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The subject device is intended for the evacuation of biological fluids from wounds or body cavities. Closed wound drainage systems have been used by various surgical specialties, including: orthopedic, general, reconstructive, neurological, gynecological, head and neck, thoracic / cardiovascular, and plastic surgery.

The Elutia ™ Coated Closed Surgical Wound Drain is a radiopaque, single-use silicone wound drain with extension tubing for use with available drain reservoirs that include an anti-reflux valve. The drain is channeled for its entire length. It is available in round or flat configurations and in multiple sizes. A low profile connector joins the drain to clear silicone extension tubing. The drain is packaged sterile in a double pouch and is non-pyrogenic. The hydrogel coating containing silver sulfadiazine has been shown to reduce bacterial contamination on the surface of the wound drain by greater than 99.99% over a 7 day period as tested under USP conditions against the following microorganisms: S. aureus, P. aeruginosa, E. coli, and C. albicans. The clinical significance of this finding is unknown. The subject device is composed of materials that have been successfully used in medical devices including the predicate devices. The subject device is composed of medical grade silicone (indwelling catheter, connector, and external tubing). The device is coated with silver sulfadiazine. USP grade silver sulfadiazine is used. The active drug substance is chemically synthesized and does not contain any animal or cell cultures derived from products or additives such as albumin or serum. The materials used in the subject device have been subjected to and passed biocompatibility testing. Additionally, the materials have been successfully used in other medical devices including the predicate devices. The subject devices are sterile single-use devices. Sterilization was performed.

Here's a breakdown of the requested information based on the provided 510(k) summary for the Elutia™ Coated Closed Surgical Wound Drain:

1. Acceptance Criteria and Reported Device Performance

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

The 510(k) summary does not explicitly state the sample size for the bacterial contamination reduction test or other performance tests (biocompatibility, packaging, etc.).

• Test Set Sample Size: Not explicitly stated.
• Data Provenance: Not explicitly stated, but based on the context of a 510(k) submission, this data would typically be generated by the manufacturer during product development and testing, likely in a laboratory setting. No country of origin for the data is specified, nor is it described as retrospective or prospective clinical data. The primary test mentioned (USP ) is a standard in vitro microbiological method.

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

N/A. This type of information (expert consensus for ground truth) is not typically applicable or reported for a device like a surgical drain, especially for the in vitro performance tests described. The "ground truth" for the bacterial reduction test is the measurable reduction in bacterial count against controls in a laboratory setting.

4. Adjudication Method for the Test Set

N/A. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies involving interpretation of medical images or patient outcomes, often with multiple human readers. This is not relevant to the in vitro and laboratory-based performance testing described for this device.

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

No. The 510(k) summary does not mention any MRMC comparative effectiveness study. The submission focuses on substantial equivalence to predicate devices based on technological characteristics and performance testing.

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

N/A. This device is a physical medical device (surgical drain), not a software algorithm or AI-based diagnostic tool. Therefore, the concept of "standalone algorithm performance" is not applicable.

7. The Type of Ground Truth Used

For the key performance claim:

• Bacterial Reduction: The ground truth was established through laboratory-based microbiological assays (USP ) comparing the coated drain's performance against control samples or expected bacterial growth.
  For other tests:
• Biocompatibility, Pyrogenicity, Physiochemical: Ground truth was based on standardized test methods and associated acceptance criteria (e.g., ISO 10993, USP ).
• Packaging Tests: Ground truth was based on standardized engineering and packaging test methods and associated acceptance criteria (e.g., ASTM 2096-04, ISO 11607, ASTM F1140-00).

8. The Sample Size for the Training Set

N/A. This device is a physical medical device, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning.

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

N/A. As there is no training set for an AI/ML algorithm, this question is not applicable.

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