Search Results

The KerraContact® Ag Perf Advanced Silver Wound Dressing is indicated for use in partial and full thickness wounds, including decubitus ulcers, venous stasis ulcers, first and second degree burns, grafts and donor sites, or other acute or chronic wounds. The dressing may be used over debrided and grafted wounds.

Exciton Technologies Inc. has developed the exsalt® technology, a proprietary chemical process, which deposits oxidized silver species onto a non-woven spunlace polyester laminated with gray Delnet® HDPE mesh layers on both sides. Silver in the KerraContact® Ag Perf Advanced Perforated Silver Wound Dressing (KerraContact® Ag Perf) inhibits bacterial growth in the dressing for up to 7 days. The concentration of the silver and oxidized silver species on the dressing is 0.4 mg/ cm² (4.5% w/w). The KerraContact® Ag Perf has been shown to be effective in vitro against Staphylococcus aureus, Escherichia coli, Enterococcus faecalis, Staphylococcus epidermidis, Pseudomonas aeruginosa, and Acinetobacter baumannii.

KerraContact® Ag Perf meets pyrogen limit specifications.

This document (K182680) is a 510(k) summary for a wound dressing, not an AI/ML device. Therefore, the questions regarding acceptance criteria and studies that prove device performance, especially those related to AI/ML and human-in-the-loop performance, adjudication methods, and training/test set details, are not applicable to this submission.

The 510(k) is demonstrating substantial equivalence of the KerraContact® Ag Perf Advanced Perforated Silver Wound Dressing to a predicate device (KerraContact® Ag Advanced Silver Wound Dressing, K113564).

Here's an analysis based on the provided text, reinterpreting "acceptance criteria" as performance characteristics and "study" as comparative evaluation to the predicate:

1. Table of Acceptance Criteria (Performance Characteristics) and the Reported Device Performance

The "acceptance criteria" here are generally that the performance characteristics of the new device are equivalent to the predicate, or that any differences do not raise new safety or effectiveness concerns.

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

This information is not provided in the text for the performance tests. The studies are described as "performance tests" and "comparative evaluation" between the subject and predicate devices. No specific sample sizes for these tests are mentioned.
The provenance of the data (e.g., country of origin, retrospective/prospective) for these in vitro or physical properties tests is also not stated.

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

This question is not applicable as this is not an AI/ML device requiring expert ground truth for interpretation of medical images or data. Performance was measured through laboratory tests.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set

This question is not applicable as this is not an AI/ML device or a study involving human interpretation that would require an adjudication method.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This question is not applicable as this is not an AI/ML device. No MRMC study was conducted.

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

This question is not applicable as this is not an AI/ML device.

7. The Type of Ground Truth Used

For the performance characteristics, the "ground truth" was established by standard laboratory testing protocols and specifications for material properties, chemical composition, and antimicrobial activity, compared against the known performance of the predicate device. For biocompatibility, it relied on established biocompatibility testing standards and results from the predicate device.

8. The Sample Size for the Training Set

This question is not applicable to this type of device. There is no concept of a "training set" for physical and chemical performance testing of a wound dressing.

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

This question is not applicable for the reasons stated above.

Ask a specific question about this device

Under the supervision of a healthcare professional, KerraCel® Ag may be used for management of acute and chronic, partial and full thickness wounds including pressure ulcers, diabetic foot ulcers, surgical wounds, traumatic wounds, first and second degree burns.

KerraCel® Ag is a soft, sterile, nonwoven dressing made of sodium carboxymethylcellulose (CMC), cellulose fibers, and silver (0.2mg Ag/ cm (1.7 wt/wt%)). The silver in the dressing provides an antibacterial barrier that inhibits bacterial growth in the dressing, as shown in vitro, for up to seven (7) days against gram positive and negative bacteria. KerraCel® Ag absorbs high amounts of wound fluid and creates a soft cohesive gel that intimately conforms to the wound surface and maintains a moist wound healing environment. KerraCel® Ag meets endotoxin limit specifications.

This document is a 510(k) summary for a medical device called KerraCel® Ag Gelling Fiber Silver Dressing. It does not describe an AI medical device. Therefore, much of the requested information regarding AI-specific studies and ground truth methodologies is not applicable.

However, I can extract information related to the device's performance based on the provided text.

