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The Glidesheath Slender Tibial Pedal Kit is indicated to facilitate placing a catheter through the skin into the lower extremity peripheral vasculature below the knee.

Both the predicate Glidesheath Slender Tibial Pedal Kit (7cm needle) and the modified Glidesheath Slender Tibial Pedal Kit (4cm needle) are used to facilitate placing a catheter through the skin into the lower extremity peripheral vasculature below the knee. It consists of an introducer (sheath and dilator), which are packaged together with a mini guide wire, an entry needle and a guide inserter.

During a diagnostic or interventional procedure in a cath lab, the stainless steel entry needle (cannula) is used to gain access to the vein or artery for placement of the mini guide wire. The nitinol mini guide wire is inserted through the cannula into the patient's blood vessel. The wire is used for placement of the sheath and dilator into the vein or artery. The Guide Inserter which is attached to the Mini Guide Wire holder is used to assist the placement of the wire into the needle.

Following guide wire insertion, the cannula is removed and the sheath and dilator are then inserted over the mini guide wire and into the blood vessel. The mini guide wire is then withdrawn from the vessel. The dilator maintains the integrity of the sheath and dilates the blood vessel during insertion. Once the sheath is situated in the vessel, the dilator is removed and an appropriate catheter can then be inserted through the sheath.

The sheath incorporates a 1-way valve and a 3-way stopcock connected by a side tube. The sheath is coated with hydrophilic coating to minimize frictional resistance when inserting or removing the sheath from the patient's blood vessel. In addition, the sheath and dilator contain bismuth, making these devices visible under fluoroscopy. The sheath, dilator, entry needle, mini guide wire and guide inserter are provided in a single package and sterilized together.

The Glidesheath Slender Tibial Pedal Kit is a disposable, ethylene oxide gas sterilized device intended for single use only.

The provided document is a 510(k) summary for a medical device called the Glidesheath Slender Tibial Pedal Kit. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through a comprehensive study involving human readers or algorithm-only performance.

Therefore, many of the requested details such as acceptance criteria, sample sizes for test and training sets, expert qualifications, and adjudication methods are not applicable nor present in this type of submission.

Here's an analysis based on the available information:

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

The document does not provide a table of acceptance criteria or specific performance metrics as typically seen in efficacy studies for AI/imaging devices. Instead, the "performance" section refers to a "Verification by Analysis" that confirms the modified device meets "predetermined criteria (Product Specifications)." These product specifications are general design and material characteristics as detailed in the comparison table on page 6, rather than clinical performance metrics.

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

This information is not applicable. The submission is a Special 510(k) for a modification (different needle length) to an already cleared device. It relies on a "Verification by Analysis" and comparison to the predicate device, not a new clinical study with a test set of data.

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 information is not applicable as no test set requiring ground truth established by experts was used.

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

This information is not applicable as no test set requiring expert adjudication was used.

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

This information is not applicable. The device is a catheter introducer kit, not an AI or imaging diagnostic device that would involve human readers or AI assistance.

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

This information is not applicable. The device is a physical medical instrument, not an algorithm.

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

This information is not applicable, as the evaluation was based on engineering verification and comparison to a predicate device, not clinical ground truth.

8. The sample size for the training set

This information is not applicable as no training set was used.

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

This information is not applicable as no training set was used.

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The Glidesheath Slender Tibial Pedal Kit is indicated to facilitate placing a catheter through the skin into the lower extremity peripheral vasculature below the knee.

The Glidesheath Slender Tibial Pedal Kit is used to facilitate placing a catheter through the skin into the lower extremity peripheral vasculature below the knee. It consists of an introducer (sheath and dilator), which are packaged together with a mini guide wire, an entry needle and a guide inserter.

During a diagnostic or interventional procedure in a cath lab, the stainless steel entry needle (cannula) is used to gain access to the vein or artery for placement of the mini guide wire. The nitinol mini guide wire is inserted through the cannula into the patient's blood vessel. The wire is used for placement of the sheath and dilator into the vein or artery. The Guide Inserter which is attached to the Mini Guide Wire holder is used to assist the placement of the wire into the needle.

Following guide wire insertion, the cannula is removed and the sheath and dilator are then inserted over the mini guide wire and into the blood vessel. The mini guide wire is then withdrawn from the vessel. The dilator maintains the integrity of the sheath and dilates the blood vessel during insertion. Once the sheath is situated in the vessel, the dilator is removed and an appropriate catheter can then be inserted through the sheath.

