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Over-the-Counter Use: For moistening absorbent wound dreaning minor cuts, minor burns, superficial abrasions, and minor irritations of the skin. Prescription Use: For moistening absorbent wound dressing and for moistening, debriding, and cleaning acute and chronic dernal lesions, such as Stage I-IV pressure ulcers, diabetic ulcers, foot ulcers, post-surgical wounds, first and second-degree burns, cuts, abrasions, and minor skin irritations and for device irrigation.

The subject device Sterile Water USP, and Sterile 0.9% Normal Saline USP is a colorless, transparent solution with no preservatives or antimicrobial agents added. It is used only for external irrigation, and not for injection purposes and it is a single use device. The subject device is packaged in clear, polypropylene (PP) bottles capped with PP Screw cap and filled with a sterile, preservative-free, clear, colorless aqueous solution and sealed with a PP/PET aluminum induction seal. The aqueous solution composition is either sterile 0.9% normal saline, both which meet their respective USP monograph criteria and contain no additives. The container and closure system for the 250mL, and 1000mL sizes include PP bottles with a PP screw cap with a PP/PET aluminum induction seal and a tamper evident plastic shrink wrap. The container and closure system for the 100mL size includes a PP bottle with a PP screw cap and a PP/PET aluminum induction seal. These single-use devices are labeled for device irrigation and wound debridement and are not intended for injection. The subject device will function by the mechanical action associated with applying and moving an aqueous solution across a wound or device surface, which facilitates the moisturizing, debridement and irrigation of these surfaces.

The provided text is a 510(k) summary for a medical device clearance, specifically for "Sterile Water USP and Sterile 0.9% Normal Saline USP" for use as sterile irrigation solutions. This document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving a device meets specific performance acceptance criteria for an AI/software device.

Therefore, the information required to answer your prompt, which is tailored for an AI/software medical device's performance evaluation (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set details), is not present in the provided document.

The document discusses performance testing, but these are primarily bench tests, biocompatibility tests, and packaging tests for the physical product (sterile water/saline solution and its container), not performance metrics for an AI/software algorithm.

Here's a breakdown of why each point in your prompt cannot be answered from the provided text:

1. A table of acceptance criteria and the reported device performance: The document does not define "acceptance criteria" in the context of an AI/software's performance (e.g., accuracy, sensitivity, specificity). It lists various tests (biocompatibility, packaging, non-clinical bench tests for chemical properties and sterility) and reports that the device "complies with the criteria" or "successfully withstood" them. These are not performance metrics for a diagnostic or AI device.

2. Sample sized used for the test set and the data provenance: Not applicable. There is no AI/software test set. The tests mentioned are for physical product characteristics (e.g., "no bottles exhibited leakage," "containers remained undamaged").

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. There is no ground truth established by experts for an AI/software test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. There is no test set in the context of AI/software performance.

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 device is sterile water/saline, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. There is no algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. "Ground truth" in the AI/software sense is not relevant here. The "truth" for this product is its chemical composition, sterility, and physical integrity, which are verified through standard laboratory tests.

8. The sample size for the training set: Not applicable. There is no training set for an AI/software.

9. How the ground truth for the training set was established: Not applicable.

In conclusion, the provided FDA 510(k) summary pertains to a physical medical device (sterile water/saline solution) and its substantial equivalence to a predicate device. It does not contain information about the development, validation, or performance of an AI/software medical device, which would typically involve the type of acceptance criteria and study details you have requested.

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The Sterile Water for Inhalation Flexoval® Bottle is intended to provide a supply of sterile water to unfilled respiratory humidifier chambers. It is intended to be used in institutional care settings by qualified staff. The Sterile Water for Inhalation is intented for use in all patient populations including adults, pediatrics, infants and neonates.

The Sterile Water for Inhalation is provided in a Flexoval® bottle which is a flexible plastic bottle with a spikeable cap at the base and is pre-filled with sterile water. The bottle is 1 liter in volume and is made of Low-Density Polyethylene (LDPE). The bottle has one administration port (cap) which is clear and natural in color. The bottle has one standard hanger that is integrated at the base of the bottle also has a multi-color adhesive label affixed by an automatic labeler. The product is sterilized by heat in an autoclave. The device is sold sterile and cannot be re-used: it is discarded after use. The device is intended for use by qualified staff.

