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Electrosurgical Coagulation of soft tissue during ENT procedures.

The devices are Class II medical devices are similar in design to the referenced predicate devices. The BiTx devices are similar in construction and in component materials as compared to laparoscopic devices (Ref. BiLAP Probes submitted in 510(k) no's. K904993 and K945975). The devices are tubular instruments, either 3mm or 5mm in diameter, with shaft lengths of 12-15cm. The intended use of the device is to electrosurgically coagulate soft tissue during the performance of ENT procedures. The energy source, Bipolar Electrosurgical Energy, is the same energy type as used for the predicate devices with indications for ENT procedures. The device incorporates a return electrode on it's distal end, eliminating the need for a return pad.

The provided text describes a 510(k) submission for a medical device (BiTx Probe) and the FDA's "Substantially Equivalent" determination. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, expert involvement, or any other details related to a performance evaluation of the device against specific criteria.

The document is a regulatory submission for pre-market notification, focusing on demonstrating substantial equivalence to existing predicate devices, rather than presenting a detailed performance study with quantitative results.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and study details. The input document simply does not contain this type of data.

Here's what the document does state, which is relevant to a 510(k) submission but not to a performance study:

• Device Name: BiTx Probe
• Intended Use: Electrosurgically coagulate soft tissue during the performance of ENT procedures.
• Mechanism of Action: Bipolar Electrosurgical Energy, similar to predicate devices.
• Comparison to Predicate Devices: The submission asserts that the device is similar in design, construction, component materials, function, and intended use as compared to predicate devices (BiLAP Probes and devices marketed by Elmed Incorporated and Ellman International).
• Conclusion for 510(k): "Everest Medical believes that no new issues of safety and effectiveness are raised and that this device is substantially equivalent."
• FDA Determination: The FDA found the device "substantially equivalent" to predicate devices, allowing it to be marketed.

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Laparoscopic grasping of tissue. Laparoscopic bipolar coagulation. Laparoscopic contraceptive coagulation of the Fallopian tissue and may be used to achieve hemostasis following transection of the Fallopian tube.

The device is a Class III medical device. The Tubal Sterilization device is similar to Everest Medical's current laparoscopic BiCOAG® forceps submitted on 510(k) no. K945975 and the pre-ennactment Tubal sterilization Wolf Kleppinger Forceps.

The provided text does not contain detailed information about specific acceptance criteria or a comprehensive study plan with the granularity required to fill out all the fields in your request for the "BiCOAG Coagulating Forceps" or the "Tubal Sterilization device".

However, based on the information available, here's what can be extracted and inferred:

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

The document mentions "Performance testing has been submitted to support the safety and functional performance of the submitted devices." and "Clinical studies evaluating histological results have been conducted using the same Wolf Bipolar generator to demonstrate equivalent effectiveness to the currently available Tubal sterilization Wolf Kleppinger Forceps."

While specific quantitative acceptance criteria are not detailed, the primary performance criterion appears to be equivalent effectiveness to the predicate device, the "Tubal sterilization Wolf Kleppinger Forceps," as demonstrated by histological results.

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

• Sample Size for Test Set: Not explicitly stated. The document only mentions "Clinical studies evaluating histological results have been conducted."
• Data Provenance: Not explicitly stated. We don't know the country of origin or if the studies were retrospective or prospective.

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)

• Number of Experts: Not explicitly stated.
• Qualifications of Experts: Not explicitly stated.

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

• Adjudication Method: Not specified.

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 Study: This is a Class III medical device (tubal sterilization forceps), not an AI-powered diagnostic device for human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable in this context. The study focuses on the device's physical performance in a surgical procedure, not its interpretation by human readers.

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

• Standalone Study: This is a surgical instrument, not an algorithm. Therefore, "standalone" performance in the context of an algorithm is not applicable. The device's performance is inherently tied to its use by a human surgeon.

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

• Type of Ground Truth: The document explicitly states "Clinical studies evaluating histological results have been conducted." This indicates that histology/pathology was the primary method for determining the effectiveness (e.g., successful tubal occlusion).

8. The sample size for the training set

• Sample Size for Training Set: Not applicable. This is a medical device, not a machine learning algorithm that requires a "training set" in the conventional sense. The "training" for such a device would involve engineering design, prototyping, and testing, not data-driven machine learning.

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

• How Ground Truth for Training Set was Established: Not applicable (as explained in point 8).

In Summary:

The provided 510(k) summary focuses on establishing substantial equivalence for a surgical instrument (tubal sterilization forceps). The key evidence presented revolves around performance testing for safety and functional performance, and clinical studies using histological results to demonstrate equivalent effectiveness to a predicate device. The information is very high-level and lacks the granular details typically found in summaries for diagnostic devices or AI algorithms regarding study designs, sample sizes, and expert evaluations.

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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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