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The Habib EndoHPB is a radiofrequency (RF) catheter which provides bipolar energy to perform partial or complete ablation of tissue in the pancreatic and biliary tracts.

The Habib EndoHPB is also intended for use to ablate malignant or benign tissue, notably to perform endoscopic biliary drainage or decompression, prior to stent placement or afterwards, to clear occluded stent.

The Habib EndoHPB is an 8F RF bipolar catheter that consists of a catheter with 2 ring electrodes, introduced via an endoscope's biopsy channel. It has an attached cable which connects the device to an RF Generator. RF is applied to the two electrodes at the top of the catheter so that heat is applied to tissue surrounding the catheter.

This document, a 510(k) Pre-market Notification for the Habib EndoHPB, details the device's substantial equivalence to a predicate device, focusing on its expanded indications for use. It outlines the performance and clinical data submitted to support these expanded uses.

Acceptance Criteria and Reported Device Performance

The provided document does not contain a typical "acceptance criteria" table with specific quantitative thresholds for device performance (e.g., sensitivity, specificity, accuracy) akin to what might be seen for diagnostic AI devices. Instead, the "acceptance criteria" for this device, which is a therapeutic radiofrequency (RF) catheter, are implicitly demonstrated through:

• Substantial Equivalence: The primary acceptance criterion for a 510(k) submission is to demonstrate that the new device is "substantially equivalent" to a legally marketed predicate device. This involves showing that the device is as safe and effective as the predicate.
• Performance Data: Non-clinical (bench) testing to confirm fundamental device properties, such as shelf-life and compatibility with new generators.
• Clinical Data: Studies to demonstrate the safety and effectiveness of the device for its expanded indications for use, particularly for the ablation of tissue in pancreatic and and biliary tracts, and for clearing occluded stents.

Therefore, the table below summarizes the differences and the justification for substantial equivalence, which serves as the "acceptance criteria" framework for this type of device submission.

Justification: "Multiple clinical studies are being submitted to demonstrate that the Habib EndoHPB is as safe and effective as the predicate. All the clinical studies provided within this submission have been performed using the subject device and clearly support the new intended use." The subject device has the same fundamental technology, design attributes, materials, and functions as the predicate. |
| Extended Shelf-Life (Device functionality and safety maintained over 3 years) | Reported Performance: New claimed shelf-life of 3 years.

Justification: "The results obtained support the claimed 3-year shelf-life." This implies non-clinical testing was performed (e.g., accelerated aging, real-time aging studies) to confirm material degradation, sterility, and functional performance over the extended period. |
| Compatibility with New Generators (Safe and effective operation when connected to additional RF generators) | Reported Performance: Compatibility with additional generators: Olympus ESG-100, Genii GI 4000, ERBE VIO 200, ERBATOM ICC 200, 300, 350. (The predicate was compatible with RITA Medical Systems 1500, RITA Medical Systems 1500X, Radionics Cosman Coagulator CC-1).

Justification: "The results obtained support... the compatibility with new generators." This implies testing was performed to ensure that the device performs as intended and safely (e.g., no overheating, appropriate power delivery, no electrical hazards) when used with these new generators, meeting relevant electrical safety and EMC standards (IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2, IEC 60601-2-18). |
| Fundamental Technological Equivalence (No significant changes in design, material, energy source, or manufacturing process that raise new questions of safety or effectiveness) | Reported Performance: "Compared to the predicate device, there has been no change or modification in design, material, energy source or manufacturing process in the subject device." The device remains an 8F RF bipolar catheter with 2 ring electrodes, stainless steel active electrode material, delivered endoscopically, single-use, and ETO sterilized. The core mechanism of action (bipolar RF energy ablation) is unchanged.

Justification: The 510(k) submission states that "the evidence collected in the table above clearly demonstrate that, except for insignificant differences, the subject device, the Habib EndoHPB, is identical to the previously cleared Habib EndoHPB (K083292) in terms of fundamental technology, design attributes, materials, features, functions, and performance." |
| Electrical Safety and Electromagnetic Compatibility (EMC) (Compliance with recognized international standards for medical electrical equipment) | Reported Performance: "Electromagnetic compatibility and electrical safety testing have been performed on the Habib EndoHPB to validate that it meets the requirements of the latest Recognized Consensus Standards."

