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The AdVance™ XP Male Sling System is intended for the treatment of male stress urinary incontinence (SUI) by the placement of a suburethral sling.

The AdVance XP Male Sling System is provided as a sterile, single-pack kit composed of the following primary components: Male Sling, Needle Passers (2), Retractor Ring, and Stay Hooks. The subject of this premarket notification is around the Male Sling component of the AdVance XP Male Sling System, specifically the implantable portion of the Male Sling assembly, which is the mesh sling and the tissue anchors. There are no modifications to the Needle Passers, or Retractor Ring and Stay Hooks (which form the Retraction System) as a part of this submission. Note that the Retraction System are comprised of purchased, off-the-shelf components cleared through K791665.

The provided text is a 510(k) summary for a medical device (AdVance™ XP Male Sling System) and does not describe a study involving acceptance criteria related to software or AI performance, nor does it include information about a test set, ground truth, expert adjudication, or MRMC studies.

The document discusses the substantial equivalence of a newly proposed medical device to a predicate device, focusing on material composition, manufacturing wash processes, sterilization, and biocompatibility. The "Performance Data" section specifically mentions "bench testing" to evaluate physical attributes of the mesh and the final product assembly.

Therefore, I cannot extract the information required by your request from the provided text, as it pertains to a different type of medical device evaluation.

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The Virtue Male Sling System is an implantable, suburethral support sling indicated for the treatment of male stress urinary incontinence (SUI).

The Applied Alexis Wound Retractor is indicated for use to:

• Access the abdominal cavity during surgery through an atraumatically retracted incision.
• Deliver maximum exposure of the abdominal cavity with minimum incision.
• Protect against wound contamination during laparoscopic and open surgery.

The smaller two sizes of Alexis are also intended to be used to:

• Seal off the incision opening to permit insufflating the peritoneum.
• Convert the incision wound to an additional trocar port site.
• Access the thoracic cavity or other soft tissue retraction during cardiac and general surgical procedures through an atraumatically-retracted incision.

The Virtue Male Sling is an implantable, suburethral support sling intended for the surgical treatment of male stress urinary incontinence (SUI). The four-arm design of the Virtue Male Sling provides a dual mechanism of action by providing both compression of the bulbous urethra and proximal urethral elevation. The Virtue Male Sling is constructed of non-absorbable medical grade knitted, monofilament polypropylene and is intended to be permanently implanted.

The Virtue Introducer is used to facilitate transobturator and pre-pubic passages during the surgical placement of the Virtue Male Sling. The introducer is manufactured from polycarbonate thermoplastic elastomer (handle) and medical grade stainless steel (needle). The Virtue Introducer is only to be used with the Virtue Male Sling System in accordance with the Instructions for Use.

The Virtue Male Sling System with Alexis Wound Retractor includes one (1) Virtue Male Sling, one (1) single-use Virtue Introducer and one (1) Alexis Wound Retractor intended to facilitate the placement of the Virtue Male Sling.

The provided FDA 510(k) summary (K231891) for the Virtue Male Sling System with Alexis Wound Retractor indicates that performance data was not necessary for the substantial equivalence determination.

Therefore, the document does not contain information regarding acceptance criteria, a study proving the device meets acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details.

The conclusion is based on the subject device having:

• Identical intended use
• Identical target population
• Identical sterilization technique
• Identical biocompatibility features
• Identical overall device design features
• Identical duration of use

compared to its predicate device (K113496, also the Virtue Male Sling System with Alexis Wound Retractor). The submission focused solely on revised labeling, which included:

• Adding a contraindication to align with other Coloplast mesh Instructions for Use (IFU) manuals.
• Updating adverse events based on post-market surveillance and literature analysis.
• Updating procedure details aligned with current literature.

The FDA determined that these labeling changes "do not raise questions of safety or effectiveness."

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The AdVance™ XP Male Sling System is intended for the treatment of male stress urinary incontinence (SUI) by the placement of a suburethral sling.

AdVance™ XP Male Sling System is a sling system which treats male stress urinary incontinence by repositioning the urethra with a suburethral mesh. The AdVance XP Male Sling System is comprised of a permanently implanted monofilament polypropylene mesh sling, two needle passers used to implant the sling, and retraction system (retractor ring and stay hooks). The male sling is connected during the procedure to the needle passers through keved connectors at each end of the male sling which are removed after the male sling is positioned. The male sling reposition the bulbar urethra 2-4cms. The AdVance™ XP Male Sling System kit is composed of four primary components: Male Sling, Needle Passers, Retractor Ring, and Stay Hooks. The AdVance™ XP Male Sling and Needle Passers are the subject of this submission. The Retraction System (retractor ring and stay hooks) is purchased pre-sterilized off the shelf components and is cleared through K791665.

