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The CleanCision™ Wound Retraction System is intended for use by a surgeon during abdominal surgery to: retract the surgical incision, provide access to the abdominal cavity, and irrigate the surgical wound edge. The device may aid in the prevention of wound edge contamination. This device is intended to deliver a sterile irrigant solution and serve as a conduit for fluid removal from the surgical wound edge.

The CleanCision™ Wound Retraction and Protection System is a sterile, single-use irrigating wound retractor device that integrates surgical retraction, wound barrier protection, and fluid delivery and removal. The wound barrier protection component is comprised of a flexible, double-walled sheath with an impermeable inner layer that protects the wound edges from contamination. The wound retraction component is formed by attaching the sheath to a fixeddiameter ring at the bottom, designed to be inserted into the abdominal cavity, and a radiallyadjustable upper retraction ring at the top, designed to remain outside of the body and be actuated to achieve wound retraction. The double-walled sheath also includes integrated fluid delivery. Fluid is delivered via gravitational feed from an external fluid bag into the device and delivered to the wound edges through the permeable outer layer of the sheath. Excess fluid is removed through the bottom ring via a connection with the hospital's standard vacuum suction mechanism.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the CleanCision Wound Retraction and Protection System:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA submission for the CleanCision Wound Retraction and Protection System (K172132) primarily focuses on demonstrating substantial equivalence to a predicate device (DEN150038) rather than presenting a performance study against predefined numerical clinical acceptance criteria. The acceptance criteria are implicit in meeting established standards and regulations for medical devices of this type, and the "reported device performance" is that the device meets these standards.

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

The document does not describe a "test set" in the context of clinical trial data or a distinct dataset with specific sample sizes for evaluating diagnostic accuracy or patient outcomes. Instead, it refers to non-clinical performance testing that was "repeated to ensure that the new design met the same essential performance specifications."

• Sample Size: Not specified in terms of patient numbers or clinical cases. The "sample size" would refer to the number of devices or material specimens tested for each non-clinical performance test (e.g., number of devices subjected to deployment force testing, number of material samples for tensile strength). These specific quantities are not provided in the summary.
• Data Provenance: The data comes from non-clinical laboratory and engineering testing, applying recognized international standards (ISO, ASTM, USP) and addressing specific performance aspects relevant to the device's function and safety. It is not patient or human-derived data, so retrospective/prospective distinctions are not applicable, nor is country of origin for clinical data.

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

This information is not applicable to this submission. The "ground truth" for the non-clinical tests described is established by the specifications and pass/fail criteria defined within the referenced international standards (ISO, ASTM, USP). There's no mention of experts establishing ground truth for performance testing results; rather, the tests themselves dictate the "truth" of whether a product characteristic meets the standard.

4. Adjudication Method for the Test Set

This is not applicable to this submission. Adjudication methods like "2+1" or "3+1" are used in clinical studies or expert reviews to resolve discrepancies in diagnoses or assessments. Since the tests are non-clinical and rely on quantitative measurements against defined standards, there is no need for expert adjudication in this context.

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

No. The document does not describe an MRMC comparative effectiveness study, nor does it refer to human readers or AI assistance. This submission is for a physical surgical device, not an AI-powered diagnostic tool. Therefore, there is no information on the effect size of human readers improving with AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No. This question is also not applicable as the device is a physical surgical tool and not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for this submission is based on:

• Compliance with established international and national standards: ISO 10993, ASTM F1670, ASTM D1004, ASTM D882, USP , USP , USP , NFPA 702.
• Engineering design specifications and functional requirements: Defining adequate forces for deployment, fluid delivery rates, and fluid removal rates.
• Substantial equivalence to a predicate device (DEN150038) for the stated intended use and indications.

Essentially, the ground truth is regulatory compliance and engineering performance specifications, validated through laboratory testing.

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" described, as this is a physical medical device and not a machine learning model.

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

This information is not applicable as there is no training set for this device submission.

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The CleanCision™ Wound Retraction and Protection System is intended for use by a surgeon during abdominal surgery to: retract the surgical incision, provide access to the abdominal cavity, and irrigate the surgical wound edge. The device may aid in the prevention of wound edge contamination. This device is intended to deliver a sterile irrigant solution and serve as a conduit for fluid removal from the surgical wound edge.

The CleanCision™ Wound Retraction and Protection System (CleanCision™ System) is a sterile, single-use surgical wound retraction and protection device that integrates surgical retraction, wound barrier protection, and controlled fluid delivery and removal, as shown in Figure 1, below. The wound barrier protection component is comprised of a flexible, doublewalled sheath with an inner layer that may aid in the prevention of wound edge contamination. The wound retraction component is formed by attaching the sheath to a fixed-diameter ring at the bottom, designed to be inserted into the abdominal cavity, and a radially-adjustable upper retraction ring at the top, designed to remain outside of the body and be actuated to achieve wound retraction. The double-walled sheath also includes integrated fluid delivery and removal. Fluid is delivered via gravitational feed from an external sterile irrigation solution bag into the device and delivered to the wound edges through the permeable outer layer of the sheath. Excess fluid is removed through a separate chamber within the sheath via a connection with the hospital's standard vacuum suction mechanism.

