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The anti-clog drain is indicated for use as an adjunctive device during open surgical procedures in order to prevent fluid accumulation within the operative site after closure of the surgical wound.

The device is inserted through the skin adjacent to open surgical incision. The distal end of the drain is positioned within the operative site prior to repair of the incision. The device's proximal end is attached to an appropriate suction source in order to allow efflux of bloody, rosanguinous, chylous, purulent fluid, intestinal, and/or other fluids from the operative site that could impair surgical wound healing. The device is indicated for use in abdominal, thoracic, head and neck, gynecological, urological, spinal, and orthopedic surgical procedures.

The wound drain catheter comprises a proximal drain segment, an internal tubular mesh assembled with a luer fitting adapter, a distal transition tube segment, and a metal trocar.

The provided document is a 510(k) premarket notification for "The CEI Anti-Blockage Wound Drain Device" (K052286). This document focuses on establishing substantial equivalence to predicate devices, rather than presenting a detailed study with acceptance criteria and performance metrics in the way a clinical trial or AI device validation study would.

Therefore, many of the requested sections (e.g., sample size for test/training sets, number of experts, adjudication methods, MRMC studies, standalone AI performance) are not applicable or not present in this type of regulatory submission. This document predates the widespread use of sophisticated AI in medical devices and the associated regulatory requirements for AI/ML performance evaluation.

Here's an analysis based on the available information:

1. Table of acceptance criteria and the reported device performance

This 510(k) submission does not present specific quantitative acceptance criteria or a study with performance metrics in a table format as would be expected for a novel AI device or a device requiring specific performance targets beyond substantial equivalence.

Instead, the "acceptance criteria" for a 510(k) are implicitly met by demonstrating substantial equivalence to legally marketed predicate devices. The performance is judged against the established safety and effectiveness of those predicates.

The device description highlights functional aspects:

• Drain segment elasticity: "sufficient elasticity to permit the cross-sectional area of the drain decrease when a pulling force is applied to it, thereby reducing the gripping force of tissue surrounding the wound."
• Tubular mesh function: "used to re-establish the drain patency when a post-operative occlusion occurs. To do this, the luer fitting adapter needs to be removed from the drain segment end and the luer fitting adapter and the mesh segment to be pulled from the drain lumen to remove the obstructing material."
• Tubular mesh radiopacity: "also provides the catheter radiopacity."
• Trocar function: "used to pull the drain through the surrounding tissue to the intended drainage site."

The document states FDA's determination that the device is "substantially equivalent" to the predicate devices (Jackson-Pratt Wound Drains, K973703, and Axiom Multipurpose Wound Drain, K993592). This is the primary "performance" and "acceptance" reported in the context of this 510(k) submission.

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

Not applicable. This is a 510(k) premarket notification for a physical medical device (wound drain), not an AI/software device that would typically involve a test set of data for performance evaluation in the way a diagnostic algorithm would. The submission focuses on device design, materials, and intended use as compared to predicates.

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)

Not applicable. Ground truth for a test set is not a concept used in this type of 510(k) submission for a physical wound drain. There is no algorithm performance being evaluated against expert ground truth.

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

Not applicable. Adjudication methods are relevant for studies establishing ground truth for diagnostic or AI-driven systems. This is not the context of this 510(k).

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. MRMC studies are typically used to evaluate the performance of diagnostic imaging aids or AI systems involving human readers. This device is a physical wound drain, not an imaging or AI system.

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

Not applicable. This device does not involve an algorithm.

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

Not applicable. Ground truth, in the context of evaluating an algorithm or diagnostic accuracy, is not relevant for this 510(k) submission. The "truth" for this device lies in its physical properties, biocompatibility, and functional similarity to established predicate devices.

8. The sample size for the training set

Not applicable. There is no algorithm or training set for this physical device.

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

Not applicable. There is no algorithm or training set for this physical device.

Summary of the Study/Evidence presented for this 510(k):

The "study" in this context is the 510(k) substantial equivalence submission itself. The evidence presented to meet the "acceptance criteria" (i.e., substantial equivalence) includes:

• Device Description: Detailed explanation of the Deutsch Anti-Blockage Wound Drain's components, materials (silicone elastomer, stainless steel), and functional design, including its unique "anti-blockage" tubular mesh feature.
• Comparison to Predicate Devices: Explicitly naming the Jackson-Pratt Wound Drains (K973703) and Axiom Multipurpose Wound Drain (K993592) as legally marketed devices claiming equivalence. While the document doesn't explicitly show a side-by-side comparison table (which is typical in 510(k) summaries), the intent of the submission is to demonstrate that the new device is as safe and effective as these predicates.
• Indications for Use: Defining the intended use for the device congruent with similar wound drains: "as an adjunctive device during open surgical procedures in order to prevent fluid accumulation within the operative site after closure of the surgical wound" across various surgical procedures (abdominal, thoracic, head and neck, gynecological, urological, spinal, and orthopedic). This aligns with the indications of typical wound drains.
• Presumably, the full 510(k) submission (not fully provided here) would have included bench testing, material characterization, biocompatibility data, and sterilization information to support the safety and performance claims relative to the predicate devices. These are the typical elements that form the "evidence" for substantial equivalence for a physical device.

Conclusion from the FDA letter: The FDA reviewed the submission and determined that "the device is substantially equivalent... to legally marketed predicate devices." This determination signifies that the device has met the regulatory "acceptance criteria" for market clearance based on the information provided, without requiring a detailed clinical trial or AI performance study typically associated with the questions posed.

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