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BiTech bipolar scissors are designed for dissecting, cutting and bipolar coagulation of tissue during general surgical procedures.

The BiTech Bipolar Scissors has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures and should not be used for these procedures.

BiTech bipolar scissors enable cutting and dissection with simulataneous bipolar coagulation. They can also be used for precise pinpoint or zone coagulation of blood-vessels and tissue. The various working lengths allow the scissors to be used for a large number of applications in open surgery.

A petented construction priciple, which was developed by Dr. J. Manushakian*, ensures that the scissors are both easy to use and to repair. The electrical contacts for both scissor blades are conducted via one section of the handle, i. e. the connection cable only needs to be attached to one ring, which significantly reduces reference duriong handling. The scissor blades are flexibly joined by means of a standard steel scissor screw which does not need to be insulated and, as a result, is not subject to wear.

The provided document describes a 510(k) notification for the BiTech Bipolar Scissors. A 510(k) submission primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting new clinical study data with specific acceptance criteria and performance metrics in the way a novel device might.

Therefore, the document does not contain the detailed information required for the requested output regarding acceptance criteria and the comprehensive study that proves the device meets those criteria. Specifically:

• No specific acceptance criteria are listed for device performance in terms of accuracy, sensitivity, specificity, etc.
• No study is described that details a test set, training set, ground truth establishment, or expert adjudication for performance evaluation.
• There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study or a standalone algorithm-only study.

Instead, the submission relies on demonstrating compliance with recognized performance standards for safety and electrical equipment, and stating substantial equivalence to existing devices.

Here's what can be extracted from the document, tailored to the spirit of your request where possible, but acknowledging the limitations of this type of submission:

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

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

• Not applicable. This submission relies on substantial equivalence and compliance with engineering standards, not on a clinical performance 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)

• Not applicable. No ground truth establishment by experts for a test set is described.

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

• Not applicable. 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

• Not applicable. This is not an AI-assisted diagnostic device, nor is an MRMC study mentioned.

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

• Not applicable. This is a surgical instrument, not an algorithm.

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

• Not applicable. For this type of device and submission, the "ground truth" for safety and efficacy is generally considered to be the established performance and safety record of the predicate devices and compliance with recognized industry standards.

8. The sample size for the training set

• Not applicable. No training set is described.

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

• Not applicable. No training set is described.

Summary of the Study/Evidence:

The "study" in a 510(k) submission like this is primarily a bench-testing and documentation effort to demonstrate:

• Compliance with recognized electrical and safety standards: DIN EN 60601-1, DIN EN 60601-2-2, and ANSI/AAMI HF18-2001. This would involve testing the device against the specific requirements and clauses within those standards.
• Substantial equivalence to legally marketed predicate devices: Ethicon (K981361) and Enable (K972558). This involves comparing the technological characteristics, intended use, and performance claims of the BiTech Bipolar Scissors to these established predicates. The document implies that the "patented construction principle" and how electrical contacts are conducted are key differentiating features, but these are presented as improvements in usability and repair, not as fundamentally altering the safety or efficacy compared to predicates for the stated intended use.
• Provision of validated user instructions: For cleaning, maintenance, and sterilization, ensuring the device can be safely and effectively prepared for use.

The FDA's letter states: "We have reviewed your Section 510(k) premarket notification of intent to market the device...and have determined the device is substantially equivalent...to legally marketed predicate devices..." This confirms the FDA's acceptance of the manufacturer's demonstration of substantial equivalence based on the provided documentation and compliance with the mentioned standards.

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The Bipolar Grasper and Bipolar Scissors are instruments used with the ZEUS® MicroWrist™ Surgical System. The Bipolar Grasper is intended to grasp, dissect, and coagulate tissue. The Bipolar Scissors provide mechanical cutting and bipolar coagulation. These bipolar instruments augment the means of performing electrosurgical procedures with the ZEUS® MicroWrist™ Surgical System.

