (which is subject to Good Manufacturing Practices) ensures consistency, but there's no data set used to "train" the product's performance.

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

Not applicable. As there is no training set for this physical device, there is no ground truth established for a training set.

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This glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner.

Powder Free Nitrile Examination Gloves, Bubble Gum Scented, Blue

The provided text is an FDA 510(k) clearance letter for Powder Free Nitrile Examination Gloves. It does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth for a medical device or AI system.

Therefore, I cannot fulfill your request for a table of acceptance criteria and device performance, or details about a study that proves the device meets acceptance criteria, as this information is not present in the provided document. The letter only states that the device is "substantially equivalent" to legally marketed predicate devices, which is a regulatory determination, not a description of a performance study.

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RCM-7 is a dental device, Apex Locator. It can be used to detect the apex of root canal.

The RCM-7 is a dental device, Apex Locator. It can be used to detect the apex of root canal.

The provided 510(k) summary for the J. MORITA USA Inc.'s RCM-7 Apex Locator does not contain the detailed information requested regarding acceptance criteria and the specific study that proves the device meets those criteria.

The document focuses on establishing substantial equivalence to previously cleared predicate devices (Root ZX and DP-ZX-VL) by comparing general intended uses, principles of operation, and technological characteristics. It lists various characteristics and whether they are identical or similar to the predicate devices. However, it does not provide:

• Specific numerical acceptance criteria for performance metrics (e.g., accuracy, precision).
• Details of a study designed to demonstrate that the RCM-7 explicitly meets such acceptance criteria.
• Information on sample sizes, data provenance, ground truth establishment, or expert involvement for any performance testing.

Therefore, most of the requested fields cannot be filled based on the provided text.

Here's an analysis of what can be inferred or what is explicitly missing:

Acceptance Criteria and Study for J. MORITA USA Inc.'s RCM-7

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size (Test Set): Not provided. The document does not describe a specific test set or study conducted for the RCM-7.
• Data Provenance: Not provided.

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

• Not provided. The document does not mention any expert involvement for establishing ground truth for performance testing of the RCM-7.

4. Adjudication method for the test set

• Not provided. No test set is described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable. The RCM-7 is an Apex Locator, a standalone dental device for root canal length measurement, not an AI-assisted diagnostic tool that would involve human readers in an MRMC study.

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

• This is an Apex Locator, which by its nature operates "standalone" in performing its measurement function. However, the document does not describe a specific "standalone performance study" with metrics and results for the RCM-7 itself. Instead, it relies on demonstrating equivalence in performance to predicate devices.

7. The type of ground truth used

• Not explicitly defined for the RCM-7. For an apex locator, ground truth for canal length would typically be established by direct measurement (e.g., manual file measurement to the apex) or highly accurate imaging, but this is not detailed for the RCM-7's submission. The document relies on the established performance of the predicate devices.

8. The sample size for the training set

• Not applicable/Not provided. The RCM-7 is an Apex Locator, likely based on electrical impedance principles, rather than a machine learning or AI-based device that would require a "training set."

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

• Not applicable/Not provided, as there is no mention of a training set for this type of device.

Summary of Missing Information:

The 510(k) summary for the RCM-7 primarily focuses on demonstrating substantial equivalence to its predicate devices by comparing their specifications and intended uses. It does not include specific clinical or performance study data, acceptance criteria, or details about ground truth establishment that would typically be found in submissions requiring such evidence. For devices demonstrating substantial equivalence through comparison, the detailed performance data for the predicate devices often serves as the benchmark, and new studies are usually not required unless there are significant technological differences that raise new questions of safety or effectiveness.

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This [MULTIPLE BRAND] latex condom has the same intended use as the predicate condom. The condom is used for contraception and for prophylactic purposes (to help prevent pregnancy and the transmission of sexually transmitted diseases).

Not Found

I am sorry, but the provided text does not contain information about acceptance criteria or a study proving a device meets those criteria. The document is an FDA 510(k) clearance letter for male natural rubber latex condoms. It indicates that the device has been found substantially equivalent to a legally marketed predicate device for contraception and prophylactic purposes.

The document discusses:

• The trade name of the device and its classification.
• The regulatory framework for medical devices.
• The intended use of the condom.

It does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for any study.
3. Details about experts or ground truth establishment.
4. Adjudication methods.
5. MRMC comparative effectiveness studies.
6. Standalone algorithm performance.
7. The type of ground truth used.
8. Training set sample sizes or ground truth establishment for a training set.

Therefore, I cannot answer your request based on the provided input.

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