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The Stellartech 100 Coagulation System is intended for coagulating soft tissue during open (non-laparoscopic or non-endoscopic) general surgical procedures. The System may also be used to coagulate blood and soft tissue to produce hemostasis.

The Stellartech 100 Coagulation System consists of the following components.

• Stellartech 100 Coagulation Generator Models #1050B-115 & 1050B-230 .
• . Stellartech 101 Probe
• Optional Stellartech Footswitch. .
  The proximal end of the Stellartech 101 Probe connects to the Stellartech 100 Coagulation Generator Models #1050B-115 & 1050B-230.

This document is a 510(k) premarket notification for the Stellartech 100 Coagulation System. It focuses on establishing substantial equivalence to predicate devices rather than presenting a study demonstrating the device meets specific acceptance criteria based on performance data.

Therefore, many of the requested categories related to performance studies, sample sizes, ground truth establishment, and expert involvement cannot be extracted from the provided text because these types of studies were not included or required for this type of submission.

Here's what can be extracted based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

   Acceptance Criteria	Reported Device Performance
   Implicit Acceptance Criteria for 510(k) Equivalence:

The device's design, principles of operation, materials, and intended use are substantially equivalent to legally marketed predicate devices.

Specific Performance Criteria (Not explicitly stated):
The document does not detail specific quantitative performance acceptance criteria (e.g., coagulation efficacy, power output ranges, safety limits) against which the device was tested. The focus is on substantial equivalence to predicate devices. | The Stellartech 100 Coagulation System is substantially equivalent to the listed predicate devices by virtue of its design, principles of operation, materials, and intended use. |

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

   • Information Not Provided: The submission is a 510(k) for substantial equivalence and does not describe a clinical study with a "test set" in the context of performance metrics. It references comparison to predicate devices.

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):

   • Information Not Provided: The submission does not detail any expert-driven ground truth establishment for a performance test set. The "ground truth" for a 510(k) substantial equivalence determination generally relies on the established safety and efficacy of the predicate devices and the manufacturer's engineering assessment of their device's equivalence.

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

   • Information Not Provided: As no performance study with a "test set" requiring adjudication is described, this information is 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 / Information Not Provided: This device is an electrosurgical unit, not an AI-assisted diagnostic or imaging device used by "readers." Therefore, an MRMC study is not relevant to this submission.

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

   • Not Applicable / Information Not Provided: This device is a physical electrosurgical system, not an algorithm. Standalone algorithm performance is not relevant.

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

   • Implicit Ground Truth for Substantial Equivalence: The ground truth for this 510(k) submission is the legally marketed predicate devices and their established safety and effectiveness. The manufacturer asserts that the Stellartech 100 Coagulation System's characteristics are "substantially equivalent" to these known devices. There is no mention of specific clinical outcomes data or pathology reviews presented in this summary to establish "ground truth" for a novel performance claim beyond equivalence.

8. The sample size for the training set:

   • Not Applicable / Information Not Provided: This device is an electrosurgical unit, not a machine learning model, so there is no "training set" in the context of AI.

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

   • Not Applicable / Information Not Provided: As there is no training set, this question is not applicable.

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The Stellartech Coagulation System 2 is indicated for use in the coagulation of bleeding and nonbleeding sites in the gastrointestinal tract including but not limited to, the esophagus. Indications include Esophageal Ulcers, Mallory-Weiss tears, Arteriovenous Malformations, Angiomata, Barrett's Esophagus, Dieulafoy Lesions, and Angiodysplasia.

The Stellartech Coagulation System 2 consists of the following components.

• . Stellartech Coagulation Catheter 2
• Stellartech Coagulation Generator 2 .
• . Stellartech Catheter Connection Cable 2
• Optional Stellartech Sheath ●
• Optional Stellartech Footswitch 2. .
• Optional Stellartech Sizing Catheter 2 .
  The proximal end of the Stellartech Coagulation Catheter 2 connects through the Stellartech Catheter Connection Cable 2 to the Stellartech Coagulation Generator 2.

The provided text is a 510(k) Safety Summary for a medical device called the "Stellartech Coagulation System 2." This document primarily focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance, rather than presenting a performance study with detailed acceptance criteria and expert-adjudicated ground truth as would be typical for AI/ML device submissions.