This premarket notification adds a bipolar grasper and bipolar scissors to the ZEUS® MicroWrist™ Surgical System. These surgical instruments are used in conjunction with an electrosurgical generator unit (ESU), and they augment the means of performing electrosurgical procedures with the ZEUS® MicroWrist™ Surgical System. These devices are additions to the MicroAssist 100 line of ZEUS surgical instruments. MicroAssist instruments consist of commercially available hand-held devices that have been modified in order to be attached to the ZEUS arm. As with all MicroAssist instruments, the distal end that is used to perform surgical tasks remains unchanged from the hand-held version. The ZEUS® MicroWrist™ Surgical System, consisting of a surgeon console and three table-mounted arms, serves as a platform for holding, positioning, and manipulating endoscopic instruments in order to perform selected surgical tasks. One arm of the ZEUS System incorporates the AESOP® endoscope positioner which provides the surgeon with a steady view of the internal operating field. The HERMES® O.R. Control Center, which uses voice-recognition technology to control devices outside the sterile field, is a standard component of the ZEUS System.

The provided document describes a 510(k) summary for Bipolar Grasper and Bipolar Scissors for the ZEUS® MicroWrist™ Surgical System. This submission focuses on establishing substantial equivalence to existing predicate devices rather than proving performance against specific acceptance criteria through a clinical study with defined performance metrics.

Therefore, many of the requested elements for a study that "proves the device meets the acceptance criteria" are not applicable to this type of regulatory submission. The document reports on non-clinical tests to demonstrate substantial equivalence, not a clinical trial with specific performance endpoints.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Not Applicable (N/A) in the context of specific performance metrics.

This 510(k) submission is for substantial equivalence. The "acceptance criteria" are implicitly met by demonstrating that the new devices are "substantially equivalent in terms of size, shape, function, activation, and intended use to the predicate devices cited." The "reported device performance" is that these characteristics are maintained, even when manipulated by the robotic system.

Also: "As with all MicroAssist instruments, the distal end that is used to perform surgical tasks remains unchanged from the hand-held version."

Conclusion: "Data provided in this submission indicate that the basic functional characteristics of these devices are substantially equivalent to the predicates." |

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

Not directly applicable as a clinical "test set" demonstrating performance metrics.

The submission relies on non-clinical tests to establish substantial equivalence. The document does not specify a "sample size" for a test set in the way one would for a clinical performance study (e.g., number of patients or cases). The "data provenance" would be from internal engineering and bench testing, likely conducted by Computer Motion, Inc. There is no mention of country of origin for clinical data.

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

N/A. Ground truth from clinical experts is not relevant here as it's not a clinical performance study. The "ground truth" for substantial equivalence is based on engineering specifications and physical characteristics compared to predicate devices.

4. Adjudication Method for the Test Set

N/A. No adjudication method is described as there isn't a clinical test set requiring expert review or consensus.

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 is a surgical instrument (bipolar grasper and scissors), not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was conducted or is relevant.

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

N/A. This device is a surgical instrument that is part of a surgical system controlled by a human surgeon (“ZEUS® MicroWrist™ Surgical System, consisting of a surgeon console and three table-mounted arms, serves as a platform for holding, positioning, and manipulating endoscopic instruments”). It is not an algorithm, and the concept of "standalone performance" for an algorithm is not applicable.

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

For this 510(k) submission, the "ground truth" for demonstrating substantial equivalence is primarily based on:

• Engineering specifications and design characteristics of the new devices (Bipolar Grasper and Bipolar Scissors).
• Comparison to the known specifications and performance of the predicate hand-held devices (Lyons™ Dissecting Forceps and Evershears®).
• The fact that "the distal end that is used to perform surgical tasks remains unchanged from the hand-held version" implies that the functional part of the device is identical to established predicate devices.

8. The Sample Size for the Training Set

N/A. As this is a 510(k) for surgical instruments demonstrating substantial equivalence through non-clinical testing, there is no "training set" in the context of machine learning or AI.

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

N/A. See point 8.

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Mechanical cutting and electrosurgical coagulation of tissue during the performance of laparoscopic and general surgical procedures.

The device is a Class II medical device. The Everest LP Bipolar Scissors and Gyrus LP Scissors are a modification to the predicate device cleared under K904993. The Bipolar Bipolar LP Scissors are identical in construction (with the exception of shaft length) and in component materials when compared to the predicate device. The scissors blades are electrically isolated from each other enabling one blade to act as a return electrode, eliminating the need for a return pad. The modification has not altered the fundamental technology of the predicate device cleared under K904993. The intended use, electrosurgical coagulation and mechanical cutting during surgical procedures is similar to the predicate device cleared under K904993. The energy source, Bipolar Electrosurgical Energy, is the same energy type as used for the predicate devices.