Justification: Compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2, IEC 60601-2-18. |

Study Proving Device Meets Acceptance Criteria

The document states that "multiple clinical studies are being submitted to demonstrate that the Habib EndoHPB is as safe and effective as the predicate" for its new intended use. However, the details of these specific studies (e.g., design, endpoints, results) are not provided within this 510(k) summary. This summary only states that such studies were submitted and supported the new intended use.

Based on the provided text, the following information regarding the study cannot be definitively extracted:

1. Sample sizes used for the test set and the data provenance: Not specified.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/specified. This is a therapeutic device, not a diagnostic AI device requiring expert consensus for ground truth on images. The "ground truth" would relate to clinical outcomes (e.g., successful ablation, stent clearance, complication rates).
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable/specified.
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 therapeutic device, not an AI-assisted diagnostic imaging device.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a therapeutic device that works with a human operator.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): While not explicitly stated, for a therapeutic device performance, the ground truth for clinical studies would typically involve outcomes data such as:
   • Successful ablation (e.g., histological confirmation if biopsies are taken, imaging follow-up)
   • Successful biliary drainage/decompression
   • Successful stent clearance
   • Complication rates (e.g., perforation, bleeding, pancreatitis)
   • Adverse event rates
   • Patient survival/quality of life (if long-term follow-up was part of the study).
7. The sample size for the training set: Not applicable. This is not an AI/machine learning device that requires a training set.
8. How the ground truth for the training set was established: Not applicable.

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The Habib EUS RFA 6700 is indicated for coagulation and ablation of soft tissue when used in conjunction with compatible radio frequency generator.

The Habib EUS RFA 6700 is a catheter that is delivered during an EUS procedure, through 19 Gauge (G) endoscopic needles. The subject device is monopolar configuration and thus, must be used in conjunction with patient grounding pad. RF energy is produced by connecting the catheter to a compatible RF generator via accessory cable. When attached to a generator, RF current is emitted from the exposed portion of the electrode and this current translates into ion agitation within the surrounding tissue, which is converted by friction into heat and induces cellular death by means of coagulation necrosis.

The provided text describes a 510(k) submission for the Habib EUS RFA 6700 device, asserting its substantial equivalence to a predicate device (K150029). The submission outlines various performance, biocompatibility, and electrical tests conducted to demonstrate that the device meets required specifications.

Here's the information extracted and organized as requested:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the sample size for any of the performance tests. The tests appear to be laboratory-based bench tests and biocompatibility tests, rather than clinical studies with patient data. Therefore, details regarding country of origin or retrospective/prospective nature of patient data are not applicable.

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

This information is not applicable. The evaluations described are primarily engineering and biocompatibility tests, not interpretations of clinical data requiring expert consensus or ground truth establishment in that context.

4. Adjudication Method for the Test Set

This information is not applicable as the tests are objective engineering and biological assessments, not subjective interpretations requiring adjudication.

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

An MRMC comparative effectiveness study was not done. This device is an electrosurgical tool, not an AI-powered diagnostic or assistive technology for human readers.

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

This information is not applicable. The device is a physical electrosurgical catheter and not a standalone algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the tests performed can be considered the established scientific and engineering standards outlined by the various ISO and IEC standards cited (e.g., ISO 10993 for biocompatibility, IEC 60601 for electrical safety). The performance bench tests would have had internal engineering specifications as their "ground truth."

8. The Sample Size for the Training Set

This information is not applicable as the device is not an AI algorithm that requires a training set.

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

This information is not applicable as the device is not an AI algorithm that requires a training set.

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The Habib EUS RFA 6700 is indicated for coagulation of soft tissue when used in conjunction with compatible radio frequency generator.

