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The Quick-Tap® Paracentesis Kit, Tray and Needle are indicated to relieve pressure by draining fluid from the peritoneal space. The fluid may be undergo diagnostic testing to assess for chemistries, infection or abnormal cells.

Abdominal paracentesis is a procedure used to remove bodily fluid from the peritoneal cavity. Fluid can be the result of liver disease, congestive heart failure or other disease that result in "ascites" fluid. Fluid may also be in the form of blood from perforated organs due to trauma. The fluid is susceptible to infection.

Abdominal paracentesis provides therapeutic relief to patients who experience bloating and difficult breathing. The procedure serves a diagnostic purpose, as well. Typically, fluid specimens are sent to a laboratory for microbiological, chemical and histological analysis.

Abdominal paracentesis can be performed at bedside or in a treatment center. The patient is prepped using sterile technique and local anesthetic. The sitting position is preferred so that gravity can assist. If preferred, a skin nick is performed with a scalpel and a large bore outer cannula is introduced into the peritoneal cavity midline between the umbilicus and pubis. A syringe can be used to collect the first sample of fluid from the patient confirming a suitable puncture site. The inner needle is withdrawn and disposed of leaving the outer cannula in place. Specimen tubes stand ready for specimen collection. The large majority of fluid is drained into bags or large containers and disposed of. There are no guidelines or standard of care that define the amount or rate of ascites fluid evacuation other than to monitor for signs of hypovolemic shock. One to two liters can be evacuated at one session. After paracentesis the cannula is removed and an adhesive bandage is placed over the puncture site. The patient is then monitored briefly for signs of distress such as persistent bleeding from the puncture site, faintness, anxiety, abnormal pulse, temperature etc.

Complications are rare but can include hemorrhage, perforation of abdominal organs, wound infection and hypovolemic shock.

There are a variety of disposable instruments used for paracentesis. These include generic angio-introducer catheters and specific needle/cannula combinations for paracentesis. Figure A-I illustrates the Ballard, Caldwell® Paracentesis Needle/Cannula.

Our proposed paracentesis needles (and thus trays and kits) are substantially equivalent in design, composition, technology and function to our present paracentesis trays (see predicate devices).

The provided text describes the 510(k) Premarket Notification Summary for the Quick-Tap® Paracentesis Kit, Tray and Needle. It focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study that proves the device meets specific acceptance criteria in the way a clinical trial for a novel drug or a new AI diagnostic would.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative, measurable sense for a new device's performance. Instead, it asserts substantial equivalence to predicate devices based on design, composition, technology, function, and a limited set of non-clinical tests.

Note: The acceptance criteria are largely implied by the substantial equivalence framework, meaning the device should perform similarly to its predicates regarding safety and efficacy for the stated intended use. Specific quantitative thresholds for tensile strength, flow rate, or visual inspection are not provided in this summary.

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

The document describes non-clinical data through direct performance testing of the device components (needles), rather than a "test set" of patient data.

• Sample Size: Not specified for the Tensile test, Flow rate, or Visual inspection. It's common for such tests to use a statistically representative sample size, but the exact number isn't mentioned in this summary.
• Data Provenance: Non-clinical (laboratory testing of the device itself), not human or animal data.

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

N/A. This is a medical device for a procedure, and its safety and efficacy are evaluated through functional and material testing, and comparison to legally marketed predicate devices, not through a diagnostic assessment requiring expert ground truth on a test set.

4. Adjudication Method for the Test Set

N/A. As there's no clinical "test set" requiring expert ground truth or diagnostic assessment, no adjudication method is applicable.

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

No. This document describes a 510(k) submission for a medical device (paracentesis kit, tray, and needle), not an AI-assisted diagnostic tool. Therefore, an MRMC comparative effectiveness study regarding human readers with or without AI assistance is not applicable and was not performed.

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

N/A. This is a physical medical device. The concept of an "algorithm only" or "standalone" performance without human interaction does not apply.

7. The Type of Ground Truth Used

The "ground truth" here is the functional integrity and material properties of the device components, relative to established engineering standards and the performance of predicate devices. This is established through:

• Engineering/Material Testing: Tensile strength, flow rate, visual inspection.
• Comparison to Predicate Devices: Demonstrating similar design, composition, technology, and function to previously cleared devices.