The provided text is a 510(k) summary for the Everest LP Bipolar Scissors and Gyrus LP Bipolar Scissors. It discusses the device's substantial equivalence to a predicate device and its intended use. However, it does not contain information about specific acceptance criteria, a study proving the device meets those criteria, or any of the detailed aspects like sample sizes, expert ground truth, or AI performance that your request asks for.

The document states:

"The Bipolar Bipolar LP Scissors are identical in construction (with the exception of shaft length) and in component materials when compared to the predicate device. The scissors blades are electrically isolated from each other enabling one blade to act as a return electrode, eliminating the need for a return pad. The modification has not altered the fundamental technology of the predicate device cleared under K904993. The intended use, electrosurgical coagulation and mechanical cutting during surgical procedures is similar to the predicate device cleared under K904993. The energy source, Bipolar Electrosurgical Energy, is the same energy type as used for the predicate devices."

"In conclusion, as the design, materials of construction, function and intended use of the Modified LP Bipolar Scissors is similar to that of the predicate devices currently cleared, Gyrus Medical Inc. believes that no new issues of safety and effectiveness are raised and that the submitted device is substantially equivalent."

This indicates that the device was cleared based on substantial equivalence to an existing predicate device (K904993), rather than requiring a new clinical performance study with specific acceptance criteria as you've outlined. The FDA's 510(k) process often relies on demonstrating that a new device is as safe and effective as a legally marketed predicate device, without necessarily requiring new, extensive clinical trials for every submission, especially for modifications that don't alter fundamental technology.

Therefore, I cannot populate the table or answer the specific questions you've posed because the provided text does not contain that type of detailed study information. The clearance was based on the premise that the device is "substantially equivalent" to one already on the market, implying that its performance would be similar, and thus, specific performance metrics and studies to prove them are not detailed in this summary.

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The Enable Endoscopic Bipolar Scissors is intended to cut tissue and control bleeding through coagulation during surgical procedures.

The ENABLE Endoscopic Bipolar Scissors are substantially equivalent to the CardioThoracic Systems. Symbiosis, Everest Medical and ENABLE Bipolar Scissors in that each consist of a handle which is connected to a pair of scissor blades with electrodes on each blade. All the devices utilize the same bipolar electrosurgical technology. i.e. radio frequency (RF) energy. 10 caurerize the blood vessels by heating proteins in the tissue to a temperature where the proteins congeal.

The ENABLE Endoscopic Bipolar Scissors contain both a negative and positive electrode on each blade. The function of the ENABLE and predicate devices is the same; current flows from a negatively charged pole through the tissue to a positively charged pole. The ENABLE, CardioThoracic. Symbiosis and Everest Bipolar Scissors are connected to a similar electrosurgical generator that supplies RF bipolar energy. The ENABLE. CardioThoracic and Everest Bipolar Scissors are all labeled for use with the Valleylab Force 2 Electrosurgical Generator or equivalent electrosurgical units. All four bipolar scissors listed in this notification are labeled for operation at a comparable range (15-35 watts). Labeling for the ENABLE Endoscopic Bipolar Scissors are provided with each product. As with other bipolar instruments. there is no need for a grounding pad for the return electrode, therefore. the current does not travel through the patient to the grounding pad as it does with monopolar instruments. Patient burns seen with monopolar devices due to electrical current passage are eliminated.

The ENABLE Endoscopic Bipolar Scissors and the listed predicate devices are of similar size with an overall length range of 33 to 48cm (13 to 19 inches) and a scissors blade length range of approximately 0.7 inches. The scissors shaft is designed to fit a standard 5mm cannula. The bipolar devices utilize similar materials of construction including stainless steel scissors blades. All of the materials utilized in the ENABLE Endoscopic Bipolar Scissors are standard medical device materials that are used in a variety of tissue contact medical devices.

The provided 510(k) summary for the ENABLE Endoscopic Bipolar Scissors focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study proving the device meets those criteria. This type of submission relies on the device being similar enough to already approved devices that it doesn't require new clinical efficacy studies.

Therefore, many of the requested details about acceptance criteria, study design, and performance metrics are not present in the provided text.