The Habib EUS RFA 6700 is a catheter that is delivered during an EUS procedure, through 19 or 22 Gauge (G) endoscopic needles. The Habib EUS RFA 6700 is monopolar configuration and thus, must be used in conjunction with patient grounding pad. RF energy is produced by connecting the catheter to a compatible RF generator via an accessory cable. When attached to a generator, RF current is emitted from the exposed portion of the electrode and this current translates into ion agitation within the surrounding tissue, which is converted by friction into heat and induces cellular death by mans of coagulation necrosis.

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

This document is a 510(k) Pre-Market Notification for a medical device called "Habib EUS RFA 6700." The purpose of a 510(k) submission is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, meaning it's as safe and effective. As such, the "acceptance criteria" here are generally to demonstrate substantial equivalence through meeting performance, biocompatibility, and electrical safety standards comparable to the predicate devices. The "study" refers to the pre-clinical (bench) testing performed to show this.

1. Table of Acceptance Criteria and Reported Device Performance

The document doesn't explicitly list "acceptance criteria" in a quantitative, pass/fail table for all performance tests. Instead, it states that the device "met the required specifications" and "performance clearly demonstrate that the Habib EUS RFA 6700 is safe and effective." The performance tests listed are qualitative descriptions of the tests performed.

However, we can infer some "acceptance criteria" for the device based on the tests conducted and the need to demonstrate substantial equivalence:

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

The document details a series of "Performance bench testing," "biocompatibility testing," and "electrical testing." However, it does not provide specific sample sizes (number of devices or tests performed) for these tests. It only lists the types of tests conducted.

For data provenance (country of origin, retrospective/prospective), the tests appear to be pre-clinical bench tests. This kind of testing generally occurs in a lab setting, likely where the device is manufactured or tested, which is EMcision Ltd. in the United Kingdom based on the submitter's address. It is not clinical data (retrospective or prospective from human subjects).

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

This information is not provided in the document. For pre-clinical bench testing, "ground truth" isn't typically established by clinical experts in the same way it would be for diagnostic AI. Instead, the "ground truth" for these tests would be the established scientific and engineering principles of the test methods (e.g., a pulling test measures force until failure, a biocompatibility test assesses cellular response). The personnel performing these tests would be engineers, lab technicians, and scientists qualified in their respective fields (materials science, electrical engineering, biology, etc.), but their specific number and qualifications are not mentioned.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided since the studies described are pre-clinical bench tests, not studies requiring expert adjudication of clinical outcomes or images. Adjudication methods like "2+1" or "3+1" are typical for clinical studies or studies involving human readers and ground truth establishment from multiple experts.

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 and not applicable. The document describes the pre-clinical validation of a physical medical device (an electrosurgical electrode), not an AI algorithm. Therefore, no MRMC study, human reader improvement with AI, or effect size is discussed.

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

This information is not provided and not applicable. The "Habib EUS RFA 6700" is a physical medical device. It is not an algorithm, and therefore, standalone algorithm performance is not relevant to this submission.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For the performance and electrical bench tests, the "ground truth" is defined by the validated test methods and specifications themselves. For example:

• Functional tests: Adherence to physical properties (e.g., dimensions, strength, flexibility), consistent activation, and effective tissue coagulation as determined by engineering and material science principles.
• Biocompatibility tests: Adherence to biological safety standards as defined by ISO 10993 series and evaluated in laboratory settings (e.g., cell cultures for cytotoxicity, animal models for implantation).
• Electrical/EMC tests: Conformance to published international and national safety standards for medical electrical equipment (e.g., IEC 60601-1, IEC 60601-2-2, various EN standards for EMC).

There is no "expert consensus" or "pathology/outcomes data" ground truth in the context of these pre-clinical tests.

8. The Sample Size for the Training Set

This information is not provided and not applicable. The "Habib EUS RFA 6700" is a physical medical device, not an AI model or algorithm that requires a training set.

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

This information is not provided and not applicable, as there is no training set for a physical medical device.

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The Habib EndoHPB is intended to be used to assist in the coagulation of tissue during Endoscopic surgical procedures in the Gastro-intestinal Tract.

The Habib EndoHPB is a bipolar radiofrequency (RF) device that consists of a catheter with 2 ring electrodes, introduced via an endoscope's biopsy channel and activated with bipolar RF energy. The Habib EndoHPB has an attached cable which connects the device to an RF Generator. The catheter is inserted into the gastrointestinal tract and the tissue is coagulated using the RF power. The Habib EndoHPB is designed for use in endoscopic procedures and is a single use sterile device.