Therefore, many of the requested categories cannot be filled as the information is not present in the provided text.

Here is an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document. The 510(k) summary focuses on substantial equivalence rather than explicit performance metrics against pre-defined acceptance criteria for a new clinical study.

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

This information is not provided. The document does not describe a new clinical study or test set for performance evaluation.

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

This information is not provided. As no new test set is described, there's no mention of ground truth establishment by experts.

4. Adjudication method for the test set

This information is 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

This information is not provided. The Stellartech Coagulation System 2 is an electrosurgical unit, not an AI/ML diagnostic tool, so an MRMC study comparing human readers with and without AI assistance would not be applicable.

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

This information is not provided. Given the device type, 'standalone algorithm performance' is not relevant.

7. The type of ground truth used

This information is not provided.

8. The sample size for the training set

This information is not provided. The document refers to prior predicate devices, implying that the "training" for this device would be based on the established clinical use and safety of those equivalent devices, not a computational training set.

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

This information is not provided. Similar to point 8, the concept of "ground truth for a training set" as it applies to AI/ML is not relevant to this traditional medical device submission.

Summary of Device and Regulatory Context (from the provided text):

The Stellartech Coagulation System 2 is an electrosurgical unit and accessories used for the coagulation of bleeding and non-bleeding sites in the gastrointestinal tract, including specific indications like Esophageal Ulcers, Mallory-Weiss tears, Arteriovenous Malformations, etc.

The device received 510(k) clearance by demonstrating substantial equivalence to a list of previously cleared Stellartech Coagulation System predicate devices (K013139, K023765, K032062, K0324552, K032721, K040240, K041383, K042909). The equivalence was based on its design, principles of operation, materials, and intended use. The 510(k) process in this context did not require a new clinical study with specific performance acceptance criteria or the establishment of ground truth as typically seen for novel diagnostic or AI-driven devices.

Ask a specific question about this device

The Stellartech Coagulation System is indicated for use in the coagulation of bleeding and non-bleeding sites in the gastrointestinal tract including but not limited to, the esophagus. Indications include Esophageal Ulcers, Mallory-Weiss tears, Arteriovenous Malformations, Angiomata, Barrett's Esophagus, Dieulafoy Lesions, and Angiodysplasia.

The Stellartech Coagulation System consists of the following components.

• Stellartech Coagulation Catheter .
• Stellartech Coagulation Catheter Connection Module .
• Stellartech Coagulation Generator .
• . Stellartech Sheath
• . Optional Stellartech Footswitch.
• . Optional Stellartech Sizing Catheter
• Optional Stellartech Sizing Sheath .
  The proximal end of the Stellartech Coagulation Catheter connects to the Stellartech Coagulation Catheter Connection Module. The Stellartech Coagulation Catheter Connection Module cable connects to the Stellartech Coagulation Generator.

The provided document is a 510(k) premarket notification for the Stellartech Coagulation System. This type of FDA submission aims to demonstrate that a new medical device is substantially equivalent to a legally marketed predicate device, rather than proving its safety and effectiveness through extensive clinical trials as would be required for a PMA (Premarket Approval).

Therefore, the document does not contain the kind of detailed information about acceptance criteria, specific device performance metrics, sample sizes for test or training sets, expert qualifications, or adjudication methods that would be present in a study designed to prove a device meets specific performance criteria.

Here's why and what information is available:

• Substantial Equivalence: The core of a 510(k) is to show that the new device has the same intended use and technological characteristics as a predicate device, or if there are differences, that those differences do not raise new questions of safety and effectiveness. This is typically done through comparisons of design, materials, performance specifications, and sometimes bench testing or limited clinical data demonstrating equivalency, not superiority or novel performance.

Based on the provided text, I cannot complete the table or answer most of the questions as the information is not present. The document states:

• F. Summary: "By virtue of design, principles of operation, materials and intended use, the Stellartech Coagulation System is substantially equivalent to devices currently marketed in the United States."
• E. Technical Characteristics: "The technological characteristics of the Stellartech Coagulation System are substantially equivalent to those of the above listed predicate devices."

This indicates that the "study" for this submission was a comparison to predicate devices, focusing on demonstrating equivalency rather than meeting specific quantifiable performance acceptance criteria in a standalone clinical or analytical study as you've outlined.