The provided text is a 510(k) summary for a medical device (AdVance™ XP Male Sling System). It details the device's characteristics, comparison to a predicate device, and various performance tests. However, it does not include information about acceptance criteria or a study proving the device meets acceptance criteria related to an AI/ML device, as requested in the prompt. The device described here is a physical surgical implant, not an AI/ML system.

Therefore, I cannot extract the requested information regarding acceptance criteria and study details for an AI/ML device from this document.

The document discusses:

• Acceptance Criteria for the physical device: Primarily demonstrated through bench testing, sterilization evaluation, and shelf life testing, showing comparability to the predicate device in terms of technological characteristics and performance.
• Device Performance: Stated that "performance testing demonstrate that the technological characteristics and performance criteria of the AdVance™ XP Male Sling System are comparable to the predicate device (K182169) and functions as intended equivalent to devices currently on the market for the same intended use."

But none of the specific AI/ML-related questions (e.g., sample sizes for test/training sets, expert ground truth, MRMC study, standalone performance) can be answered from this content.

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The AdVance™ XP Male Sling System is intended for the treatment of male stress urinary incontinence (SUI) by the placement of a suburethral sling.

AdVance™ XP is a sling system which treats male stress urinary incontinence by repositioning the urethra with a suburethral mesh. The AdVance XP system is comprised of a permanently implanted monofilament polypropylene mesh sling, two needle passers used to implant the sling, SKW retractor and percutaneous needle. The sling is connected during the procedure to the needle passers through keyed connectors at each end of the sling which are removed after the sling is positioned. The sling repositions the bulbar urethra 2-4cms.

This is a 510(k) premarket notification for the AdVance™ XP Male Sling System, which is a surgical mesh used for treating male stress urinary incontinence (SUI). The document does not describe a study involving an AI/Machine Learning device or its acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study details, ground truth, and sample sizes for AI model training/testing cannot be extracted from this document.

However, I can provide information about the general performance assessment conducted for this medical device, which is a non-AI product.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is not an AI device, there are no "acceptance criteria" for an algorithm's performance. Instead, the "performance criteria" refer to the physical and functional characteristics of the medical device. The document states:

The following information cannot be provided as the document describes a traditional medical device (surgical mesh), not an AI/Machine Learning diagnostic or assistive 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 for a non-AI device.

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 for a non-AI device.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for a non-AI device.

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 for a non-AI device. There are no "human readers" or "AI assistance" involved in the direct assessment of this surgical mesh.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable for a non-AI device.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For a traditional medical device like this, "ground truth" would be related to established safety and performance standards, clinical outcomes, and successful use in target patients, often from the predicate device's history and relevant clinical literature. The document mentions "clinical evaluations" and "clinical literature searches."

8. The sample size for the training set
Not applicable for a non-AI device.

9. How the ground truth for the training set was established
Not applicable for a non-AI device.

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The Virtue Male Sling System is an implantable, suburethral support sling indicated for the treatment of male stress urinary incontinence (SUI).

The Applied Alexis Wound Retractor is indicated for use to:
Access the abdominal cavity during surgery through an atraumatically retracted incision.
Deliver maximum exposure of the abdominal cavity with minimum incision. Protect against wound contamination during laparoscopic and open surgery.
The smaller two sizes of Alexis are also intended to be used to:
Seal off the incision opening to permit insufflating the peritoneum. Convert the incision wound to an additional trocar port site. Access the thoracic cavity or other soft tissue retraction during cardiac and general surgical procedures through an alraumatically-retracted incision.

The Coloplast Virtue Male Sling System consists of a polypropylene mesh with four arms. The four arms are each covered with a sleeve and a suture is affixed at each end to allow for attachment to the introducer. The introducer consists of a handle and stainless steel wireform. The device kit (implant plus introducer) is provided sterile and for single use only.

The Alexis Wound Retractor is constructed as a cylindrical membrane sheath that has two rings attached to each open end. The rings are molded in a plastic material. The wound Retractor package includes an incision template. The device is manufactured in four sizes, small, medium, medium-large, and large.

