(55 days)
The Arthrex Fiberwire® Family is intended for use in soft tissue approximation and or ligation including allograft tissue.
The Arthrex Fiberwire™ and FiberTape™ Families are intended for use in soft tissue approximation and/or ligation including allograft tissue.
Arthrex Fiberwire® and FiberTape™ sutures of varying lengths, diameters, and needle types are made of long chain polyesters, braided with nylon or silk, and sterilized for surgical use. They are available in dyed and non-dyed varieties, with or without needles.
It appears there might be a misunderstanding of the provided document. The text is a 510(k) summary for a medical device (Arthrex FiberWire® Family sutures) submitted to the FDA.
This type of document primarily focuses on establishing "substantial equivalence" to existing legally marketed devices, rather than presenting a study with acceptance criteria and device performance results in the way a diagnostic or AI-driven device might.
Therefore, most of the information requested in your prompt regarding acceptance criteria, study details, sample sizes, ground truth, and expert adjudication is not applicable to this 510(k) summary for a surgical suture.
Here's why and what information can be extracted:
- Substantial Equivalence: For devices like sutures, the FDA's 510(k) process typically relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device. This is often achieved by showing similar materials, design, intended use, and performance characteristics, rather than extensive clinical studies with specific performance metrics and acceptance criteria as one might see for an AI algorithm or a diagnostic test.
Let's address the points of your prompt based on the provided text, indicating where information is not available or not applicable:
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A table of acceptance criteria and the reported device performance:
- Not Applicable. The document does not present quantitative acceptance criteria or detailed performance results for the suture in the way a diagnostic device would. The core claim is "substantial equivalence" to predicate devices. There are no reported numerical performance metrics like sensitivity, specificity, or accuracy that would require acceptance criteria.
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Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Not Applicable. There is no "test set" in the context of an AI or diagnostic study described here. The evaluation is based on comparing the new suture's characteristics to those of predicate sutures.
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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. No "ground truth" establishment by experts in this manner is described. The assessment is a regulatory review by the FDA based on the information provided by the manufacturer.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. No adjudication method for a test set is described.
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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 AI-assisted diagnostic or imaging device. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed or would be relevant.
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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.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable. The "ground truth" for a suture's safety and effectiveness is primarily established through its materials, manufacturing processes, and comparison to devices with a known safe and effective history (predicate devices) as determined by regulatory bodies. There isn't a specific "ground truth" derived from clinical outcomes or expert consensus described as part of a formal study in this document.
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The sample size for the training set:
- Not Applicable. There is no "training set" as this is not an AI or machine learning device.
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How the ground truth for the training set was established:
- Not Applicable. As there's no training set, there's no ground truth for it.
In summary, the provided 510(k) summary is for a physical medical product (surgical suture) and therefore does not contain the types of information requested that are typically associated with performance studies for diagnostic devices or AI algorithms. The primary "study" implicitly referenced is the comparison to predicate devices to establish substantial equivalence.
§ 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.