However, I can extract the following relevant information:

• Device Name: Stellartech Coagulation System
• Intended Use: Coagulation of bleeding and non-bleeding sites in the gastrointestinal tract (esophagus), including Esophageal Ulcers, Mallory-Weiss tears, Arteriovenous Malformations, Angiomata, Barrett's Esophagus, Dieulafoy Lesions, and Angiodysplasia.
• Predicate Devices: Stellartech Coagulation System (K013139, K023765, K032062, K032452, K032721, K040240, K041383)

Therefore, the table and answers will reflect the absence of this detailed information in a 510(k) submission focused on substantial equivalence.

Acceptance Criteria and Device Performance (Based on available 510(k) information)

Study Information (Based on available 510(k) information)

1. Sample size used for the test set and the data provenance:

   • Sample Size: Not applicable/Not provided. This 510(k) focuses on substantial equivalence through comparison of technological characteristics and intended use to predicate devices, not on a clinical "test set" in the context of an AI/diagnostic algorithm.
   • Data Provenance: Not applicable/Not provided. The submission relies on design and functional comparisons to existing devices, not on a dataset of clinical cases.

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

   • Not applicable/Not provided. There was no "test set" requiring expert-established ground truth mentioned in this 510(k).

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

   • Not applicable/None. There was no "test set" requiring adjudication mentioned in this 510(k).

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 device is an electrosurgical coagulation system, not an AI or diagnostic imaging device that would involve human readers or AI assistance in interpretation.

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

   • Not applicable. This device is an electrosurgical coagulation system, not an algorithm.

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

   • Not applicable/Not explicitly stated as ground truth. The "ground truth" for a 510(k) is essentially the established safety and effectiveness profile of the predicate devices. The new device demonstrates equivalency to this established profile.

7. The sample size for the training set:

   • Not applicable/Not provided. This type of submission does not involve a "training set" like an AI/machine learning model would.

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

   • Not applicable/Not provided. There was no "training set" for this submission.

In summary, the provided document is a regulatory submission focused on demonstrating "substantial equivalence" of a medical device to existing predicate devices under 21 CFR 878.4400. It does not detail a study involving performance metrics, test sets, training sets, or expert consensus as would be common for diagnostic algorithms or novel devices undergoing more rigorous clinical evaluation.

Ask a specific question about this device

The Stellartech Coagulation System is indicated for use in the coagulation of bleeding and nonbleeding sites in the gastrointestinal tract including but not limited to, the esophagus. Indications include Esophageal Ulcers, Mallory-Weiss tears, Arteriovenous Malformations, Angiomata, Barrett's Esophagus, Dieulafoy Lesions, and Angiodysplasia.

The Stellartech Coagulation System consists of the following components.

• Stellartech Coagulation Catheter .
• Stellartech Coagulation Catheter Connection Module t
• . Stellartech Coagulation Generator
• Stellartech Sheath .
• Optional Stellartech Footswitch. .
• Optional Stellartech Sizing Catheter .
• Optional Stellartech Sizing Sheath .
  The proximal end of the Stellartech Coagulation Catheter connects to the Stellartech Coagulation Catheter Connection Module. The Stellartech Coagulation Catheter Connection Module cable connects to the Stellartech Coagulation Generator.

The provided text is a 510(k) premarket notification for the Stellartech Coagulation System. It focuses on establishing substantial equivalence to previously marketed predicate devices rather than providing a detailed study proving performance against specific acceptance criteria.

Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, and MRMC studies is not available in the provided document. This type of information is typically found in design validation studies, clinical trials, or performance testing reports, which are not included in this summary.

Here's a breakdown of what can and cannot be extracted from the provided text, following your requested format:

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

• Not Available: The document does not specify quantitative acceptance criteria (e.g., specific thresholds for coagulation effectiveness, safety metrics, or device longevity) nor does it report specific performance data from a study that would demonstrate meeting such criteria. The submission is based on substantial equivalence, implying that its performance is assumed to be similar to legally marketed predicate devices without explicitly stating and measuring against specific acceptance targets.

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

• Not Available: No test set or data provenance is mentioned. This submission is a regulatory filing for substantial equivalence, not a clinical study report.