The sheath incorporates a 1-way valve and a 3-way stopcock connected by a side tube. The sheath is coated with hydrophilic coating to minimize frictional resistance when inserting or removing the sheath from the patient's blood vessel. In addition, the sheath and dilator contain bismuth, making these devices visible under fluoroscopy.

The sheath, dilator, entry needle, mini guide wire and guide inserter are provided in a single package and sterilized together.

The Glidesheath Slender Tibial Pedal Kit is a disposable, ethylene oxide gas sterilized device intended for single use only.

The Glidesheath Slender Tibial Pedal Kit is a medical device, and the provided document is a 510(k) summary for its premarket notification to the FDA. As such, the concept of "acceptance criteria" and "device performance" in this context refers to demonstrating substantial equivalence to a legally marketed predicate device rather than achieving specific quantitative performance metrics typically seen in AI/software medical devices.

The "study" that proves the device meets the acceptance criteria is a combination of non-clinical tests (packaging, cadaver testing) and a comparison to existing PRIME Registry data, rather than a clinical trial directly evaluating the device's efficacy against a predefined standard.

Here's an attempt to extract the requested information, understanding that some categories might not be directly applicable or phrased differently for a medical device clearance like this.

1. Table of Acceptance Criteria and Reported Device Performance

• Identical materials, formulation, geometry, source, processing, and sterilization method for individual components.
• Successful packaging verification testing.
• Demonstrated clinical feasibility in cadaver testing.
• Favorable comparison to PRIME Registry data. |
  | Packaging Durability: Packaging must ensure the durability of the device throughout distribution. | Packaging verification testing was performed, including Visual Inspection (Post Environmental Conditioning and Distribution Simulation), Detecting Seal Leaks by Dye Penetration (ASTM F1929-15), Seal Strength (ASTM F88/F88M-15), and Climatic Stressing (ASTM F2825-10). The packaging was found to be durable. |
  | Clinical Feasibility (Cadaver Testing): Device compatible with insertion angles and acceptable for use in Below-The-Knee (BTK) access; protocols used by physicians in standard practice are equivalent to the test protocol. | Cadaver testing using lower leg models demonstrated that the Glidesheath Slender sheath is compatible with insertion angles for ultrasound-guided BTK access in four BTK vessels. The kit and components were deemed acceptable for BTK access. A follow-up survey confirmed physician protocols align with the study's access protocol. |
  | Biocompatibility: Meet biological safety requirements for an external communicating device, circulating blood with limited contact (up to 24 hours), per EN ISO 10993-1 and FDA Guidance. | No additional biocompatibility testing was performed as all components are identical to predicate/reference devices in materials, formulation, etc. The device is considered to have substantially equivalent biocompatibility. |
  | Sterilization (SAL 10-6): Achieve a Sterility Assurance Level (SAL) of 10-6 in accordance with ISO 11135:2014. | The device was adopted into an existing ethylene oxide sterilization process validated via the overkill half-cycle approach to achieve an SAL of 10-6. |
  | Sterilant Residuals: Ethylene oxide (EO) and ethylene chlorohydrin (ECH) levels must not exceed average daily doses of 4 mg and 9 mg, respectively, after 24 hours of heated aeration, per EN ISO 10993-7:2008. | Sterilant residual testing demonstrated that EO and ECH levels did not exceed the specified limits after 24 hours of heated aeration. |

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

• Test Set for Packaging: The document does not specify the exact sample size for each packaging test (Visual Inspection, Seal Leaks, Seal Strength, Climatic Stressing).
• Test Set for Cadaver Testing: The document mentions "lower leg models" but does not specify the number of cadavers or individual access attempts.
• Test Set for Clinical Comparison (PRIME Registry): "The first 71 patients treated with the Terumo Glidesheath Slender when undergoing an index endovascular procedure using a tibial access point."
  • Data Provenance: The document states this was compared "to a literature based dataset of procedures using radial and femoral access," implying this data might be a mix of prospective collection (for the 71 patients) and retrospective (for the literature comparison). No country of origin is specified for the PRIME Registry data, but generally, medical device registries can be multinational.

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

• Packaging Testing: No external experts are mentioned for ground truth establishment; testing was done against established ASTM/ISO standards.
• Cadaver Testing: The study involved "physicians." A "follow-up survey" was conducted to confirm protocols. The number and specific qualifications of these physicians are not detailed beyond being "physicians" involved in BTK access.
• Clinical Comparison (PRIME Registry): The PRIME Registry data itself is likely based on clinical outcomes and assessments made by healthcare professionals during actual procedures. The document does not specify experts involved in establishing "ground truth" for comparative purposes, rather, it uses existing clinical data.

