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The CP Medical nonabsorbable C-PTFETM Surgical Suture is a removable, nonabsorbable surgical suture intended for use in general soft tissue approximation and/or ligation, including dental surgical procedures. CP Medical C-PTFETM sutures are contra indicated for use in microsurgery, ophthalmic procedures, or peripheral neural tissue.

The CP Medical C-PTFETM Surgical Sutures are Nonabsorbable, Polytetraflouroethylene, single use, sterile, disposable, monofilament sutures and are provided with or without needles. Individual sutures are available in a "racetrack" configuration, attached around a HDPE delivery system, and/or in a figure 8 in a Tyvek/film pouch. The CP Medical C-PTFETM Surgical Sutures are sterilized via EO in accordance with EN ISO-11135:2014

This document is primarily a 510(k) premarket notification letter and summary for a surgical suture and does not describe a study involving an AI/Machine Learning device or a diagnostic device. Therefore, most of the requested information regarding AI/ML acceptance criteria and study design (e.g., sample sizes for test and training sets, expert ground truth, adjudication methods, MRMC studies, standalone performance) is not applicable to this document.

The document discusses the substantial equivalence of the C-PTFE™ Surgical Suture to a predicate device based on non-clinical performance testing and biocompatibility.

Here's a breakdown of what can be extracted from the provided text, and what cannot:

Information that can be extracted:

1. A table of acceptance criteria and the reported device performance (Non-Clinical Performance Testing):

The document mentions that the C-PTFE™ Surgical Suture was tested against recognized standards to demonstrate substantial equivalence to the predicate device. While specific quantitative "acceptance criteria" and "reported performance" values are not provided in a detailed table format within this summary, the document states that the new device's performance was compared to the predicate device and found to be "substantially equivalent" or "comparable."

• USP-40-NF35:2017, Nonabsorbable Surgical Suture (6-393)
• USP-40-NF35:2017, Tensile Strength () (6-394)
• USP-40-NF35:2017, Diameter () (6-395)
• USP-40-NF35:2017, Sutures – Needle Attachment () (6-396)

Conclusion: "Based on the technological characteristics and non-clinical performance testing, the CP Medical C-PTFE™ Surgical Suture performs comparably [to] the predicate device, MonoTex K140415." "Test report 17-033 confirmed equivalency." |
| Sterility | Yes | Sterilized via EO in accordance with EN ISO-11135:2014. Confirmed as "Yes" (Sterile) and "EO" (Sterilization method) in comparison table. |
| Electrical Safety and EMC | Not Applicable | No electrical components, no electrical safety information required. |
| Software Verification and Validation | Not Applicable | No software in the device, no software required to function. |
| Mechanical and Acoustical Testing | Not Applicable | This section does not apply to this device. |

2. Sample sizes used for the test set and the data provenance:

• Test Set Sample Size: Not explicitly stated as a number of devices or units. The testing refers to conformance with USP standards and biocompatibility tests, where sample sizes are typically defined by the standards themselves, but not detailed here.
• Data Provenance: Not specified beyond the general nature of lab-based/bench testing and animal studies (for biocompatibility). No mention of country of origin or retrospective/prospective clinical data for performance assessment, as this is a non-clinical submission.

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

• Not Applicable. This submission is for a medical device (suture) and relies on objective, standardized physical and material testing, and animal biocompatibility studies, not on human expert interpretation of images or clinical outcomes that would require "ground truth" establishment by multiple human experts.

4. Adjudication method for the test set:

• Not Applicable. As above, there's no "adjudication" in the context of expert consensus for a test set, as this is not a diagnostic or AI device study.

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 not a study for an AI/ML device.

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

• Not Applicable. This is not an AI/ML device.

7. The type of ground truth used:

• Objective Test Standards and Biocompatibility Endpoints: The "ground truth" or reference for this device's performance is established by conformance to recognized industry standards (USP, ISO) for physical properties (e.g., tensile strength, diameter) and biological responses (e.g., tissue reaction in animal models for biocompatibility). There is no "pathology" or "outcomes data" in the typical diagnostic sense.

8. The sample size for the training set:

• Not Applicable. This is not a study for an AI/ML device, so there is no concept of a "training set."

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

• Not Applicable. As above, no training set.

In summary, this document pertains to the regulatory submission for a surgical suture, demonstrating its substantial equivalence to a predicate device through non-clinical laboratory testing and biocompatibility assessments, rather than an AI/ML or diagnostic device that would require comprehensive clinical performance studies with expert-adjudicated ground truth.

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