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 Available: The concept of a "ground truth" and expert adjudication is not present in this type of regulatory submission focusing on substantial equivalence for a medical device like a coagulation system. Ground truth is usually relevant for AI/ML device assessments that rely on image or data interpretation.

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

• Not Available: Not applicable, as no test set or ground truth adjudication process is described in this document.

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 Available: This device is a medical instrument (electrosurgical unit), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant or described.

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

• Not Available: This device is a physical electrosurgical system, not an algorithm. Standalone performance as typically described for AI/ML devices is not applicable or discussed.

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

• Not Available: Ground truth is not a concept discussed in this 510(k) summary. The device's safety and effectiveness are established by demonstrating substantial equivalence to predicate devices, implying that their previously established safety and effectiveness apply to this new device due to similar design and intended use.

8. The sample size for the training set

• Not Available: There is no mention of a training set. This is a medical device, not an AI/ML product developed using training data.

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

• Not Available: Not applicable, as there is no training set described.

Summary of Device and Regulatory Context (based on provided text):

The Stellartech Coagulation System is an electrosurgical unit and accessories intended for use in the coagulation of bleeding and non-bleeding sites in the gastrointestinal tract, including specific indications such as Esophageal Ulcers, Mallory-Weiss tears, Arteriovenous Malformations, Angiomata, Barrett's Esophagus, Dieulafoy Lesions, and Angiodysplasia.

The 510(k) premarket notification (K041383) establishes substantial equivalence to several predicate Stellartech Coagulation Systems (K013139, K023765, K032062, K032452, K032721, K040240). The basis for FDA clearance is that the technological characteristics, design, principles of operation, materials, and intended use are substantially equivalent to these already marketed predicate devices. This means that extensive de novo studies with explicit acceptance criteria and performance reporting, as requested in your prompt regarding AI/ML devices, are typically not required for a 510(k) submission based on substantial equivalence to well-established technology.

Ask a specific question about this device

The Stellartech Coagulation System is indicated for use in the coagulation of bleeding and non-bleeding sites in the gastrointestinal tract including but not limited to, the esophaqus. Indications include Esophageal Ulcers, Mallory-Weiss tears, Arteriovenous Malformations, Angiomata, Barrett's Esophagus, Dieulafoy Lesions, and Angiodysplasia.

The Stellartech Coagulation System consists of the following components.

• Stellartech Coagulation Catheter .
• Stellartech Coagulation Catheter Connection Module ●
• Stellartech Coagulation Generator .
• Stellartech Sheath .
• Optional Stellartech Footswitch. ◆
• Optional Stellartech Pressure Gauge
• Optional Stellartech Sizing Catheter .
• 후 Optional Stellartech Sizing Sheath
  The proximal end of the Stellartech Coagulation Catheter connects to the Stellartech Coagulation Catheter Connection Module. The proximal end of the Stellartech Coagulation Catheter Connection Module cable connects to the Stellartech Coagulation Generator.

The provided document is a 510(k) safety summary for the Stellartech Coagulation System. It focuses on demonstrating substantial equivalence to predicate devices and does NOT contain information about acceptance criteria, performance studies, sample sizes, expert qualifications, or ground truth establishment relevant to an AI/ML device.

Therefore, I cannot provide the requested information. The document pertains to a traditional medical device (electrosurgical unit), not an AI/ML device, and thus does not involve the types of studies and criteria typically associated with AI/ML performance evaluation.

Ask a specific question about this device

The Stellartech Coagulation System is indicated for use in the coagulation of bleeding and non-bleeding sites in the gastrointestinal tract including but not limited to, the esophagus. Indications include Esophageal Ulcers, Mallory-Weiss tears, Arteriovenous Malformations, Angiomata, Barrett's Esophagus, Dieulafoy Lesions, and Angiodysplasia.

The Stellartech Coagulation System consists of the following components.

• Stellartech Coagulation Generator .
• Stellartech Probe Connection Module .
• Stellartech Coagulation Probe .
• Optional Accessory Stellartech Sizing Probe .
• . Optional Stellartech Footswitch.
  The proximal end of the Stellartech Coagulation Probe connects to the Stellartech Probe Connection Module. The proximal end of the Stellartech Probe Connection Module cable connects to the Stellartech Coagulation Generator.