Here's an analysis based on the available information:

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

The document does not explicitly state quantitative acceptance criteria or detailed performance metrics from a dedicated study. Instead, it relies on demonstrating equivalence through:

• Intended Use Equivalence: Stating the intended use is "substantially equivalent to the intended use statements of CardioThoracic, Symbiosis, Everest and ENABLE Bipolar Scissors."
• Technological Equivalence: Describing similar design (handle, scissor blades, electrodes), same bipolar electrosurgical technology (RF energy to cauterize), similar current flow mechanisms, compatible electrosurgical generators (Valleylab Force 2 or equivalent), comparable operating range (15-35 watts), and similar size and materials.
• Compliance with Standards: Listing compliance with relevant industrial/international standards.

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

Not applicable. This 510(k) submission is for substantial equivalence, not a clinical study involving a test set of data. The "testing" referred to is likely engineering verification and validation demonstrating compliance with the listed standards, rather than a clinical performance study. There are no patient data sets or provenance mentioned.

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. This device is not an AI/diagnostic device that requires expert ground truth establishment for a test set.

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

Not applicable. There is no test set in the context of diagnostic performance.

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

Not applicable. This device is a surgical instrument, not an AI-assisted diagnostic or decision support system.

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

Not applicable. This is a physical surgical device.

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

Not applicable. The "ground truth" for this submission is based on the established safety and effectiveness of its predicate devices and compliance with recognized industry standards for design, manufacturing, and general safety.

8. The sample size for the training set

Not applicable. This device does not involve a "training set" in the context of machine learning.

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

Not applicable.

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The PowerStar Bipolar Scissors are limited-life reusable instruments available in various standard sizes and shapes similar to conventional surgical scissors. These scissors can be connected to the bipolar output mode on electrosurgical generators to facilitate dissection, transection, and bipolar coagulation.

The intended use of the PowerStar Bipolar Scissor is to cut and coagulate soft tissue in open surgical procedures.

The PowerStar Bipolar Scissors are non-sterile, reusable devices intended to facilitate cutting and bipolar coagulation of soft tissue in open surgical procedures such as general, gynecological, oncologic, vascular, plastic, thoracic, ear, nose and throat, urological, and cardiovascular surgeries.

The PowerStar Bipolar Scissors are limited-life reusable instruments available in various standard sizes and shapes similar to conventional surgical scissors. These scissors can be connected to the bipolar output mode on electrosurgical generators to facilitate dissection, transection, and bipolar coagulation.

The provided text describes a 510(k) summary for the PowerStar Bipolar Scissors, a medical device for cutting and coagulating soft tissue. However, it does not contain information about acceptance criteria, specific performance metrics, or a detailed study proving the device meets acceptance criteria as would be
expected for AI/ML-based medical devices.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device. Therefore, I cannot generate the requested table and detailed study information based on the provided text.

Here's why and what information is available:

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

• Information in text: The document states, "Preclinical laboratory and clinical evaluations were performed to ensure that the device functions as intended. Sufficient data have been gathered from preclinical and clinical testing to assess that the device performs as clinically intended."
• Missing Information: No specific acceptance criteria (e.g., minimum cutting efficiency, maximum coagulation time, specific power delivery, etc.) are provided. No quantitative performance data against any such criteria is reported.

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

• Information in text: The document mentions "preclinical laboratory and clinical evaluations" and "pre-clinical and clinical testing."
• Missing Information: No details on sample sizes for any test sets, data provenance (country, retrospective/prospective), or the nature of these tests are supplied.

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 in text: This concept is not applicable to the device described. The device is a surgical instrument, not an AI/ML diagnostic tool that relies on expert interpretation for ground truth.
• Missing Information: Not relevant to this type of device.

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

• Information in text: Not relevant to this type of device.
• Missing Information: Not relevant to this type of device.

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:

• Information in text: Not applicable. This is a surgical instrument, not an AI/ML diagnostic aid.
• Missing Information: Not relevant to this type of device.

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

• Information in text: Not applicable. This is a surgical instrument, not an AI/ML algorithm.
• Missing Information: Not relevant to this type of device.

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

• Information in text: Not applicable. The "ground truth" for a surgical instrument would be its functional performance (e.g., ability to cut tissue cleanly, achieve hemostasis) demonstrated through direct observation or measurable physical parameters in laboratory or clinical environments.
• Missing Information: Not relevant in the context of typical AI/ML ground truth definition.