4. Adjudication Method for the Test Set

• Packaging Testing: Adjudication is inherently built into meeting the criteria of the referenced ASTM/ISO standards. No human adjudication is specified beyond standard quality control procedures.
• Cadaver Testing: The document implies assessment by physicians performing the procedures. No formal adjudication method (e.g., 2+1, 3+1 consensus) for the cadaver test results is described.
• Clinical Comparison (PRIME Registry): The document does not describe any specific adjudication method for the PRIME Registry data or the literature-based dataset. Registry data typically relies on established clinical reporting.

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 device is a catheter introducer (hardware), not an AI/software device that would typically involve human readers interpreting output with or without AI assistance. The clinical evaluation focused on comparing the device's performance to predicate devices and existing clinical practices using registry data.

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

No, this question is not applicable. The device is a physical medical instrument (catheter introducer kit), not an algorithm or software. Its performance is tied to its physical characteristics and how it functions during a medical procedure, not an algorithm's output.

7. The Type of Ground Truth Used

• Packaging Testing: Ground truth was based on adherence to established international standards (ASTM and ISO).
• Cadaver Testing: Ground truth was based on direct observation of the device's performance and compatibility with BTK access in simulated use, assessed by physicians. This can be considered a form of "expert assessment" in a simulated environment.
• Clinical Comparison (PRIME Registry): Ground truth was established through real-world clinical outcomes and procedural observations recorded in the PRIME Registry and a literature-based dataset. This could be considered a form of "outcomes data" and "clinical assessment."

8. The Sample Size for the Training Set

This question is not applicable. This is a hardware medical device, not a machine learning or AI model, thus there is no "training set" in the context of algorithm development.

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

This question is not applicable as there is no training set for a hardware device.

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The Glidesheath Slender is indicated to facilitate placing a catheter through the skin into the radial artery.

The Glidesheath Slender consists of an introducer (sheath and a dilator), which are packaged together with an entry needle, mini guide wire and guide wire inserter. The Glidesheath Slender devices (all sheath sizes) are used to facilitate placing a catheter through the skin into the radial artery. The sheath and dilator contain bismuth, making these devices visible under fluoroscopy. The sheath is coated with hydrophilic coating to minimize frictional resistance when inserting or removing the sheath from the patient's blood vessel.

The entry needle (cannula) is used to gain access to the radial artery for placement of the mini guide wire. The entry needle is offered in either the stainless steel (SS) entry needle version or the Surflo (SR) IV catheter (which includes a needle). There are two different types of stainless-steel entry needles that are available in various gauges and lengths. The two needle types are referenced in the documentation as TPC and TRI. These initials are only used in internal Terumo documents.

The mini guide wire is used for placement of the sheath and dilator into the radial artery. The mini guide wire is offered in three versions made out of three materials, either a stainless-steel spring coil model (stainless steel), a nitinol model with palladium tip (nitinol) or a polyurethane plastic model with a nitinol core (plastic).

During either a diagnostic or interventional catheterization procedure, a physician will perform the following procedure. The mini guide wire is inserted through a cannula placed in the patient's blood vessel. A guide wire inserter is provided to assist in insertion of the mini guide wire into the cannula. Following guide wire insertion, the cannula is removed, and the sheath and dilator are then inserted over the mini guide wire and into the blood vessel. The mini guide wire is then withdrawn from the vessel. The dilator maintains the integrity of the sheath and dilates the blood vessel during insertion. Once the sheath is situated in the vessel, the dilator is removed, and an appropriate catheter can then be inserted through the sheath.

The entry needle, the mini guide wire and the guide wire inserter are all accessories to the Glidesheath Slender sheath/dilator. The accessories for a given product code are provided with the Glidesheat Slender sheath/dilator in an individual package and sterilized together.

The acceptance criteria and study proving the device meets them are detailed for the Glidesheath Slender. The device is a catheter introducer for radial artery access.

Here's a breakdown of the information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document provides a comprehensive list of performance tests conducted on various components of the Glidesheath Slender. The "Reported Device Performance" column implicitly states that the "Glidesheath Slender tested met the predetermined acceptance criteria and results support a determination of substantial equivalence." This means that for each test item listed, the device's performance fell within the acceptable parameters defined by the cited standards (ISO, ASTM, in-house) or internal requirements.

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

The document describes non-clinical performance testing, which typically involves testing of device units according to engineering standards rather than a "test set" of patient data. The specific number of units tested for each performance test item is not provided in this summary. The data provenance is internal to the manufacturer (Terumo Medical Corporation) and follows recognized international and in-house standards. This is not patient data, so "country of origin" and "retrospective/prospective" are not applicable in the usual sense for clinical studies.