The Coloplast Virtue Male Sling System with Alexis Wound Retractor consists of one Virtue Sling System and one small Alexis Wound Retractor, provided in a single shelf box.

The submission K113496 by Coloplast A/S for the "Virtue Male Sling System with Alexis Wound Retractor" describes non-clinical testing to demonstrate substantial equivalence to its predicate devices. This 510(k) summary does not include any clinical studies, and therefore, does not provide information on acceptance criteria for device performance based on human studies, nor details like sample sizes for test sets, data provenance, expert qualifications, or adjudication methods for such studies. It also does not involve AI.

Here's an analysis of the provided information, focusing on the non-clinical tests mentioned:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not explicitly stated. The "simulated use tests in a cadaveric laboratory" imply a sample size of cadavers, but the specific number is not provided.
• Data Provenance: The cadaveric laboratory testing would be considered prospective for the purposes of evaluating the design modifications. The location of the cadaveric lab is not specified.

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

This information is not provided as no clinical study or expert-adjudicated ground truth for device performance in humans was conducted. The non-clinical tests relied on engineering and scientific assessments.

4. Adjudication method for the test set

This information is not provided as it pertains to expert consensus in clinical studies, which were not conducted.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a surgical sling and wound retractor, not an AI-powered diagnostic or assistive tool for human readers.

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

No, this device is not an algorithm or AI system. Its performance is evaluated through physical tests and material properties.

7. The type of ground truth used

For the non-clinical tests, the "ground truth" was established by engineering design specifications and objective measurements gathered from the design verification testing, simulated cadaveric use tests, and established material and sterilization standards.

8. The sample size for the training set

Not Applicable. There is no "training set" as this is not an AI/algorithm-based device.

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

Not Applicable. There is no "training set" for this type of medical device.

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The Virtue Male Sling System is an implantable, suburethral support sling indicated for the treatment of male stress urinary incontinence (SUI).

The Applied Alexis Wound Retractor is indicated for use to:

• Access the abdominal cavity during surgery through an atraumatically . retracted incision.
• Deliver maximum exposure of the abdominal cavity with minimum incision.
• . Protect against wound contamination during laparoscopic and open surgery.

The smaller two sizes of Alexis are also intended to be used to:

• . Scal off the incision opening to permit insufflating the peritoneum.
• Convert the incision wound to an additional trocar port site. ●
• Access the thoracic cavity or other soft tissue retraction during cardiac and . general surgical procedures through an atraumatically-retracted incision.

The Coloplast Virtue Male Sling System consists of a polypropylene mesh with four arms. The four arms are each covered with a sleeve and a suture is affixed at each end to allow for attachment to the introducer. The introducer consists of a handle and stainless steel wireform. The device kit (implant plus introducer) is provided sterile and for single use only. The Alexis Wound Retractor is constructed as a cylindrical membrane sheath that has two rings attached to each open end. The rings are molded in a plastic material. The wound Retractor package includes an incision template. The device is manufactured in four sizes, small, medium, medium-large, and large. The Coloplast Virtue Male Sling System with Alexis Wound Retractor consists of one Virtue Sling System and one small Alexis Wound Retractor, provided in a single shelf box.

The Coloplast Virtue Male Sling System with Alexis Wound Retractor Convenience Kit (K111881) is not an AI/ML device. It is a surgical mesh system and wound retractor. The provided text describes the device's technical characteristics and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study demonstrating device performance relative to such criteria that would typically be associated with AI/ML systems.

The 510(k) summary explicitly states:

• "Summary Of Clinical Tests Submitted (As Applicable): Not applicable"
• "The Virtue System and Alexis Retractor devices have been subjected to biocompatibility and mechanical testing and were found substantially equivalent to the predicates per 510ks K101297 and K041711; thus, no additional biocompatibility or mechanical testing was conducted to support this Special 510(k)."

Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, or any studies related to AI/ML performance, as these concepts are not relevant to this specific device and are not discussed in the provided regulatory submission.

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The Coloplast VIRTUE Ventral Urethral Elevation Sling System is an implantable, suburethral support sling indicated for the treatment of male stress urinary incontinence (SUI).

The modified Coloplast Virtue Ventral Urethral Elevation Sling System consists of a polypropylene mesh with four arms. The four arms are each covered with a sleeve and a suture is affixed at each end to allow for attachment to the introducer. The introducer consists of a handle and stainless steel wireform. The device kit (implant plus introducer) is provided sterile and for single use only.