8. The sample size for the training set:

• Information in text: No training set is mentioned as this is not an AI/ML device.
• Missing Information: Not relevant to this type of device.

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

• Information in text: No training set is mentioned as this is not an AI/ML device.
• Missing Information: Not relevant to this type of device.

Summary from the provided text:

The document states that the PowerStar Bipolar Scissors are "substantially equivalent" to an existing legally marketed device. This determination is based on "preclinical laboratory and clinical evaluations" that "ensure that the device functions as intended" and provide "sufficient data...to assess that the device performs as clinically intended" and "assess the safety and effectiveness characteristics of the modified device."

Key Takeaway: The provided text is a 510(k) summary for a conventional surgical instrument, not an AI/ML-driven device. As such, it details the intended use, indications, and substantial equivalence claim, but it does not include the specific types of performance metrics, study designs (like MRMC), and ground truth methodologies that would be relevant for an AI/ML medical device.

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The OSCAR™ Bipolar Scissors with OSCAR™ Bipolar Disposable Cartridges is intended to cut tissue and control bleeding through coagulation during open surgical procedures and in general surgery.

The OSCAR™ Bipolar Scissors is a reusable electrosurgical instrument consisting of an instrument handle with a pair of scissors blades which attaches to the OSCAR™ Bipolar Disposable Cartridges and an electrosurgical generator. Electric current flows between the electrodes in the cartridges and the stainless steel cutting surfaces of the blades. The electrosurgical generator controls the flow of the electric current down the electrode. The overall length of the device is between 4 and 11 inches. The power cord connecting the handle to the power control unit is approximately 120 inches. The blades are between 1 and 2 inches in length.

The surgeon places the opened scissors across the tissue to be cut and closes the scissors handle while moving the scissors across the tissue. Energizing the electrosurgical generator via the generator's footswitch, the surgeon can simultaneously cut and coagulate the target tissue. The surgeon can vary the current flow rate according to the tissue and the amount of bleeding encountered. The power setting for the OSCAR™ Bipolar Scissors is 20-30 watts.

Acceptance Criteria and Device Performance Study for OSCAR™ Bipolar Scissors with OSCAR™ Bipolar Disposable Cartridges (K981219)

Based on the provided 510(k) summary, the device's acceptance criteria and the study proving its performance are primarily established through a demonstration of substantial equivalence to legally marketed predicate devices. The document does not describe a traditional performance study with specific quantitative acceptance criteria for the OSCAR™ device itself, but rather relies on the equivalency to already approved devices.

Here's a breakdown of the requested information, reflecting the nature of a 510(k) submission for substantial equivalence:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not applicable in the context of this 510(k) summary. The submission relies on the existing safety and effectiveness profiles of the predicate devices rather than new performance data for a dedicated test set designed to establish new performance metrics for the OSCAR™ device.
• Data Provenance: Not applicable. The "data" here refers to the established performance and safety profiles of the cited predicate devices (e.g., Symbiosis Bipolar Scissors, Everest Medical Bipolar Scissors, CardioThoracic Systems MIDCAB/SVH Bipolar Scissors, Ethicon PowerStar Bipolar Scissors, ENABLE Bipolar Scissors), which were legally marketed prior to this submission. Information regarding their specific testing or data provenance is not provided here.

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

• Number of Experts: Not applicable. There was no specific "test set" in the traditional sense for the OSCAR™ device in this 510(k) submission, and therefore no ground truth established by experts specifically for the OSCAR™ device to meet new performance benchmarks. The ground truth is effectively the regulatory acceptance of the predicate devices.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable, as no specific test set requiring adjudication was used for the OSCAR™ device's performance claims.

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

• MRMC Comparative Effectiveness Study: Not applicable. This device is a surgical instrument, not an AI-assisted diagnostic or interpretation tool.

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

• Standalone Study: Not applicable. This device is a manual surgical instrument and does not involve an algorithm or AI.

7. The type of ground truth used

• Type of Ground Truth: The "ground truth" in this 510(k) submission is the established safety and effectiveness of the legally marketed predicate devices. The OSCAR™ Bipolar Scissors are shown to be substantially equivalent in intended use, function, physical characteristics, materials, and sterilization method to these pre-existing devices. This equivalency implicitly means that if the predicate devices are safe and effective, then a substantially equivalent new device will also be safe and effective.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. The device is not based on machine learning or AI, so there is no "training set."