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

This information is not applicable as the document explicitly states: "This 510(k) does not include data from clinical tests." The performance testing described is engineering and biocompatibility testing, where "ground truth" is established by adherence to specified physical and chemical properties and compliance with recognized standards.

4. Adjudication Method for the Test Set:

This information is not applicable as clinical data or expert review of cases is not part of this 510(k) summary.

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

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "This 510(k) does not include data from clinical tests." Therefore, there is no information on how much human readers improve with AI vs. without AI assistance.

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

This is not applicable as the device is a physical medical instrument (catheter introducer), not an AI algorithm or software.

7. The Type of Ground Truth Used:

For the performance testing, the "ground truth" is established by:

• International Standards: ISO 11070:2014, ASTM F640-12, ISO 11135:2014, EN ISO 10993-1, EN ISO 10993-7:2008.
• FDA Guidance: FDA PTCA Guidance, FDA Guidance on Use of International Standard ISO 10993-1.
• In-house standards: Internal specifications developed by Terumo Medical Corporation.

These standards and guidances define acceptable physical, mechanical, chemical, and biological properties for device components.

8. The Sample Size for the Training Set:

This is not applicable as the device is a physical medical instrument and does not involve a "training set" in the context of machine learning or AI.

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

This is not applicable for the same reason as above.

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The Glidesheath Slender is used to facilitate placing a catheter through the skin into the radial artery.

Both the predicate Glidesheath Slender 6Fr (GSS 6Fr) and the modified Glidesheath Slender 5Fr & 7Fr (GSS 5Fr & 7Fr) consist of an introducer sheath and a dilator which are packaged together with an entry needle, mini guide wire and guide wire inserter. The GSS devices (all sheath sizes) are used to facilitate placing a catheter through the skin into the radial artery. The sheath and dilator contain bismuth, making these devices visible under fluoroscopy. The sheath is coated with hydrophilic coating to minimize frictional resistance when inserting or removing the sheath from the patient's blood vessel.

The entry needle (cannula) is used to gain access to the radial artery for placement of the mini guide wire. The entry needle is offered in two versions, either a stainless steel entry needle or a Surflo IV catheter (K891087).

The mini guide wire is used for placement of the sheath and dilator into the radial artery. The mini guide wire is offered in two versions, either a stainless steel (spring coil) model or a polyurethane (nitinol core) plastic model.

The mini guide wire is inserted through a cannula placed in the patient's blood vessel. A guide wire inserter is provided to assist in insertion of the mini guide wire into the cannula. Following guide wire insertion, the cannula is removed and the sheath and dilator are then inserted over the mini guide wire and into the blood vessel. The mini guide wire is then withdrawn from the vessel. The dilator maintains the integrity of the sheath and dilates the blood vessel during insertion. Once the sheath is situated in the vessel, the dilator is removed and an appropriate catheter can then be inserted through the sheath.

This document describes a 510(k) premarket notification for the Glidesheath Slender (GSS) device, specifically for the 5Fr and 7Fr sizes. The submission claims substantial equivalence to the predicate GSS (6Fr) device (K122980). Therefore, the study is a non-clinical performance study comparing the modified device to the predicate.

Here's an analysis of the provided information concerning acceptance criteria and the study:

1. Table of Acceptance Criteria and the Reported Device Performance:

The document primarily relies on adherence to established international and internal standards as acceptance criteria. The device performance is generally stated as "met the requirements" or "results were within the predetermined acceptance criteria." Quantitative data for specific performance metrics are not provided in this summary.

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

• Sample Size: The document does not explicitly state the sample sizes used for each specific non-clinical test.
• Data Provenance: The tests are "non-clinical tests" and were conducted to "ensure safety and effectiveness of the modified GSS (5Fr & 7Fr) device throughout the shelf-life, verify conformity to applicable ISO and internal standards and acceptance criteria, and demonstrate substantial equivalence to the predicate device." The manufacturer is Terumo Medical Corporation, with production facilities in Japan (Ashitaka Factory of Terumo Corporation). This indicates the data is likely from internal testing by the manufacturer, not from a patient population. It is retrospective in the sense that it evaluates the manufactured device, not prospective in a clinical trial sense. The "country of origin of the data" would be Japan, where the manufacturing and potentially some testing occurs, and potentially the US, where Terumo Medical Corporation is located for regulatory affairs.