This document is a 510(k) Premarket Notification from Hometa Inc. for their "Sterile Water for Inhalation in 1L Flexoval® Bottles." It focuses on demonstrating substantial equivalence to a predicate device, "Sterile Water for Inhalation Flex Bag, USP" by Cardinal Health Inc.

The document does not describe an AI/ML-driven medical device evaluation. Therefore, it does not contain the information requested in your prompt regarding acceptance criteria, study details for an AI/ML device, such as sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth establishment, or training set details.

The study described in this document is primarily focused on non-clinical testing to ensure the new device (Sterile Water for Inhalation in Flexoval Bottles) performs equivalently to the existing predicate device (Sterile Water for Inhalation Flex Bag). The testing includes:

• Functional Testing (per ISO 15747): Resistance to temperature, pressure, and leakage; penetration ability of the insertion point; adhesion strength and impermeability of the insertion point; transparency; resistance to dropping; and hanger integrity.
• Physicochemical and Biological Testing (per USP methods and internal validated methods): Total Organic Carbon, Conductivity, Oxidizable Substances, Process Bioburden, Sterility, and Bacterial Endotoxins.
• Sterilization Validation (per ISO 17665): Moist heat sterilization to achieve a Sterility Assurance Level (SAL) of 10^-6, using Geobacillus stearothermophilus as a biological indicator.
• Biocompatibility Testing (per ISO 10993 series): Extractable/leachables testing, toxicological risk assessment, cytotoxicity, sensitization testing, intracutaneous reactivity test, and material-mediated pyrogenicity.

The "acceptance criteria" discussed in this document are the standards and requirements for these non-clinical tests to demonstrate that the new device is safe and effective and performs as intended, similar to the predicate. The reported "performance" is that the device met these standards.

Therefore, I cannot provide the requested table or details related to AI/ML device evaluation. The information in the provided text pertains to the substantial equivalence of a medical consumable (sterile water) based on physical, chemical, and biological properties, not an AI/ML algorithm.

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The Sterile Water for Inhalation Flex Bag USP is intended to provide a supply of sterile water to unfilled respiratory humidifier chambers It is intended to be used In institutional and non institutional care settings

The Sterile Water for Inhalation Flex Bag USP is a flexible plastic bag with a single port at the base and is pre-filled with sterile water Tubular feed sets connect the sterile water bags to unfilled humidifier chambers The humidifier chamber is then filled with sterile water from the sterile water bags via gravity

Here's an analysis of the provided text regarding the acceptance criteria and study for the "Sterile Water for Inhalation Flex Bag USP":

Acceptance Criteria and Study for Sterile Water for Inhalation Flex Bag USP

This 510(k) summary focuses on demonstrating substantial equivalence to predicate devices for a "Sterile Water for Inhalation Flex Bag USP." The primary objective is to prove that the new device meets its intended performance requirements and is comparable to existing legally marketed devices.

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided text does not explicitly state the sample size used for any test set or the data provenance (e.g., country of origin, retrospective or prospective). The summary only broadly mentions "Verification and Validation Testing."

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

This information is not provided in the document. The type of device (sterile water in a bag) typically relies on chemical, microbiological, and physical testing, rather than expert interpretation of complex images or data to establish 'ground truth' in the way a medical AI device would.

4. Adjudication Method for the Test Set

This information is not applicable/provided in the context of this device. Adjudication methods like '2+1' or '3+1' are typically used for studies involving human interpretation (e.g., radiologists reading images) where disagreement among experts needs resolution. This is not relevant for the testing of a sterile water bag.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI assistance on human readers interpreting medical images or data, which is not applicable to a sterile water bag.

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

No, a standalone algorithm performance study was not done. This device is a medical product (sterile water bag), not a software algorithm or AI.

7. The Type of Ground Truth Used

The ground truth for this device would be established through a combination of:

• Chemical Analysis: Verifying the water meets USP (United States Pharmacopeia) standards for sterile water for inhalation.
• Microbiological Testing: Confirming sterility.
• Physical Testing: Assessing bag integrity, port functionality, and compatibility with humidification systems.
• Performance Testing: Ensuring effective delivery of sterile water from the bag to humidifier chambers via gravity feed as intended.

The document refers to "Verification and Validation Testing," which implies these types of objective, measurable criteria were used to establish the "ground truth" of the device's performance characteristics.

8. The Sample Size for the Training Set

This information is not provided and is not applicable for this type of device. The concept of a "training set" is relevant for machine learning or AI models, not for a physical medical device like a sterile water bag.