Here's an analysis of the acceptance criteria and the studies performed for the CleanCision™ Wound Retraction and Protection System, based on the provided document.

1. Table of Acceptance Criteria and Reported Device Performance

The document describes several non-clinical performance tests with explicit acceptance criteria. The performance for all these tests was reported as "Pass".

Summary of Conclusions from Non-Clinical Studies: "Test results confirmed the CleanCision™ System met all device requirements. The device requirements are appropriate for the device's indications for use."

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

The document describes non-clinical (bench) studies, animal studies, and human factors/usability studies. These are not typically referred to as "test sets" in the context of clinical studies for diagnostic AI algorithms, but rather represent validation testing for device safety and performance.

• Bench Studies: Sample sizes are mentioned for specific tests:
  • Retraction Ring Actuation Force: 15 retraction assemblies
  • Irrigating Fluid Delivery Flow Rate: 15 devices
  • Suction Flow Rate: 15 devices
  • Other bench tests (Resistance to Synthetic Blood, Tear and Tensile Strength, Flammability, Tubing Connection Strength) do not explicitly state sample sizes but generally refer to testing "barrier material" or "test specimen."
• Animal Study: The sample size is not explicitly stated as a number, but it refers to a "porcine large animal model." The language "all animals had normal clinical observations" implies more than one.
• Human Factors/Usability Study (Cadaver Study): The sample size refers to multiple "surgeon-users" but a specific number is not provided, stating "All users were able to successfully insert, utilize, and remove the device as expected."

Data Provenance:

• Bench Studies: These are laboratory tests conducted by the manufacturer (Prescient Surgical). The origin is internal to the company's R&D/engineering efforts.
• Animal Study: Conducted in a porcine (pig) large animal model. The location/country is not specified. It is a prospective study as it involved device implantation and observation.
• Human Factors/Usability Study: This was a cadaver study. The location/country is not specified. It is a prospective study involving simulated use by surgeons.

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

This section is largely not applicable in the traditional sense for a medical device that is not an AI diagnostic. The "ground truth" for this type of device is established through:

• Bench Tests: The "ground truth" is based on objective measurements against engineering specifications and industry standards (e.g., ASTM, ISO, USP, NFPA). No human experts are used to establish "ground truth" in the way they would for imaging interpretation.
• Animal Study: The "ground truth" involves clinical observations, pathology (gross assessment, histological evaluation, cytology analysis), and clinical pathology (CBC, Serum Chemistry Panel, peritoneal fluid analysis). These analyses would be performed by veterinarians, veterinary pathologists, and clinical pathologists. The document doesn't specify the number or qualifications of these experts, but their professional roles imply relevant expertise. The study surgeon also provided assessment.
• Human Factors/Usability Study: "Surgeon-users" were involved, implying qualified surgeons. The document states, "Surgeons found that the force required to deploy the device was acceptable," and "The feedback specifically indicated that the device should prevent the majority of fluid from leaking into the abdominal cavity."

4. Adjudication Method for the Test Set

Again, this is largely not applicable in the traditional sense for this device.

• Bench Tests: Adjudication is based on direct measurement against predefined numerical or qualitative acceptance criteria. No human adjudication is typically involved beyond confirming test procedure execution and result interpretation.
• Animal Study: Pathological findings and clinical observations would be interpreted by relevant experts (e.g., pathologists). While consensus might be sought in complex cases, a formal adjudication process like 2+1 or 3+1 for ground truth is not explicitly described, nor is it standard for this type of animal study.
• Human Factors/Usability Study: The "adjudication" was based on feedback and satisfaction of "surgeon-users" and their ability to successfully perform tasks. Explicit multi-expert adjudication method is not mentioned.

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

No, an MRMC comparative effectiveness study was not done.

MRMC studies are typically conducted for diagnostic devices, especially those involving human interpretation of images or data, often comparing human performance with and without AI assistance. The CleanCision™ System is an irrigating wound retractor device and not a diagnostic tool where "human readers improve with AI vs without AI assistance" would be relevant.

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

No, a standalone algorithm-only study was not done.

This device does not contain an AI algorithm in the described function. Its performance is based on its mechanical, material, and fluid handling properties, which are evaluated through bench, animal, and usability studies.

7. The Type of Ground Truth Used

• Biocompatibility: Established by adherence to ISO standards and objective laboratory analyses for cytotoxicity, sensitization, irritation, systemic toxicity, particulates, pyrogenicity, and hemolysis.
• Bench Performance Testing: Established by objective measurements against engineering specifications and industry standards (ASTM, NFPA, etc.).
• Animal Study: Established by a combination of:
  • Clinical observations: Direct observation of the animals.
  • Clinical pathology: Laboratory analysis of blood and fluid samples.
  • Gross pathology: Macroscopic examination during necropsy.
  • Histopathology: Microscopic examination of tissue specimens.
  • Cytology analysis: Microscopic evaluation of cells.
• Human Factors/Usability Study: Established by observed successful device usage and qualitative feedback from "surgeon-users" during simulated use.

8. The Sample Size for the Training Set

Not applicable. This device is a physical medical device, not an AI or machine learning algorithm that requires a "training set" of data.

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

Not applicable. As there is no training set, there is no ground truth established for one.

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