This 510(k) submission (K032721) for the Stellartech Coagulation System does not contain a study that proves the device meets specific acceptance criteria in the manner you've outlined for AI/diagnostic devices.

Here's why and what information can be extracted from the provided text:

This is a substantial equivalence (510(k)) submission for an electrosurgical device. The core of a 510(k) is to demonstrate that a new device is as safe and effective as a legally marketed predicate device, not necessarily to prove efficacy against pre-defined performance metrics through clinical trials, especially for common device types like electrosurgical units.

Therefore, many of your requested fields related to diagnostic study design (like sample sizes for test and training sets, ground truth establishment, expert adjudication, MRMC studies, standalone performance) are not applicable and are not present in this document.

What can be described from the provided text:

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

• Acceptance Criteria: The primary "acceptance criteria" for a 510(k) is substantial equivalence to predicate devices. This means the device must demonstrate comparable safety and effectiveness. The document doesn't list quantifiable performance metrics with targets in the way one would for a diagnostic AI. Instead, it relies on the predicate devices having already established safety and effectiveness.
• Reported Device Performance: The document states: "The technological characteristics of the Stellartech Coagulation System are substantially equivalent to those of the above listed predicate devices." It does not provide specific performance data (e.g., coagulation time, power output, precision of ablation) for the new device or the predicates. Instead, it relies on the known performance of the predicate device family.

2. Sample sized used for the test set and the data provenance:

• Not applicable / Not provided. This device is an electrosurgical unit, not an AI diagnostic system. There is no "test set" of images or patient data in the context of diagnostic performance.
• The "study" is a comparison to predicate devices, which typically involves engineering testing, bench testing, and potentially some animal or cadaveric testing (though not detailed here) to ensure the new device functions similarly to the predicate. This is qualitative rather than a quantitative diagnostic performance study.

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

• Not applicable / Not provided. Ground truth is not established in this manner for an electrosurgical system's 510(k). The "ground truth" for predicate devices is their long-standing use and FDA clearance for safety and effectiveness.

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

• Not applicable / None. No adjudication method for a test set is described, as there isn't a diagnostic 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:

• No. This is an electrosurgical device, not an AI clinical decision support or diagnostic tool that assists human readers. Therefore, an MRMC study is not relevant or included.

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

• Not applicable. There is no "algorithm only" performance for this type of device. The device is used by a human operator.

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

• For this device, the "ground truth" for its safety and effectiveness is primarily established by:
  • The regulatory history and performance of the predicate devices. These predicates have been legally marketed and are presumed safe and effective for their indicated uses.
  • Engineering and functional testing to ensure the new device meets specifications consistent with the predicate.
  • Biocompatibility and electrical safety testing (implied for any medical device but not detailed in this summary).

8. The sample size for the training set:

• Not applicable / Not provided. There is no "training set" of data for this type of device.

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

• Not applicable / Not provided. As there is no training set, there's no ground truth establishment for it.

In summary: The provided document is a 510(k) summary for an electrosurgical device, which is cleared based on substantial equivalence to existing predicate devices. It does not involve the kind of diagnostic performance studies with acceptance criteria, test sets, or training sets that are typical for AI/CADe devices. The "study" here is a regulatory review comparing technical characteristics and indications to existing cleared devices.

Ask a specific question about this device

The Stellartech Coagulation System is indicated for use in the coagulation of bleeding and non-bleeding sites in the gastrointestinal tract including but not limited to, the esophagus. Indications include Esophageal Ulcers, Mallory-Weiss tears, Arteriovenous Malformations, Angiomata, Barrett's Esophagus, Dieulafoy Lesions, and Angiodysplasia.

The Stellartech Coagulation System consists of the following components.

• Stellartech Coagulation Generator ●
• Stellartech Coagulation Probe Connection Module ●
• Stellartech Coagulation Probe ●
• Optional Stellartech Sizing Probe .
• Optional Stellartech Footswitch. .
  The proximal end of the Stellartech Coagulation Probe connects to the Stellartech Coagulation Probe Connection Module. The proximal end of the Stellartech Coagulation Probe Connection Module cable connects to the Stellartech Coagulation Generator.