Here's a summary of the acceptance criteria (implied by the comparative testing) and reported device performance for KerraCel® Ag, along with other applicable information:

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as numerical targets in this document. Instead, the study's goal was to demonstrate substantial equivalence to a predicate device (Aquacel® Ag with Hydrofiber® Silver Impregnated Antimicrobial Dressing - K080383) and a reference device (Aquacel® Ag Extra with Hydrofiber® Dressing with Silver and Strengthening Fiber - K121275). Therefore, the "acceptance criteria" can be inferred as "comparable to" or "no significant difference from" the predicate and reference devices.

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

• Bench Performance Tests: The sample sizes for each specific bench test (Silver Content, Moisture Content, Absorbency, etc.) are not specified in this document.
• Biocompatibility Testing: The number of samples tested for each biocompatibility test (Cytotoxicity, Sensitization, Irritation, Genotoxicity, Systemic Toxicity, Implantation) is not specified.
• Porcine Wound Healing Study:
  • Sample Size: Six pigs were involved, with eight 2x2 cm full-thickness wounds created per animal (totaling 48 wounds).
  • Data Provenance: The study was a "Pre-Clinical Study" conducted on porcine models. The country of origin is not explicitly stated. The study design is prospective as it involves active treatment and follow-up.

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

Given this is a 510(k) for a wound dressing, not an AI device, there were no "experts" establishing ground truth in the context of diagnostic interpretation.

• In the porcine wound healing study, the evaluation included "Histopathology evaluation." This would typically involve veterinary pathologists. Their specific number and qualifications are not stated.

4. Adjudication Method for the Test Set

Not applicable for device performance and animal studies in this context. Adjudication methods are typically relevant for human clinical trials or expert review of diagnostic results.

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

Not applicable. This is not an AI medical device.

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

Not applicable. This is a physical wound dressing, not an algorithm.

7. The Type of Ground Truth Used

• Bench Performance Tests: The "ground truth" for these tests would be the measured physical and chemical properties themselves, using standardized testing methods.
• Biocompatibility Testing: The "ground truth" is established through adherence to recognized international standards (e.g., ISO 10993-1:2009 for biocompatibility) and the specific endpoint measurements of each test (e.g., cytotoxicity assays, irritation scores).
• Porcine Wound Healing Study:
  • Clinical Findings: Direct observation of the wounds by study personnel.
  • Planimetric Analysis: Measurement of wound area.
  • Histopathology Evaluation: Microscopic examination of tissue samples by trained pathologists, providing a "ground truth" on tissue response and healing at a cellular level.

8. The Sample Size for the Training Set

Not applicable. This is a physical device, not an AI model that requires a training set.

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

Not applicable.

Ask a specific question about this device

The exsalt® SD7 Wound Dressing with Adhesive Backing is indicated for use in partial and full thickness wounds, including decubitus ulcers, venous stasis ulcers, diabetic ulcers, first and second degree burns, grafts and donor sites, or other acute or chronic wounds. The dressing may be used over debrided and grafted wounds. The exsalt® SD7 Wound Dressing with Adhesive Backing provides an antibacterial barrier that inhibits bacterial growth in the dressing pad for up to 7 days.

Exciton Technologies Inc. has developed the exSALT® technology, a proprietary chemical process, which deposits oxidized silver species onto a substrate; a non-woven polyester with a gray Delnet® HDPE mesh layer thermally laminated to one side (wound contact layer). The pad is backed with a clear polyurethane film with acrylate adhesive to hold the dressing in the exsalt® SD7 Wound Dressing with Adhesive Backing inhibits bacterial growth in the dressing pad. The concentration of the silver and oxidized silver species on the dressing pad is 0.4 mg/cm² (1.8%w/w). The exsalt® SD7 Wound Dressing with Adhesive Backing has been shown to be effective in vitro against Staphylococcus aureus. Enterococcus faecalis, Staphylococcus epidermidis, Pseudomonas aeruginosa, and Acinetobacter baumannii for up to 7 days.

The provided text describes a Special 510(k) submission for the exsalt® SD7 Wound Dressing with Adhesive Backing, which is an modification of an already cleared device, exsalt® SD7 Wound Dressing (K103067). This type of submission generally focuses on demonstrating that the changes do not raise new questions of safety or effectiveness, often by comparing the modified device's performance to the predicate device.