The provided K083292 submission for the Habib EndoHPB does not include detailed acceptance criteria or a specific study that proves the device meets such criteria in the way typically associated with AI/ML device performance evaluation.

Instead, this submission is for a conventional electrosurgical unit and relies on a demonstration of substantial equivalence to a predicate device (Habib Endoblate catheter, K072383).

Here's an analysis based on the provided text, highlighting what is and isn't present regarding acceptance criteria and performance studies:

Acceptance Criteria and Reported Device Performance

The submission focuses on the device functioning "as intended" and meeting "design specifications" to establish substantial equivalence, rather than defining specific, quantifiable acceptance criteria like sensitivity, specificity, or AUC which are common for AI/ML devices.

No specific quantitative metrics or thresholds (e.g., specific coagulation depth, lesion size uniformity, power output ranges) are explicitly stated as acceptance criteria in the provided text. The evaluation is qualitative and comparative against the predicate.

Study Information (as applicable to this type of device submission)

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

   • Not explicitly stated. The submission mentions "Performance testing was undertaken," but does not detail the nature of this testing (e.g., in vitro, ex vivo, animal studies, human trials), the number of samples/cases tested, or their origin. For a device like this, testing might involve bench testing on tissue phantoms or ex vivo tissue samples.

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

   • Not applicable/Not stated. Given that this is an electrosurgical device for tissue coagulation, the "ground truth" would likely be objectively measurable physical effects (e.g., tissue temperature, lesion depth, lack of charring, power delivery metrics) rather than subjective expert interpretation of images or clinical findings. The submission does not specify the involvement of experts in establishing ground truth for performance testing.

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

   • Not applicable/None stated. Adjudication methods are typically used for establishing ground truth in AI/ML performance studies where human interpretation is involved. For this device, performance is likely assessed through objective measurements against design specifications and physical properties.

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:

   • No, an MRMC study was not done. This is not an AI/ML device, and therefore this type of study is not relevant.

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

   • Not applicable. This is not an AI/ML algorithm. The performance of the device ("algorithm only") would be its physical output and effect on tissue, which was assessed through "performance testing." However, the term "standalone" in this context is typically reserved for AI/ML algorithms.

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

   • Implied objective measurements against design specifications and functional intent. For an electrosurgical device, ground truth would relate to the physical effects of energy delivery on tissue (e.g., measurable coagulation, temperature profiles, impedance changes) rather than diagnostic interpretations. The submission doesn't explicitly state the methodology for establishing "ground truth," but it would involve standard engineering and biological testing.

7. The sample size for the training set:

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

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

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

In summary: The K083292 submission for the Habib EndoHPB demonstrates safety and effectiveness through substantial equivalence to a predicate device, supported by general "performance testing" to ensure it functions as intended and meets design specifications. It does not provide the detailed, quantitative acceptance criteria and study methodologies, particularly those related to a test set and ground truth establishment, that would be expected for an AI/ML-driven medical device.

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The Habib Hexablate 10 is intended to be used to assist in coagulation of tissue during intraoperative surgical procedures.

The Habib Hexablate 10 is a bipolar radiofrequency (RF) device that consists of a handle and an array of seven parallel electrodes which extend out from the handle. The electrode configuration consists of six electrodes in a ring and one electrode in the center of the ring. The Habib Hexablate 10 has an attached cable which connects the device to an RF Generator. The electrodes are inserted into tissue and the tissue is coagulated using RF power. The Habib Hexablate 10 is designed for use in surgery and is a single use device.

The provided text is a 510(k) premarket notification for the Habib Hexablate 10, an electrosurgical cutting and coagulation device. This type of submission generally focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than comprehensive de novo clinical studies with detailed acceptance criteria and standalone performance metrics.