This document is a 510(k) premarket notification for the Stellartech Coagulation System. It declares substantial equivalence to previously cleared predicate devices but does not contain any information regarding acceptance criteria or the study that proves the device meets acceptance criteria. This type of submission typically focuses on demonstrating that a new device is as safe and effective as a legally marketed predecessor, often without requiring new clinical performance studies if the technological characteristics and intended use are sufficiently similar.

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

Ask a specific question about this device

The Stellartech Coagulation System is indicated for use in the coagulation of bleeding and non-bleeding sites in the gastrointestinal tract including but not limited to, the esophagus, Indications include Esophageal Ulcers, Mallory-Weiss tears, Arteriovenous Malformations, Angiomata, Barrett's Esophagus, Dieulafoy Lesions, and Angiodysplasia.

The Stellartech Coagulation System consists of the following components.

• Stellartech Coagulation Generator ●
• Stellartech Coagulation Probe Connection Module ●
• Stellartech Coagulation Probe .
• Optional Stellartech Footswitch. .
  The proximal end of the Stellartech Coagulation Probe connects to the Stellartech Coagulation Probe Connection Module. The proximal end of the Stellartech Coagulation Probe Connection Module cable connects to the Stellartech Coagulation Generator.

The provided text is related to a 510(k) clearance for the Stellartech Coagulation System. It focuses on regulatory approval based on substantial equivalence to predicate devices, rather than a study demonstrating specific performance metrics against acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment is not present in the provided document.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

This information is not provided in the document. The 510(k) summary focuses on demonstrating "substantial equivalence" of the Stellartech Coagulation System to existing predicate devices (Hobbs Medical Dilation Balloon Catheter, Stellartech Coagulation System K013139, Stellartech Coagulation System K023765) based on design, principles of operation, materials, and intended use. It does not provide specific acceptance criteria or performance metrics for the device itself.

2. Sample sized 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 document. The submission is a regulatory premarket notification based on equivalence, not a clinical study with a test set.

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 provided in the document. No test set or ground truth establishment is described.

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

This information is not provided in the document. No test set or adjudication method is described.

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 provided in the document. The device is an electrosurgical unit, not an AI-assisted diagnostic tool, so an MRMC study related to human reader improvement with AI would not be applicable.

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

This information is not provided in the document. The device is a physical electrosurgical system, not an algorithm.

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

This information is not provided in the document. No ground truth is mentioned as it's not a study requiring such data.

8. The sample size for the training set

This information is not provided in the document. No training set is mentioned.

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

This information is not provided in the document. No training set or ground truth establishment is described.

Ask a specific question about this device

The Stellartech Coagulation System is indicated for use in the coagulation of bleeding and non-bleeding sites in the gastrointestinal tract including but not limited to, the esophagus. Indications include Esophageal Ulcers, Mallory-Weiss tears, Arteriovenous Malformations, Angiomata, Barrett's Esophagus, Dieulafoy Lesions, and Angiodysplasia.

The Stellartech Coagulation System consists of the following components.

• Stellartech Coagulation Generator .
• Stellartech Coagulation Probe Connection Module ●
• Stellartech Coagulation Probe .
• Optional Stellartech Footswitch. .
  The proximal end of the Stellartech Coagulation Probe connects to the Stellartech Coagulation Probe Connection Module. The proximal end of the Stellartech Coagulation Probe Connection Module cable connects to the Stellartech Coagulation Generator.

The provided document is a 510(k) Safety Summary for a medical device called the "Stellartech Coagulation System." This type of document is submitted to the FDA to demonstrate that a new device is substantially equivalent to a legally marketed predicate device.

It's important to understand that a 510(k) submission primarily focuses on demonstrating "substantial equivalence" of a new device to existing predicate devices, rather than establishing acceptance criteria through new clinical studies measuring performance against specific metrics.

Therefore, the document does not contain information about:

• A table of acceptance criteria and reported device performance directly derived from a new study specific to this submission.
• Sample sizes used for a test set, data provenance, or the number/qualifications of experts for ground truth establishment.
• Adjudication methods, MRMC comparative effectiveness studies, or standalone algorithm performance studies.
• Training set sample sizes or how their ground truth was established.

Instead, the document asserts substantial equivalence based on prior predicate devices and their established safety and effectiveness.

