(47 days)
Modified USS polypropylene sutures are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic, and neurological surgery.
Modified USS Polypropylene Suture is composed entirely of biocompatible materials which are in compliance with ISO 10993-1 for their intended patient contact profile.
The provided text describes a 510(k) premarket notification for a medical device: the Modified USS Polypropylene Suture. This type of submission aims to demonstrate substantial equivalence to a predicate device, rather than proving the device meets specific acceptance criteria through a comprehensive clinical study.
Therefore, the input does not contain the information requested in the prompt regarding acceptance criteria, a specific study proving device performance against those criteria, or details about sample sizes, ground truth establishment, or expert involvement in such a study.
Instead, the submission focuses on demonstrating that the performance of the Modified USS Polypropylene Suture is substantially equivalent to a previously marketed predicate device (USS Polypropylene Suture, K954808, and Modified USS Polypropylene Suture, K010909). This is typically achieved through bench testing and material characterization to show that the new device has the same technological characteristics and performs similarly to the predicate.
Here's a breakdown of what can be inferred from the provided text, and what cannot:
Information that CANNOT be Extracted from the Provided Text:
- A table of acceptance criteria and the reported device performance: This document does not detail specific acceptance criteria or performance metrics for the Modified USS Polypropylene Suture as part of a standalone study. It only states its performance is "substantially equivalent" to predicate devices.
- Sample size used for the test set and the data provenance: Not applicable to this type of submission which relies on substantial equivalence.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method for the test set: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not mentioned or applicable.
- Standalone (algorithm only) performance study: Not applicable.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable as no clinical study with "ground truth" is described.
- Sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
What can be inferred from the text about the "study" (in the context of a 510(k)):
The "study" in this context is primarily a comparative analysis demonstrating substantial equivalence.
- Type of "Study": Comparative analysis for substantial equivalence.
- Acceptance Criteria & Reported Performance:
- Acceptance Criteria Implied: The device must demonstrate similar mechanical properties, biocompatibility, and intended use as the predicate device(s).
- Reported Performance: "The performance of the Modified USS Polypropylene Suture is substantially equivalent to the currently marketed USS Polypropylene Suture, which has been successfully used in clinical applications as a wound closure device."
- Ground Truth for Comparison: The established performance and safety profile of the predicate device (USSC Polypropylene Suture K954808 and Modified USS Polypropylene Suture K010909) serves as the "ground truth" for comparison.
- Training Set (Analogy): The historical data and successful clinical use of the predicate device could be considered analogous to a "training set" in that it informs the performance expectations and safety profile against which the new device is compared. The specific details of this data are not provided in the extract.
- How Ground Truth for "Training Set" was established: For the predicate device, its ground truth was established through its own 510(k) clearance based on substantial equivalence and subsequent "successful clinical applications."
Summary Table:
| Feature | Description (Based on provided text) |
|---|---|
| Acceptance Criteria | Implied: Demonstrate substantial equivalence in performance (e.g., mechanical properties, biocompatibility) and intended use to the predicate devices. |
| Reported Device Performance | "The performance of the Modified USS Polypropylene Suture is substantially equivalent to the currently marketed USS Polypropylene Suture, which has been successfully used in clinical applications as a wound closure device." |
| Sample Size (Test Set) | Not applicable for this type of submission. Demonstration of substantial equivalence relies on comparative testing to predicates, not a clinical trial with a "test set" to prove absolute performance against specific criteria. |
| Data Provenance (Test Set) | Not applicable. |
| Number of Experts & Qualifications (Test Set GT) | Not applicable. |
| Adjudication Method (Test Set) | Not applicable. |
| MRMC Comparative Effectiveness Study | No. |
| Standalone Performance Study | No. The study is a comparative one against predicate devices. |
| Type of Ground Truth Used | For comparison: The established performance and safety profile of the predicate device(s) (USSC Polypropylene Suture K954808, Modified USS Polypropylene Suture K010909) from their own regulatory clearances and "successful clinical applications." |
| Sample Size (Training Set) | Not applicable in the traditional sense. The "training data" is the historical performance and data of the predicate devices. Specific quantitative sample sizes are not provided in the text. |
| How Ground Truth for Training Set was Established | The predicate devices' ground truth was established through their prior 510(k) clearances (also based on substantial equivalence) and documented "successful clinical applications" over time, indicating their safety and effectiveness for their intended use. |
§ 878.5010 Nonabsorbable polypropylene surgical suture.
(a)
Identification. Nonabsorbable polypropylene surgical suture is a monofilament, nonabsorbable, sterile, flexible thread prepared from long-chain polyolefin polymer known as polypropylene and is indicated for use in soft tissue approximation. The polypropylene surgical suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be undyed or dyed with an FDA approved color additive; and 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.