This document describes the 510(k) summary for the Coloplast Virtue™ Ventral Urethral Elevation Sling System. The submission claims substantial equivalence to previously cleared devices (K082640 and K091152).

Here's an analysis based on the provided text, addressing your specific questions:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not contain explicit acceptance criteria or detailed reported device performance in a quantitative manner. The submission relies on demonstrating substantial equivalence through "bench testing compared to the predicate device and existing specifications." This implies that the 'acceptance criteria' were met if the bench test results for the modified device were comparable to the predicate and fell within established specifications, but these specifics are not provided in the summary.

Since no specific performance metrics are provided in the document, a table cannot be constructed with performance data.

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

The document only mentions "bench testing." It does not specify a sample size for the test set, nor does it provide any information on data provenance (e.g., country of origin, retrospective or prospective) for any clinical or non-clinical studies. Bench testing typically refers to laboratory-based evaluations, not human or observational data.

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

Since only "bench testing" is mentioned and there are no clinical studies or human-involved test sets described, there is no information provided regarding experts establishing ground truth or their qualifications.

4. Adjudication Method for the Test Set

As there are no clinical studies or human-involved test sets described, there is no adjudication method mentioned.

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

No. The document explicitly states "nonclinical tests" and "bench testing." It does not mention any multi-reader multi-case comparative effectiveness study or any studies involving human readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This device is a surgical sling system, not an algorithm or AI. Therefore, the concept of "standalone (algorithm only without human-in-the-loop performance)" is not applicable. The "device performance" would refer to the mechanical and biological performance of the sling itself.

7. The Type of Ground Truth Used

For the "bench testing," the ground truth would be established by engineering and material specifications – i.e., whether the physical properties and performance characteristics (e.g., tensile strength, pore size, biocompatibility) of the modified device meet predefined engineering standards and are comparable to the predicate device. The document does not provide details on these specific ground truths.

8. The Sample Size for the Training Set

This device is a physical medical device, not an AI/ML algorithm. Therefore, the concept of a "training set" with a sample size for machine learning is not applicable.

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

As explained above, the concept of a "training set" for this type of device is not applicable.

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The Coloplast VIRTUE Ventral Urethral Elevation Sling System is an implantable, suburethral support sling indicated for the treatment of male stress urinary incontinence (SUI).

The modified Coloplast VIRTUE Ventral Urethral Elevation Sling System consists of a polypropylene mesh with four arms. The four arms are each covered with a sleeve . and a suture is affixed at each end to allow for attachment to the introducer. The introducer consists of a handle and stainless steel wireform. The device kit (implant plus introducer) is provided sterile and for single use only.

This 510(k) summary does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria. The document describes a medical device called the "VIRTUE Ventral Urethral Elevation Sling System" and its substantial equivalence to a previously cleared device. It details the device's components (polypropylene mesh with four arms, sleeves, sutures, and an introducer), its intended use for male stress urinary incontinence (SUI), and the regulatory classification.

The document is a regulatory communication from the FDA to Coloplast Corporation, confirming the substantial equivalence of the modified VIRTUE device. It does not include performance data, clinical study results, or specific acceptance criteria.

Therefore, I cannot provide the requested information from this text.

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The Coloplast VIRTUE Ventral Urethral Elevation Sling System is an implantable, suburethral support sling indicated for the treatment of male stress urinary incontinence (SUI).

The Coloplast VIRTUE Ventral Urethral Elevation Sling System consists of a polypropylene mesh with four arms. The four arms are each covered with a sleeve and a suture is affixed at each end to allow for attachment to the introducer. The introducer consists of a handle and stainless steel wireform. The device kit (implant plus introducer) is provided sterile and for single use only.

The provided text is a 510(k) summary for the Coloplast VIRTUE™ Ventral Urethral Elevation Sling System. The available information primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific acceptance criteria based on performance metrics.

Therefore, many of the requested elements for a study proving acceptance criteria cannot be extracted from this document, as a such a study (with specific performance metrics, ground truth, and reader studies) appears not to have been conducted or detailed in this 510(k) summary. The submission relies on comparative analysis and bench testing.

Here's an attempt to answer the questions based only on the provided text, indicating where information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not specified. The document refers to "bench testing" but does not give details on the number of samples or specific test cases.
• Data Provenance: Not specified. Given it's bench testing, it would likely be laboratory-generated data rather than patient data.