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

This information is not provided and is not applicable for this type of device. As explained above, there is no "training set" in the context of this product. The 'ground truth' for the device itself is established through direct, objective testing and adherence to established standards (like USP).

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Sterile Water and Saline Solutions are defined as an accessory to a device that is intended For Device Cleaning and Irrigation.

Automated Liquid Packaging, Inc. Sterile Water and Saline Solutions are products that have been used in the medical community for decades. The only ingredient in the two solutions other than water is Sodium Chloride; there are no preservatives or stabilizers.

The irrigation bottle is manufactured of 100% low density polyethylene (LDPE) and contains no color or chemical additives.

The two solutions are sterile, aseptically filled and are hermetically sealed for single use only.

The provided document is limited to a 510(k) summary for Sterile Water and Saline Bottles for Irrigation. This type of document is for a medical device and typically does not contain the detailed clinical study information such as acceptance criteria, statistical analysis, and expert adjudication that would be found in a submission for an AI/ML-driven diagnostic device.

Here's an analysis based on the lack of this information in the provided document, addressing each point:

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

   • Acceptance Criteria: Not specified in the document. For a product like sterile water and saline solutions, acceptance criteria would likely relate to sterility, chemical composition (e.g., sodium chloride concentration), pH, particulate matter, and container integrity, as well as biological compatibility with ISO 10993 standards. However, specific thresholds are not provided.
   • Reported Device Performance: The document states, "All materials used in the fabrication of Sterile Water and Saline Solutions were evaluated through biological qualification safety tests as outlined in ISO 10993 Part-1 'Biological Evaluation of Medical Devices'. These materials also were tested in accordance with industry recognized test methods and were found to be acceptable for the intended use." No specific performance metrics (e.g., success rates, purity levels, sterility assurance levels) or quantitative results are provided.

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 and not present in the document. The testing described is material qualification and product performance testing (e.g., sterility, biological safety), not a clinical trial with a test set of patient 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 and not present. Ground truth, in the context of diagnostic AI/ML, refers to a definitive diagnosis or outcome. For this device, "ground truth" would relate to laboratory test results (e.g., sterility tests, chemical analysis) rather than expert clinical interpretation of patient data.

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

   • Not applicable and not present. Adjudication methods are used in clinical studies where multiple human readers or experts disagree on an outcome. The testing performed for this device would involve laboratory methods with pre-defined pass/fail criteria.

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 and not present. This type of study is relevant for AI-powered diagnostic tools that assist human interpretation. The sterile water and saline solutions are not an AI device.

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

   • Not applicable and not present. This refers to the performance of an AI algorithm independently. The device in question is a physical product (sterile solutions), not an algorithm.

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

   • The "ground truth" for this device's performance would be established through laboratory testing results (e.g., microbiological cultures for sterility, chemical assays for composition, physical testing for container integrity) against established standards (e.g., USP monographs, ISO 10993 for biocompatibility). The document vaguely refers to "biological qualification safety tests as outlined in ISO 10993 Part-1" and "industry recognized test methods."

8. The sample size for the training set:

   • Not applicable and not present. Training sets are used for machine learning models. The manufacturer performed product performance and material safety testing, not AI model training.

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

   • Not applicable and not present. As there is no AI model or training set, this question is not relevant to the provided document.

Summary for the given document:

The provided 510(k) summary for Sterile Water and Saline Bottles for Irrigation, USP, describes a conventional medical device. It focuses on demonstrating substantial equivalence to a predicate device based on intended use and performance attributes. The "study" mentioned is the "Summary of testing" which involved:

• Evaluating materials through biological qualification safety tests as outlined in ISO 10993 Part-1 "Biological Evaluation of Medical Devices."
• Testing materials "in accordance with industry recognized test methods."

The objective of these tests was to confirm that the materials and the final product were "acceptable for the intended use" (device cleaning and irrigation) and met safety standards, rather than proving diagnostic accuracy or human reader improvement for an AI/ML product. The document does not provide specific data, acceptance criteria thresholds, sample sizes for these tests, or details about how the ground truth for these tests was established beyond adherence to "industry recognized test methods" and ISO 10993.

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• For Irrigation of Medical Device Only .
• Not for Injection or Flushing of Skin Tissues .

Not Found

The provided text is a 510(k) summary from the FDA for a medical device (Sterile Water & Sterile 0.9% Sodium Chloride) and does not describe a study or specific acceptance criteria and performance related to an AI/ML powered device. The document is a clearance letter indicating the device is substantially equivalent to previously marketed devices.