8. The Sample Size for the Training Set

N/A. There is no machine learning "training set" involved as this is a physical medical device.

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

N/A. Same as above, no machine learning training set applies.

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Intended to remove, by cutting, a specimen of tissue for microscopic examination from the lungs or bronchial passageways. Patient population; Any patient demonstrating an abnormality or condition indicative of malignancy or benign obstruction as noted through bronchoscopy, x-ray, MRI, etc.

Figure A-1 depicts all but a few reusable biopsy forceps designs. All operate on a 4-bar linkage arrangement as shown. Transverse motion of the control cable results in the pendulum motion of the handle consists of a slide, finger spool or finger ring arrangement and a thumb ring. The jaws are actuated by transverse motion of the finger spool that connects to the control cable is connected to the clevis. The linkages are hinged on small pins, the jaws rotate about an axle pin that is supported by the fork. With the exception of the handle, all the components are fabricated from ASTM 302, 303 or 304 stainless steel. The handle components are fabricated from a suitable material able to withstand several reprocessing cycles.

Here's a breakdown of the acceptance criteria and study information for the Ballard Reusable Bronchial Biopsy Forceps, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly present a table of "acceptance criteria" with quantitative targets for each test. Instead, it describes various tests performed and implies that the device met the necessary performance for substantial equivalence. The "reported device performance" is primarily qualitative, stating that the device passed the tests.

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

The document does not provide details on the sample size for the test set used in the functional, sterilization, reprocessing, or tensile equivalence tests. It also does not specify the data provenance (e.g., country of origin, retrospective or prospective).

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 in the document. The studies conducted are primarily engineering/performance tests (functional, sterilization, reprocessing, tensile) directly comparing the device to a predicate, not clinical studies requiring expert ground truth for interpretation of observational data.

4. Adjudication Method (for the test set)

This information is not applicable as the tests performed are not clinical trials requiring adjudication of expert interpretations but rather performance tests against defined specifications or predicate device characteristics.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or described. The submission focuses on demonstrating substantial equivalence through non-clinical performance testing against a predicate device.

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

This question is not applicable as the device is a physical medical instrument (biopsy forceps), not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical tests appears to be:

• Performance Specifications/Benchmarks: For functional tests, this would be the expected performance of a biopsy forceps.
• Predicate Device Characteristics: For sheath length, diameter, jaw geometry, and reprocessing parameters, the Olympus FB Series Biopsy Forcep (K962555) served as the direct comparator for substantial equivalence.
• Established Industry Standards/Protocols: For sterilization, reprocessing, and tensile strength, the tests would have been performed according to accepted methods to demonstrate safety and effectiveness.

8. The Sample Size for the Training Set

This question is not applicable. The device is a physical medical instrument, not a learning algorithm or AI model that requires a training set.

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

This question is not applicable for the same reason as above.

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The intended use of the Lutz Needle is for the administration of single-shot epidural anesthesia.
To introduce single-shot anesthetic agents into the epidural space.

The needle presented in this application is equivalent to other anesthesia conduction needles on the market that have been approved for marketing through the Premarket notification process. This is a "me too" device. The subject device has the same technological characteristics as legally marketed predicate devices. The features, specifications, and mode of action are substantially equivalent.

The provided document describes a 510(k) premarket notification for the "Lutz Needle," an anesthetic conduction needle. The submission details the device's equivalence to predicate devices based on non-clinical data and adherence to international standards.

Here's an analysis 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

The document mentions "First article inspection for dimensional criteria and conformance to standards." This implies an initial testing phase for newly manufactured samples. However, the specific sample size used for this "first article inspection" is not explicitly stated.

Regarding data provenance, the testing was conducted "in vitro," which implies a laboratory setting. There is no information about the country of origin of the data or whether it was retrospective or prospective in the context of clinical studies (as it was a non-clinical evaluation).

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. The evaluation was based on conforming to international standards and dimensional criteria, which would typically involve engineering and quality control personnel, not clinical experts for "ground truth" establishment in the sense of diagnostic accuracy.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided. Adjudication methods are relevant for clinical studies where multiple reviewers assess outcomes, typically in diagnostic or prognostic contexts. The provided document describes non-clinical, in vitro testing against engineering standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This information is not provided and is not applicable. The device is an anesthetic conduction needle, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies evaluating human readers with or without AI assistance are irrelevant to this submission.

