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BIPAD Hand Activated, Disposable Bipolar Electrocautery Cords are intended to connect an electrosurgical device to and electrosurgical generator. They are indicated for use with bipolar forceps during general surgical procedures.

The BiPAD® Hand Activated, Disposable Bipolar Electrocautery Cords, Model BP105-C (Codman) and BP105-M (Medtronic) have been designed as an accessory to electrosurgical instruments where bipolar electrosurgical coagulation is desired during surgery. The device is a sterile, disposable, bipolar cord that connects to the electrosurgical generator on one end and the active instrument (bipolar forceps) on the other end. The cord has an integrated hand switch to activate the coagulating current of the RF generator. The device is intended for use with currently marketed Electrosurgical generators and bipolar surgical forceps to control bleeding.

The provided text is a 510(k) Summary for the BiPAD® Hand Activated, Disposable Bipolar Electrocautery Cords. It describes the device, its intended use, and the non-clinical tests performed to demonstrate its substantial equivalence to a predicate device.

The document does not describe the acceptance criteria or a study that proves the device meets the acceptance criteria in the format requested, which typically relates to performance metrics for diagnostic or AI-powered devices. The BiPAD device is an electrosurgical accessory, and the "acceptance criteria" here are aligned with regulatory compliance, safety, and functional equivalence rather than specific performance metrics like sensitivity or specificity.

However, I can extract information related to the tests and their compliance with established standards, which serves as the "proof" of the device meeting regulatory acceptance criteria.

Here's an interpretation based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Study Details:

The document describes non-clinical studies (bench testing, electrical safety, biocompatibility, sterilization, packaging) rather than a clinical study or a study specifically designed to establish performance metrics like sensitivity/specificity for an AI or diagnostic device.

• 2. Sample size 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 the test set" in the context of diagnostic performance testing. Instead, it mentions that "All testing was performed on final devices." The number of devices tested for each type of non-clinical evaluation (electrical safety, biocompatibility, etc.) is not detailed.
  • Data provenance is not explicitly stated, but these are typically laboratory bench tests and compliance assessments, not human subject data.

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

  • This question is not applicable as the studies described are not focused on establishing ground truth for diagnostic interpretation. The "ground truth" for these tests would be the established scientific and engineering principles codified in the standards (e.g., a device either meets the electrical safety limits or it doesn't).

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

  • This is not applicable. The tests performed are objective measurements against established technical standards, 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

  • No, an MRMC comparative effectiveness study was not done. The device is a hand-activated electrosurgical cord, not an AI-powered diagnostic tool. The document explicitly states: "The proposed BIPAD® Hand Activated, Disposable Bipolar Electrocautery Cord did not require formal clinical study since substantial equivalence to the legally marketed predicate device was proven with verification/validation testing."

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

  • No. This is not an algorithm or AI device.

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

  • The "ground truth" for these non-clinical tests is adherence to established technical standards and regulations (e.g., electrical safety limits, biocompatibility requirements, sterilization efficacy).

• 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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