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

• Ground Truth for Training Set Establishment: Not applicable, as there is no training set.

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The intended use of the PowerStar Bipolar Scissor is to cut and coagulate soft tissue in open surgical procedures.

The PowerStar Bipolar Scissors are non-sterile, reusable devices intended to facilitate cutting and bipolar coagulation of soft tissue in open surgical procedures such as general, gynecological, oncologic, vascular, plastic, thoracic, ear, nose and throat, urological, and cardiovascular surgeries.

Surgical procedures would include the following:

General Surgery
Bowel
Breast Biopsies
Hernia Repair
Lysis of Adhesions
Upper GI
GI (other)
Cholecystectomy
Thyroid
Splenectomy

OB/GYN Surgery
Hysterectomy
Salpingo-oophrectomy
Mvomectomy
Endometriosis
Ovariohysterectomy

Oncological Surgery
Mastectomy
Axillary Node Dissection

Plastic Surgery
Mammoplasty
Blepharoplasty
Rhytidectomy
Panniculectomy
Forearm Pedicle Flap
Facial

Urological Surgery
Nephrectomy
Prostatectomy
Cystotomy

Ear, Nose & Throat Surgery
Neck Mass
Mastoidectomy
Typanoplasty
Tonsillectomy

Cardiovascular/Thoracic Surgery
Femoral Popliteal Bypass
Internal Mammary Artery (IMA) Harvesting
Pericardial Window
Biopsy of the Thymus

The PowerStar Bipolar Scissors are limited-life reusable instruments available in various standard sizes and shapes similar to conventional surgical scissors. These scissors can be connected to the bipolar output mode on electrosurgical generators to facilitate dissection, transection, and bipolar coagulation.

The PowerStar Bipolar Scissors are non-sterile, reusable devices intended to facilitate cutting and bipolar coagulation of soft tissue in open surgical procedures such as general, gynecological, oncologic, vascular, plastic, thoracic, ear, nose and throat, urological, and cardiovascular surgeries.

The provided text is related to a 510(k) submission for the PowerStar Bipolar Scissors, a surgical device. The document details the device description, intended use, and a statement of substantial equivalence to an existing device.

However, the text does not contain any information regarding acceptance criteria, specific performance metrics, sample sizes for test or training sets, ground truth establishment methods, or details about any studies (standalone, MRMC, or otherwise) that would "prove the device meets the acceptance criteria." The document states that "Preclinical laboratory and clinical evaluations were performed to ensure that the device functions as intended" and "Sufficient data have been gathered from preclinical and clinical testing to assess that the device performs as clinically intended," but it does not provide any specifics about these evaluations or the data.

Therefore, I cannot populate the table or answer the specific questions requested because the necessary information is not present in the provided document.

Summary of missing information:

• Acceptance Criteria & Reported Performance: Not specified.
• Sample size (test set) & Data provenance: Not specified.
• Number of experts & qualifications: Not specified.
• Adjudication method: Not specified.
• MRMC comparative effectiveness study: No details provided; only a general statement about clinical evaluations.
• Standalone performance study: No details provided.
• Type of ground truth used: Not specified.
• Sample size (training set): Not applicable, as this is a physical medical device, not an AI/algorithm-based device in the context of "training set."
• How ground truth for training set was established: Not applicable.

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The ENABLE Bipolar Scissors with ENABLE Bipolar Disposable Cartridges are intended to cut tissue and control bleeding through coagulation during general surgery.

The ENABLE Bipolar Scissors is a reusable electrosurgical instrument consisting of an instrument handle with a pair of scissors blades which attaches to the ENABLE Bipolar Disposable Cartridges and an electrosurgical generator. Electric current flows from the electrodes in the cartridges to the stainless steel cutting surfaces of the blades. The electrosurgical generator controls the flow of the electric current down the electrode. The overall length of the device is between 4 and 11 inches. The power cord connecting the handle to the power control unit is approximately 120 inches. The blades are between 1 and 2 inches in length.

