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The Implicitguide™ Surgical Suture System is indicated for use in soft tissue approximation and elevation of subdermis and underlying muscle.

The ImplicitCare Implicitguide™ Surgical Suture System combines USP size 4-0 braided nonabsorbable poly(ethylene terephthalate), or polyester, surgical suture with a set of manual instruments designed to efficiently and accurately place the suture for the purpose of performing approximation of tissue and elevation of subdermis/underlying muscle procedure. All components of the Implicitguide™ Surgical Suture System are provided sterile, and are intended for single use only. The manual instruments consist of the following: Tape (marking tape) to aid in marking the skin for needle (Suturod) point of entry locations)- if needed, Lancet to create a point of entry for needle (Suturod) and suture, Clearing device to clear subcutaneous ligamentous attachments around the puncture site, Two (2) stainless steel Suturods™ which, like suture needles, guide the suture through the tissue. Each Suturod™ has an internal light guide which, when connected to the Light Handle, illuminates the distal tip of the Suturod™M, Light Handle which contains an LED light source to connect to Suturod™.

Here's a summary of the acceptance criteria and study information for the Implicitguide™ Surgical Suture System based on the provided text. It's important to note that the document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against novel acceptance criteria in a clinical trial. Therefore, some requested information (like effect size of AI, standalone algorithm performance, or detailed ground truth for training) is not applicable or not present in this type of submission.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Biocompatibility/Suture Mechanical Tests: The tests were conducted on the TEVDEK® II polyester suture, which is described as being "exactly the same suture" as used in the Implicitguide™ system. The sample size for these specific tests is not explicitly stated, but it would have followed the requirements of the standards (e.g., ISO, USP). The data provenance is implied to be from Teleflex Medical (formerly Genzyme Corp.), the manufacturer of TEVDEK® II. These are likely retrospective, pre-existing test results.
• Cadaver Tests: Four cadavers (two females aged 92 and 84, two males aged 58). Data provenance: University of Maryland, State Anatomy Board, Baltimore, MD, USA. This was a prospective, specifically designed pre-clinical test.
• EMC Evaluation: Not specified as a "test set" in terms of biological samples. The "test required" refers to the device itself being subjected to EMC testing in a laboratory environment.
• Design Verification Tests: Sample sizes for each specific design verification test (e.g., number of sutures for attachment force, number of Suturods for bending) are not explicitly stated, but are implied by the nature of engineering design verification. The data provenance is ImplicitCare, LLC's internal testing.

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

• Biocompatibility/Suture Mechanical Tests: Ground truth is established by compliance with international standards (ISO, AAMI) and USP monographs, which are developed by expert consensus in those fields. No individual experts for a specific test set are mentioned as establishing "ground truth" in the way one would for clinical imaging studies.
• Cadaver Tests: Two Board Certified plastic surgeons, Dr. Gregory Mueller and Dr. Sherrell Aston, performed the procedures and evaluated the results. Their CVs were on file, indicating their qualification as experts.
• EMC Evaluation & Design Verification Tests: Ground truth is defined by the technical specifications of the standards (IEC, EN) and internal design requirements. Expert involvement would be in the design and interpretation of these tests, but not in establishing "truth" for a clinical test set.

4. Adjudication Method for the Test Set

• Cadaver Tests: No explicit adjudication method (like 2+1 or 3+1) is mentioned. The description states the procedures were "conducted by" the two plastic surgeons. It implies they jointly or individually evaluated the results, possibly through consensus, but this is not detailed.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, an MRMC comparative effectiveness study was not done. The submission explicitly states: "No clinical testing was conducted to support this submission." This type of study is typically associated with clinical trials evaluating diagnostic or prognostic devices with human readers interpreting cases.

6. Standalone (Algorithm Only) Performance Study

• No, a standalone (algorithm only) performance study was not done. This device is a surgical suture system, not an AI algorithm.

7. Type of Ground Truth Used

• Biocompatibility/Suture Mechanical: Established by compliance with recognized standards and monographs (e.g., ISO, USP) and prior regulatory approval (510(k) for predicate suture). This is a form of regulatory and scientific consensus.
• Cadaver Tests: Expert evaluation/observation by Board Certified plastic surgeons during a pre-clinical cadaver study.
• EMC Evaluation & Design Verification: Technical specifications and engineering requirements for the device components, validated against international standards.

8. Sample Size for the Training Set

• This information is not applicable. The device is a surgical suture system and does not involve machine learning algorithms that require a "training set." The submission details non-clinical tests demonstrating safety and equivalence.

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.

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