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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 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 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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