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

• This information is not available in the provided document. The study described is bench testing and comparative analysis, not a clinical study involving experts establishing ground truth for performance metrics in a patient context.

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

• This information is not applicable and not available. Adjudication methods are typically used in clinical studies or reader studies where multiple experts assess cases. The described testing is bench testing.

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. The device is a surgical sling system, not an AI or diagnostic imaging device.

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

• Not applicable. The device is a physical surgical implant, not an algorithm.

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

• For the bench testing, the "ground truth" would be objective measurements of physical properties (e.g., tensile strength, elasticity, pore size) and material properties that are compared against predefined specifications or the predicate device's characteristics. The document implies comparison to the predicate device's known characteristics as the "truth" for equivalence.

8. The sample size for the training set

• Not applicable / Not available. The device is a physical product, not an AI algorithm that requires a training set. The "testing" involved bench testing, not machine learning model training.

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

• Not applicable / Not available. (See point 8).

In summary: The 510(k) summary focuses on demonstrating "substantial equivalence" of the Coloplast VIRTUE™ Ventral Urethral Elevation Sling System to a legally marketed predicate device (AMS AdVance Male Sling System) through a comparison of design, materials, performance characteristics (via bench testing), and indications for use. It does not contain details of a clinical study with quantifiable acceptance criteria for diagnostic accuracy, reader performance, or patient outcomes that would typically involve experts, ground truth, or specific sample sizes in the manner implied by the questions.

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I-STOP® Trans Obturator Male / Female Sling is intended to be used as a sub-urethral sling implant for the treatment of male stress urinary incontinence post-prostatectomy. And for females: for the treatment of urinary stress incontinence due to intrinsic sphincter deficiency and/or intrinsic sphincter deficiency.

I-STOP® Trans Obturator Male / Female Sling is a sterile, single use kit consisting of one sling of knitted monofilament polypropylene, two stainless two polycarbonate handles and two stainless steel needles molded with polycarbonate handles.

This 510(k) summary does not contain the detailed information necessary to complete all sections of your request. The document describes a medical device, the I-STOP® Trans Obturator Male / Female Sling, and states that it underwent "Mechanical tests, biocompatibility tests in compliance with ISO 10993 and chemical tests" as well as "Three studies on this surgical technique and three anatomical studies." However, it does not provide specific acceptance criteria, performance metrics, sample sizes for test or training sets, ground truth establishment methods, or details about expert involvement in a way that aligns with your request for AI/algorithm performance studies.

Therefore, I cannot generate the requested table and fully answer all questions as the provided text is primarily a 510(k) notification for a surgical mesh device, not a study evaluating an AI/algorithm's performance.

Here's what can be extracted and what cannot:

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

• Cannot be provided. The document discusses compatibility with ISO 10993 for biocompatibility and mentions "mechanical tests" and "chemical tests," but it does not specify acceptance criteria for these tests nor does it report detailed performance results against such criteria in a quantifiable manner. It also mentions "clinical tests" and "anatomical studies," but again, no specific acceptance criteria or performance results are detailed.

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

• Cannot be provided. The document states "Three studies on this surgical technique and three anatomical studies," but provides no details on sample sizes, study design (retrospective/prospective), or data provenance for these studies.

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)

• Cannot be provided. This information is typically relevant for studies involving subjective assessments or interpretation (like imaging studies) where human experts establish ground truth. As this is a surgical mesh device, the "ground truth" would likely relate to objective clinical outcomes or mechanical properties, not expert interpretation in the way relevant for AI performance studies. The document does not discuss expert involvement in establishing ground truth for any tests.

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

• Cannot be provided. Not applicable given the nature of the device and the lack of AI-specific 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

• Cannot be provided. This document is for a physical surgical device, not an AI or imaging-based diagnostic tool. Therefore, an MRMC study related to AI assistance for human readers is not relevant or described.

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

• Cannot be provided. Not applicable, as this is not an algorithm or AI device.

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

• Cannot be provided. The document does not specify the ground truth used for its "clinical tests" or "anatomical studies." For a surgical mesh, ground truth for clinical studies would typically be patient outcomes (e.g., continence rates, complication rates) or histological analysis (for biocompatibility).

8. The sample size for the training set

• Cannot be provided. The concept of a "training set" applies to machine learning and AI algorithms. This device is a physical surgical implant.

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

• Cannot be provided. Not applicable, as this is not an AI/algorithm device.

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