The surgeon places the opened scissors across the tissue to be cut and closes the scissors handle while moving the scissors across the tissue. Energizing the electrosurgical generator via the generator's footswitch, the surgeon can simultaneously cut and coagulate the target tissue. The surgeon can vary the current flow rate according to the tissue and the amount of bleeding encountered. The power setting for the ENABLE Bipolar Scissors is 20-30 watts.

The provided text is a 510(k) summary for the ENABLE Bipolar Scissors with ENABLE Bipolar Disposable Cartridges. It focuses on establishing substantial equivalence to predicate devices rather than presenting a performance study with acceptance criteria.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets them, as this type of data is not present in the provided document.

The document discusses:

• Intended Use: To cut tissue and control bleeding through coagulation during general surgery.
• Product Description: A reusable electrosurgical instrument with disposable cartridges, connected to an electrosurgical generator, designed to simultaneously cut and coagulate tissue.
• Predicate Devices: Several other bipolar scissors (Symbiosis, Everest Medical, CardioThoracic Systems, Ethicon PowerStar) are listed as substantially equivalent in intended use, function, physical characteristics, materials, and sterilization method.
• Regulatory Classification: Class II.
• Power Setting: 20-30 watts for operation.

The document does not include:

1. A table of acceptance criteria and reported device performance.
2. Details about sample sizes for test sets, data provenance, or ground truth establishment.
3. Information on expert involvement, adjudication methods, MRMC studies, or standalone algorithm performance.
4. Sample sizes for training sets or ground truth establishment for training.

The 510(k) process primarily relies on demonstrating substantial equivalence to a legally marketed predicate device rather than comprehensive de novo clinical studies with pre-defined acceptance criteria for performance metrics.

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The CTS MIDCAB/SVH Bipolar Scissors is intended to cut tissue and control bleeding through coagulation, in general and cardiothoracic surgery, including minimally invasive direct coronary artery bypass ("MIDCAB") and saphenous vein harvesting procedures.

The CTS MIDCAB/SVH Bipolar Scissors is an electrosurgical instrument which consists of a pair of scissor blades which are connected to a handle instrument and an electrosurgical generator. Electric current flows from the electrode to the stainless steel cutting surface of the blades and from the stainless steel cutting surface of one blade to the stainless steel cutting surface of the other blade. The flow of the electric current down the electrode is controlled by the power generator. The overall length of the device, which consists of the handle, tube and blades, is approximately 13 inches. The power cord connecting the handle to the power control unit is approximately 120 inches. The blades are approximately 0.5 inches in length.

The surgeon places the opened scissors across the tissue to be cut and depresses the actuation lever while moving the scissors forward against the tissue. By energizing the power control unit on the actuation lever, the surgeon can simultaneously cut and coagulate the target tissue. Alternately, the power control unit may be controlled via a foot pedal. The surgeon can vary the current flow rate according to the tissue and the amount of bleeding encountered. The power setting used for the CTS Bipolar Scissors is 20-30 watts.

The CTS Bipolar Scissors is provided sterile, nonpyrogenic and for single use.

The provided text is for a 510(k) summary for a medical device (CTS MIDCAB™ /SVH™ Bipolar Scissors) and does not contain information about acceptance criteria or a study proving that the device meets such criteria. Typically, 510(k) summaries for surgical instruments like this focus on demonstrating substantial equivalence to predicate devices rather than presenting performance criteria and detailed study results that would be found for diagnostic devices or AI/ML-driven software.

Therefore, I cannot fulfill your request for the specific sections you've outlined based on the given information.

Here's why and what kind of information would be needed:

• Acceptance Criteria and Reported Device Performance: This would require a clearly defined set of performance metrics (e.g., cutting time, coagulation effectiveness, tissue damage assessment, safety parameters) with specific quantifiable targets and the results from testing to demonstrate achievement of those targets.
• Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone, Ground Truth, Training Set: These are all components of a clinical or performance study that would establish the efficacy and safety of a diagnostic or AI/ML-enabled device. For a surgical instrument like the bipolar scissors, the "proof" often comes from bench testing, animal studies, and sometimes limited human use studies focused on safety and direct function, rather than large-scale diagnostic accuracy studies.

In the context of the provided 510(k) summary, the "study" is the substantial equivalence comparison to predicate devices, which relies on demonstrating similar intended use, technology, and performance, rather than an independent clinical trial with predefined acceptance criteria for novel performance.

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