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The neurological sponge is a cotton or rayon pattie used to keep exposed tissue from drying out during surgery. It is used to absorb excess fluids and to protect the tissue from trauma during surgery. It is also used to assist in the gentle suction of fluids.

Neurosurgical Paddies are used to keep exposed tissue from drying out or to absorb excess fluids and to protect the tissue from trauma during surgery. They are manufactured from either cotton or viscose fibers cut into rectangular pads of various sizes with a suture string attached for ease in count verification and with an x-ray detectable marker sewn to it as an extra precaution. The paddies are normally packaged 10 per count card of a single size and may be sterilized for end use or sold non sterile for kit packers. They are single use items that can be ETO sterilized twice or E-beam sterilized once.
HE, Inc.'s product will be made from cotton and/or or rayon in sizes and shapes similar to the predicate devices as they have been since 2005 under a 510(k) license. The most commonly used sizes are ½' x ½', ½' x 1", ½" x 3", 1" x 1" and 1" x 3".

The provided document is a 510(k) summary for a medical device called "Neuro Patties and/or Neurosponges" by HE, Inc. This submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a de novo study with acceptance criteria and performance data in the typical AI/CADe sense. Therefore, many of the requested elements (like "reported device performance," "sample sizes," "number of experts," "adjudication method," "MRMC study," "stand-alone study," "ground truth type," and "training set size") are not applicable to this type of regulatory submission.

The document primarily states that the device is substantially equivalent to a legally marketed predicate device (McNeil Healthcare, Inc. under K935883). Substantial equivalence means that the new device has the same intended use and the same technological characteristics as the predicate, or if it has different technological characteristics, the differences do not raise different questions of safety and effectiveness and the device is as safe and effective as the predicate.

Here's a breakdown of the available information in relation to your request:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria:
The "acceptance criteria" in this context is the FDA's determination that the device is substantially equivalent to a predicate device and therefore can be marketed. There are no specific quantitative performance metrics like sensitivity, specificity, or AUC mentioned. Instead, the acceptance is based on demonstrating:

• Same intended use.
• Identical technological characteristics (materials, manufacturing process, design) OR
• If technological characteristics differ, these differences do not raise new safety or effectiveness concerns, and the device is as safe and effective as the predicate.

Reported Device Performance:
The document does not provide quantitative "performance" data in terms of accuracy, precision, etc., for the HE, Inc. device. Its performance is implicitly deemed acceptable because it is identical to the predicate device in terms of materials, intended use, and manufacturing process.

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

• Not Applicable. This is a substantial equivalence submission based on direct comparison to a predicate device's existing regulatory approval, not a performance study involving a test set of data. The "test" is the comparison of device characteristics against those of the predicate.
• The data provenance mentioned relates to the predicate device's prior approval (K935883 from McNeil Healthcare, Inc.) and the history of HE, Inc. manufacturing the same product under license since 2005.

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

• Not Applicable. There was no "test set" or "ground truth" establishment in the context of image analysis or diagnostic performance for this type of device (neurosurgical paddies). The "ground truth" for the regulatory approval is that the predicate device was already approved as safe and effective.

4. Adjudication Method for the Test Set

• Not Applicable. No test set or expert adjudication was performed as part of this substantial equivalence submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No. An MRMC study is not relevant for this type of device (neurosurgical paddies). This device is a surgical aid, not a diagnostic imaging or AI tool.

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

• Not Applicable. This device is a physical medical product, not an algorithm, and does not have a "standalone" performance apart from its physical use in surgery.

7. The Type of Ground Truth Used

• The "ground truth" for this submission is that the predicate device (McNeil Healthcare, Inc.'s Neurological Sponges under K935883) was previously determined by the FDA to be safe and effective. The argument of the 510(k) is that the HE, Inc. device is identical or sufficiently similar to this already-approved device.

8. The Sample Size for the Training Set

• Not Applicable. This submission does not involve an AI algorithm with a training set.

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

• Not Applicable. There is no training set for an AI algorithm in this context.

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