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

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

The submission explicitly states: "All performance characteristics of the exsalt® SD7 Wound Dressing with Adhesive Backing are the same as the predicate." This indicates that the primary study proving the device meets the acceptance criteria is a comparison to the predicate device (exsalt® SD7 Wound Dressing, K103067). The core argument is that, because the wound-contacting materials and the underlying technology are the same, and the modifications (addition of adhesive backing) do not impact the core performance aspects, the new device inherently meets the same performance standards as the predicate.

The document lists "The following performance tests were conducted on the exsalt® SD7 Wound Dressing". While it doesn't explicitly state new tests were conducted on the "exsalt® SD7 Wound Dressing with Adhesive Backing" for all these characteristics, the phrasing implies that these characteristics were evaluated for the predicate device, and the new device is deemed equivalent based on its identical core components. Biocompatibility testing was specifically performed on the adhesive backing component to ensure its safety.

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

• Sample Size for Test Set: Not specified for individual performance tests. The document refers to the predicate device's performance results as the basis for equivalence. For biocompatibility, the adhesive film was tested, but specific sample sizes are not given.
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). The studies are internal performance tests conducted by Exciton Technologies Inc. or their commissioned labs.

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)

• Number of Experts: Not applicable or specified. Performance testing for medical devices like wound dressings typically involves standardized laboratory methods, not expert consensus on interpretations.
• Qualifications of Experts: Not specified. Standard laboratory personnel or qualified technicians would perform these types of tests.

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

• Adjudication Method: Not applicable. This is not a study requiring human interpretation or adjudication of results in the way image analysis or clinical trials might. The performance tests are objective laboratory 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

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices involving human interpretation, not for wound dressings.

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

• Standalone Performance: Not applicable. This device is a wound dressing, not an algorithm or AI system.

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

• Type of Ground Truth: The "ground truth" for the performance characteristics are established scientific and engineering standards and methods for testing wound dressings, and the performance of the previously cleared predicate device. For example:
  • Antibacterial Effectiveness: In vitro testing against specific bacterial strains.
  • Biocompatibility: Standardized tests (e.g., ISO 10993 series) for cytotoxicity, irritation, and sensitization.
  • Material properties: Standardized tests for silver content, pH, absorbency, etc.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This device doesn't involve a machine learning algorithm or AI that requires a "training set."

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

• Ground Truth for Training Set: Not applicable, as there is no training set for this type of device.

Ask a specific question about this device

The exsalt™ T7 Wound Dressing is indicated for use in partial and full thickness wounds, including decubitus ulcers, venous stasis ulcers, diabetic ulcers, first and second degree burns, grafts and donor sites, or other acute or chronic wounds. The dressing may be used over debrided and grafted wounds. The exsalt™ T7 Wound Dressing provides an antibacterial barrier that inhibits bacterial growth in the dressing for up to 7 days.

Exciton Technologies Inc. has developed the exsalt™ technology, a proprietary chemical process, which deposits oxidized silver species onto a non-woven polyester with gray Delnet® HDPE mesh layers thermally bonded on both sides. Silver in the exsalt™ T7 Wound Dressing inhibits bacterial growth in the dressing. The concentration of the silver and oxidized silver species on the dressing is 0.4 mg/cm² (4.5% w/w). The exsalt™ T7 Wound Dressing is known to be effective in vitro against Staphylococcus aureus, Enterococcus faecalis, Staphylococcus epidermidis, Pseudomonas aeruginosa, and Acinetobacter baumannii for up to 7 days. The exsalt™ T7 Wound Dressing consists of 2 outer layers of HDPE with an inner layer of polyester which are all silver-coated. The skin-contacting materials in both the exsalt™ T7 Wound Dressing and the predicate are the same. The exsalt™ T7 Wound Dressing is sterilized by gamma irradiation.

The provided document is a 510(k) summary for a medical device (exsalt™ T7 Wound Dressing). This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving a device meets specific performance criteria through a standalone clinical study or multi-reader multi-case (MRMC) study for an AI algorithm.

Therefore, many of the requested categories related to AI algorithm evaluation, such as acceptance criteria in terms of diagnostic performance metrics, sample sizes for test/training sets, expert adjudication methods, and MRMC study details, are not applicable to this type of device and submission.

However, I can extract the relevant information regarding performance testing that was conducted.

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

The device's performance is not proven through a single, comprehensive study with explicit acceptance criteria for diagnostic metrics. Instead, the submission relies on demonstrating substantial equivalence to a predicate device (exsalt™ SD7 Wound Dressing, K103067 and K083870) through a series of performance tests and by asserting that differences in design (specifically the substrate configuration) do not raise new issues of safety or effectiveness.

