(66 days)
General soft tissue approximation including use in cardiovascular, ophthalmic, and neurological procedures.
The polyblend surgical suture meets USP requirements as described in the USP monograph for nonabsorbable surgical sutures. CP Medical non-absorbable polyblend surgical sutures made with a braided, twisted core of polyethylene terephthalate and a polyethylene cover, are available in sterile form to an SAL of 106. Sterilization is performed by either Ethylene Oxide or Gamma Irradiation.
The provided text describes a 510(k) premarket notification for a medical device called "CP Fiber, Non-Absorbable Polyblend Surgical Suture." This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving safety and effectiveness through clinical trials with specific acceptance criteria as you might see for novel devices.
Therefore, the information you're requesting regarding acceptance criteria, study details, sample sizes, and expert ground truth is not applicable to this document. This submission primarily relies on comparing the new device's characteristics and performance to already approved predicate devices.
However, I can extract information related to the device and its equivalence to the predicate:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: The primary acceptance criterion for this 510(k) submission is substantial equivalence to the predicate devices. This means the new device must meet the same performance standards as the predicate devices and be suitable for the same indications for use. Specifically, it must meet USP requirements for nonabsorbable sutures.
- Reported Device Performance (from text):
- Device Type: Non-absorbable polyblend surgical suture.
- Composition: Braided, twisted core of polyethylene terephthalate and a polyethylene cover.
- Sterility: Available in sterile form to an SAL of 10^-6 (Sterility Assurance Level). Sterilization by Ethylene Oxide or Gamma Irradiation.
- USP Compliance: Meets USP requirements as described in the USP monograph for nonabsorbable surgical sutures.
- Predicate Device Compliance: Both predicate and proposed devices are indicated for use in soft tissue approximation; both meet USP for nonabsorbable sutures, may be silicone-coated or uncoated, and may be dyed or undyed with an appropriate FDA listed color additive. The sutures may also be provided with or without a standard needle attached.
2. Sample size used for the test set and the data provenance:
- Not applicable. This 510(k) submission does not describe a test set or clinical study in the manner implied by these questions. Equivalence is primarily demonstrated through material properties, manufacturing processes, and adherence to recognized standards (like USP) that are common to the predicate device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. There is no mention of a "test set" requiring expert-established ground truth in this submission.
4. Adjudication method for the test set:
- Not applicable. No test set requiring adjudication is described.
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 surgical suture, not an imaging or diagnostic device that would typically involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device (suture), not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable. The "ground truth" here is the established performance and safety profile of the predicate devices and the universally accepted standards for surgical sutures (e.g., USP monograph).
8. The sample size for the training set:
- Not applicable. No "training set" in the context of machine learning or clinical trials is mentioned.
9. How the ground truth for the training set was established:
- Not applicable. As above, no training set.
In summary: The provided document is a 510(k) premarket notification. These submissions demonstrate "substantial equivalence" of a new device to a legally marketed predicate device, rather than proving safety and effectiveness through new clinical studies with specific acceptance criteria that require extensive clinical data, sample sizes, and expert input as you might expect for a PMA or a novel device. The "study" here is primarily a comparison of the new device's characteristics and performance to established standards and the predicate device.
§ 878.5000 Nonabsorbable poly(ethylene terephthalate) surgical suture.
(a)
Identification. Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed color additive. Also, the suture may be provided with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.