Therefore, I cannot provide the requested information. The document does not contain details about:

1. Acceptance criteria or device performance data.
2. Sample sizes for test or training sets.
3. Data provenance.
4. Expert qualifications or the number of experts.
5. Adjudication methods.
6. MRMC comparative effectiveness studies.
7. Standalone performance.
8. Type of ground truth.
9. How ground truth was established for training data.

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SWFIPS is a combination product intended to be used by patients, pharmacists or physicians for the reconstitution and administration of approved prescription drug products.

SWFIPS is not labeled or intended for stand alone use. The indications for use of the reconstituted drug or biologic are contained in the package insert for each product.

SWFIPS is a glass piston syringe filled with USP Sterile Water for Injection.

SWFIPS is composed of an assembled glass piston syringe filled with a diluent, Sterile Water for Iniection. USP.

SWFIPS is used for the reconstitution of non-liquid injectable drugs, in containers, and subsequent injection, according to their labeling.

The provided text is a 510(k) summary for a medical device called SWFIPS (Sterile Water for Injection Prefilled Syringe). This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that a device meets specific acceptance criteria through a clinical or performance study in the way a new, non-equivalent device might.

Therefore, the sections of your request regarding acceptance criteria, study details, sample sizes, expert involvement, MRMC studies, standalone performance, and ground truth for training are not directly applicable or available in the typical 510(k) summary. The document focuses on comparing the new device to a predicate device to establish substantial equivalence.

Here's an analysis based on the information available in the provided text, addressing your points where possible and explaining why others are not present:

1. Table of Acceptance Criteria and the Reported Device Performance

This 510(k) summary does not present a table of specific acceptance criteria (e.g., specific thresholds for accuracy, sensitivity, or specificity) and corresponding reported device performance for the SWFIPS device in the way a diagnostic or therapeutic device might.

Instead, the "performance" described relates to its characteristics, intended use, and conformance to existing standards for its components and contents, primarily to establish substantial equivalence to a predicate device.

The document states:

• "The Sterile Water for Injection contained in the syringe conforms to USP monograph specifications at release and throughout the shelf life."
• "The glass and the elastomeric closures meet USP requirements."
• "The SWFIPS has been tested according to a stability protocol designed to support the shelf life claim."

These statements imply that the performance (e.g., sterility, chemical composition of water, integrity of materials) meets relevant USP (United States Pharmacopeia) standards and internal stability protocols. However, no quantitative performance metrics or specific acceptance criteria are provided in a table format.

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 provided in the 510(k) summary. The document describes a comparison to a predicate device and mentions stability testing, but it does not detail any specific "test set" in terms of patient data or clinical samples. The "tested according to a stability protocol" likely refers to in-house laboratory testing of the product itself, not a study involving human subjects or patient 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 and not provided. SWFIPS is a prefilled syringe with sterile water, not a device that generates data requiring expert interpretation or "ground truth" establishment in a diagnostic sense.

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

This information is not applicable and not provided. Similar to point 3, the device type does not involve an adjudication process for a test set.

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 and not provided. MRMC studies are typically for diagnostic imaging devices where human readers interpret images, sometimes with AI assistance. This device is a prefilled syringe for drug reconstitution and administration, with no AI component or human interpretation task.

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

This information is not applicable and not provided. The device is a physical medical product (a syringe with sterile water), not an algorithm or software. Therefore, the concept of "standalone algorithm performance" does not apply.

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

This information is not applicable in the traditional sense for this device. The "ground truth" for components like the Sterile Water for Injection is its conformance to USP monograph specifications, which are established chemical and physical standards. For the physical components (glass, closures), it's conformance to USP requirements. This is a form of "ground truth" based on established scientific and regulatory standards for chemical purity and material properties, rather than clinical outcomes or diagnostic certainty.

8. The sample size for the training set

This information is not applicable and not provided. This device is not an AI/ML algorithm that requires a "training set."

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

This information is not applicable and not provided. As above, there is no "training set" for this device.

Summary of Device Comparison for Substantial Equivalence:

The core of this 510(k) submission is to demonstrate substantial equivalence to a predicate device, the BD® GLASPAK® syringe. The substantial equivalence argument is based on:

• Intended Use: Both used for reconstitution of non-liquid drugs and injection of drug solutions.
• Material Compatibility: Both container materials are biocompatible and chemically compatible with Sterile Water for Injection.
• Syringe Tip Compatibility: Both syringe tips are compatible with a female Luer fitting.
• Technological Characteristics: Both employ the same technological characteristics, with the key difference being that SWFIPS is pre-filled.