Based on the provided text, the following can be extracted:

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

The document does not explicitly state quantitative acceptance criteria or detailed reported device performance in a table format. It broadly states:

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

The document does not specify a sample size for a test set. It mentions "Performance testing" but does not elaborate on the methodology, number of samples, or data provenance (country of origin, retrospective/prospective). This is typical for a 510(k) where the focus is often on bench testing and comparison to an existing device rather than a new clinical trial.

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)

No information is provided regarding experts used to establish ground truth.

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

No information is provided regarding an adjudication method.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC comparative effectiveness study was performed or mentioned, as this device is not an AI-powered diagnostic tool. It is an electrosurgical device for tissue coagulation.

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

A standalone performance evaluation was done in the sense that the device itself was tested for its ability to function as intended and meet design specifications. However, this is not in the context of an "algorithm only" or "AI" standalone performance, as the device is a physical electrosurgical tool. The "Performance Data" section indicates that the device was evaluated to ensure it "functions as intended and meets design specifications."

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

The document does not specify the type of ground truth. Given the nature of the device (electrosurgical for tissue coagulation), ground truth would likely be established through objective measurements of coagulation zone size, tissue necrosis, temperature profiles, and potentially histological examination of treated tissue in preclinical models, but these details are not provided in the summary.

8. The sample size for the training set

No information is provided regarding a training set. This is not applicable as the device is not an AI/machine learning model that requires a training set.

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

Not applicable, as there is no training set for an AI/machine learning model.

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The Habib Laparoscopic Hexablate is intended to be used to assist in coagulation of tissue during laparoscopic intraoperative surgical procedures

The Habib Laparoscopic Hexablate is a bipolar radiofrequency (RF) device that consists of a handle, laparoscopic shaft and introducer and an array of seven parallel electrodes which extend out from the laparoscopic shaft. The electrode configuration consists of six electrodes in a ring and one electrode in the center of the ring. The Habib Laparoscopic Hexablate has an attached cable which connects the device to the Habib Hexablate Switch Unit and then to an RF Generator. The electrodes are inserted into tissue is coagulated using RF power. The Habib Laparoscopic Hexablate is designed for use in laparoscopic surgery and is a single use device.

The provided text describes a medical device, the "Habib Laparoscopic Hexablate," and its 510(k) submission to the FDA. However, the document does not include detailed acceptance criteria or a specific study that proves the device meets those criteria in the context of device performance as one might expect for a robust clinical trial.

Instead, the "Performance Data" section states: "Performance testing was done to ensure that the Habib Laparoscope Hexablate functions as intended and meets design specifications. Sufficient data was obtained to show that the device is substantially equivalent to the predicate device, and meets safety and effectiveness criteria."

This indicates that the device's performance was evaluated primarily against its predicate devices (Habib Hexablate (K071103) and Habib 4X Laparoscopic (K062935)) to demonstrate substantial equivalence for regulatory approval, rather than through a separate study with predefined acceptance criteria for novel clinical efficacy. The FDA's letter confirms this is a substantial equivalence determination.

Therefore, many of your specific questions cannot be answered from the provided text, as the focus is on regulatory equivalence rather than a clinical effectiveness study with defined performance metrics.

Here's the information that can be extracted or inferred:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, specific numerical acceptance criteria for performance (e.g., coagulation depth, accuracy, etc.) and corresponding reported device performance values are NOT explicitly stated.

The "Performance Data" section generally states:

• Acceptance Criteria (Implied): The device functions as intended and meets design specifications. It is substantially equivalent to the predicate device, and meets safety and effectiveness criteria.
• Reported Device Performance: "Sufficient data was obtained to show that the device is substantially equivalent to the predicate device, and meets safety and effectiveness criteria."

The "Technological Differences" section provides some comparative details, implying performance equivalence:

• Habib Laparoscopic Hexablate vs. Habib Hexablate (K071103): "Both devices use bipolar RF energy through a number of electrodes to create a volume of coagulated tissue. The primary difference is that the Habib Laparoscopic Hexablate is used via a laparoscopic port. The size and shape of the coagulation zone created by each device is similar."
• Habib Laparoscopic Hexablate vs. Habib 4X Laparoscopic (K062935): "Both devices use bipolar RF energy through a number of electrodes to create a volume of coagulated tissue during laparoscopic procedures." The main difference is the number and deployment of electrodes.

