(491 days)
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".
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Biocompatibility | ||
| Cytotoxicity | Non-cytotoxic | Non-cytotoxic |
| Sensitization | Non-sensitizer | Non-sensitizer |
| Irritation | Non-irritant | Non - irritant |
| Acute Systemic Toxicity | No acute systemic toxicity response | No acute systemic toxicity response was observed from test article extract. |
| Particulate Testing | Results met USP Limits of ≤ 25 particles per mL for (b) (4) and ≤ 5 particles per mL for (b) (4) µm for nominal volumes of (b) (4) | Met USP Limits |
| Rabbit Pyrogen Test (Material Mediated) | Non-pyrogenic | Non-pyrogenic |
| Limulus Amebocyte Lysate (LAL) Bacterial Endotoxin Testing | Non-pyrogenic | Non-pyrogenic |
| Hemocompatibility (Hemolysis) | Non-hemolytic | Non - hemolytic |
| Bench Performance Testing | ||
| Retraction Ring Actuation Force | 21.1N (21.1 N is the force required to remove the bag spike from a fluid bag and the tubing connection should be stronger so the bag spike would disconnect from the bag before the tubing would pull out of the pliable membrane) | 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.
§ 878.4371 Irrigating wound retractor device.
(a)
Identification. An irrigating wound retractor device is a prescription device intended to be used by a surgeon to retract the surgical incision, to provide access to the surgical wound, to protect and irrigate the surgical wound, and to serve as a conduit for removal of fluid from the surgical wound.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The patient-contacting components of the device must be demonstrated to be biocompatible and evaluated for particulate matter.
(2) Performance data must demonstrate the sterility and pyrogenicity of the patient-contacting components of the device.
(3) Performance data must support shelf life by demonstrating continued functionality and sterility of the device over the identified shelf life.
(4) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. Performance testing must:
(i) Characterize the tear resistance, tensile strength, and elongation properties of the barrier material;
(ii) Demonstrate that the liquid barrier material is resistant to penetration by blood, and is non-flammable;
(iii) Characterize the forces required to deploy the device;
(iv) Characterize the device's ranges of operation, including flow rates and maximum suction pressures;
(v) Demonstrate the ability of the device irrigation apparatus to maintain a user defined or preset flow rate to the surgical wound; and
(vi) Demonstrate the ability of the device to maintain user defined or preset removal rates of fluid from the surgical wound.
(5) The labeling must include or state the following information:
(i) Device size or incision length range;
(ii) Method of sterilization;
(iii) Flammability classification;
(iv) Non-pyrogenic;
(v) Shelf life; and
(vi) Maximum flow rate and suction pressure.