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

This information is not provided and is not applicable. As mentioned above, the device is a physical medical instrument, not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical testing was based on international engineering standards (ISO 9626, ISO 594, ISO 7864) and dimensional criteria. This is a form of objective, measurable truth derived from established specifications.

8. The Sample Size for the Training Set

This information is not provided and is not applicable. The device is a physical product, not a machine learning model, so there is no concept of a "training set" in this context.

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

This information is not provided and is not applicable for the same reasons as point 8.

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The MIC-KEY® G™ Low Profile Gastrostomy Replacement Kit is designed as a replacement Gastrostomy tube. It can be used in any well formed gastric tract where a low profile device is considered desirable.

Gastrostomy tube feeding may be indicated for patients needing long term enteral support, including but not limited to, feeding, hydrating, medication delivery, and decompressing, secondary to a primary condition relating to the head or neck. These conditions may include:

Stroke Cancer Head or neck tumors, injuries, or trauma Neurological disorders resulting in a chewing or swallowing disorder.

The MIC-KEY® "G"™ Low Profile Gastrostomy Replacement Kit is intended to be used for patients requiring enteral support or decompression via a gastrostomy and is designed to be a balloon - secured replacement gastrostomy tube. A tapered distal tip eases insertion through the gastric tract and the balloon is then inflated to assure secure placement. The tapered tip makes the tube less traumatic to place than skin level tubes with mushroom type tips.

Device modification: The modification to this device is a change in balloon material formulation.

The device is packaged sterile and is marketed with a number of accessories; reference page 19 - Kit Certification, "Special" 510(k) Premarket Notification.

The provided text describes a "Special" 510(k) premarket notification for a device modification. The modification is a change in the balloon material formulation of the MIC-KEY® "G"™ Low Profile Gastrostomy Replacement Kit. The submission focuses on demonstrating substantial equivalence to a predicate device, as such it relies on non-clinical data for performance evaluation.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document explicitly states: "The testing of and acceptance criteria of the proposed device was identical to the testing and acceptance criteria of the predicate device." However, the specific numerical or qualitative criteria for each test are not detailed in the provided text. It only indicates that the proposed device met these unspecified criteria which were identical to the predicate.

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

The document does not specify the sample size used for the non-clinical tests (Visual/Dimensional Inspection, Balloon Burst Strength, High Acid Balloon Life Study). It mentions "the proposed MIC-KEY® 'G'™ Gastrostomy Tube" as the subject of testing, implying that samples of the modified device were used.

The data provenance is retrospective, as it refers to comparing the modified device's performance to an already legally marketed predicate device (MIC-KEY® "G"™ Low Profile Gastrostomy Tube -510(k) K922667/B). The tests were conducted "in vitro".

The country of origin for the data is implicitly the United States, as Ballard Medical Products is located in Draper, UT, and the submission is to the US FDA.

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

This information is not applicable as the study described is a non-clinical, in-vitro performance evaluation of a device modification, not a study involving human subjects or expert assessment of clinical data. The "ground truth" for these engineering tests would be the established specifications and performance characteristics of the predicate device.

4. Adjudication Method for the Test Set

This information is not applicable for the reasons stated in point 3.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done, If So, What was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance

This information is not applicable. The device is a medical tube for enteral feeding, not an imaging or diagnostic device that would involve "human readers" or AI assistance in the context of interpretation.

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

This information is not applicable for the reasons stated in point 5.

7. The Type of Ground Truth Used

The ground truth used for these non-clinical tests was the established performance specifications and acceptance criteria of the legally marketed predicate device. The goal was to demonstrate that the modified device performed identically to the predicate device in terms of these engineering benchmarks.

8. The Sample Size for the Training Set

This information is not applicable. This is not a machine learning or AI-driven device, so there is no concept of a "training set."

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

This information is not applicable for the reasons stated in point 8.

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The Ballard Medical Products® Faciletome™ Bow String Papillotome(s) is intended to be used for patients requiring transendoscopic cannulation and sphincterotomy of the Papilla of Vater and/or the Sphincter of Oddi.