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 given text. The document refers to "Performance testing" but does not detail the nature of these tests (e.g., in vitro, ex vivo, animal studies) or any human subject data, test set size, or data provenance. Given the nature of a 510(k) for substantial equivalence, clinical trials with large human test sets are often not required if bench and possibly animal testing support the claims relative to the predicate.

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 given text. The document doesn't describe a ground truth establishment process by experts.

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

This information is not provided in the given text.

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. The provided text describes an electrosurgical device, not an AI or imaging diagnostic device. Therefore, an MRMC study involving human readers' improvement with 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

Not applicable. This device is an electrosurgical instrument for direct surgical application, not a standalone algorithm.

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

The concept of "ground truth" in the context of diagnostic or interpretive AI/imaging is not applicable to this device. The performance evaluation would likely involve engineering parameters, tissue coagulation studies (which might use histology/pathology as a "ground truth" for coagulation depth/volume, but this is not specified), and comparison to predicate device performance.

8. The sample size for the training set

This information is not provided and is not applicable as this is not a machine learning/AI device.

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

This information is not provided and is not applicable as this is not a machine learning/AI device.

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The Habib Endoblate is a radiofrequency (RF) catheter which provides bipolar energy to enable the Endoscopist to cauterize and coagulate tissue in the gastrointestinal tract

The Habib Endoblate is a bipolar radiofrequency (RF) device that consists of a catheter with 3 contact electrodes and 1 ring electrode, introduced via an endoscope's biopsy channel and activated with bipolar RF energy. The Habib Endoblate has an attached cable which connects the device to an RF Generator. The catheter is inserted into the gastrointestinal tract and the tissue is coagulated using the RF power. The Habib Endoblate is designed for use in endoscopy and is a single use sterile device.

The provided text describes the Habib Endoblate device and its 510(k) clearance, but it does not contain detailed acceptance criteria or a study proving that the device meets specific performance criteria with quantitative metrics.

The document states: "Performance testing was undertaken to ensure that the Habib Endoblate functions as intended and meets design specifications. Sufficient data was obtained to show that the device is substantially equivalent to the predicate device and meets safety and effectiveness criteria."

This is a general statement required for 510(k) submissions, indicating that some testing was performed to demonstrate substantial equivalence to a legally marketed predicate device (Gold Probe catheter, K970278). However, the specific results of this performance testing, the acceptance criteria used, or the study details are not included in this summary.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance, or details about sample sizes, ground truth, expert involvement, or comparative effectiveness studies, as this information is not present in the provided text.

The information that can be extracted relevant to your request is limited to:

• Predicate Device: Gold Probe catheter manufactured by Boston Scientific Inc. (K970278)
• Basis for Clearance: Substantial equivalence to the predicate device.
• Technological Characteristics: Both devices use bipolar RF energy through a number of electrodes to coagulate tissue.

To obtain the detailed performance data, acceptance criteria, and study results, one would typically need to refer to the full 510(k) submission document or supporting technical files, which are not included here.

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The Habib™ VesCoag is a catheter intended to be used for the coagulation of blood vessels during general surgery.

The Habib™ VesCoag is a bipolar radiofrequency (RF) device that consists of a catheter, wire connections, hub, Y connector and two ring electrodes are configured with two rings creating proximal and distal heating zones. The Habib™ VesCoag has an attached cable which connects the device to an RF Generator. The catheter is inserted into the vessel and the tissue is coagulated using the RF power. The Habib™ VesCoag is designed for use in surgery and in imaging/radiological procedures and is a single use sterile device.

The provided text is a Fragment of a 510(k) summary for the Habib™ VesCoag. This type of regulatory document typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed independent study with specific acceptance criteria and performance metrics.

Based solely on the provided text, here's what can be extracted and what cannot:

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

The provided document does not explicitly state predefined acceptance criteria for specific performance metrics of the Habib™ VesCoag in a quantifiable way (e.g., "coagulation time

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The Habib Hexablate is intended to be used to assist in coagulation of tissue during intraoperative surgical procedures.

