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The Scion Cardio-Vascular Clo-SurPLUS P.A.D., is intended for the local management of bleeding wounds and to provide a barrier to bacterial penetration of the dressing in all patients and for the promotion of rapid control (hemostasis) of bleeding in patients following hemodialysis and for those on anticoagulation therapy. The dressing is indicated for the following wounds: lacerations, abrasions, nose bleeds, and the skin surface puncture sites for vascular procedures, percutaneous catheters or tubes.

The Scion Cardio-Vascular Clo-SurPLUS P.A.D. is a soft, non-woven pad that provides an optimal wound-healing environment, combining an effective antibacterial barrier activity with exudates management. Clo-SurPLUS P.A.D. has demonstrated in-vitro antibacterial activity meant to prevent microbial colonization and penetration of the dressing. Clo-SurPLUS P.A.D. is a sterile topical hemostasis pad, packed in a foil pouch and sterilized by E-beam radiation to a 10-6 SAL.

The provided text describes a 510(k) submission for the Scion Cardio-Vascular Clo-SurPLUS P.A.D., which is a topical hemostasis pad. The purpose of a 510(k) is to demonstrate that a new device is substantially equivalent to a legally marketed predicate device. This process typically involves demonstrating that the new device has similar technological characteristics and performs as safely and effectively as the predicate.

The document discusses an in-vitro study conducted to demonstrate the effectiveness of the Clo-SurPLUS P.A.D. as an antimicrobial substance. However, it explicitly states: "The clinical significance of the findings in this vitro study is unknown." This indicates that no clinical study (human trials) was performed to establish clinical performance or acceptance criteria in a real-world setting for this particular 510(k) submission.

Therefore, many of the requested details, such as specific acceptance criteria for clinical performance, sample sizes for test sets (clinical), ground truth methodologies, expert qualifications, adjudication methods, MRMC studies, or standalone performance, are not present in this document because a clinical performance study was not the basis of this 510(k) submission. The equivalence was primarily based on the device's technological characteristics and its in-vitro antimicrobial activity.

Here's a breakdown of the information available based on your request, highlighting what is provided and what is not:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Test Set (in-vitro study): The sample size for the in-vitro antimicrobial study involved challenging three product concentrations of Clo-SurPLUS P.A.D. with a 10^5 CFU/mL concentration of eight different organisms (bacteria and fungi). This is an in-vitro (laboratory) study, not a clinical test set.
• Data Provenance: In-vitro laboratory data. The country of origin is not specified but is typically internal to the manufacturer or a contract lab. The study was conducted as part of the 510(k) submission.

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

• This information is not applicable for the in-vitro antimicrobial study. Ground truth in such a study is established by standard microbiological techniques and quantification of microbial growth/reduction, not by expert consensus in a clinical sense.

4. Adjudication method for the test set

• Not applicable as it was an in-vitro quantitative assay, not a clinical trial requiring adjudication of human observations or interpretations.

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

• No, a MRMC comparative effectiveness study was not done. This device is a topical hemostasis pad, not an AI-powered diagnostic or interpretive device.

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

• Not applicable, as this is a physical medical device, not an algorithm.

7. The type of ground truth used

• For the in-vitro antimicrobial study, the ground truth was established by quantitative microbiological assay measuring the concentration of various bacterial and fungal organisms over time. For the basis of the 510(k), the ground truth for substantial equivalence was established by comparing the technological characteristics of the Clo-SurPLUS P.A.D. to predicate devices based on existing scientific literature on poly-D-glucosamine and poly-N-acetylglucosamine.

8. The sample size for the training set

• Not applicable. This is a physical medical device, not a machine learning model requiring a training set.

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

• Not applicable.

Summary of Device Rationale for 510(k) Clearance:

The 510(k) submission for the Clo-SurPLUS P.A.D. focused on establishing substantial equivalence to legally marketed predicate devices primarily through:

• Technological Characteristics: The device is described as a soft, non-woven pad made of poly-D-glucosamine and poly-N-acetylglucosamine (chitosan), noting its biocompatibility, biodegradability, hemostatic, and anti-infective properties, which are similar to existing literature and predicate devices.
• In-vitro Antimicrobial Activity: An in-vitro study demonstrated that the pad could reduce the concentration of various bacteria and fungi. However, the document explicitly states that the clinical significance of these in-vitro findings is unknown.
• Intended Use: The intended use for local management of bleeding wounds, bacterial barrier, and promotion of hemostasis aligns with the predicate devices.

This 510(k) summary does not describe a clinical study (i.e., human trials) to prove specific clinical acceptance criteria for the device's performance in patients. The clearance was based on in-vitro data and demonstrating similar technological characteristics and intended use to predicate devices already on the market.

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