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

This is a non-clinical, performance testing study focused on engineering and material properties. There is no human "ground truth" establishment in the traditional sense, as these tests are based on objective physical standards (e.g., ISO, ASTM, USP, internal engineering standards). Therefore, this question is not applicable to the provided study description.

4. Adjudication Method for the Test Set:

Not applicable, as this is objective non-clinical performance testing against defined standards, not subjective assessments 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 non-clinical performance study of a physical medical device (an introducer sheath), not an AI algorithm or an imaging device involving human readers.

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

Not applicable. This is a physical medical device.

7. The type of ground truth used:

The "ground truth" in this context refers to the defined specifications and requirements set forth by international standards (ISO, ASTM, USP) and the manufacturer's own internal standards. These are objective engineering and material science metrics. It is not an expert consensus, pathology, or outcomes data in the biological sense.

8. The sample size for the training set:

Not applicable. This is not a machine learning or artificial intelligence study, so there is no "training set."

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

Not applicable. There is no training set in this context.

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The Glidesheath Slender is used to facilitate placing a catheter through the skin into the radial artery.

The Glidesheath Slender consists of an introducer sheath and a dilator which are packaged together with an entry needle and mini guide wire. The Glidesheath Slender is used to facilitate placing a catheter through the skin into the radial artery. The sheath and dilator contain bismuth. making these devices visible under fluoroscopy. The sheath is coated with hydrophilic coating to minimize frictional resistance when inserting or removing the sheath from the patient's blood vessel.

The entry needle (cannula) is used to gain access to the radial artery for placement of the mini guide wire. The entry needle is offered in two versions, either a stainless steel needle or a Surflo IV catheter (K891087).

The mini guide wire is used for placement of the sheath and dilator into the radial artery. The mini guide wire is offered in two versions, either a stainless steel (spring coil) model or a polyurethane (nitinol core) plastic model.

A guide wire inserter is also provided to assist in insertion of the mini guide wire into the cannula.

The provided 510(k) summary describes the Glidesheath Slender, a catheter introducer. This document focuses on demonstrating substantial equivalence to a predicate device (Terumo Glidesheath K082644) through performance testing, material comparison, and biocompatibility evaluations, rather than reporting on a study measuring a specific clinical outcome with defined acceptance criteria for device performance.

Therefore, many of the requested sections related to acceptance criteria, device performance, expert-established ground truth, MRMC studies, standalone performance, and training/test set details are not applicable as this is a submission for a medical device that relies on bench testing and material equivalency, not an AI/software as a medical device (SaMD).

Here's an analysis based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria or quantifiable device performance results for clinical outcomes. Instead, it lists various performance tests conducted according to ISO standards and internal standards to verify substantial equivalence to the predicate device. The implied acceptance criterion for each test is that the Glidesheath Slender performs adequately and comparably to the predicate device, thereby ensuring safety and effectiveness.

Table of Performance Tests and General Outcome (as inferred from the document):

The "reported device performance" is implicitly that the device successfully met all these technical and biological safety requirements, thereby demonstrating substantial equivalence to the predicate device.

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

The document refers to "bench tests" and "each lot of production" for LAL tests. It does not specify a distinct "test set" in the context of patient data. The tests are focused on component and assembly performance, material properties, and sterilization, typically involving a representative number of units or material samples from manufacturing lots. No patient data or clinical data is mentioned for these performance tests.

• Test Set Sample Size: Not specified in the context of patient data; applies to manufactured units/samples for bench testing.
• Data Provenance: Not applicable as these are bench tests and laboratory evaluations, not data from a specific country of origin or retrospective/prospective patient studies.

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

Not applicable. This device's evaluation relies on established engineering standards, biocompatibility protocols, and manufacturing quality controls, not an expert consensus on a "ground truth" derived from patient cases.

4. Adjudication method for the test set

Not applicable. No expert adjudication process is described for these types of performance tests.

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

Not applicable. This is not an AI/SaMD device, and therefore, an MRMC study is not relevant to its evaluation.

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

Not applicable. This is not an AI/SaMD device.

7. The type of ground truth used

The "ground truth" for this device's evaluation is defined by established engineering specifications, material composition standards, ISO/FDA recognized test methods, and biocompatibility requirements. For instance, the ground truth for "Dimensional verification" is the specified blueprint dimensions, and for "Corrosion resistance," it's the absence of corrosion under specified conditions.

8. The sample size for the training set

Not applicable. This is not an AI/SaMD device; there is no "training set."

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

Not applicable. There is no "training set" or corresponding ground truth.

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