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Containment and Counting of Sponges in the Operating Room or a hospital setting.

Pocket Count: Transparent, compartmentalized, disposable bag which allows visual confirmation of sponge count and visual estimate of absorbed fluid. Pocket Count provides partial containment of contaminated sponges, thereby, decreasing worker exposure to contents.
SafeTCount: Transparent, disposable hand shaped covering which is used to collect sponges. When the covering is turned inside out it contains the contaminated sponges thereby decreasing worker exposure to contents. The SafeTCount allows visual confirmation of sponge count and visual estimate of absorbed fluid.

This document is a 510(k) premarket notification for the "Pocket Count or SafeTCount" surgical sponge counter. It primarily focuses on demonstrating substantial equivalence to pre-existing predicate devices. As such, it does not contain a typical study where specific acceptance criteria are set and then experimentally proven by the device.

Instead, the document details a comparison study to establish substantial equivalence based on design and intended use, rather than a performance study with quantitative acceptance criteria.

Here's an analysis of the information provided:

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

The document does not present acceptance criteria in the traditional sense of measurable performance targets (e.g., accuracy, sensitivity, specificity) with associated reported device performance. Instead, the "performance" section of the substantial equivalence comparison table (page 3, {3}) states:

This indicates the device's capacity, which is a design specification, not a performance metric that would typically be tested against acceptance criteria in a clinical study. The "acceptance criteria" here implicitly revolve around demonstrating that the new devices (Pocket Count and SafeTCount) are substantially equivalent in their intended use, design, material, and performance characteristics (like capacity) to legally marketed predicate devices.

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 applicable. This submission is for a physical device (surgical sponge counter) and does not involve a "test set" of data in the context of an algorithm or diagnostic device. The evaluation is based on comparing design features and stated capacities to predicate devices.
• Data Provenance: Not applicable for a typical "test set" as described for an algorithm. The data provenance would refer to the characteristics of the predicate devices themselves (e.g., "legally marketed in interstate commerce prior to May 28, 1976").

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

Not applicable. "Ground truth" in this context would generally refer to a medical diagnosis or outcome used to evaluate an AI/diagnostic device. For a surgical sponge counter, the "truth" is whether it effectively contains and allows counting of sponges as designed, which is assessed through design comparison and manufacturer claims, not expert consensus on diagnostic data.

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

Not applicable. There is no test set in the sense of diagnostic data requiring adjudication. The FDA's review process determines substantial equivalence based on the submitted information comparing the device to predicates.

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 document is for a physical medical device (surgical sponge counter), not an AI or diagnostic tool that would involve human readers or cases.

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

Not applicable. This is not an algorithm or software device.

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

Not applicable. The "ground truth" for this type of device is its functional design and capacity to hold sponges, which is inherently understood through its physical properties and intended use. The comparison is against predicate devices that perform the same function.

8. The sample size for the training set

Not applicable. This is not an AI or algorithm-driven device that requires a training set.

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

Not applicable. There is no training set for this device.

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