The document states: "All performance characteristics of the exsalt™ T7 Wound Dressing are the same as the predicate(s)." and "The exsalt™ T7 Wound Dressing raised no new safety concerns relative to biocompatibility. Testing performed on the exsalt™ SD7 Wound Dressing (K083870) showed that it was nontoxic, non-irritant, and did not elicit a sensitization response."

The antibacterial effectiveness for exsalt™ T7 is specifically mentioned as being effective in vitro against the listed bacteria for up to 7 days, which is consistent with the intended function.

Details Not Applicable for this 510(k) Submission:

The following information types are typically relevant for AI/software as a medical device (SaMD) submissions involving diagnostic or screening performance, but are not provided or applicable in this 510(k) for a wound dressing, which focuses on material properties, safety, and functionality claims based on in vitro testing and equivalence to an existing product:

2. Sample size used for the test set and the data provenance: Not applicable. Performance tests were likely conducted on laboratory samples of the dressing, not a patient test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No "ground truth" in the clinical diagnostic sense was established.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. "Ground truth" was likely defined by standardized laboratory test results for material and antimicrobial properties.
8. The sample size for the training set: Not applicable. This is not an AI device that requires a training set.
9. How the ground truth for the training set was established: Not applicable.

Ask a specific question about this device

The exsalt™ SD7 Wound Dressing is indicated for the management of partial and full thickness wounds, including decubitus ulcers, venous stasis ulcers, diabetic ulcers, first and second degree burns, grafts and donor sites, or other acute or chronic wounds. The dressing may be used over debrided and grafted wounds.

Exciton Technologies Inc. has developed the exsalt™ technology, a proprietary chemical process, which deposits oxidized silver species onto a non-woven needled polyester coated with gray Delnet® HDPE mesh layers on both sides (STRATEX®). Silver in the exsalt™ SD7 Wound Dressing inhibits microbial growth in the dressing. The concentration of the silver and oxidized silver species on the dressing is 0.4 mg/cm² (2.5% w/w). The exsalt™ SD7 Wound Dressing has been shown to be effective in vitro against Staphylococcus aureus, Escherichia coli, Pseudomonas aeruginosa, and Enterococcus faecalis when they are in direct contact with the dressing. In addition, in vitro data have demonstrated that exsalt™ SD7 Wound Dressing maintains its antibacterial activity for up to 7 days against Pseudomonos aeruginosa and Staphylococcus aureus.

Here's a breakdown of the acceptance criteria and study information for the exsalt™ SD7 Wound Dressing based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not specify the exact sample sizes for each in-vitro test (e.g., how many dressings tested per bacterial strain, or how many iterations for physical tests). It only states that "in vitro data have demonstrated..."
• Data Provenance: The studies were in vitro (laboratory-based) and conducted by the manufacturer, Exciton Technologies Inc., based in Canada. Given the context of a premarket notification, these are prospective studies conducted to support the device's claims.

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

• This information is not provided in the document. For in-vitro studies, ground truth is typically established by the scientific methodology itself (e.g., bacterial count reduction based on established laboratory protocols), rather than by expert consensus on individual "cases."

4. Adjudication Method for the Test Set

• This information is not applicable as the studies described are in-vitro efficacy and physical performance tests, not human-reader-based 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

• No, an MRMC comparative effectiveness study was not done. This device is a wound dressing, and the studies described are primarily in-vitro performance and biocompatibility assessments, not studies involving AI-assisted human readers.

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

• Not applicable. This device is a physical wound dressing and does not involve an algorithm or AI.

7. The Type of Ground Truth Used

• The ground truth for the performance tests (e.g., antimicrobial activity, physical properties) was established through laboratory-based, scientific measurement and observation using validated protocols (e.g., bacterial culture methods for antimicrobial efficacy, standardized tests for absorptive capacity). For biocompatibility, it was based on standardized biological reactivity tests.

8. The Sample Size for the Training Set

• Not applicable. This device does not involve machine learning or AI models, therefore there is no "training set."

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

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

Ask a specific question about this device

The exsalt™ Wound Dressing is indicated for first aid to help minor cuts, scrapes, abrasion, lacerations and scalds.