Here's what the document does provide and why the requested information is not present:

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

   • N/A. The document does not present specific acceptance criteria in the form of performance metrics (like sensitivity, specificity, accuracy, etc.) and then report the device's measured performance against those criteria. The acceptance criterion for a 510(k) is "substantial equivalence" to a predicate device. The "performance" demonstrated is that its technical characteristics, principles of operation, materials, and intended use are comparable to legally marketed predicate devices.

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

   • N/A. No new clinical or test set data is presented in this 510(k) summary for performance evaluation against specific metrics. The substantial equivalence argument relies on the inherent safety and effectiveness of the predicate devices.

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):

   • N/A. As no new test set is described, there's no mention of experts for establishing ground truth.

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

   • N/A. No test set described.

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:

   • N/A. This device (Electrosurgical Unit) is not an AI/imaging diagnostic device, and no MRMC study or AI assistance is mentioned.

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

   • N/A. This is not an algorithmic device.

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

   • N/A. As no new performance study is detailed, no ground truth types are described. The "ground truth" in a 510(k) for substantial equivalence is the safety and effectiveness of the legally marketed predicate devices.

8. The sample size for the training set:

   • N/A. This is not an AI/machine learning device that requires a training set.

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

   • N/A. Not applicable, as it's not an AI/machine learning device.

In summary: The provided document is a 510(k) submission, which aims to demonstrate "substantial equivalence" to existing devices, not to present novel clinical study data with specific acceptance criteria and performance metrics. The information requested (acceptance criteria, study details, sample sizes, ground truth methods, MRMC studies, etc.) is typically found in PMA (Premarket Approval) applications or clinical studies for novel devices, not generally in 510(k) summaries like this one.

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The Stellartech Coagulation System is indicated for use in the coagulation of bleeding and non-bleeding sites in the gastrointestinal tract including but not limited to, the esophagus. Indications include Esophageal Ulcers, Mallory-Weiss tears, Arteriovenous Malformations, Angiomata, Barrett's Esophagus, Dieulafoy Lesions, and Angiodysplasia.

The Stellartech Coagulation System consists of the following components.

• Stellartech Coagulation Generator ●
• Stellartech Coagulation Probe Connection Module .
• Stellartech Coagulation Probe .
• Optional Stellartech Footswitch. ●
  The proximal end of the Stellartech Coagulation Probe connects to the Stellartech Coagulation Probe Connection Module. The proximal end of the Stellartech Coagulation Probe Connection Module cable connects to the Stellartech Coagulation Generator.

The provided text is a 510(k) Safety Summary for a medical device called the "Stellartech Coagulation System." This type of document is submitted to the FDA to demonstrate substantial equivalence to a legally marketed predicate device, rather than to establish acceptance criteria and prove a device meets them through a clinical study in the way a new, high-risk device might.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria, specifically:

• A table of acceptance criteria and reported device performance.
• Sample size used for the test set or data provenance.
• Number of experts or their qualifications for establishing ground truth.
• Adjudication method for the test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study results.
• Standalone (algorithm only) performance.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

Explanation of the provided document's purpose:

The document focuses on demonstrating substantial equivalence to existing predicate devices (e.g., Stellartech Radiofrequency Generator, ArthroCare Electrosurgery System Generator, etc.). This means the manufacturer is asserting that their new device is as safe and effective as devices already on the market, rather than proving a novel claim against specific performance criteria derived from a new clinical study. The FDA's review (as indicated in the letter from Celia M. Witten, Ph.D., M.D.) confirms this substantial equivalence based on design, principles of operation, materials, and intended use.

The document lists:

• Trade Name: Stellartech Coagulation System
• Common Name: Electrosurgical Unit and Accessories
• Classification Name: Device, Electrosurgical Cutting and Coagulation and Accessories (21 CFR 878.4400)
• Indicated Use: Coagulation of bleeding and non-bleeding sites in the gastrointestinal tract, including specific conditions like Esophageal Ulcers, Mallory-Weiss tears, etc.
• Predicate Devices: A list of previously cleared electrosurgical devices.
• Device Description: Components of the Stellartech Coagulation System.
• Conclusion: The device is substantially equivalent to currently marketed devices.

In summary, this 510(k) submission is not a clinical study report designed to show an AI/device meets specific performance metrics against an established ground truth with quantified acceptance criteria. It's a regulatory document demonstrating that a new device is "like" an old, already-approved device.

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