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A Single use, non sterile dispersive electrode with or without a pre-attached cord to adhere to the infant patient over the entire pad surface to complete the electrosurgical circuit between the generator, the active electrode, and the patient.

The E Surgical Infant Patient Return Electrode Dual Plate is a single use, non-sterile disposable electrode with and without a pre-attached cord. The use is to complete an electrical circuit during electro surgery between the generator, the active electrode, and an infant patient.

The provided text describes the 510(k) summary for the E Surgical Electrosurgical Infant Patient Return Electrode, Dual Plate with Cord. Here's an analysis of the acceptance criteria and study information:

Acceptance Criteria and Reported Device Performance

Study Information

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

   • The document does not specify the sample size for any specific test set used to demonstrate compliance with the ANSI/AAMI HF-18 standard or ISO 10993.
   • The document does not specify the data provenance (e.g., country of origin, retrospective or prospective) for any testing.

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

   • This information is not applicable and not provided. The studies described are related to compliance with engineering and biocompatibility standards, not clinical diagnostic performance requiring expert interpretation or "ground truth" in the traditional sense of medical image analysis or disease detection.

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

   • This information is not applicable and not provided. Adjudication methods are typically used in studies where human experts are making judgments that need to be resolved, such as in clinical trials or diagnostic accuracy studies. The compliance studies mentioned (ANSI/AAMI HF-18, ISO 10993) involve objective measurements against predefined standards.

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 comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic or assistive devices involving human readers. The E Surgical device is an electrosurgical accessory, not a diagnostic tool or an AI-assisted device.

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

   • This information is not applicable and not provided. The device is not an algorithm; it is a physical medical device. The "studies" mentioned are compliance tests against established standards for physical device performance and safety.

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

   • For the performance data mentioned (compliance with ANSI/AAMI HF-18 and ISO 10993), the "ground truth" is defined by the objective criteria and methodologies outlined within those respective standards. For example, for thermal safety, the ground truth would be defined by specific temperature thresholds and measurement protocols outlined in the ANSI/AAMI HF-18 standard. For biocompatibility, it would be the outcomes of specific tests as per ISO 10993 (e.g., cytotoxicity, irritation, sensitization).

7. The sample size for the training set:

   • This information is not applicable and not provided. The E Surgical Infant Patient Return Electrode is a physical medical device, not a machine learning or AI model that requires a training set.

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

   • This information is not applicable and not provided. As stated above, the device does not involve a training set.

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