The Habib Hexablate is a bipolar radiofrequency (RF) device that consists of a handle and an array of seven parallel electrodes which extend out from the handle. The electrode configuration consists of six electrodes in a ring and one electrode in the center of the ring. The Habib Hexablate has an attached cable which connects the device to the Habib Hexablate Switch Unit and then to an RF Generator. The electrodes are inserted into tissue is coagulated using RF power. The Habib Hexablate is designed for use in surgery and is a single use device.

The provided text describes the Habib Hexablate device and its 510(k) submission (K071103) for market clearance. However, it does not contain the detailed information required to fill out the table describing acceptance criteria and a study proving the device meets those criteria, or all the associated study design parameters.

The document is a summary of safety and effectiveness, a 510(k) clearance letter, and an indications for use statement. It provides a high-level statement about performance data but no specifics on acceptance criteria or the study methodology used.

Here's a breakdown of what can be extracted and what is missing:

Information that can be extracted:

• Device Name: Habib Hexablate
• Intended Use/Indications For Use: To assist in coagulation of tissue during intraoperative surgical procedures.
• Predicate Device: Habib 4X (K051420)
• Description of Technological Differences: The Habib Hexablate has the same basic technological characteristics as the Habib 4X, both using bipolar RF energy through electrodes to create a volume of coagulated tissue. The primary difference is the size and shape of the coagulation zone and the Hexablate's aspiration feature through the center electrode to remove fluids and gases.
• Statement on Performance Data: "Performance testing was done to ensure that the Habib Hexablate functions as intended and meets design specifications. Sufficient data was obtained to show that the device is substantially equivalent to the predicate device, and meets safety and effectiveness criteria."

Information that is missing from the provided text and cannot be generated:

• A table of acceptance criteria and the reported device performance: Explicit acceptance criteria and specific performance results are not detailed. The document only states "meets design specifications" and "meets safety and effectiveness criteria."
• Sample size used for the test set and data provenance: No information on the number of cases, patients, or origin of data.
• Number of experts used to establish the ground truth for the test set and their qualifications: Not mentioned.
• Adjudication method for the test set: Not mentioned.
• If a multi reader multi case (MRMC) comparative effectiveness study was done, and the effect size: Not mentioned. This type of study is more common for imaging/diagnostic devices, not typically for electrosurgical coagulation devices focused on tissue effect.
• If a standalone (algorithm only without human-in-the-loop performance) was done: Not applicable as this is a physical medical device, not an AI algorithm.
• The type of ground truth used: Not explicitly stated, though for a coagulation device, ground truth would likely involve measurements of coagulation zone size/shape, tissue histology post-coagulation, or animal model observations.
• The sample size for the training set: Not applicable for this type of device and study as described.
• How the ground truth for the training set was established: Not applicable.

Conclusion based on provided text:

The provided document (a 510(k) summary and clearance letter) confirms that performance testing was conducted and data were found sufficient to establish substantial equivalence to a predicate device (Habib 4X, K051420) and meet safety and effectiveness criteria for tissue coagulation during intraoperative surgical procedures. However, the specific details of these performance tests, including explicit acceptance criteria, performance metrics, study design (sample sizes, ground truth establishment, expert involvement), and results, are not present in this summary. These details would typically be found in the full 510(k) submission or associated test reports, which are not included here.

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The Habib 4X is intended to be used to assist in coagulation of tissue during intraoperative surgical procedures.

Not Found

The provided text is a 510(k) clearance letter from the FDA for the Habib 4X device, an electrosurgical cutting and coagulation device. This type of document does not typically contain the detailed study information required to answer your specific questions about acceptance criteria, device performance, sample sizes, ground truth establishment, or expert qualifications for AI/ML device studies.

The letter focuses on:

• Confirming substantial equivalence to a predicate device.
• Indicating that the device can be marketed subject to general controls.
• Outlining relevant regulations.
• Providing the stated Indications for Use.

Therefore, based solely on the provided text, I cannot reconstruct the specific information you requested. The document does not describe a study, acceptance criteria, or performance metrics in the way your questions demand for an AI/ML device.

Ask a specific question about this device