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The Cypris eXact Suture Placement Device is indicated for use in general soft tissue approximation when used with sutures.

The Cypris eXact Suture Placement Device is for use in general soft tissue approximation by surgeons, and it is single-use and provided sterile. It is a hand-held device used for the placement of a surgical suture, and the device consists of a handle, needle driver, and tissue capture port. The handle is designed for manual manipulation of the suture placement device, allowing the surgeon to advance the device to the desired deployment site. The needle driver functions to pass the suture when it is advanced and retracted. The tissue capture port consists of a capture chamber, needle, and hook assembly, and holds the tissue to be sutured during either manual palpation or vacuum-assisted palpation of tissue into the tissue capture port. Suture placement is achieved by advancing and retracting the needle driver.

{
"1. A table of acceptance criteria and the reported device performance": {
"Acceptance Criteria": [
"Biocompatibility endpoints evaluated (cytotoxicity, sensitization, irritation, acute systemic toxicity, and material-mediated pyrogenicity)",
"Integrity of the sterile barrier and functionality of the device after 3 years of real-time aging",
"Performance as expected",
"Use of vacuum-assisted palpation equivalent to manual palpation by the predicate device",
"Peak suction force measurement at 25.0 inHg"
],
"Reported Device Performance": [
"Device underwent testing for cytotoxicity, sensitization, irritation, acute systemic toxicity, and material-mediated pyrogenicity.",
"Testing demonstrated integrity of the sterile barrier and functionality after 3 years of real-time aging (shelf-life is 3 years).",
"Testing demonstrated that the subject device performs as expected.",
"Testing demonstrated that the use of vacuum-assisted palpation is equivalent to the use of manual palpation by the predicate device.",
"At a vacuum level of 25.0 inHg, the minimum, maximum, and average measured peak suction force achieved was 0.753 lbf, 1.052 lbf, and 0.904 lbf, respectively."
]
},
"2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)": "The provided text describes non-clinical testing. It does not mention specific sample sizes for a test set in the context of clinical data or human subjects. The data provenance is not specified, but the testing appears to be laboratory-based (non-clinical).",
"3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)": "Not applicable. This is a non-clinical study for a manual surgical instrument, not an AI/imaging device requiring expert ground truth establishment for a test set.",
"4. Adjudication method (e.g. 2+1, 3+1, none) for the test set": "Not applicable. This is a non-clinical study for a manual surgical instrument, not an AI/imaging device requiring an adjudication method.",
"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": "Not applicable. This is a non-clinical study for a manual surgical instrument, not an AI/imaging device. No MRMC study was conducted or mentioned.",
"6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done": "Not applicable. This is a non-clinical study for a manual surgical instrument. No algorithm or standalone performance testing was mentioned.",
"7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)": "Not applicable. For this non-clinical study, ground truth was established by adherence to performance specifications and established biocompatibility standards.",
"8. The sample size for the training set": "Not applicable. This is a non-clinical study for a manual surgical instrument, not an AI/machine learning device requiring a training set.",
"9. How the ground truth for the training set was established": "Not applicable. This is a non-clinical study for a manual surgical instrument, not an AI/machine learning device. No training set was used or ground truth established for one."
}

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