The bow string papillotome is one of the most commonly used E.R.C.P. (Endoscopic Retrograde Colangio-Pancreatography) devices and has been established in the industry for several years. It has evolved into several variations on one general theme, facilitating entrance into the biliary tree. It performs this by housing a stainless steel mono-filament or stranded wire that is to be the active wire when monopolar, surgical power is introduced into the device handle connection. A sheath runs the length of the wire and allows only that portion of the wire that is needed to cut be exposed and insulates the remainder from the patient. The bow geometry and wire tension aid in cutting the tissue at the precise location. The wire is attached to a handle, that when manipulated, allows the operator to apply tension forming a " bow" at the distal end.

The Ballard Medical Products® Faciletome™ Bow String Papillotome is placed under direct vision of a duodenscope, with or without fluoroscopic aid. The single lumen, double lumen and triple lumen designs have a variety of cutting wire lengths as well as a variety of precurved tip configurations in the precurved model type.

The provided text is a 510(k) Premarket Notification Summary Statement for the Ballard Medical Products® Faciletome™ Bow String Papillotome. It describes the device, its intended use, and its substantial equivalence to a predicate device.

Here's an analysis of the requested information based on the provided text:

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

The document does not explicitly present a table of acceptance criteria with reported device performance in the format of specific quantitative metrics for a clinical study. Instead, it lists non-clinical (in vitro) tests performed to demonstrate substantial equivalence to a predicate device.

The conclusion states that based on indications for use, technological characteristics, and performance testing, the device is "safe and effective for its intended use" and "substantially equivalent" to the predicate device. This implies that the device met the acceptance criteria for these non-clinical tests.

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

The document refers to "in vitro tests" and does not describe a clinical test set involving human patients or data with specific provenance (e.g., country of origin). The testing was non-clinical.

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

Not applicable. The tests performed were non-clinical (in vitro) and would not involve experts establishing ground truth in the context of clinical outcomes.

4. Adjudication method for the test set

Not applicable. There was no clinical test set requiring adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, an MRMC comparative effectiveness study was not done. The document focuses on demonstrating substantial equivalence to a predicate device through technological characteristics and non-clinical testing.

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

Not applicable. This is a medical device (papillotome), not an AI algorithm. Its performance is inherent to its physical and electrical properties, and its use involves human application.

7. The type of ground truth used

For the non-clinical tests, the "ground truth" was established by objective physical and electrical measurements against predefined engineering specifications or industry standards for similar devices. There was no clinical ground truth (e.g., pathology, outcomes data) used in this submission summarized in the provided text.

8. The sample size for the training set

Not applicable. This is a medical device, not an AI or machine learning model, so there is no concept of a "training set" in this context.

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

Not applicable. As noted above, there is no training set mentioned for this medical device.

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The MIC-KEY® G™ Low Profile Gastrostomy Replacement Kit is designed as a replacement Gastrostomy tube. It can be used in any well formed gastric tract where a low profile device is considered desirable.

Gastrostomy tube feeding may be indicated for patients needing long term enteral support, including but not limited to, feeding, hydrating, medication delivery, and decompressing, secondary to a primary condition relating to the head or neck. These conditions include:

Stroke Cancer Head or neck tumors, injuries, or trauma Neurological disorders resulting in a chewing or swallowing disorder.

The MIC-KEY® "G"™ Low Profile Gastrostomy Replacement Kit is intended to be used for patients requiring enteral support or decompression via a gastrostomy, and is designed to be a balloon - secured replacement gastrostomy tube. A tapered distal tip eases insertion through the gastric tract and the balloon is then inflated to assure secure placement. The tapered tip makes the tube less traumatic to place than skin level tubes with obturator placed mushroom type tips.

The balloon in this device is mounted (distal cuff) to the distal inner lumen of the feeding tube, the proximal cuff is mounted to the outer diameter of the feeding tube. While the balloon length is equivalent to the predicate MIC-KEY, the overall length of the device has been decreased to facilitate the balloon, when inflated, to surround the device distal tip.

The device is packaged sterile and is marketed with a number of accessories; reference Section 11 - Kit Certification, "Special" 510(k) Premarket Notification.