Differences noted, without adverse effect to safety or efficacy:

• SWFIPS is filled with 1 mL Sterile Water for Injection (predicate is empty).
• SWFIPS is terminally sterilized by steam (predicate by ethylene oxide).

The 510(k) states that these differences do not adversely affect safety or efficacy, therefore supporting the claim of substantial equivalence. The "performance" described relates to the components meeting USP standards and stability protocols, which implicitly demonstrate that the device is safe and effective for its stated intended use and is equivalent to an already marketed device.

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The sterile water and sterile saline are indicated for device irrigation only.
The Welcon Sterile Water for Irrigation and Sterile 0.9% Normal Saline for irrigation are indicated for use in device irrigation procedures. The sterile water and saline are not indicated for injection.

The Welcon Sterile Water and Sterile 0.9% Normal Saline for Device Irrigation are individual, single-use 4 oz. (120 ml.) cups of fluid intended to be used for irrigation. The individual container consists of a plastic cup with a heat-sealed, adhesive-backed foil lid.

The provided text is for a 510(k) premarket notification for "Sterile Water/Saline for Device Irrigation." This product is a medical device, but it is not an AI/ML powered device.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set information is not applicable to this document.

The document explicitly states: "Substantial equivalence for these devices was based solely on design characteristics; no performance or safety data was included in this premarket notification. The materials, performance specifications and essential design characteristics of the Welcon devices are identical to those of the Intermed predicate devices."

The only "testing" mentioned is: "USP bacterial endotoxin testing was performed to verify that the sterile water and saline solutions conform with USP requirements." This is a quality control test to ensure the product meets a basic sterility standard, not a performance study as would be conducted for an AI/ML device.

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The intended use of these sterile single use devices is as accessories to medicinal non-ventilatory nebulizers in respiratory therapy or for tracheal irrigation or lavage.

The intended use indication is identical to those devices to which substantial equivalence is claimed. The use of these devices for inhalation therapy is well-established.

The single-use devices are color-coded unit blow-fill-sealed containers with liquid contents as labeled for inhalation therapy. The devices contain no preservative. They are sterile and pyrogen-free.

This 510(k) premarket notification is for Sterile Water for Inhalation, USP. This product is a Class II medical device, specifically an accessory to medicinal non-ventilatory nebulizers and a nebulizer accessory.

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document explicitly states: "Clinical testing is not necessary to show substantial equivalence for either safety or efficacy of intended use to the predicate devices as there are several various in vitro analytical methods (water purity, fill uniformity; sterility; container integrity) and physical-chemical characteristics (water properties; unit configuration) available which demonstrate this equivalence." (Section 7. Non-Clinical and Clinical Testing)

Therefore, there appears to be no "test set" in the traditional sense of a clinical study involving human subjects or a defined dataset for AI model evaluation. The assessment was based on analytical and physical-chemical testing of the manufactured product. The data provenance is internal to the manufacturer's quality control and testing processes.

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

Given that no clinical "test set" was used, the concept of experts establishing ground truth for such a set is not applicable here. The ground truth for the product specifications (e.g., USP monograph criteria) would have been established by the United States Pharmacopeia (USP) and other relevant regulatory bodies.

4. Adjudication Method for the Test Set:

Not applicable, as no clinical test set requiring adjudication was used.

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

No. This device is a sterile solution (Sterile Water for Inhalation, USP). It is not an imaging or diagnostic device that would typically involve human readers or an AI algorithm requiring an MRMC study.

6. Standalone (i.e. algorithm only without human-in-the-loop performance) Performance:

Not applicable. This device is a physical product (sterile water), not an algorithm or AI system.

7. Type of Ground Truth Used:

The "ground truth" used for this device's acceptance was:

• USP Monograph Criteria: The legally defined specifications for Sterile Water for Inhalation, USP.
• Manufacturer's Internal Quality Control Specifications: Based on the USP and good manufacturing practices.
• Predicate Device Characteristics: The known and established characteristics of legally marketed predicate devices.

8. Sample Size for the Training Set:

Not applicable. This is not an AI/ML device that requires a training set. The manufacturing processes and quality checks are based on established scientific principles and regulatory standards, not on data-driven learning models.

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

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

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