The exsalt™ Wound Dressing consists of 2 outer layers of HDPE with an inner layer of absorbent polyester, all coated with silver. Exciton Technologies Inc. has developed exsalt™ technology; a proprietary chemical process, which deposits oxidized silver species onto the non-woven polvester coated with Delnet® HDPE mesh layers on both sides (STRATEX®). Silver in the exsalt™ SD7 Wound Dressing inhibits microbial growth in the dressit™ Wound Dressing has been shown to be effective in vitro against Staphylococcus aureus, Escherichia coli, Pseudomonas aeruginosa, and Enterococcus faecalis.

The provided text describes the "exsalt™ Wound Dressing" and its 510(k) submission. It details performance tests conducted but does not contain information about a study proving the device meets acceptance criteria in the context of an AI/ML device. This document concerns a physical wound dressing, not an AI/ML device.

Therefore, I cannot fulfill the request as it asks for information pertinent to AI/ML device studies (such as sample sizes for test/training sets, experts for ground truth, MRMC studies, standalone performance, etc.) which are not applicable to the provided document about a wound dressing.

The document discusses various performance tests for the physical wound dressing, such as Absorptive Capacity, Moisture Content, Drop Penetration, Adhesion, Abrasion, Silver Content, Anti-microbial (bacterial) Effectiveness, Bactericidal Effectiveness, Biocompatibility, and Biological Reactivity. It states that these characteristics were found to be substantially equivalent to a predicate device and that the dressing showed no new safety concerns. However, it does not present these as specific numerical "acceptance criteria" alongside "reported device performance" in a table as requested for an AI/ML context.

Ask a specific question about this device

The exSALT ™ SD7 Wound Dressing is indicated for the management of partial and full thickness wounds, including decubitus ulcers, venous stasis ulcers, diabetic ulcers, first and second degree burns, grafts and donor sites, or other acute or chronic wounds. The dressing may be used over debrided and grafted wounds.

The exSALT™ SD7 Wound Dressing consists of 2 outer layers of HDPE with an inner layer of absorbent polyester, all coated with silver. The dressing is available in various sizes and can be cut to size. Silver in the exSALT™ SD7 Wound Dressing kills bacteria which are in direct contact with the dressing.

This document describes Exciton Technologies Inc.'s 510(k) submission for the exSALT™ SD7 Wound Dressing, seeking substantial equivalence to the Acticoat® 7 Dressing. The study focuses on comparing the technological characteristics and performance data between the two devices.

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 exact sample sizes for each test conducted. It states that "the results of physical, efficacy, and biocompatibility testing" were used for comparison. The data provenance is not explicitly mentioned (e.g., country of origin). The studies appear to be retrospective in the sense that they are laboratory tests performed to compare the new device against an existing predicate, rather than new clinical trials as part of a prospective study.

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

The document does not mention the use of experts or a ground truth established by experts for the test set. The "ground truth" for this type of device comparison is based on standardized laboratory testing methods for physical, efficacy, and biocompatibility properties, with the predicate device serving as the benchmark.

4. Adjudication Method for the Test Set:

No adjudication method is mentioned, as the data are laboratory measurements and comparisons to a predicate device's established performance, rather than human expert assessments.

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

No, an MRMC comparative effectiveness study was not done. This type of study is typically used for diagnostic imaging devices where human readers interpret results, and an AI's impact on their performance is being evaluated. This document concerns a wound dressing, and the evaluation is based on laboratory performance metrics.

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

The entire evaluation is effectively a "standalone" performance assessment of the device's physical, chemical, and biological properties in a laboratory setting, without human-in-the-loop interaction in its performance evaluation. The device itself is not an algorithm, but a physical product.

7. The Type of Ground Truth Used:

The "ground truth" for this submission is implicitly based on established benchmark performance of the predicate device (Acticoat® 7 Dressing) and internationally recognized standards for testing physical properties, antimicrobial efficacy, and biocompatibility. For instance:

• Physical properties: Measured parameters like absorptive capacity, moisture content, etc., are inherent properties of the material.
• Antimicrobial efficacy: Laboratory tests against specific bacteria (e.g., Pseudomonas aeruginosa, Staphylococcus aureus) providing quantitative kill rates.
• Biocompatibility: Standardized in vitro and in vivo tests for toxicity, irritation, and sensitization.

8. The Sample Size for the Training Set:

This question is not applicable. Wound dressings are physical medical devices, not AI/ML algorithms that require training sets of data.

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

This question is not applicable, as there is no training set for this device.

Ask a specific question about this device