Here's a breakdown of the acceptance criteria and study information for the MIC-KEY® "G"™ Low Profile Gastrostomy Replacement Kit, based on the provided text:

Acceptance Criteria and Reported Device Performance

Study Information

1. Sample sizes used for the test set and the data provenance: Not specified in the provided text. The text only mentions "non-clinical data" and "in vitro tests."
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The study involved non-clinical, in vitro testing, not expert-adjudicated test sets.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This was an in vitro mechanical testing study, not one requiring adjudication by experts.
4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a medical device, not an AI diagnostic tool. No MRMC study was mentioned.
5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a medical device, not an algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The ground truth was established by the in vitro mechanical properties of the device, specifically its balloon cuff glue bond, visual/dimensional characteristics, and balloon burst strength, as compared to a predicate device.
7. The sample size for the training set: Not applicable. This was a non-clinical, in vitro study for a physical device, not a machine learning model.
8. How the ground truth for the training set was established: Not applicable.

Summary of the Study:

The provided document describes a "Special" 510(k) premarket notification for a modification to an existing medical device, the MIC-KEY® "G"™ Low Profile Gastrostomy Replacement Kit. The study conducted to demonstrate the device meets acceptance criteria was a non-clinical, in vitro performance testing study.

The core of the study involved comparing the modified device to its predicate device (MIC-KEY® Low Profile Gastrostomy Kit #K922667/B) using identical testing and acceptance criteria. The tests performed were:

• Balloon Cuff Glue Bond Inspection
• Visual/Dimensional Inspection
• Balloon Burst Strength

The document explicitly states: "The testing of and acceptance criteria of the proposed device was identical to the testing and acceptance criteria of the predicate device." It then concludes that based on the performance testing, the device is "safe and effective for its intended use." This implies that the modified device met the same performance standards as the predicate device for these critical mechanical characteristics. No specific numerical results or sample sizes for these tests are provided in the excerpt.

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As with the great majority of other ET suction catheters, the indication for endotracheal suctioning is to provide a patent airway by removing excess fluids, secretions, exudate and transudate through the artificial airway. These include patients with indwelling oral or nasal endotracheal tubes, and tracheostomy tubes. This system applies to intubated patients requiring a full range of respiration and ventilatory support. They may be spontaneously breathing, on mechanical ventilation, or partially supported by mechanical devices. The TRACH CARE® closed suction system, as well as other suction catheters, can also be used for saline lavage and surfactant delivery to the distal airway. The closed system device allows for multiple suction episodes utilizing the same catheter. The protective sleeve of the closed system isolates the flora from the patient's secretions, thus reducing the risk of cross-contamination to health care providers and other patients.

5 French through 18 French TRACH CARE® Closed Suction Endotracheal Suction Catheters with MICROBAN® and various airway connectors.

This device, the TRACH CARE® with MICROBAN®, is an Endotracheal Suction Catheter. The 510(k) summary indicates that the submission requests permission to market a device with a label change, extending the recommended use time from "24 hours" to "72 hours."

The submission explicitly states: "The device of this submission is identical in design, material, chemical composition, and all other logical characteristics as the predicate device. This submission requests permission to market a device with a label change in contraindications FROM "Do not use for more than 24 hours." TO "Do not use for more than 72 hours. Change more frequently if catheter becomes soiled or develops any other factor which reduces device efficiency.""

This implies that the acceptance criteria and study proving the device meets them are based on demonstrating that the device remains safe and effective for the extended 72-hour use period, given that its physical characteristics are otherwise identical to the previously cleared 24-hour version. However, the provided text does not contain any specific performance data, acceptance criteria, or details of a study that directly prove the device meets these extended use criteria for the 72-hour period. The clearance is based on the substantial equivalence argument of the label change.

Therefore, many of the requested details cannot be extracted from the provided text.

Here's what can be inferred or stated based on the available information:

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

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

• Not provided. The document does not describe any specific test set or study conducted for the 72-hour extended use claim.

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 / Not provided. Since no specific test set or study is described, this information is not available.

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

• Not applicable / Not provided.

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 a medical device (endotracheal suction catheter), not an AI-powered diagnostic tool. Therefore, an MRMC study or AI-related metrics are irrelevant.

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

• Not applicable. This is not an algorithmic device.

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

• Not provided. The basis for extending the use time to 72 hours is not detailed in terms of specific ground truth data or studies. The substantial equivalence argument relies on the physical identity to the predicate.

8. The sample size for the training set

• Not applicable / Not provided. This is not an AI/machine learning device that requires a training set.

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

• Not applicable / Not provided.

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